Hematologic Malignancies and Cellular Therapy Clinical Trials

15 trials identified.

MacroGenics: Ph1 MGD006 Dual Affinity Re-Targeting (DART) for R/R AML (CP-MGD006-01)
Principal Investigator: Erba, Harry
Protocol Number: PRO00057708

Age Group: Adult
Scope: National

Phase: I (Cancer Control)
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Relapsed or Refractory Acute Myeloid Leukemia 
or
Intermediate-2/High Risk Myelodysplastic Syndrome
What is the Purpose of this Study?
We are doing this study to learn if the study drug, MGD006, is safe and will work for people who have AML and/or MDS.  We also want to know the best dose and side effects that may happen when taking the study drug. 
Who Can Participate in the Study?
Adults with  Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS) who:
- Have liver and kidney function that is good enough for it to be safe to get the study drug

--- Patients with AML must be unlikely to get better with standard treatment
--- Patients with MDS must have had treatment failure with induction therapy

- Have not received an allogeneic stem cell transplantation
- Have not had previous treatment with radiotherapy, chemotherapy or immunotherapy in the 4 weeks prior to study treatment
- Do not have central nervous system leukemia
- Do not have active uncontrolled infections, including HIV, Hepatitis B or C 
What is Involved?
If you choose to join this study:
- You will have a screening visit that includes a physical exam, ECG test to see how your heart is working, blood work and a urine test

During Treatment:
- You will get the study drug, MGD006 for 28 days through a needle in your arm

Follow up at end of Treatment will include:
- Checking for any side effects, a physical exam, bone marrow aspirate and biopsy, blood work, and urine test
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

ECOG-ACRIN E4512 for Early Stage Non-Small Cell Lung Cancer
Principal Investigator: Crawford, Jeffrey
Protocol Number: PRO00060199

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Lung

Contact: DCI Clinical Research Team, Thoracic Oncology
Email:

What is the Condition Being Studied?
Early Stage Non-Small Cell Lung Cancer
What is the Purpose of this Study?
We are doing this study to see if giving the study drug Crizotinib after surgery (or chemotherapy and/or radiation therapy) will help prevent the cancer from returning.
Who Can Participate in the Study?
Adults with non-small cell lung cancer who:
- Have complete surgical resection of their cancer
- Have had no prior treatment with crizotinib
- Are not pregnant or nursing
What is Involved?
If you choose to join this study, you will:
- Be randomized (like the flip of a coin) to get either:
-- Group 1: The study drug crizotinib twice a day for up to 2 years
-- Group 2: Be followed for observation for up to 10 years
- Get CT scans every 6 months if less than 4 years from study entry and then every 12 months for up to 10 years from study entry
Participating Institutions:
  • Duke University Health System : Thoracic Oncology DCI Clinical Research Team
  • Johnston Health (Smithfield) : Thoracic Oncology DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Thoracic Oncology DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Thoracic Oncology DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Thoracic Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Gamida Cell: GC 05.01.020 Ph3 NiCord vs Unmanipulated UCB for Hematological Malignancies
Principal Investigator: Horwitz, Mitchell
Protocol Number: PRO00072499

Age Group: Both
Scope: National

Phase: III (Cancer Control)
Disease Site: Lymphoid Leukemia; Myeloid and Monocytic Leukemia; Other Hematopoietic

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Acute lymphoblastic leukemia (ALL); Acute myelogenous leukemia (AML); Chronic myelogenous leukemia (CML); Chronic myelomonocytic leukemia (CMMoL); Myelodysplastic Syndrome (MDS); Lymphoma
What is the Purpose of this Study?
We are doing this study to learn whether NiCord transplants are better than transplants with standard, unmanipulated cord blood units (CBU). 
Who Can Participate in the Study?
Patients 12-65 years of age who:
- Have a diagnosis of hematological malignancy
- Are candidates for unrelated cord blood transplantation
- Qualify with HLA-matched UCB units with sufficient pre-cryopreserved total nucleated cell dose and CD34+ cell dose
What is Involved?
If you choose to join the study, you will:
- Go through the following phases: screening, randomization, conditioning, and transplantation/follow-up
- Be randomized (like the flip of a coin) to receive either NiCord® or unmanipulated cord blood transplantation
- Be given medications to support you during study drug administration 
- Receive unmanipulated CBU(s) or NiCord CF or NiCord NF through the central catheter (injection at the vein)
- Have bone marrow biopsies and/or aspirate, as needed
- Have heart and lung function tests while on the study
- CT Scan (or PET-CT) of your abdomen and pelvis, as needed
- Have blood tests to evaluate overall health and genetic testing
- Be in the study for approximately 478 days from the signing of informed consent to the last visit one year following transplantation
- Have the option to participate in a long term follow-up optional sub-study
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

