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Trial record 99 of 144 for:    "Acute promyelocytic leukemia"

Clofarabine and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Leukemia, Chronic Myelogenous Leukemia, or Myeloproliferative Disorders

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: NCT00293410
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : May 6, 2010
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as clofarabine and cyclophosphamide, 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 and cyclophosphamide in treating patients with relapsed or refractory acute leukemia, chronic myelogenous leukemia, or myeloproliferative disorders.

Condition or disease Intervention/treatment Phase
Chronic Myeloproliferative Disorders Leukemia Myelodysplastic/Myeloproliferative Diseases Drug: clofarabine Drug: cyclophosphamide Phase 1

Detailed Description:



  • Determine the feasibility and tolerability of administering clofarabine and fractionated cyclophosphamide in patients with relapsed or refractory acute leukemia, chronic myelogenous leukemia, or high-risk myeloproliferative disorders
  • Determine the maximum tolerated dose of clofarabine and fractionated cyclophosphamide in these patients.
  • Determine the toxic effects of these drugs in these patients.


  • Obtain preliminary data of biologic and pharmacodynamic effects of this regimen on marrow and circulating leukemic blasts in these patients.

OUTLINE: This is a dose-escalation study. Patients are stratified according to age (adult vs child).

Patients receive cyclophosphamide IV over 2 hours on day 0. Patients then receive clofarabine IV over 2 hours and cyclophosphamide IV over 2 hours on days 1-3 and 8-10. Treatment with clofarabine and cyclophosphamide repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of clofarabine and cyclophosphamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 10 patients are treated at the MTD.

After completion of study treatment, patients are followed periodically for 1 year.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Primary Purpose: Treatment
Official Title: Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Adults and Children With Relapsed or Refractory Acute Leukemias
Study Start Date : November 2005
Actual Primary Completion Date : April 2010

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed leukemia or myeloproliferative disorders, including 1 of the following:

    • Acute myeloid leukemia (AML) of any subtype

      • Treatment-related AML OR AML evolving from myeloproliferative disorders (MPD) or transformed from myelodysplastic syndrome
    • Acute lymphocytic leukemia
    • Acute progranulocytic leukemia

      • Must not be eligible for arsenic or retinoic acid therapy
    • Chronic myelogenous leukemia in accelerated phase or blast crisis
    • High-risk MPD, including any of the following:

      • Myelofibrosis
      • Chronic myelomonocytic leukemia with 5%-19% blasts
      • Relapsed or refractory juvenile myelomonocytic leukemia
  • Relapsed and/or refractory disease with progressive disease since last therapy

    • No more than 3 prior induction regimens with cytotoxic agents for adults
    • Must be in second relapse for patients < 21 years of age


  • ECOG performance status 0-2 (for adults) OR Lansky 50-100% (for pediatric patients)
  • Bilirubin ≤ 1.5 mg/dL (may be elevated due to hemolysis in adult patients)
  • AST and ALT ≤ 5 times upper limit of normal
  • Creatinine ≤ 2.0 mg/dL (for adults)
  • Normal renal function (for pediatric patients)
  • Cardiac function normal as measured by MUGA scan or echocardiogram
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for at least 6 months after completion of study treatment
  • HIV negative
  • No active graft-versus-host disease ≥ grade 2
  • No active, uncontrolled infection
  • No fever
  • No unstable CT scans of the lungs, sinuses, or abdomen within the past 4 weeks
  • No arrhythmias (other than atrial flutter or fibrillation) requiring medication
  • No dyspnea at rest or with minimal exertion
  • No uncontrolled congestive heart failure
  • No myocardial infarction within the past 3 months
  • No history of severe coronary artery disease
  • No other significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance or interfere with consent, study participation, follow up, or interpretation of study results


  • Must have recovered from all acute toxic effects from prior treatment
  • More than 30 days since prior investigational cytotoxic agents
  • At least 3 days since prior azacitidine, thalidomide, hydroxyurea, imatinib mesylate, or interferon
  • At least 1 week since prior growth factors except epoetin alfa
  • More than 3 weeks since any other prior anticancer therapy
  • No concurrent chemotherapy, radiotherapy, or immunotherapy
  • No other concurrent anticancer investigational or commercial agents
  • No routine prophylactic use of a colony-stimulating factor (filgrastim [G-CSF] or sargramostim [GM-CSF])

    • Therapeutic use of colony-stimulating factors may be considered at the discretion of the investigator
  • No prolonged use of corticosteroids to prevent or treat emesis or as a chemotherapeutic agent

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): NCT00293410

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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
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Study Chair: Judith E. Karp, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00293410     History of Changes
Other Study ID Numbers: J0561 CDR0000456431
P30CA006973 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: May 6, 2010
Last Verified: May 2010
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
adult acute promyelocytic leukemia (M3)
childhood acute promyelocytic leukemia (M3)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
recurrent adult acute myeloid leukemia
recurrent childhood acute myeloid leukemia
secondary acute myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
accelerated phase chronic myelogenous leukemia
chronic idiopathic myelofibrosis
chronic myelomonocytic leukemia
juvenile myelomonocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
acute undifferentiated leukemia
blastic phase chronic myelogenous leukemia
childhood chronic myelogenous leukemia
adult acute basophilic leukemia
adult acute eosinophilic leukemia
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)
adult erythroleukemia (M6a)
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic