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Acute Myeloid Leukemia | Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia

Acute Myeloid Leukemia research study

What is the primary objective of this study?

Study Design: 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. 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. The intent of this study is to allow patients to proceed to transplant (independent of this study) within 42 days of Day 1 of Clofarabine based therapy.

Who is eligible to participate?

Inclusion Criteria: - Diagnosis of acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) with <5% blasts in the bone marrow (M1) by morphology and that meets one of the following criteria: - Flow cytometric evidence of MRD (≥ 0.1% leukemic blasts for ALL or <5% leukemic blasts for AML detected in the bone marrow) OR - Molecular/cytogenetic evidence of disease (FISH or PCR methodology) performed within 7 days - AND with the intent of going on to an allogeneic hematopoietic cell transplantation (allo-HCT) independent of this study - Age 0 to 60 years - Karnofsky Performance Status ≥ 50% for patients 16 years and older and Lansky Play Score ≥ 50 for patients under 16 years of age - Patients must have a life expectancy ≥ 8 weeks as determined by the enrolling investigator - Have acceptable organ function as defined within 7 days of study registration: - Renal: creatinine clearance ≥70mL/min/1.73m2 or serum creatinine based on age/gender - Hepatic: aspartate aminotransferase (ALT) < 5 x upper limit of normal (ULN) and total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age - Cardiac: left ventricular ejection fraction ≥ 40% by echocardiogram (ECHO/MUGA) - Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. At least 14 days must have elapsed from prior chemotherapy; at least 7 days must have elapsed since receiving biological therapy. Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor and at least 14 days since pegfilgrastim (Neulasta®) administration. - Sexually active females of child bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment and for 2 months after the last dose of chemotherapy. Sexually active men must agree to use barrier contraceptive for the duration of treatment and for 2 months after the last dose of chemotherapy. - Voluntary written consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care Exclusion Criteria: - Acute Promyelocytic Leukemia (APL) - Active central nervous system (CNS) leukemia or known chloromatous disease - Receiving or plans to receive concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy other than is specified in the protocol - Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) - Pregnant or lactating. The agents used in this study are known to be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. - Known allergy to any of the agents or their ingredients used in this study

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ClofarabineDays 1-5: Clofarabine 30 mg/m^2 for 0-30 years of age or 20 mg/m^2 for > 30 years of age intravenously (IV) over 2 hours

Drug:EtoposideDays 1-5: Etoposide 100mg/m^2 IV over 2 hours

Drug:CyclophosphamideDays 1-5: Cyclophosphamide 300 mg/m^2 as a 30-60 minute infusion

Biological:allogeneic hematopoietic cell transplantationBetween Days 28 and 42: infused independent of this study

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ALL patients receiving transplantPatients intent on receiving an allogeneic hematopoietic cell transplantation (allo-HCT) with the diagnosis of acute lymphoblastic leukemia (ALL) along with Clofarabine, Etoposide and Cyclophosphamide.

AML patients receiving transplantPatients intent on receiving an allogeneic hematopoietic cell transplantation (allo-HCT) with the diagnosis of acute myeloid leukemia (AML) along with Clofarabine, Etoposide and Cyclophosphamide.

Study Status

Withdrawn

Start Date: December 2013

Completed Date: January 2016

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Number of Patients Unable to Proceed to Transplantation

Secondary Outcome: Rate of Pre-Transplant Chemotherapy-Induced Aplasia

Study sponsors, principal investigator, and references

Principal Investigator: Michael Burke, M.D.

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01677949

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