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Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma

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.
ClinicalTrials.gov Identifier: NCT00047021
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 11, 2010
National Cancer Institute (NCI)
Information provided by:
Case Comprehensive Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and mitoxantrone in treating patients who have recurrent or refractory leukemia or lymphoma.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: sargramostim Drug: cytarabine Drug: mitoxantrone hydrochloride Phase 2

Detailed Description:


  • Determine non-hematologic toxic effects of high-dose cytarabine and high-dose mitoxantrone in patients with recurrent or refractory leukemia or lymphoma.
  • Determine the in vitro T/NK lymphocyte proliferative responses to patient's leukemia/lymphoma cells before and after treatment with this regimen.

OUTLINE: Patients receive high-dose cytarabine IV over 1 hour on days 1-5 and high-dose mitoxantrone IV over 15-30 minutes on day 5. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.

Patients who achieve at least stable disease or a response may receive a second course beginning at least 14 days after the first course is completed.

Patients are followed for 3 months.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within approximately 2-3 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies
Study Start Date : November 2001
Primary Completion Date : August 2005
Study Completion Date : September 2005

Intervention Details:
    Biological: sargramostim
    Sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.
    Drug: cytarabine
    high-dose cytarabine IV over 1 hour on days 1-5
    Drug: mitoxantrone hydrochloride
    high-dose mitoxantrone IV over 15-30 minutes on day 5.

Primary Outcome Measures :
  1. Event free survival at day 14 (myeloid engraftment) [ Time Frame: day 14 ]

Secondary Outcome Measures :
  1. Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment [ Time Frame: followed for 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • One of the following must be present:

    • Histologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia

      • More than 5% blasts in the bone marrow or peripheral blood unrelated to recovery of normal hematopoiesis from prior chemotherapy
      • Failed at least 1 attempt at induction chemotherapy
    • Diagnosis of non-Hodgkin's lymphoma or Hodgkin's lymphoma

      • Refractory or relapsed after at least 1 regimen of standard chemotherapy
    • Diagnosis of chronic myelogenous leukemia in accelerated phase or blast crisis

      • Received at least 1 myelotoxic chemotherapy regimen
  • Active CNS involvement allowed



  • 55 and under

Performance status

  • ECOG 0-2

Life expectancy

  • At least 5 weeks


  • Lymphoma patients:

    • WBC at least 2,000/mm^3*
    • Platelet count at least 20,000/mm^3* NOTE: *Unless due to bone marrow involvement or disease process


  • Bilirubin no greater than 3 times normal*
  • AST/ALT no greater than 3 times normal*
  • Alkaline phosphatase no greater than 3 times normal*
  • No severe liver failure NOTE: *Unless related to leukemia


  • Creatinine clearance greater than 50 mL/min
  • No severe renal failure


  • LVEF at least 45% by MUGA


  • DLCO at least 60% of predicted


  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No psychiatric illness that would preclude informed consent
  • No medical illness or other condition that would preclude study participation


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • At least 24 hours since prior hydroxyurea
  • At least 1 week since other prior chemotherapy

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • Recovered from prior therapy

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 ClinicalTrials.gov identifier (NCT number): NCT00047021

United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-7284
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Mary J. Laughlin, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Responsible Party: Mary J. Laughlin, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00047021     History of Changes
Other Study ID Numbers: CWRU5Y01
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 2010

Keywords provided by Case Comprehensive Cancer Center:
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
recurrent childhood large cell lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent/refractory childhood Hodgkin lymphoma
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
childhood chronic myelogenous leukemia
atypical chronic myeloid leukemia
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Additional relevant MeSH terms:
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
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors