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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01656031
• Other study ID #: 21204 Phase 2
• Secondary ID: CCCWFU-21204ILEX
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 31, 2012
• Last updated: October 22, 2015
• Start date: February 2005

Study information

• Verified date: October 2015
• Source: Comprehensive Cancer Center of Wake Forest University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 39
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• clofarabine

• cytarabine

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Comprehensive Cancer Center of Wake Forest University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML	Response to the therapy is measured by a defined improvement in Neutrophil and platlet counts, along with improved cellularity of bone marrow biopsy (>20% with maturation of all cell lines), <5% blasts, auer rods must not be detectable and extramedullary leukemia or soft tissue involvment must not be present.	5 weeks	No