Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating… (NCT00611351) | Clinical Trial Compass
CompletedPhase 2
Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer
United States5 participantsStarted 2005-06-07
Plain-language summary
RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain 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 tacrolimus and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer.
Who can participate
Age range
19 Years – 65 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:
* Pathologically confirmed diagnosis of 1 of the following:
* Acute myeloid leukemia
* Acute lymphocytic leukemia
* Chronic myelogenous leukemia beyond first chronic phase (i.e., 2nd chronic phase, accelerated phase, or blast crisis)
* Multiple myeloma
* Myelodysplastic syndromes
* Malignant lymphoma
* Myelofibrosis
* Requirement for myeloablative conditioning regimen confirmed by attending physician
* Available donor must meet the following criteria:
* HLA phenotypically identical unrelated donor by low, intermediate, or high resolution for HLA class I antigens, and by high resolution for HLA class II antigens
* Matched at the A, B, and DRβ1 loci
* Single HLA-A or HLA-B antigen mismatch allowed
* Meets all National Marrow Donor Program or foreign registry criteria for allogeneic bone marrow/stem cell donors
* Peripheral blood stem cells are the preferred product on this study but bone marrow is allowed
* Karnofsky performance status 70-100%
* DLCO ≥ 50% predicted
* LVEF ≥ 45%
* Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 65 mL/min
* Serum total bilirubin ≤ 2.0 mg/dL
* Fertile patients must use effective contraception
Exclusion Criteria:
* No active uncontrolled infection
* Not pregnant or nursing/negative pregnancy test
* No HIV infection
* No chronic active hepatitis B or C or evidence of cirrhosis on liver biopsy
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
Transplantation-related Mortality at 100 Days Post-transplantation