Syros Pharmaceuticals: SY-1425-201 Ph2 SY-1425 Tamibarotene AML-MDS
Principal Investigator: Rizzieri, David
Protocol Number: PRO00072859

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) 
What is the Purpose of this Study?
We are doing this study to find out if the study drug, SY-1425-201, works in treating AML and MDS in patients with, or with out a certain biomarker in their blood.
Who Can Participate in the Study?
Adults who 
- Have the biomarker Retinoic Acid Receptor Alpha OR Acute Myeloid Leukemia OR Myelodysplastic Syndrome who:
- Have relapsed and/or refractory AML that has failed to achieve a complete or partial response following standard therapy
- Have relapsed and/or refractory higher risk MDS that has failed to achieve a complete or partial response
- Have new diagnosed AML who are unlikely to tolerate standard intensive chemotherapy 
- Have stopped other chemotherapy, radiation therapy, growth factor and other investigational agents at least two weeks before starting study treatment
- Are willing to be tested for the RARA and IRF8 biomarkers
- Do not have an elevated white blood cell count
- Do not have significant heart disease
- Do not have active, uncontrolled infection, HIV, Hepatitis B or C
- Do not have active, uncontrolled central nervous system leukemia
What is Involved?
If you choose to join the study, you will:
- Have a screening visit to make sure it is safe for you to be in the study

During treatment, you will
- Take the study drug, SY-1425-201, by mouth twice a day every day for 28 days

After treatment is finished, you will have follow-up visits that include physical exams and other tests, every three months for up to 2 years.
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

ANHL1522- Rituximab and Immune Cells from Donors to Treat PTLD
Principal Investigator: Wagner, Lars
Protocol Number: PRO00082215

Age Group: Both
Scope: National

Phase: II (Cancer Control)
Disease Site: Lymphoid Leukemia

Contact: Wagner, Lars
Phone:

What is the Condition Being Studied?
Post-Transplant Lymphoproliferative Disease (PTLD)
What is the Purpose of this Study?
We are doing this study to learn if we can improve the treatment for patients with PTLD by treating patients with special immune system cells called LMP-specific T cells. 

These cells come from donors and are tested to find out which cells are a match for each patient. 
Who Can Participate in the Study?
Children and young adults who:
- Are Age 29 or younger
- Have a history of solid organ transplantation
- Are newly diagnosed polymorphic or monomorphic PTLD 
- Have measurable disease
- Recovered from previous chemotherapy, immunotherapy, or radiotherapy
What is Involved?
If you choose to be in this study, you will: 
- Begin study treatment LMP-specific T cells (LMP-TC) with three doses of anti-B-cell medicine rituximab once a week for 21 days
- Get imaging scans to look at your tumor size

- After induction chemotherapy (first line of treatment for cancer), you will be put into one of the following groups:
A) Get another 21-day course of rituximab
B) Get either 1 or 2 six week courses of LMP-specific T cells 
Participating Institutions:
  • Duke University Health System : Lars Wagner
View this trial at ClinicalTrials.gov

MSKCC 15-059: Selection of Cell Donors Using KIR and HLA
Principal Investigator: Rizzieri, David
Protocol Number: PRO00084344

Age Group: Adult
Scope: National

Phase: N/A
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Patients with AML who receive a stem cell transplant
What is the Purpose of this Study?
We are doing this study to find out if the risk for relapse (return of a disease or condition) is lower among patients with KIR advantageous donors who receive a stem cell transplant. The results from this study can be used to help patients who receive stem cell transplants in the future.   
Who Can Participate in the Study?
Adults who:  
- Have been diagnosed with acute myelogenous leukemia  
- Are a candidate for stem cell transplant  
- Have an unrelated donor for transplant (you may still consent to participate if you don't know the status of your donor)
What is Involved?
This is an observational study    
- There are no labs or study visits   
- If you choose to participate, you will be asked to sign a consent form allowing Duke to send the study sponsor information from your medical record including survival, disease status, and treatment.
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

Alliance A041501 (B-Cell Acute Lymphoblastic Leukemia)
Principal Investigator: Crawford, Jeffrey
Protocol Number: PRO00084507

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Lymphoid Leukemia

Contact: DCI Clinical Research Team, Leukemia - Multiple Myeloma
Email:

