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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University Identifier:
First received: February 23, 2006
Last updated: August 5, 2014
Last verified: August 2014

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 Intervention Phase
Drug: clofarabine
Drug: cytarabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Safety profile and tolerability [ Designated as safety issue: Yes ]

Enrollment: 53
Study Start Date: February 2005
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00295841

United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Study Chair: Bayard L. Powell, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University Identifier: NCT00295841     History of Changes
Other Study ID Numbers: CDR0000466307, CCCWFU-21204, ILEX-CCCWFU-21204, CCCWFU-BG04-519
Study First Received: February 23, 2006
Last Updated: August 5, 2014
Health Authority: United States: Federal Government

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
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, Lymphoid
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 25, 2014