Overview

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

Status:
Withdrawn
Trial end date:
2016-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Treatments:
Clofarabine
Cyclophosphamide
Etoposide
Etoposide phosphate
Criteria
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