What is the Condition Being Studied?
B-Cell Acute Lymphoblastic Leukemia
What is the Purpose of this Study?
We are doing this study to find out if it is better, the same, or worse adding the study drug Inotuzumab to the usual chemotherapy than getting chemotherapy alone.
Who Can Participate in the Study?
Adults with newly diagnosed B-cell acute lymphoblastic leukemia who: 
- Are 18 or less than 40 years of age
- Have had no prior treatment for acute lymphoblastic leukemia except for limited treatment of less than 7 days
- Do not have Down Syndrome
- Are not pregnant or nursing
What is Involved?
If you choose to join this study, you will:

- Be randomized (put into one of two groups by chance like the flip of a coin) and get either:

-- Group 1: The usual series of leukemia treatments divided into five courses of different combinations of chemotherapy drugs. Depending on the type of ALL, radiation may also be given.
 
-- Group 2: The usual chemotherapy drugs for this type of cancer plus the study drug inotuzumab. Inotuzumab will be given through a vein in 3 doses over a 28-day period called a cycle for a total of 2 cycles. Depending on the type of ALL, radiation may also be given. 

- Be involved in the five courses of chemotherapy for about 3 years, 3 months for males and about 2 years and 3 months for females.

- Get a bone marrow aspirate and biopsy prior to beginning the study and at the end of the chemotherapy courses 1, 2, 4, and 5 to monitor your disease, and if your disease progresses.

- Be followed for up to 10 years after completion of treatment.
Participating Institutions:
  • Duke University Health System : Leukemia - Multiple Myeloma DCI Clinical Research Team
View this trial at ClinicalTrials.gov

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML
Principal Investigator: Horwitz, Mitchell
Protocol Number: PRO00084711

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
AML patients with the FLT3/ITD genetic mutation who are eligible for allogeneic transplant
What is the Purpose of this Study?
We are doing this study to learn if it is safe and effective (works well) to treat patients who have FLT3/ITD AML with a study drug called gilteritinib after transplant. We want to know if this drug works better than a placebo to stop the AML from coming back and what kind of side-effects it may cause.
Who Can Participate in the Study?
Adult men and women who are  
- Candidates for allogeneic transplant  
- Have AML with the FLT3 AML genetic mutation in a CR1 following consolidation therapy  
- Have not had a previous allogeneic transplant
What is Involved?
If you join the study, you will  
- Go through a screening process that includes having a bone marrow biopsy (removal of soft tissue in the bone) that must be done at Duke, blood tests, physical exams, and other tests and questionnaires  
- Be randomized (like the flip of a coin) to receive the drug gilteritinib or placebo (a sugar pill) for two years starting 30-90 days after your allogeneic transplant 
--- Neither you nor your study team or doctor will know what you are taking (although they can find out in an emergency)  
- Have bone marrow biopsies between 30-90 days, 3 months, 6 months, 12, months, 18 months, and 24 months after your transplant  
- Complete health quality of life surveys 8 times during the study  
- Have blood tests monthly while on study drug  
- Have ECG during screening and monthly while on study drug  
- Followed for survival for up to 5 years after stopping drug.
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory chronic graft vs host disease after allogenic stem cell transplantation (REACH 3)
Principal Investigator: Horwitz, Mitchell
Protocol Number: PRO00085097

Age Group: Both
Scope: National

Phase: III (Cancer Control)
Disease Site: Other Hematopoietic

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Chronic graft vs host disease that is refractory (does not respond) to steroids
What is the Purpose of this Study?
We are doing this study to learn about the safety and effectiveness of the drug ruxolitinib in patients with moderate to severe corticosteroid refractory chronic graft vs host disease.  
Who Can Participate in the Study?
Patients older than 12 who have been diagnosed with moderate or severe chronic graft vs host disease and had an allogeneic stem cell transplant.
What is Involved?
If you choose to join this study, you will
- Be randomized (as in the flip of a coin) to receive 
-- A study drug called I11ruxolitinib by mouth twice a day or 
-- Best available therapy (selected by your physician)   

- You will be treated or followed for three years  
- You must be able to swallow pills 
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)
Principal Investigator: McKinney, Matthew
Protocol Number: PRO00085229

