Completed

Idarubicin and Cladribine in Recurrent and Refractory Acute Myeloid Leukemia: A POG Phase II Study

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What is being tested

filgrastim

+ cladribine

+ idarubicin

BiologicalDrug
Who is being recruted

Hematologic Diseases+2

+ Hemic and Lymphatic Diseases

+ Neoplasms

Until 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 1998
See protocol details

Summary

Principal SponsorChildren's Oncology Group
Last updated: July 25, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00003178
Principal SponsorChildren's Oncology Group
Last updated: July 25, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasmsNeoplasms by Histologic TypeLeukemia

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Experimental
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.

Group III

Experimental
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 235 locations

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, United StatesOpen University of Alabama at Birmingham Comprehensive Cancer Center in Google Maps

University of South Alabama Medical Center

Mobile, United States

Phoenix Children's Hospital

Phoenix, United States

Arizona Cancer Center

Tucson, United States
Completed235 Study Centers