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

Information source: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia

Intervention: Clofarabine (Drug); Etoposide (Drug); Cyclophosphamide (Drug); allogeneic hematopoietic cell transplantation (Biological)

Phase: Phase 2

Status: Recruiting

Sponsored by: Masonic Cancer Center, University of Minnesota

Official(s) and/or principal investigator(s):
Michael Burke, M.D., Principal Investigator, Affiliation: Masonic Cancer Center, University of Minnesota

Overall contact:
Michael J. Burke, M.D., Phone: 612-625-0032, Email: burke283@umn.edu

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.

Clinical Details

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

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

Primary outcome: Number of Patients Unable to Proceed to Transplantation

Secondary outcome:

Rate of Pre-Transplant Chemotherapy-Induced Aplasia

Rate of Infectious Complications

Treatment-Related Mortality After Transplant

Disease-Free Survival After Transplant

Rate of Leukemic Relapse After Transplant

Detailed description: 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 enrolled.

Eligibility

Minimum age: N/A. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Michael J. Burke, M.D., Phone: 612-625-0032, Email: burke283@umn.edu

Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota 55455, United States; Recruiting
Brenda Weigel, M.D., Phone: 612-626-5501, Email: weige007@umn.edu
Brenda Weigel, M.D., Principal Investigator
Additional Information

Starting date: December 2013
Last updated: April 22, 2015

Page last updated: August 23, 2015

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