Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodyspla… (NCT01885689) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
United States72 participantsStarted 2014-02-10
Plain-language summary
This phase II trial studies how well clofarabine and melphalan before a donor stem cell transplant works in treating patients with a decrease in or disappearance of signs and symptoms of myelodysplasia or acute leukemia (disease is in remission), or chronic myelomonocytic leukemia. Giving chemotherapy, such as clofarabine and melphalan, before a donor 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. When the healthy stem cells from a donor are infused into a patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving clofarabine and melphalan before transplant may help prevent the cancer from coming back after transplant, and they may cause fewer side effects than standard treatment.
Who can participate
Age range18 Years – 75 Years
SexALL
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:
* Patients in 1st or 2nd remission with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), who are eligible for stem cell transplant. Remission defined as no circulating blasts, \< 5% blasts in the bone marrow, normalization of previously detected cytogenetic abnormalities, no extramedullary disease
* High risk myelodysplastic syndrome (MDS)
* Intermediate II and high risk by International Prognostic Scoring System (IPSS)
* Intermediate, high, or very high by World Health Organization (WHO) classification-based Prognostic Scoring System (WPSS)
* Transfusion dependent
* Therapy-related MDS or MDS evolved from previous hematological disorder (excepting myelofibrosis)
* Patients with chronic myelomonocytic leukemia (CMML) are allowed to be enrolled
* Patients with MDS that has evolved to AML must be in remission
* Patients must not be eligible for full ablative regimens by the attending physician
* Patients with AML or MDS arising from myeloproliferative neoplasm can be enrolled after principal investigator (PI) approval on case to case basis, depends on the spleen size and degree of bone marrow fibrosis
* Performance status of \>= 70% on the Karnofsky scale
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect she is pre…
What they're measuring
1
Progression-free Survival at 2 Years
Timeframe: From start of protocol treatment to death due to any cause, disease relapse/progression, or last follow-up, whichever comes first, assessed up to 2 years.