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Chemotherapy in Treating Children With Recurrent Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003178
First Posted: January 27, 2003
Last Update Posted: July 25, 2014
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose

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 idarubicin and cladribine in treating children who have recurrent acute myeloid leukemia.


Condition Intervention Phase
Leukemia Biological: filgrastim Drug: cladribine Drug: idarubicin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Idarubicin and Cladribine in Recurrent and Refractory Acute Myeloid Leukemia: A POG Phase II Study

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event Free Survival
    EFS will be estimated by Kaplan-Meier31 method. Prognostic factor analyses will be performed descriptively due to the limited sample size.


Enrollment: 120
Study Start Date: March 1998
Study Completion Date: March 2007
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1st Untreated Relapse for AML
Patients receive idarubicin IV over 15 minutes on days 1-3, cladribine IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts have recovered for 2 days. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response after completion of course 1 may proceed to other chemotherapy or bone marrow transplantation at the discretion of the protocol investigator. Patients with extramedullary disease may receive intrathecal chemotherapy or radiotherapy to symptomatic sites.
Biological: filgrastim
Other Names:
  • Granulocyte Colony-Stimulating Factor
  • r-metHuG-CSF
  • G-CSF
  • Neupogen®
  • NSC #614629
Drug: cladribine
Other Names:
  • 2-chlorodeoxyadenosine
  • CDA
  • Leustatin
  • NSC #105014)
Drug: idarubicin
Other Names:
  • 4-demethoxydaunorubicin
  • Idamycin
  • NSC#256439)
Experimental: Primary Refractory AML
Patients receive idarubicin IV over 15 minutes on days 1-3, cladribine IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts have recovered for 2 days. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response after completion of course 1 may proceed to other chemotherapy or bone marrow transplantation at the discretion of the protocol investigator. Patients with extramedullary disease may receive intrathecal chemotherapy or radiotherapy to symptomatic sites.
Biological: filgrastim
Other Names:
  • Granulocyte Colony-Stimulating Factor
  • r-metHuG-CSF
  • G-CSF
  • Neupogen®
  • NSC #614629
Drug: cladribine
Other Names:
  • 2-chlorodeoxyadenosine
  • CDA
  • Leustatin
  • NSC #105014)
Drug: idarubicin
Other Names:
  • 4-demethoxydaunorubicin
  • Idamycin
  • NSC#256439)
Experimental: MDS
Patients receive idarubicin IV over 15 minutes on days 1-3, cladribine IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts have recovered for 2 days. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response after completion of course 1 may proceed to other chemotherapy or bone marrow transplantation at the discretion of the protocol investigator. Patients with extramedullary disease may receive intrathecal chemotherapy or radiotherapy to symptomatic sites.
Biological: filgrastim
Other Names:
  • Granulocyte Colony-Stimulating Factor
  • r-metHuG-CSF
  • G-CSF
  • Neupogen®
  • NSC #614629
Drug: cladribine
Other Names:
  • 2-chlorodeoxyadenosine
  • CDA
  • Leustatin
  • NSC #105014)
Drug: idarubicin
Other Names:
  • 4-demethoxydaunorubicin
  • Idamycin
  • NSC#256439)

Detailed Description:

OBJECTIVES:

  • Determine the complete response rate in children with primary refractory or recurrent acute myeloid leukemia (AML) or secondary AML treated with idarubicin and cladribine. (Refractory AML stratum closed as of 4/3/01) (Secondary AML stratum closed as of 04/02/02)
  • Compare the remission reinduction rates in children who relapse at 1 year or earlier vs more than 1 year from time of initial remission.
  • Determine the toxic effects of this regimen in this patient population.

OUTLINE: Patients are stratified according to disease characteristics (primary or secondary acute myeloid leukemia (AML) with first untreated relapse vs primary refractory AML). (Refractory AML stratum closed as of 4/3/01) (Secondary AML stratum closed as of 04/02/02)

Patients receive idarubicin IV over 15 minutes on days 1-3, cladribine IV over 2 hours on days 1-5, and filgrastim (G-CSF) subcutaneously beginning on day 6 and continuing until blood counts have recovered for 2 days. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response after completion of course 1 may proceed to other chemotherapy or bone marrow transplantation at the discretion of the protocol investigator. Patients with extramedullary disease may receive intrathecal chemotherapy or radiotherapy to symptomatic sites.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 51-102 patients will be accrued for this study within 3 years.

  Eligibility

Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS:

  • One of the following diagnoses:

    • Acute myeloid leukemia (AML) (FAB M0-M7)
    • Secondary AML in first relapse (Secondary AML stratum closed as of 04/02/02)
    • AML in primary induction failure (Refractory AML stratum closed as of 04/03/01)
    • Myelodysplastic syndromes (MDS) (not related to Down syndrome) (MDS stratum closed as of 04/03/01)
  • Extramedullary disease allowed
  • Relapse more than 6 months after allogeneic or autologous bone marrow transplantation allowed

PATIENT CHARACTERISTICS:

Age:

  • Under 21 at diagnosis

Performance status:

  • Karnofsky 50-100% (over 10 years)
  • Lansky 50-100% (10 years and under)

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • ALT less than 3 times normal

Renal:

  • Creatinine less than 2 times normal

Cardiovascular:

  • Shortening fraction greater than 29%
  • Ejection fraction greater than 55% with normal wall motion

Other:

  • No uncontrolled infection
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • At least 12 weeks since prior idarubicin and recovered
  • At least 2 weeks since other prior chemotherapy and recovered

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
  Contacts and Locations
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): NCT00003178


  Show 235 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Craig A. Hurwitz, MD Maine Children's Cancer Program at Barbara Bush Children's Hospital
  More Information

Publications:
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00003178     History of Changes
Other Study ID Numbers: 9720
COG-P9720 ( Other Identifier: Children's Oncology Group )
POG-9720 ( Other Identifier: Pediatric Oncology Group )
CDR0000065993 ( Other Identifier: Clinical Trials.gov )
First Submitted: June 2, 2000
First Posted: January 27, 2003
Last Update Posted: July 25, 2014
Last Verified: July 2014

Keywords provided by Children's Oncology Group:
recurrent childhood acute myeloid leukemia
childhood acute myeloblastic leukemia without maturation (M1)
childhood acute myeloblastic leukemia with maturation (M2)
childhood acute promyelocytic leukemia (M3)
childhood acute myelomonocytic leukemia (M4)
childhood acute monoblastic leukemia (M5a)
childhood acute monocytic leukemia (M5b)
childhood acute erythroleukemia (M6)
childhood acute megakaryocytic leukemia (M7)
childhood acute minimally differentiated myeloid leukemia (M0)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Lenograstim
Cladribine
Idarubicin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents