Reduced Intensity Donor Stem Cell Transplant in Treating Patients With High Risk Acute Lymphocyti… (NCT00031655) | Clinical Trial Compass
CompletedPhase 2
Reduced Intensity Donor Stem Cell Transplant in Treating Patients With High Risk Acute Lymphocytic Leukemia in Complete Remission
United States30 participantsStarted 2001-09
Plain-language summary
The reason for doing this study is to determine whether a new method of blood stem cell transplant (also known as bone marrow transplant) is able to treat acute lymphocytic leukemia. Blood stem cells are the "seed cells" necessary to make all blood cells. This new method of transplant uses a combination of low dose radiation and chemotherapy that may be less toxic and cause less harm than a conventional transplant. This lower dose transplant is called a "nonmyeloablative transplant". Researchers want to see if using less radiation and less chemotherapy combined with new immune suppressing drugs after the transplant will help a stem cell transplant to work. Researchers hope that this treatment will cure acute lymphocytic leukemia with fewer side effects. Researchers are hoping to see a mixture of recipient and donor blood cells after transplant. This mixture of donor and recipient blood cells is called "mixed chimerism". Researchers hope that donor cells will attack and eliminate the leukemia. This is called the "graft-versus-leukemia" effect. In addition, after the transplant, white blood cells from the donor may be given to enhance or "boost" the graft-versus-leukemia effect, and hopefully remove all remaining cancer cells. This study is being done because at the present time blood stem cell transplantation (or bone marrow transplantation) is the only known curative therapy for acute lymphocytic leukemia. Because of age or underlying health status acute lymphocytic leukemia patients have a higher likelihood of experiencing severe harm from a conventional blood stem cell transplant. Researchers are doing this study to see if this new nonmyeloablative method of low dose radiation and low dose chemotherapy given before transplant and immune suppressive drugs after transplant will help make the transplant safer and also cure acute lymphocytic leukemia
Who can participate
Age range
75 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:
* ADULT PATIENTS:
* Patients 50-75 years old with high risk ALL in first CR (CR1) or ALL in CR \>= second CR (CR2)
* Patients \>= 18 years old and \< 50 years old with high risk ALL in CR1 who are not eligible for a conventional allogeneic transplantation based on general medical condition
* Patients \>= 18 years old and \< 50 years old with high risk ALL in CR1 who refuse a conventional allogeneic transplant
* Patients \>= 18 years old and \< 50 years old with ALL in CR \>= CR2 who are not eligible for a conventional allogeneic transplantation based on general medical condition
* Patients \>= 18 years old and \< 50 years old with high risk ALL in CR \>= CR2 who refuse a conventional allogeneic transplant
* CR is defined as \< 5% blasts by morphology on a bone marrow aspirate and the absence of peripheral blasts
* High risk adult ALL in CR1 includes those patients with one or more of the following:
* Age \>=30 years
* Non T-cell phenotype
* Cytogenetic abnormalities including t(9;22), t(4;11), trisomy 8, or monosomy 7
* Failure to achieve CR after 4 weeks of induction chemotherapy
* PEDIATRIC PATIENTS:
* Patients \< 18 years old with ALL in high risk CR1 who are not candidates for conventional allogeneic transplantation based on general medical condition
* Patients \< 18 years old with ALL in CR \>= CR2 who are not candidates for conventional allogeneic transplantation based on general medical condition
* Patients \< 12 years old require approval…
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
Leukemia-free survival
Timeframe: 1 year
Trial details
NCT IDNCT00031655
SponsorFred Hutchinson Cancer Research Center/University of Washington Cancer Consortium