A Phase II Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia

NCT ID: NCT01656031

Last Updated: 2017-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2008-11-30

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying clofarabine when given together with cytarabine to see how well they work in treating patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.

Detailed Description

OBJECTIVES:

• Determine the response rate in adult patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with high-dose cytarabine followed by clofarabine.

OUTLINE: This is an open-label phase II study. Patients are stratified according to diagnosis (acute myeloid leukemia vs acute lymphoblastic leukemia Phase II: Patients receive high-dose cytarabine followed by clofarabine (at the dose determined in phase I) on days 1-3.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 39 patients were accrued for this study.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

high-dose cytarabine and clofarabine

high-dose cytarabine (2000 milligram/meter squared/day) administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days

Group Type: EXPERIMENTAL

clofarabine

Intervention Type: DRUG

cytarabine

Intervention Type: DRUG

Interventions

clofarabine

Intervention Type: DRUG

cytarabine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Pathologic confirmation of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL)

• No M3 AML
• Meets 1 of the following criteria:

• In first relapse
• In second relapse after a second complete remission (CR) that lasted ≥ 3 months
• Refractory to initial induction therapy
• No symptomatic CNS involvement

PATIENT CHARACTERISTICS:

• ECOG performance status ≤ 2
• Creatinine < 2 mg/dL
• Bilirubin ≤ 2 mg/dL
• AST and ALT ≤ 4 times upper limit of normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 weeks after completing study treatment
• Ejection fraction ≥ 45% by echocardiogram
• No active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant
• No psychiatric disorders that would interfere with giving consent, study participation, or follow-up procedures
• No other severe concurrent disease that would preclude study treatment

PRIOR CONCURRENT THERAPY:

• At least 1 week since prior therapy and recovered
• No other concurrent chemotherapy

• Hydroxyurea to control WBC count before starting study treatment allowed
• No concurrent corticosteroids unless used for diseases other than leukemia
• No concurrent palliative radiotherapy
• No concurrent growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF]) in patients with AML

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayard L. Powell, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

CCCWFU-21204

Identifier Type: -

Identifier Source: secondary_id

ILEX-CCCWFU-21204

Identifier Type: -

Identifier Source: secondary_id

CCCWFU-BG04-519

Identifier Type: -

Identifier Source: secondary_id

21204 Phase 2

Identifier Type: -

Identifier Source: org_study_id