Donor Stem Cell Transplant, Pentostatin, and Total-Body Irradiation in Treating Patients With Hem… (NCT00816413) | Clinical Trial Compass
WithdrawnPhase 1/2
Donor Stem Cell Transplant, Pentostatin, and Total-Body Irradiation in Treating Patients With Hematological Cancer
Stopped: Screenings yielded inadequate eligible subjects to enroll.
0Started 2008-09
Plain-language summary
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant and giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects of giving a donor stem cell transplant after pentostatin and total-body irradiation and to see how well it works in treating patients with hematological cancer.
Who can participate
Age range
19 Years – 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 • Diagnosis of a confirmed hematological malignancy that has relapsed or is at high risk for relapsing, including any of the following:
Acute myeloid leukemia (AML) meeting any of the following criteria:
Antecedent hematologic disorder Therapy related Primary induction failure
In first complete remission (CR1) with poor-risk cytogenetics, as defined by the following:
del(5q)/-5 del(7q)/-7 abn(3q) t(6;9) del(20q) del(17p)
+13 Complex karyotype t(9;22) = 11q23 rearrangement In second complete remission (CR2) or greater
Acute lymphoblastic leukemia meeting any of the following criteria:
In CR1 with WBC \> 50,000/mm³ at diagnosis
In CR1 with poor-risk cytogenetics (i.e., t\[9;22\], t\[1;19\], t\[4;11\]) AND meets at least 1 of the following criteria:
19-75 years of age AND received prior high-dose chemotherapy, total-body irradiation (TBI), or a radiation dose that precludes administration of 12 Gy of TBI = 50-75 years of age = 19-75 years of age with hematopoietic stem cell transplantation (HSCT) comorbidity index ≥ 3 CNS or testicular involvement at diagnosis No CR within 4 weeks of initial treatment Primary induction failure In CR2 or greater
Myelodysplastic syndromes meeting the following criteria:
Intermediate-2 or high-risk category as determined by International Prognostic Scoring System Not considered a candidate for intensive or standard chemotherapy or HSCT
Chronic myelogenous leukemia meeting any of the following criteria:
First chronic …
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.