Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Ca… (NCT00450450) | Clinical Trial Compass
CompletedPhase 3
Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
United States27 participantsStarted 2007-12-31
Plain-language summary
This randomized phase III trial is studying donor bone marrow transplant with or without G-CSF to compare how well they work in treating young patients with hematologic cancer or other diseases. Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate and tacrolimus or cyclosporine before and after transplant may stop this from happening. It is not yet known whether donor bone marrow transplant is more effective with or without G-CSF in treating hematologic cancer or other diseases.
Who can participate
Age range
21 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 hematologic cancer or other disease, including any of the following:
* Chronic myelogenous leukemia in first or second chronic phase
* Acute lymphoblastic leukemia (ALL), meeting any of the following criteria:
* Relapsed ALL enrolled on a Children's Oncology Group (COG) relapse clinical trial OR received ≥ 1 round of reinduction therapy (4-6 weeks) and 1 round of intensive consolidation chemotherapy (3-6 weeks)
* ALL in second complete remission (CR)\* after a bone marrow, extramedullary, or combined bone marrow and extramedullary relapse
* Very high-risk ALL in first CR, defined as any of the following:
* Philadelphia chromosome-positive ALL
* Hypodiploidy (\< 44 chromosomes)
* Mixed lineage leukemia rearrangement
* Induction failure
* Acute myeloid leukemia in first or second CR
* Induction therapy must be completed
* Juvenile myelomonocytic leukemia
* Myelodysplastic syndromes
* No clinically evident CNS or extramedullary disease
* No blasts seen on cerebrospinal fluid cytospin
* Post-relapse reinduction therapy must be completed
* Not planning to receive reduced-intensity conditioning regimen
* Not planning to receive a graft that has undergone T-cell depletion
* No Down syndrome
* Matched sibling donor must be available and must be enrolled on ASCT0631D companion study
* Karnofsky performance status (PS) 60-100% (patients \> 16 years of age) OR Lansky PS 60-100% (patients ≤ 16 years…
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.