Cytarabine and Clofarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00295841
Recruitment Status : Completed
First Posted : February 24, 2006
Last Update Posted : April 19, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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 I trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Drug: clofarabine Drug: cytarabine Phase 1

Detailed Description:


  • 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.
  • Document the safety profile and tolerability of this regimen in these patients.
  • Phase I: Patients receive high-dose cytarabine IV over 3 hours followed by clofarabine IV over 2 hours on days 1-5. Treatment repeats for up to 4 courses (1-2 induction courses, 2-3 post-remission courses) in the absence of disease progression or unacceptable toxicity.

A cohort of 3-6 patients receives the starting dose of clofarabine. If 1 of 6 patients experiences dose-limiting toxicity (DLT), a subsequent cohort of patients receives clofarabine at the next higher dose. If ≥ 2 of 6 patients experience DLT, the dose of cytarabine is reduced and subsequent cohorts of patients receive cytarabine at reduced doses and clofarabine as per the dose-escalation scheme above.

PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I 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 Start Date : February 2005
Actual Primary Completion Date : January 7, 2015
Actual Study Completion Date : January 7, 2015

Primary Outcome Measures :
  1. Response rate
  2. Safety profile and tolerability

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00295841

United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study Chair: Bayard L. Powell, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences Identifier: NCT00295841     History of Changes
Other Study ID Numbers: CDR0000466307
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: September 2015

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
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)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs