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Protocol No. 2011LS158 Principal Investigator Weigel, Brenda
Phase Phase II
Age Group Both Scope Local
Title HM2012-05: A Phase II Trial Investigating Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia
Objective The primary objective is to determine the impact of the study treatment in eliminating the presence of minimal residual disease without causing a significant delay of allo-HCT due to treatment related toxicity.
Treatment The administration of the study drugs will follow institutional drug and supportive care guidelines. Only 1 treatment course is permitted.
Description This is a two-stage Phase II trial investigating the efficacy of Clofarabine, Cyclophosphamide and Etoposide in acute leukemia patients with detectable minimal residual disease (MRD) prior to allo-HCT.
Key Eligibility Patients intent on receiving an allogeneic hematopoietic cell transplantation (allo-HCT) with the diagnosis of acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) in morphologic remission (M1 marrow; <5% leukemia blasts) with presence of minimal residual disease (MRD positivity).
Applicable Disease Sites Leukemia, not otherwise specified
Leukemia, other
Lymphoid Leukemia
Myeloid and Monocytic Leukemia
Drugs Involved CLOFARABINE
CYCLOPHOSPHAMIDE (CYTOXAN, NEOSAR)
ETOPOSIDE (VP-16)
Status Open
Participating Institutions Masonic Cancer Center
Detailed Eligibility Must be between 0 and 60 years of age with adequate renal, hepatic and cardiac function. Sexually active females of child bearing potential must agree to use adequate contraception and sexually active men must agree to use barrier contraceptive for the duration of treatment and for 2 months after the last dose of chemotherapy. Anyone with acute promyelocytic leukemia, active CNS leukemia or systemic fungal, bacterial, viral, or other infection not controlled is not eligible. Women who are pregnant or nursing are not eligible. A signed informed consent and HIPAA authorization are required.
Treatment Type Treatment
Contact Brenda Weigel Phone:612-626-5501
Email:weige007@umn.edu
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