Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia

NCT00049569 | Completed

• 5 other identifiers: NCI-2012-01798COG-AALL01P2CDR0000258120AALL01P2U10CA098543
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining more than one chemotherapy drug with imatinib mesylate may kill more cancer cells. Randomized phase II trial to study the effectiveness of combination chemotherapy and imatinib mesylate in treating children who have relapsed acute lymphoblastic leukemia.

Conditions

L1 Childhood Acute Lymphoblastic Leukemia; L2 Childhood Acute Lymphoblastic Leukemia; Non-T, Non-B Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Lymphoblastic Leukemia; T-cell Childhood Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (2)

• Feasibility assessed by excessive early deaths, induction failures, and early relapses

  Up to 4 months

• Toxicity assessed using CTC version 2.0

  Will be tabulated in detail.

  Up to 4 months

Secondary Outcomes (5)

• Overall remission reinduction (CR2) rate

  Up to 4 months

• EFS

  4 months

• MRD

  Up to 4 months

• Feasibility of combining intensive re-induction therapy with imatinib mesylate

  Up to 4 months

• Percentage of patients who were able to complete the triple re-induction therapy with imatinib mesylate

  Up to 4 months

Study Arms (2)

Arm I

EXPERIMENTAL

See detailed description.

Drug: cytarabine; Drug: methotrexate; Drug: vincristine sulfate; Drug: prednisone; Drug: pegaspargase; Drug: doxorubicin hydrochloride; Drug: imatinib mesylate; Drug: cyclophosphamide; Drug: etoposide; Biological: filgrastim; Drug: leucovorin calcium; Drug: asparaginase

Arm II

EXPERIMENTAL

See detailed description.

Drug: cytarabine; Drug: methotrexate; Drug: vincristine sulfate; Drug: prednisone; Drug: pegaspargase; Drug: doxorubicin hydrochloride; Drug: imatinib mesylate; Drug: cyclophosphamide; Drug: etoposide; Biological: filgrastim; Drug: leucovorin calcium; Drug: asparaginase; Drug: therapeutic hydrocortisone

Interventions

cytarabine DRUG

Given IT

Arm I; Arm II

methotrexate DRUG

Given IT

Arm I; Arm II

vincristine sulfate DRUG

Given IV

Arm I; Arm II

prednisone DRUG

Given PO

Arm I; Arm II

pegaspargase DRUG

Given IM

Arm I; Arm II

doxorubicin hydrochloride DRUG

Given IV

Arm I; Arm II

imatinib mesylate DRUG

Given PO

Arm I; Arm II

cyclophosphamide DRUG

Given IV

Arm I; Arm II

etoposide DRUG

Given IV

Arm I; Arm II

filgrastim BIOLOGICAL

Given SC

Arm I; Arm II

leucovorin calcium DRUG

Given IV

Arm I; Arm II

asparaginase DRUG

Given IM

Arm I; Arm II

therapeutic hydrocortisone DRUG

Given IT

Arm II

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with acute lymphoblastic leukemia (ALL) in first relapse involving the bone marrow (M3 marrow), with or without associated extramedullary disease; this includes patients who are Philadelphia chromosome-positive
• Shortening fraction of \>= 28% by echocardiogram, or ejection fraction of \>= 50% by gated radionuclide study
• Cumulative prior anthracycline exposure of =\< 350 mg/m\^2 (each 10 mg/m\^2 dose of idarubicin should be calculated as the isotoxic equivalent of 50 mg/m\^2 of daunorubicin or adriamycin)
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

You may not qualify if:

• Patients with B-cell ALL (L3 morphology or evidence of myc translocation by molecular or cytogenetic technique) are not eligible
• Patients with Down syndrome are excluded due to the administration of methotrexate in Block 2
• Patients who have undergone prior stem cell transplantation (SCT) are ineligible if:
• They received SCT less than 12 months prior to study entry
• They are still receiving immunosuppression for the treatment of graft-versus-host disease (GVHD)
• They have active fungal infection at time of study entry
• They have had invasive filamentous fungal infection at any time post-SCT
• Pregnant or lactating females are ineligible as the medications used in this protocol could be harmful to unborn children and infants
• Patients with prior isolated extramedullary relapse are ineligible

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cytarabine; Methotrexate; Vincristine; Prednisone; pegaspargase; Doxorubicin; Imatinib Mesylate; Cyclophosphamide; Etoposide; Filgrastim; Leucovorin; Asparaginase; Hydrocortisone

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Aminoglycosides; Glycosides; Carbohydrates; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Piperazines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Coenzymes; Enzymes and Coenzymes; Amidohydrolases; Hydrolases; Enzymes; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Elizabeth Raetz

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2003
• Primary Completion: March 1, 2006
• Last Updated: October 8, 2013

Record last verified: 2013-10

Locations

US (1)