Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hemato… (NCT00134017) | Clinical Trial Compass
CompletedPhase 2
Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hematologic Cancer
United States142 participantsStarted 2004-06
Plain-language summary
RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and 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 cyclophosphamide, mycophenolate mofetil, or tacrolimus after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.
Who can participate
Age range
6 Months – 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.
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following hematologic malignancies:
* Acute myeloid leukemia (AML), meeting 1 of the following criteria:
* AML beyond first complete remission (CR1)
* Refractory AML
* AML arising from myelodysplastic syndromes (MDS)
* Secondary AML
* MDS
* Refractory anemia with excess blasts with \> 10% blasts in bone marrow
* Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
* ALL in CR1 with 1 of the following high-risk features:
* Philadelphia chromosome (Ph)-positive disease
* Less than 1 year of age at diagnosis
* Cytogenetic abnormalities involving chromosome 11q23
* ALL beyond CR1
* Refractory ALL
* Chronic myeloid leukemia beyond first chronic phase
* Chronic myelomonocytic leukemia
* Chronic lymphocytic leukemia
* Stage III-IV disease
* Does not meet criteria for other bone marrow transplantation (BMT) studies
* Myeloproliferative disorders
* Ph-negative disease
* Hodgkin's or non-Hodgkin's lymphoma
* Chemotherapy-resistant disease
* Paroxysmal nocturnal hemoglobinuria with life-threatening thrombosis
* Multiple myeloma
* Stage II or III disease
* Very high-risk disease
* Having an unrelated donor is considered a high-risk condition
* Meets medical criteria for myeloablative BMT for the Sidney Kimmel Comprehensive Cancer Center
* Bone marrow donor available, meeting 1 of the following criteria:
* Genotypica…
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
Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD)
Timeframe: Day 100
Trial details
NCT IDNCT00134017
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins