Adult Clinical Trials

BMT and Cellular Therapies

If you need additional information about any of the trials listed or would like to inquire about other open trials, please contact the BMT and Cellular Therapies Clinical Trials Office at 919.681.5027.

12 trials identified.

A Pilot Trial of CMV Specific Donor Lymphocyte Infusions from 3-6/6 HLA Matched Family Member Following Nonmyeloablative Allogeneic Stem Cell Transplantation
Phase: Phase I
Sponsor: PI initiated
Principal Investigator: Nelson Chao
Contact: Krista Rowe, RN, MSN, AOCNS
Phone: 919.684.7115
Reference Number: 00013947

A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age
Phase: Phase III
Sponsor: External Investigator-Sponsored (External Med Ctr)
Principal Investigator: Gwynn Long
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.668.6524
Purpose: Objective of this study is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs Progression-free survival (by at least 9 months).
Reference Number: 00027023
View this trial at ClinicalTrials.gov

A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
Phase: N/A
Sponsor: PI initiated
Principal Investigator: Nelson Chao
Contact: Krista Rowe
Phone: 919.681.5027
Reference Number: 00032263

A Multi-Center Trial Comparing Reduced Intensity Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients Aged 50-75 with Intermediate-2 and High Risk Myelodysplastic Syndrome BMT CTN Protocol 1102
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Mitchell Horwitz
Contact: BMT Cell Therapy Oncology Research Team
Phone: 919.681.5027
Purpose: This study is designed as a multicenter trial, with biological assignment to one of two study arms; Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell transplantation (RIC-alloHCT), Arm 2: Non-Transplant Therapy/Best Supportive Care.
Reference Number: 00050652
View this trial at ClinicalTrials.gov

Patient-Centered Home-Based Hematopoietic Stem Cell Transplantation
Phase: N/A
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Nelson Chao
Contact: BMT Cell Therapy Oncology Research Team
Phone: 919.668.1002
Purpose: Hematopoietic stem cell transplantation (HCT) has the potential to cure a variety of malignant and non-malignant diseases. However, it is associated with significant morbidity, and treatment-related mortality. This is due in large part to the prolonged pancytopenia and immunosuppression associated with the preparatory regimen of chemotherapy and/or radiation and the wait until engraftment of the transplanted hematopoietic stem cells. During this vulnerable period, infectious complications are common. Historically HCT patients were kept in protected environments to safeguard their health during the pancytopenic phase; despite these measures, infectious complications and graft versus host disease (GVHD) remained common and lead to significant morbidity and mortality after HCT. Currently patients are still closely watched in the inpatient or day hospital environment, though recent practices allow patients more freedom. This study randomizes eligible patients to receive post-transplant care at home vs. in the hospital or clinic, per standard of care. The primary objective is to compare the incidence of grade II-IV acute GVHD at 6 months in patients receiving patient-centered medical home (PCMH) vs standard care.
Reference Number: 00051024
View this trial at ClinicalTrials.gov

A Phase II Trial for the prevention of gastrointestinal toxicity from total body irradiation or high dose chemotherapy with pasireotide
Phase: Phase II
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Anthony Sung
Contact: BMT Cell Therapy Oncology Research Team
Phone: 919.681.5027
Purpose: The purpose of this study is to evaluate if the drug, Pasireotide, is safe and effective in reducing the gastrointestinal side effects of the drugs received to prepare for allogeneic stem cell transplant. The study will also evaluate if Pasireotide is effective in reducing acute and chronic Graft-versus-Host-Disease (GvHD) after transplant.
Reference Number: 00051736
View this trial at ClinicalTrials.gov

A RANDOMIZED PHASE II TRIAL TO EVALUATE PROGRESSION-FREE SURVIVAL RATES IN PATIENTS RECEIVING NK CELL-ENRICHED DONOR CELL INFUSIONS WHEN ADMINISTERED ALONE OR ADMINISTERED WITH THE TLR9 AGONIST, DUK-CPG-001, FROM A 4-6/8 HLA-MATCHED RELATED OR 7-8/8 HLA-MATCHED DONOR FOLLOWING REDUCED INTENSITY OR NON-ABLATIVE ALLOGENEIC STEM CELL TRANSPLANTATION
Phase: Phase II
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: David Rizzieri
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.5027
Purpose: This is a randomized, parallel phase II study to evaluate the rates of progression-free survival and unacceptable toxicity in patients receiving NK cell-enriched donor lymphocyte infusions (DLIs) when administered alone or administered with the TLR9 agonist, DUK-CPG-001, from a 7-8/8 HLA-matched related or unrelated donor (Cohort A) or 4-6/8 HLA-matched related donor (Cohort B) following nonmyeloablative allogeneic stem cell transplantation. Randomization will be stratified for disease types (myeloid versus lymphoid malignancies). Primary endpoints are analyzed separately in Cohort A and B. Cohort A: 7-8/8 HLA-matched related or unrelated donor (NK cell enriched-DLI only arm or NK cell enriched-DLI + DUK-CPG-001 arm) Cohort B: 4-6/8 HLA-matched related donor (NK cell enriched-DLI only arm or NK cell enriched-DLI + DUK-CPG-001 arm)
Reference Number: 00057501
View this trial at ClinicalTrials.gov

