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Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia

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ClinicalTrials.gov Identifier: NCT00006462
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 20, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating children who have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Drug: gemcitabine hydrochloride Phase 2

Detailed Description:


  • Determine the response rate in children with relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia treated with gemcitabine.
  • Assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease histology (acute lymphoblastic leukemia vs acute myelogenous leukemia).

Patients receive gemcitabine IV over 6 hours weekly for 3 weeks. Treatment repeats every 4 weeks for a maximum of 2 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 10-20 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine (NSC #613327) in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
Study Start Date : April 2001
Primary Completion Date : August 2003
Study Completion Date : September 2006

Arm Intervention/treatment
Experimental: Relapsed acute lymphoblastic and acute Myelogenous leukemia
Gemcitabine hydrochloride will be given as 10 mg/m2/min x 360 minutes weekly for three weeks. After a one-week rest period it may be repeated in patients without progressive disease or limiting toxicity.
Drug: gemcitabine hydrochloride
Other Name: NSC 613327

Primary Outcome Measures :
  1. Determine the response rate to Gemcitabine
    To determine the response rate to Gemcitabine administered as 10 mg/m2/min x 360 minutes weekly for 3 weeks in patients with relapsed acute lymphoblastic and acute myelogenous leukemia.

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of relapsed acute lymphoblastic leukemia or acute myelogenous leukemia

    • M3 marrow (at least 25% blasts in bone marrow aspirate)
    • Refractory to conventional therapy



  • 21 and under at diagnosis

Performance status:

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy:

  • At least 2 months


  • Not specified


  • Bilirubin normal
  • SGOT or SGPT no greater than 2.5 times upper limit of normal


  • Creatinine normal OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • No concurrent immunomodulating agents


  • At least 2 weeks since prior chemotherapy
  • No other concurrent chemotherapy for cancer

Endocrine therapy:

  • No concurrent corticosteroids except for treatment of adrenal crises with suppressed pituitary/adrenal response
  • Concurrent low-dose hydrocortisone (less than 100 mg/m2) allowed for allergic reactions to amphotericin or transfusions


  • Concurrent radiotherapy to localized painful lesions allowed


  • Not specified


  • Recovered from any 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): NCT00006462

  Show 225 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Anne Angiolillo, MD Children's Research Institute

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00006462     History of Changes
Other Study ID Numbers: ADVL0022
COG-ADVL0022 ( Other Identifier: Children's Oncology Group )
CCG-A0999 ( Other Identifier: Children's Cancer Group )
CDR0000068271 ( Other Identifier: Clinical Trials.gov )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 20, 2014
Last Verified: February 2014

Keywords provided by Children's Oncology Group:
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myeloid, Acute
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
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs