Adult Clinical Trials

Leukemia and multiple myeloma

If you need additional information about any of the trials listed or would like to inquire about other open trials, please contact Leukemia Clinical Trials Office at 919.681.4769 or the Multiple Myeloma Clinical Trial Office at 919.668.6524.

36 trials identified.

Genetic Epidemiology of Chronic Lymphocytic Leukemia
Phase: N/A
Sponsor: Internal Investigator Initiated Non-therapeutic/Non-interventional
Principal Investigator: J Brice Weinberg
Contact: Ruth Stanton
Phone: 919.416.8029
Purpose: The goal of this research is to identify genes that may be related to the risk of developing CLL. Objectives: The objective of this study to investigate possible candidate susceptibility genes for familial chronic lymphocytic leukemia (CLL) by identifying and recruiting high-risk families. Through our ongoing study of familial aggregation in CLL kindreds (protocol 2003-0498 'Genetic Study of Chronic Lymphocytic Leukemia'), we have identified CLL patients who have one or more living or dead relative(s) affected with CLL or other leukemias or lymphomas. We will also identify patients in high-risk families from referrals from leukemia clinicians and from self-referrals from patients who learn about our study from the ClinicalTrials.gov website. We plan to invite probands (patients diagnosed with CLL) and their family members with other leukemias and lymphomas and a sample of unaffected relatives to participate in a genetic/linkage study. We will obtain demographic and clinical information along with specimens (blood or buccal samples) from all participants. These families will be part of the Genetic Epidemiology of CLL Consortium, a multicenter, multidisciplinary consortium, based at the Mayo Clinic Cancer Center under the direction of Susan Slager, PhD. This is funded from NCI through a subcontract with Mayo Clinic. Genotypic data will be analyzed at Mayo Clinic, and coded, de-identified data will be shared with the NIH Genome-Wide Association Studies (GWAS) data repository.
Reference Number: 00005573
View this trial at ClinicalTrials.gov

An Open Label Assessment of Safety and Efficacy of Ruxolitinib (INCB018424) in Subjects with Primary Myelofibrosis, Post Essential Thrombocythemia-Myelofibrosis and Post Polycythemia Vera-Myelofibrosis Who Have Platelet Counts of 50 x 10^9/L to 100 x 10^9/L
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Murat Arcasoy
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms and potential side effects in patients with PMF, PPV-MF and PET-MF who have platelet counts of 50 x 10^9/L to 100 x 10^9/L. It is anticipated that individualized dose optimization from the starting ruxolitinib level of 5 mg bid will be associated with reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.
Reference Number: 00031423
View this trial at ClinicalTrials.gov

AAML1031 A Phase III Randomized Trial for Patients with de novo AML using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND#69896, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Susan Kreissman
Contact: Dr. Susan Kreissman
Phone: 919.684.3401
Purpose: This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia.
Reference Number: 00031615
View this trial at ClinicalTrials.gov

Safety and Efficacy of Chemotherapy combined with Adoptive Transfer of HLA-Haploidentical Donor Lymphocyte Infusion in Older Patients with High-Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome
Phase: Phase I
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Anthony Sung
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: The primary hypothesis is that chemotherapy followed by donor lymphocyte infusion (DLI) from HLA-haploidentical donors is a safe procedure that will not cause Graft versus Host Disease (GVHD) or increased treatment-related mortality. The Investigator further believes that this will improve outcomes of elderly patients with high-risk AML or MDS compared to chemotherapy alone, and that that this benefit will be even greater in donor-recipient pairs that share maternal-fetal microchimerism or non-inherited maternal antigen (NIMA) mismatch. A large part of this trial will include immune function assays as well as assessments of efficacy, toxicity, and GVHD. Because this therapy may be a tolerable alternative to allogeneic hematopoietic stem cell transplantation (alloHSCT) for elderly patients, the Investigator will validate functional measurements (e.g. Comprehensive Geriatric Assessment (CGA)) with biologic correlates (cytokine and genomic profiles) and clinical outcomes.
Reference Number: 00043247
View this trial at ClinicalTrials.gov

Phase I Study of Pomalidomide, Bortezomib, and Dexamethasone (PVD) as First-Line Treatment of AL Amyloidosis or Light Chain Deposition Disease
Phase: Phase I
Sponsor: External Investigator-Sponsored (External Med Ctr)
Principal Investigator: Yubin Kang
Contact: HEMATOLOGY CLINICAL TRIALS OFFICE
Phone: 919.668.6524
Purpose: This phase I trial studies the side effects and best dose of pomalidomide and bortezomib when given together with dexamethasone in treating patients with amyloid light-chain amyloidosis or light chain deposition disease. Biological therapies, such as pomalidomide, may stimulate the immune system in different ways and stop abnormal cells from growing. Bortezomib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide and bortezomib together with dexamethasone may be an effective treatment for amyloid light-chain amyloidosis or light chain deposition disease
Reference Number: 00044386
View this trial at ClinicalTrials.gov

A Phase I Study of L-Asparaginase Encapsulated in Red Blood Cells (eryaspase) in Combination with the CALGB Regimen During Induction and Consolidation Phases for Adult Patients with Acute Lymphoblastic Leukemia
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: David Rizzieri
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: Asparaginase (Asp) is used during the induction phase of ALL treatment for children and young adults. Its efficacy is counterbalanced by its toxicity, mainly in patients 40 years or older. The efficacy rate in older adult population is lower than for children or young adults. A recent review on outcomes in older adults with ALL pointed out that there were significantly more drug reductions, omissions or delays in the older group as compared to younger adults and that asparaginase was the drug most commonly omitted. The investigational product ERYASPASE is a dispersion for infusion of homologous red blood cells (RBC) encapsulating E. coli L-asparaginase. A previous European phase I/II clinical study in children and adults (<55 yo) at first relapse of ALL was conducted to determine the optimal dose of homologous RBC encapsulating native E. coli Asp (GRASPA®) in 24 patients with relapsed ALL. The activity and safety profiles of 3 doses of GRASPA® (50, 100 and 150 IU/kg) in combination with standard chemotherapy were compared to free native Asp. The global safety profile is also improved, reducing hypersensitivity, liver toxicity and coagulation disorders. Study showed that a single dose of GRASPA® 150 IU/kg induced a depletion in plasmatic asparagine for 18.6 days, i.e. similar to that obtained with 8 injections of 10,000 IU/m² of free native Asp. A reduction in the incidence and severity of the allergic reactions and coagulation disorders were observed with GRASPA® (Domenech 2011). A French phase II study designed to determine the maximum tolerated dose of GRASPA® in combination with a polychemotherapy regimen in ALL patients older than 55 yo at first diagnosis has been performed, and showed that both 100 and 150 IU/kg doses fulfilled the predefined criteria for efficacy and tolerability but the better profile of 100 IU/kg dose was considered the optimal dose in this setting. A phase II/III trial in adult and children patients with relapsed ALL is currently ongoing. Based on these results, the combination of ERYASPASE with the CALGB chemotherapy regimen appears to be an attractive combination for the treatment of adults patients with ALL/LBL.
Reference Number: 00046940
View this trial at ClinicalTrials.gov

A Multicenter Phase 1/2b Study of the Brutons Tyrosine Kinase Inhibitor, Ibrutinib (PCI-32765), in Combination with Carfilzomib (Kyprolis) in Subjects with relapsed or relapsed and refractory Multiple Myeloma
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Cristina Gasparetto
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.668.6524
Purpose: Phase 1 will be an open-label study. The dose escalation portion of the study is designed to establish the MTD of ibrutinib in combination with carfilzomib with or without dexamethasone. Phase 2b will be an open-label, multicenter study designed to evaluate the overall response rate when ibrutinib is administered in combination with carfilzomib and dexamethasone.
Reference Number: 00049683
View this trial at ClinicalTrials.gov

SL-401 in Patients with Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: David Rizzieri
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.668.4769
Purpose: This is a non-randomized, open-label, multi center study. A cycle of therapy is 5 consecutive days every 21 days for 6 or more cycles. Stage I will consist of a brief run-in period in which patients with BPDCN (previously untreated and previously treated) and AML (persistent/recurrent and previously untreated) will be treated with SL-401 at 3 dose levels. During Stage 2, two cohorts of BPDCN and AML patients will be treated at the maximum tolerated dose or maximum tested dose in which multiple dose-limiting toxicities are not observed (identified in Stage 1).
Reference Number: 00050098
View this trial at ClinicalTrials.gov

A Phase 1b Study of ABT-199 (GDC-0199) in Combination with Azacitidine or Decitabine in Treatment Nave Subjects with Acute Myelogenous Leukemia Who Are = 60 Years of Age and Who Are Not Eligible for Standard Induction Therapy
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: David Rizzieri
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety of orally administered ABT-199 combined with decitabine or azacitidine and the preliminary efficacy of these combinations. In addition, there is a DDI sub-study only at a single site, to assess the pharmacokinetics and safety of ABT-199 in combination with posaconazole.
Reference Number: 00055547
View this trial at ClinicalTrials.gov

A Phase 1, First-in-Human, Dose Escalation Study of MGD006, a CD123 x CD3 Dual Affinity Re-Targeting (DART) Bi-Specific Antibody-Based Molecule, in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: David Rizzieri
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: The primary goal of this Phase 1, dose-escalation study, is to determine the maximum tolerated dose level of MGD006 in patients with AML and MDS whose disease is not expected to benefit from cytotoxic chemotherapy. Studies will also be done to see how the drug acts in the body (pharmacokinetics [PK], pharmacodynamics) and to evaluate potential anti-tumor activity of MGD006.
Reference Number: 00057708
View this trial at ClinicalTrials.gov

A Phase 1/2 Study of SL-401 as Consolidation Therapy for Adult Patients with Adverse Risk Acute Myeloid Leukemia in First CR, and/or Evidence of Minimal Residual Disease (MRD) in First CR
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: David Rizzieri
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: This is a non-randomized open label multi-center study. Patients who are in their first complete remission (CR) following induction therapy will be treated with SL-401, which will be administered as a brief intravenous infusion for 5 consecutive days every 28 days for 6 or more cycles. Stage 1 will consist of a period in which approximately 6-9 patients will be treated with SL-401 at 3 dose levels. During Stage 2, approximately 24-29 patients with minimal residual disease (MRD) in their bone marrow will be treated at a maximum tolerated dose or maximum tested dose in which multiple dose-limiting toxicities are not observed (identified in Stage 1).
Reference Number: 00058309
View this trial at ClinicalTrials.gov

A PHASE 3 OPEN-LABEL RANDOMIZED STUDY OF QUIZARTINIB (AC220) MONOTHERAPY VERSUS SALVAGE CHEMOTHERAPY IN SUBJECTS WITH FLT3-ITD POSITIVE ACUTE MYELOID LEUKEMIA (AML) REFRACTORY TO OR RELAPSED AFTER FIRST-LINE TREATMENT WITH OR WITHOUT HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT) CONSOLIDATION
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: David Rizzieri
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.
Reference Number: 00062876
View this trial at ClinicalTrials.gov

A Phase II Study of Ibrutinib in Combination with Fludarabine, Cyclophosphamide, and Rituximab (iFCR) in Previously Untreated, Younger Patients with Chronic Lymphocytic Leukemia
Phase: Phase II
Sponsor: External Investigator-Sponsored (External Med Ctr)
Principal Investigator: Danielle Brander
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: This research study is evaluating a new drug called ibrutinib in combination with the standard drugs fludarabine, cyclophosphamide, and rituximab (FCR) as a possible treatment for Chronic Lymphocytic Leukemia (CLL).
Reference Number: 00062914
View this trial at ClinicalTrials.gov

A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects with Light Chain (AL) Amyloidosis
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Cristina Gasparetto
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.668.6524
Purpose: This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.
Reference Number: 00063420
View this trial at ClinicalTrials.gov

Phase 1/1b, First-in-Human, Dose-Escalation and Expansion Study of FLX925 Administered Orally to Subjects with Relapsed or Refractory Acute Myeloid Leukemia
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: David Rizzieri
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: This first-in-human (FIH) clinical trial is a Phase 1/1b, open-label, sequential-group, dose-escalation and cohort expansion study evaluating the safety, PK, PD, and antitumor activity of FLX925 in subjects with relapsed or refractory AML.
Reference Number: 00064219
View this trial at ClinicalTrials.gov

A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients with Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Joseph Moore
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: The purpose of this study is to compare and characterize the efficacy and safety of ponatinib in patients with resistant chronic myeloid leukemia (CML) in chronic phase (CP) in a range of doses.
Reference Number: 00064341
View this trial at ClinicalTrials.gov

Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) with FLT3 Mutation
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: David Rizzieri
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919 .681.4769
Purpose: The purpose of this study is to determine the clinical benefit of ASP2215 therapy in patients with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory to or have relapsed after first-line AML therapy as shown with overall survival compared to salvage chemotherapy. This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
Reference Number: 00064933
View this trial at ClinicalTrials.gov

A Phase 1, Open-label, Dose-escalation, Multicenter Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Activity of ADCT-301 in Patients with Relapsed or Refractory CD25-positive Acute Myeloid Leukemia or CD25-positive Acute Lymphoblastic Leukemia
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: David Rizzieri
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: This study evaluates ADCT-301 in patients with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL). Patients will participate in a dose-escalation phase (Part 1) and receive ADCT-301 every 3 weeks. In Part 2 of the study, patients will receive a recommended dose of ADCT-301 every 3 weeks.
Reference Number: 00066343
View this trial at ClinicalTrials.gov

A PHASE 3, MULTICENTER, OPEN-LABEL, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF AG-221 (CC-90007) VERSUS CONVENTIONAL CARE REGIMENS IN OLDER SUBJECTS WITH LATE STAGE ACUTE MYELOID LEUKEMIA HARBORING AN ISOCITRATE DEHYDROGENASE 2 MUTATION
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Carlos Decastro
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.
Reference Number: 00066615
View this trial at ClinicalTrials.gov

A Phase 1/2 Open label Study of SL-401 in combination with Pomalidomide and Dexamethasone in Relapsed or Relapsed and Refractory Multiple Myeloma
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Cristina Gasparetto
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.668.6524
Purpose: A Phase 1/2, Open Label Study of SL-401 in Combination with Pomalidomide and Dexamethasone In Relapsed and Refractory Multiple Myeloma
Reference Number: 00069269
View this trial at ClinicalTrials.gov

A Phase 1b/2 Study of Selinexor (KPT-330) in Combination with Backbone Treatments for Relapsed/Refractory Multiple Myeloma
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Cristina Gasparetto
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.668.6524
Purpose: This study will independently assess the efficacy and safety of two combination therapies for the treatment of patients with relapsed/refractory multiple myeloma (RR MM): selinexor + dexamethasone + pomalidomide (SdP), selinexor + dexamethasone + bortezomib (SdB), and selinexor + dexamethasone + lenalidomide (SdL).
Reference Number: 00069273
View this trial at ClinicalTrials.gov

A Phase 2, Randomized, Controlled, Open-Label, Clinical Study of the Efficacy and Safety of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Patients With Higher-Risk Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Carlos Decastro
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: The purpose of this study is to evaluate the efficacy and safety of pevonedistat plus azacitidine versus single-agent azacitidine in participants with higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia and low-blast acute myelogenous leukemia.
Reference Number: 00069276
View this trial at ClinicalTrials.gov

A Phase 2, Open-label, Translational Biology Study of Momelotinib in Transfusion-Dependent Subjects with Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Murat Arcasoy
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919 .681.4769
Purpose: This study will evaluate the transfusion independence response rate in transfusion-dependent adults with myelofibrosis after treatment with momelotinib (MMB).
Reference Number: 00069408
View this trial at ClinicalTrials.gov

A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Danielle Brander
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously treated chronic lymphocytic leukemia.
Reference Number: 00070143
View this trial at ClinicalTrials.gov

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Cristina Gasparetto
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.668.6524
Purpose: This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.
Reference Number: 00070414
View this trial at ClinicalTrials.gov

A randomized, double-blind phase 3 study of vadastuximab talirine (SGN-CD33A) versus placebo in combination with azacitidine or decitabine in the treatment of older patients with newly diagnosed acute myeloid leukemia (AML)
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Carlos Decastro
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine extends overall survival longer than placebo combined with either azacitidine or decitabine.
Reference Number: 00072026
View this trial at ClinicalTrials.gov

S1318: A Phase II Study of Blinatumomab and POMP (Prednisone, Vincristine, Methotrexate, 6-Mercaptopurine) for Patients = 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL) and of Dasatinib, Prednisone and Blinatumomab for Patients = 65 Years of Age with Newly Diagnosed Philadelphia-Chromosome Positive (Ph+) ALL, Relapsed/Refractory Philadelphia-Chromosome Positive (Ph+) ALL, and Philadelphia-Chromosome-Like Signature (Ph-Like) ALL (Newly Diagnosed or Relapsed/Refractory) with Known or Presumed Activating Dasatinib-Sensitive Mutations or Kinase Fusions (DSMKF)
Phase: Phase II
Sponsor: Cooperative Group Initiated
Principal Investigator: Jeffrey Crawford
Contact: Leukemia Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: This phase II trial studies the side effects and how well blinatumomab and combination chemotherapy or dasatinib, prednisone, and blinatumomab work in treating older patients with acute lymphoblastic leukemia. Monoclonal antibodies, such as blinatumomab, find cancer cells and help kill them. Drugs used in chemotherapy, such as prednisone, vincristine sulfate, methotrexate, and mercaptopurine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab with combination chemotherapy or dasatinib and prednisone may kill more cancer cells.
Reference Number: 00072067
View this trial at ClinicalTrials.gov

Efficacy Study of Inecalcitol in Combination with Decitabine in Acute Myeloid Patients Unfit for Standard Chemotherapy
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: David Rizzieri
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: Evaluate the effect of the addition of inecalcitol to decitabine treatment on overall survival in previously untreated AML patients aged 65 years or more who are randomly assigned to receive decitabine with or without inecalcitol.
Reference Number: 00072423
View this trial at ClinicalTrials.gov

A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 in Patients with Chronic Lymphocytic Leukemia (CLL) who are Intolerant to Prior BTK or PI3K-Delta Inhibitor Therapy
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Danielle Brander
Contact: Leukemia Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: This is a Phase 2, open-label, study of TGR-1202, a PI3K delta inhibitor, administered as a single agent in Chronic Lymphocytic Leukemia (CLL) patients who are intolerant to prior BTK inhibitors (ibrutinib, other) or prior PI3K delta inhibitors (idelalisib, other)
Reference Number: 00072486
View this trial at ClinicalTrials.gov

An Open-Label, Randomized Phase 3 Trial of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Cristina Gasparetto
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.668.6524
Purpose: This is a phase 3 multicenter, randomized, open label study designed to evaluate the clinical benefit and safety of the combination therapy of Nivolumab, pomalidomide, and dexamethasone (N-Pd the investigational arms, when compared to pomalidomide and dexamethasone (Pd; the control arm) in subjects with relapsed and refractory multiple myeloma (rrMM). The study includes a third arm evaluating the clinical benefit and the safety of the combination therapy of elotuzumab, nivolumab, pomalidomide and dexamethasone (NE-Pd, the exploratory arm) in the same patient population. Subjects in the control arm (Pd) are allowed to cross-over to the exploratory arm (EN-Pd) at the time of progression.
Reference Number: 00072528
View this trial at ClinicalTrials.gov

A Multi-Center, Open-Label, Extension Study of Ublituximab (TG-1101) in Combination with TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Danielle Brander
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: This is a multi-center, open-label, study to evaluate the safety and efficacy of ublituximab (TG-1101) in combination with TGR-1202 for patients who have progressed on treatment arms previously enrolled in Protocol UTX-TGR-304
Reference Number: 00072590
View this trial at ClinicalTrials.gov

A Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination with TGR-1202 Compared to Obinutuzumab in Combination with Chlorambucil in Patients with Chronic Lymphocytic Leukemia (CLL)
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Danielle Brander
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: This study evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) patients.
Reference Number: 00072597
View this trial at ClinicalTrials.gov

A Biomarker-Directed Phase 2 Trial of SY-1425, a Selective Retinoic Acid Receptor Alpha Agonist, in Adult Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: David Rizzieri
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: The purpose of this study is to determine the activity of SY-1425 in patients with relapsed/refractory acute myeloid leukemia (AML), relapsed/refractory high-risk myelodysplastic syndrome (MDS), newly diagnosed older AML patients who are unsuitable or unable to tolerate conventional therapy (as a monotherapy or in combination with azacitidine), or lower-risk myelodysplastic syndrome (MDS) patients who are positive for a RARA biomarker.
Reference Number: 00072859
View this trial at ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) versus Treatment Choice in Adults with Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated with Hypomethylating Agents
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: David Rizzieri
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in subjects with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 subjects from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 subjects) or Treatment Choice (approximately 136 subjects). The study consists of a 14-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual subject participation will vary. Subjects may continue to receive treatment for as long as they continue to benefit.
Reference Number: 00074201
View this trial at ClinicalTrials.gov

An open-label, dose-escalation and multi-center study to evaluate the safety and pharmacokinetics of SAR650984 in patients with relapsed/refractory multiple myeloma (RRMM).
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Cristina Gasparetto
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.668.1979
Purpose: Primary Objective: - Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM). - Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab Secondary Objectives: - Part A: - To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM. - Part B: - To evaluate the safety of SAR650984 (isatuximab). - To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS) . - To assess the pharmacokinetics (PK) of SAR650984 (isatuximab). - To evaluate the immunogenicity of SAR650984 (isatuximab).
Reference Number: 00074327
View this trial at ClinicalTrials.gov

A Randomized Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects with Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (= 65 years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Carlos Decastro
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.4769
Purpose: This is a Phase 2, multicenter, randomized, parallel-group, open-label study consisting of 3 phases: Screening, Treatment, and Follow-up. To confirm the safety, ie, the absence of overlapping toxicities of the combination treatment regimen, an early safety monitoring will be performed based on approximately the first 12 subjects randomized. A total of approximately 72 subjects will be included in the Myelodysplastic syndromes (MDS) cohort and approximately 110 subjects in the Acute Myeloid Leukemia (AML) cohort.
Reference Number: 00075114
View this trial at ClinicalTrials.gov