Bone Marrow Transplant Using a Reduced Intensity Regimen That is Given in Two Steps (NCT01350258) | Clinical Trial Compass
TerminatedPhase 1/2
Bone Marrow Transplant Using a Reduced Intensity Regimen That is Given in Two Steps
Stopped: Poor accrual
United States8 participantsStarted 2011-04
Plain-language summary
This is a research study involving the treatment of patients with hematological cancers with allogeneic (cells from a donor) hematopoietic stem cell transplant (HSCT). HSCT is often referred to as bone marrow transplant. Patients who are not expected to have long term survival after conventional therapy will undergo HSCT as a curative therapy after receiving front line therapy for their disease. This project is based on an HSCT approach that has been used at TJU since 2006 with the goal of optimizing this type of treatment further. In this new study, the investigators will substitute the chemotherapy agent, Melphalan (Mel), for cyclophosphamide (CY). Cyclophosphamide was used in the original trial. The research question is whether side effects are less using Mel and if donor T cells can be made tolerant to the recipient with the use of Mel. The proposed study is also more specific in terms of performance status and organ function entry criterion. The investigators observed in the original trial that patients with poor performance upon admission for transplant did not have as good outcomes.
Because many older patients are treated according to this type of transplant, the chemotherapy and radiation used are less intensive than other types of transplant. The name for this in the transplant field is a reduced intensity hematopoietic stem cell transplant. The abbreviations most used in this document are RIC for reduced intensity conditioning, HSCT which refers to the transplant itself, and MEL which refers to the drug, Melphalan.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Any patient with a high-risk hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied. High risk is defined as:
✓. Patients must have a related donor who is at least a 4 antigen match at the HLA-A; B; C; DR loci.
✓. Patients must adequate organ function:
✓. Performance status \> or = 80% (TJU Karnofsky) for patients \> or = 60 years old or \> or = 70% for patients \< 60.
✓. HCT-CI Score \< or = 4 points for patients \> or = 60 years old or \< or = 5 points for patients \< 60.
✓. Patients must be willing to use contraception if they have childbearing potential
✓. Able to give informed consent
Exclusion criteria
✕. Performance status \< 80% (TJU Karnofsky) for patients \> or = 60 years old or \< 70% for patients \< 60.
✕. HCT-CI Score \> 4 points for patients \> or = 60 years old or \> 5 points for patients \< 60.
What they're measuring
1
Phase 1: Defined Dose of Melphalan (MEL)
Timeframe: 100 days post-transplant
2
Phase 2: Non-Relapse Mortality (NRM)
Timeframe: 100 days post-treatment
Trial details
NCT IDNCT01350258
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
✕. Active involvement of the central nervous system with malignancy
✕. Inability to obtain informed consent
✕. Pregnancy
✕. Patients with life expectancy of \< 6 months for reasons other than their underlying hematologic/oncologic disorder
✕. Patients who have received alemtuzumab within 8 weeks of the transplant admission, or who have recently received horse or rabbit ant-thymocyte globulin and have an ATG level of \> or = 2 ugm/ml