Bone Marrow Transplant Using a Reduced Intensity Regimen That is Given in Two Steps
Status:
Terminated
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University