Clofarabine and High-Dose Melphalan Followed by Donor Stem Cell Transplant in Patients With Acute… (NCT00641030) | Clinical Trial Compass
CompletedPhase 1
Clofarabine and High-Dose Melphalan Followed by Donor Stem Cell Transplant in Patients With Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Myelodysplastic Syndromes
United States20 participantsStarted 2007-07
Plain-language summary
RATIONALE: Giving chemotherapy, such as clofarabine and melphalan, before a donor stem cell 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 cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when given together with high-dose melphalan followed by a donor stem cell transplant in treating patients with acute myeloid leukemia, acute lymphocytic leukemia, or myelodysplastic syndromes.
Who can participate
Age range
1 Year – 120 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 one of the following:
* Acute myeloid leukemia
* Acute lymphocytic leukemia
* Myelodysplastic syndromes
* Disease meets 1 of the following criteria:
* In first complete remission (CR)
* In second CR
* In relapse
* No more than 50% blasts in bone marrow
* Not deemed eligible for standard transplantation regimens by the attending physician, or at high risk for relapse
* No suspected or proven CNS leukemia
* HLA-matched (6/6) sibling donor available
PATIENT CHARACTERISTICS:
* Karnofsky performance status 50-100%
* Glomerular filtration rate (pediatric patients) or creatinine clearance ≥ 60 mL/min OR serum creatinine \< 1.5 times upper limit of normal (ULN)
* Serum bilirubin ≤ 2.0 mg/dL
* AST and ALT ≤ 2.5 times ULN
* LVEF ≥ 50% by ECHO or MUGA scan
* DLCO or FEV\_1 ≥ 40% predicted
* Not pregnant
* Negative pregnancy test
* No concurrent uncontrolled illness including, but not limited to, any of the following:
* Ongoing, active, or poorly controlled infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Poorly controlled pulmonary disease
* Psychiatric illness/social situation that would limit compliance with study requirement
* No active cytomegalovirus (CMV) or fungal disease
* HIV negative
PRIOR CONCURRENT THERAPY:
* Recovered from prior intensive chemotherapy (pediatric patients)
* At least 100 days since prior autologous stem cell transplantation
* At least 100…
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
Maximum tolerated dose
Timeframe: 4 weeks from the start of treatment
2
Dose-limiting toxicity as assessed by NCI CTCAE v3.0 and the Modified Bearman scale