A Randomized, Multi-Center, Phase III Trial of Calcineurin Inhibitor-Free Interventions for Prevention of Graft-versus Host-Disease
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Mitchell Horwitz
Contact: BMT Oncology Clinical Trials Office
Phone: 919.681.5027
Purpose: The study is designed as a three arm randomized Phase III, multicenter trial comparing two calcineurin inhibitor (CNI)-free strategies for Graft-versus-Host Disease (GVHD) prophylaxis to standard tacrolimus and methotrexate (Tac/Mtx) in patients with hematologic malignancies undergoing myeloablative conditioning hematopoietic stem cell transplantation.
Reference Number: 00058005
View this trial at ClinicalTrials.gov

Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib after Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma
Phase: Phase II
Sponsor: Cooperative Group Initiated
Principal Investigator: Cristina Gasparetto
Contact: BMT Oncology Clinical Trials Office
Phone: 919.681.5027
Purpose: This study is designed to compare progression-free survival (PFS) from randomization among patients randomized on the BMT CTN 1302 protocol, Multicenter Phase II, Double-blind Placebo Controlled Trial of Maintenance Ixazomib after Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Multiple Myeloma. It is hypothesized that Ixazomib maintenance therapy will result in improved PFS in patients with high-risk multiple myeloma following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) compared to placebo.
Reference Number: 00063517
View this trial at ClinicalTrials.gov

A Phase I Trial of Fostamatinib and Chronic Graft-vs.-Host Disease Development after Allogeneic Stem Cell Transplantation
Phase: Phase I
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Stefanie Sarantopoulos
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.684.7115
Purpose: The purpose of this study is to evaluate whether fostamatinib, a drug that blocks activated B cells will be effective in preventing chronic graft vs host disease (cGVHD) after allogeneic stem cell transplant. Activated B cells may play a role in development of cGVHD. Inhibiting the B cell activation using fostamatinib after allogeneic stem cell transplant may prevent the development of cGVHD.
Reference Number: 00064227
View this trial at ClinicalTrials.gov

Prospective, Phase II/III, Randomized Clinical Study to Compare BEGEDINA Versus Conventional Treatment For Treating Steroid Resistant Acute Graft-Versus-Host Disease
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Mitchell Horwitz
Contact: BMT Oncology Clinical Trials Office
Phone: 919.681.5027
Purpose: The objectives of this study are to determine the efficacy and safety of BEGEDINA® in subjects with steroid resistant acute graft versus host disease (GvHD). GvHD is a rare and complex immunological disease occurring in some recipients of allogeneic hematopoietic stem cell transplants (HSCTs) and affecting principally the skin, liver and gastrointestinal (GI) tissues. The disease is life threatening and may be acute or chronic and the first choice treatment for patients with acute GvHD (Grade II or higher) is the immunosuppressive corticosteroid hormone methylprednisolone. However, some GvHD patients may be resistant to this treatment leading to disease progression and a high rate of morbidity and mortality, primarily from infections and/or multi-organ failure. There are currently no other satisfactory therapies. BEGEDINA® is a therapeutic monoclonal antibody that recognises and binds to CD26 on CD4+ T lymphocytes. BEGEDINA® reduces the activity of CD26 in these cells and inhibits the immune response leading to improvement in patients that have shown steroid resistance. This study is therefore aimed at demonstrating that BEGEDINA® is a safe and effective treatment for steroid-resistant GvHD patients where no other such treatments are currently available.
Reference Number: 00066047
View this trial at ClinicalTrials.gov

A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Mitchell Horwitz
Contact: BMT CELLULAR THERAPIES Oncology Clinical Trials Office
Phone: 919.681.5027
Purpose: This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute lymphoblastic leukemia or acute myeloid leukemia, myelodysplastic syndrome or chronic myeloid leukemia, all with required disease features rendering them eligible for allogeneic transplantation.
Reference Number: 00072499
View this trial at ClinicalTrials.gov