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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. HIV positive
. 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