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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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
clofarabine
cytarabine
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4)

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

high-dose cytarabine and clofarabine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 31, 2012
Last Updated
May 25, 2017
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01656031
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high-dose cytarabine and clofarabine
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
clofarabine
Intervention Type
Drug
Intervention Name(s)
cytarabine
Primary Outcome Measure Information:
Title
Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML
Description
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.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayard L. Powell, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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