Stem Cell Transplantation for Hematological Malignancies
Stopped early · Phase 2/Phase 3
Conditions studied: Leukemia, Lymphocytic, Acute, AML, MDS
In brief
This protocol using busulfan, cyclophosphamide and melphalan has been designed as conditioning therapy for patients receiving stem cell transplantation for acute leukemia or myelodysplastic syndrome (MDS). The hypothesis is that this new regimen will be well tolerated and will cure the patient.
Key facts
- Study ID
- NCT00176839
- Run by
- Masonic Cancer Center, University of Minnesota
- People needed
- 11
- Starts
- 2000-06-07
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2017-12-05
Who can join
Age: any, up to 35. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have a diagnosis of acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and currently be in complete remission.
- Patients must be either:
- - <18 years of age who are at least 6 months after initial hematopoietic cell transplant (HCT),
- - 19-35 years of age and at least 18 months after initial HCT, or
- - <35 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (TBI) containing preparative therapy
- Adequate major organ function including:
- - Cardiac: ejection fraction > or = 45%
- - Renal: creatinine clearance > or = 40 mL/min
- - Hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites)
- - Karnofsky performance status > or = 70% or Lansky score > or = 50%
- Women of child bearing age must be using adequate birth control and have a negative pregnancy test.
- Written informed consent.
You may not qualify if…
- Eligible for TBI containing preparative regimen.
- Active uncontrolled infection within one week of HCT.
- Pregnant or lactating females.
Where it is running
- Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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