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Lymphoid Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Relapsed or refractory marginal zone lymphoma (MZL) with or without prior exposure to a BTK inhibitor
What is the Purpose of this Study?
We are doing this study to learn how well INCB050465 works in patients with marginal zone lymphoma (MZL) that is relapsed or refractory after at least 1 systemic treatment regimen.
Who Can Participate in the Study?
Adults with marginal zone lymphoma (MZL) that is relapsed or has not responded to treatment and who: 
- Have previously received 1 or more lines of systemic therapy, including at least 1 anti-CD20 antibody
- Have measurable disease at least 1 lesion larger than 1.5 cm as assessed by CT   
- Have not had any prior treatment with idelalisib or other PI3K inhibitor  
- Don't have active graft versus host disease  
- Don't have liver disease, Hepatitis B or C infection or risk of reactivation 
What is Involved?
If you choose to join the study:
- You will have a screening visit that will include questions, physical examination, blood work, bone marrow biopsy, CT scans, and ECGs.   
- Once your eligibility is confirmed you will be randomly assigned (like the flip of a coin) to one of two groups that will get different doses of INCB050465, which will be taken by mouth every day in 8 week cycles. 

Your study doctor will tell you what dose you will receive.  

You will come back to the clinic every 4 weeks to:  
- Get a new package of tablets 
- Have a physical examination 
- Answer questions about your medications and how you are doing,   
- Have ECGs before you receive your dose and 1.5 hrs after your dose  
- Have CT scans (every 8 weeks)   
- Have a bone marrow biopsy (every 8 weeks) to confirm response if the bone marrow biopsy was positive during screening.    
- Follow up at end of treatment, 30-35 days later, and then every 12 weeks.
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

Incyte INCB 39110-209 Ph2 Itacitinib PMF, PET-MF and PV-MF
Principal Investigator: Arcasoy, Murat
Protocol Number: PRO00086011

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Other Hematopoietic

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Myelofibrosis
What is the Purpose of this Study?
We are doing this study to learn about the effects of the drug itacitinib taken with ruxolitinib or itacitinib alone.
Who Can Participate in the Study?
Adults who:
- Have a confirmed diagnosis of PMF, PPV-MF, or PET-MF 
- Have a bone marrow biopsy specimen available or willingness to undergo a bone marrow biopsy 
- Have a life expectancy of at least 24 weeks
- Have an ECOG performance status of 0, 1, or 2.
What is Involved?
If you choose to join this study, you will: 
- Get blood tests, MRIs, plasma lab tests as well as spleen/liver assessments
- Have Lipid panel test (measuring how much fat you have in your blood)
- Have multiple discussions about your current and past health
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

ECOG-ACRIN EA4151
Principal Investigator: Crawford, Jeffrey
Protocol Number: PRO00088210

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Lymphoid Leukemia

Contact: SOM Clinical Research Team, Hematology -
Phone:

What is the Condition Being Studied?
Mantle cell lymphoma
What is the Purpose of this Study?
We are doing this study to find out whether an autotransplant improves survival in mantle cell lymphoma patients who have achieved an excellent (minimal residual disease-negative) first complete remission (CR).
Who Can Participate in the Study?
Adults from age 18 to 70 years old who have:
- mantle cell lymphoma confirmed by histology
- have achieved a radiologic complete or partial remission
- must not be pregnant or nursing
What is Involved?
If you agree to be in this study you will:
- Have CT (computed tomography) scan of the chest, abdomen, and pelvis
- Have PET (positron emission tomography) scan
- Have a bone marrow aspirate and biopsy
Be randomized (put into one of four groups by chance like a flip of a coin) and receive either:
Group 1 - complete the initial chemotherapy and receive an autotransplant
Group 2 - complete the initial chemotherapy and NOT receive autotransplant
Groups 3 & 4 - complete initial chemotherapy and undergo high-dose chemotherapy and autotransplant, followed by three years of maintenance rituximab.
Participating Institutions:
  • Duke University Health System : Hematology - SOM Clinical Research Team
View this trial at ClinicalTrials.gov

BeiGene: BGB-3111-304 Phase 3 BGB-3111 Untreated CLL/SLL
Principal Investigator: Brander, Danielle
Protocol Number: PRO00089853

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Lymphoid Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
What is the Purpose of this Study?
We are doing this study to compare the effects, good or bad, of the investigational drug BGB-3111 versus a known standard treatment called bendamustine plus rituximab (B+R) on lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Who Can Participate in the Study?
Adults who:
- Have a confirmed diagnosis of CD20-positive CLL or SLL 
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Have a life expectancy greater than or equal to 6 months 
- Have adequate bone marrow and organ function
What is Involved?
If you choose to join this study, you will:
- Have tests, exams and procedures that are part of your standard care and for study purposes
- Complete questionnaires asking you about your general health, well-being, and overall quality-of-life
- Have your blood tested to find out whether you have CLL/SLL that has a mutation (a change) in one of the chromosomes called '17p deletion'
- Complete a drug diary to show when you have taken a study drug dose, or when you have missed a dose for any reason
Participating Institutions:
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

