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A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Lymphoblastic Leukemia; Acute Myelogenous Leukemia; Relapsed Leukemia

Intervention: clofarabine (Drug); Etoposide (Drug); Cyclophosphamide (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company

Summary

Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefit have not been conducted. The purpose of the phase 1 portion of this study was to determine if clofarabine added to a combination of etoposide and cyclophosphamide is safe in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). The purpose of the phase 2 portion of the study was to measure the effectiveness of the combination therapy in children with ALL.

Clinical Details

Official title: A Phase 1/2 Dose-Escalation Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Pediatric Patients With Refractory or Relapsed Acute Leukemias.

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

Primary outcome:

Maximum Tolerated Dose (MTD) in Phase 1

Participants With Dose Limiting Toxicity in Phase 1

Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 2

Secondary outcome:

Summary of Participants With Adverse Events (AEs) in Phase 1

Percentage of Participants Achieving A Response Over the First Two Treatment Cycles in Phase 1

Time to Remission for Participants Who Had a Response in Phase 1

Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 1

Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 1

Number of Participants With 4-month Event Free Survival in Phase 1

Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 1

Summary of Participants With Adverse Events (AEs) in Phase 2

Time to Remission for Participants Who Had a Response in Phase 2

Kaplan Meier Estimate of Duration of Remission (DOR) for Participants Who Achieved Overall Remission (OR) in Phase 2

Kaplan Meier Estimates of Event-free Survival (EFS) for Participants in Phase 2

Number of Participants With 4-month Event Free Survival in Phase 2

Kaplan Meier Estimates of Overall Survival (OS) for Participants in Phase 2

Eligibility

Minimum age: 1 Year. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- NOTE: the following eligibility criteria were applicable to acute lymphoblastic

leukemia (ALL) and acute myelogenous leukemia (AML) patients for the Phase 1 portion of this study, and to ALL patients for the Phase 2 portion of the study (only ALL patients were allowed in the Phase 2 portion of the study).

- ALL with > 25% blasts in bone marrow; AML with ≥ 5% blasts in bone marrow; ALL and

AML patients may have extramedullary disease

- Karnofsky Performance Status ≥ 50 for patients > 10 years old; Lansky Performance

Status ≥ 50 for patients ≤ 10 years old

- Prior therapy: AML: 1-2 prior induction regimens and ≤ 1 hematopoietic stem cell

transplant (HSCT); ALL: 1-3 prior induction regimens

- Adequate liver, renal, pancreatic, and cardiac function

- Have received no prior HSCT (study amended in Phase 2 to exclude patients with prior

HSCT) Exclusion Criteria:

- NOTE: the following eligibility criteria were applicable to ALL and AML patients for

the Phase 1 portion of this study, and to ALL patients for the Phase 2 portion of the study (only ALL patients were allowed in the Phase 2 portion of the study).

- Burkitt's leukemia

- Previous treatment with clofarabine

- Uncontrolled systemic fungal, bacterial or other infection and 48 hrs negative blood

cultures required for patients with a history of fever within 3 days of enrollment

- Active CNS involvement (i. e., should be CNS1 or CNS2)

- Inadequate time since last therapy: ≤ 14 days since last cytotoxic chemotherapy; ≤ 7

days since last biologic therapy; ≤ 14 days since last monoclonal antibody therapy

- Have received prior HSCT (study amended in Phase 2 to exclude patients with prior

HSCT)

- Pregnant or lactating

- Have tested positive for hepatitis B or hepatitis C infection or history of cirrhosis

Locations and Contacts

Children's Hospital of Alabama, Birmingham, Alabama, United States

Children's Hospital of Los Angeles, Los Angeles, California, United States

Rady Children's Hospital, San Diego, California, United States

Connecticut Children's Medical Center, Hartford, Connecticut, United States

Children's Memorial Hospital, Chicago, Illinois, United States

St. Vincent Children's Hospital, Indianapolis, Indiana, United States

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Children's Hospital of Michigan, Detroit, Michigan, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

New York School of Medicine, New York, New York, United States

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Seattle Children's Hospital, Seattle, Washington, United States

Additional Information

Starting date: March 2006
Last updated: March 17, 2014

Page last updated: August 23, 2015

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