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A Phase II Trial Investigating Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia

Phase 2
60 Years
Not Enrolling
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia

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Trial Information

A Phase II Trial Investigating Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia

Patients will be stratified at the time of enrollment based on diagnosis (ALL versus AML).
Based on this two-stage optimal design, a maximum of 49 patients with ALL and a maximum of
49 patients with AML will be needed. For each disease cohort, 21 patients will be enrolled
in stage 1. If at the end of stage 1, the criteria is met for activating stage 2 (based on
success of clearing MRD, proceeding to transplant within 42 days and without excessive
toxicity) for one or both groups, stage 2 will be activated with an additional 28 patients

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

- 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

- Have acceptable organ function as defined within 7 days of study registration:

- Renal: creatinine clearance ≥70mL/min/1.73m2 or serum creatinine based on

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients Unable to Proceed to Transplantation

Outcome Description:

The primary endpoint of this study will be to determine the impact of Clofarabine, Cyclophosphamide and Etoposide on the conversion to an minimal residual disease (MRD) negative state at day 30 (<0.01% leukemic blasts by flow cytometry) or day 42 if day 30 marrow is un-evaluable due to hypocellularity per RECIST criteria as well as the ability of patients to reach allo-HCT without significant delay due to study treatment related toxicity. Unable to proceed to transplant by Day 42 will be considered unacceptable.

Outcome Time Frame:

Between Day 30 and Day 42

Safety Issue:


Principal Investigator

Michael Burke, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

July 2013

Completion Date:

August 2018

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Neoplasm, Residual



Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota  55455