MEI: ME-522-001 Ph1 Voruciclib R/R B Cell Malignancies
Principal Investigator: Brander, Danielle
Protocol Number: PRO00091877

Age Group: Adult
Scope:

Phase: I
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
B-cell type cancers
What is the Purpose of this Study?
We are doing this study to find out if a drug called Voruciclib is safe and to find out the most helpful dose of the drug for B-cell type cancer.
Who Can Participate in the Study?
Adults who:
- Have a histologically-confirmed diagnosis of FL, MCL, MZL, SLL, CLL, or DLBCL 
- Have a life expectancy greater than 3 months
- Have the presence of measurable disease defined per the 2008 International workshop on CLL guidelines, or by 2014 Lugano criteria for non-Hodgkin lymphoma 
- Have an Eastern Cooperative Oncology Group (ECOG) performance status less than, or equal to 1 
What is Involved?
If you choose to join this study you will:
- Have information about you collected, such as your age, sex, race/ethnicity, and your medical history including assessing symptoms related to your disease
- Get ECGs (3 times in a row) 
- Have blood collected for health assessments and blood chemistry
- Have your ability to perform everyday tasks assessed 
- Have tests preformed, which may include a biopsy (to look at your disease)
Participating Institutions:
  • Duke Cancer Center Cary : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Center for Living/Sarah Stedman Nutrition : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Primary Care : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Private Diagnostic Clinic (PDC) : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Raleigh Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Regional Hospital : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Hematological Malignancies, Cellular Therapy and ABMT
  • Johnston Health (Smithfield) : Hematological Malignancies, Cellular Therapy and ABMT
  • Maria Parham Health (Henderson) : Hematological Malignancies, Cellular Therapy and ABMT
  • Scotland Health Care System (Laurinburg) : Hematological Malignancies, Cellular Therapy and ABMT
  • Southeastern Regional Medical Center (Lumberton) : Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov

GlycoMimetics:301 Phase3 GMI-1271 in People with RR AML
Principal Investigator: Erba, Harry
Protocol Number: PRO00100665

Age Group: Adult
Scope:

Phase: III
Disease Site: Myeloid and Monocytic Leukemia

Contact: Cellular Therapy and ABMT, Hematological Malignancies,
Email:

What is the Condition Being Studied?
Relapsed/Refractory Acute Myeloid Leukemia 
What is the Purpose of this Study?
We are doing this study to learn if the study drug uproleselan (GMI-1271) is helpful when given together with chemotherapy to patients with relapsed/refractory AML, compared to chemotherapy alone. 

We also want to learn if uproleselan is safe when given with chemotherapy with patients that have relapsed/refractory AML
Who Can Participate in the Study?
Adults who:
-Have either primary refractory or relapsed AML (first or second untreated relapse)
What is Involved?
If you join the study, you will:
- Go through a screening process that includes having a bone marrow biopsy (removal of soft tissue in the bone) and aspirate, blood tests, physical exams, and other tests to determine eligibility for the study.
-Be randomized (like the flip of a coin) to receive chemotherapy with either uproleselan or placebo (saline). Neither you nor your study team or doctor will know what you are taking.
-Be hospitalized up to 60 days if you join main part of the study (depend on how long you need to be in the hospital for AML intervention your study doctor prescribes). 
-Receive uproleselan or placebo (saline) directly into your vein (intravenously).
-Have blood tests to check your blood counts and kidney and liver function 
-Have bone marrow exam, as needed to check your disease.
-Have heart scans (ECG)  as needed
-After the End of Study Intervention visit be contacted  every month for 2 years and every three months thereafter indefinitely for survival information.

Participating Institutions:
  • Duke Cancer Center Cary : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Center for Living/Sarah Stedman Nutrition : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Primary Care : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Private Diagnostic Clinic (PDC) : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Raleigh Hospital : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Regional Hospital : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke University Health System : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Johnston Health (Smithfield) : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Maria Parham Health (Henderson) : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Scotland Health Care System (Laurinburg) : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
  • Southeastern Regional Medical Center (Lumberton) : Hematological Malignancies, Cellular Therapy and ABMT, Hematological Malignancies, Cellular Therapy and ABMT
View this trial at ClinicalTrials.gov