Imatinib Mesylate and Combination Chemotherapy With or Without a Donor Stem Cell Transplant in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

NCT00618501 | Completed Phase 2

• 3 other identifiers: CDR0000586176AMC-UUCM-2005-0238NOVARTIS-AMC-UUCM-2005-0238
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Imatinib mesylate may also stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known which treatment regimen is most effective in treating acute lymphoblastic leukemia. PURPOSE: This phase II trial is studying the side effects of giving imatinib mesylate together with combination chemotherapy with or without a donor stem cell transplant and to see how well it works in treating patients with newly diagnosed acute lymphoblastic leukemia.

Conditions

Leukemia

Keywords

untreated adult acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (3)

• Proportion of patients achieving hematologic and molecular complete response (CR) after induction chemotherapy and imatinib mesylate

• Duration of hematologic CR

• Durations of hematologic and molecular CR after hematopoietic stem cell transplantation

Secondary Outcomes (3)

• Overall survival

• Clinical toxicities

• Prognostic factors in patients treated with this regimen

Interventions

cytarabine DRUG

daunorubicin hydrochloride DRUG

etoposide DRUG

imatinib mesylate DRUG

leucovorin calcium DRUG

methotrexate DRUG

prednisolone DRUG

therapeutic hydrocortisone DRUG

vincristine sulfate DRUG

allogeneic hematopoietic stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Acute lymphoblastic leukemia (ALL) or acute mixed lineage leukemia * Newly diagnosed disease * Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia or Ph+ acute mixed lineage leukemia * Positive result for RT-PCR for Bcr-Abl transcript (Ph+ ALL or Philadelphia-chromosome positive acute mixed lineage leukemia) PATIENT CHARACTERISTICS: * Bilirubin \< 2 mg/dL * SGOT \< 3 times upper limit of normal * Creatinine \< 2.0 mg/dL * Ejection fraction \> 45% by MUGA scan * Not nursing * Fertile patients must use effective contraception * No known sensitivity to study drugs * No severe medical conditions that, in the view of the investigator, prohibits participation in the study PRIOR CONCURRENT THERAPY: * No other investigational agents in the past 30 days

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center - University of Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Leukemia

Interventions

Cytarabine; Daunorubicin; Etoposide; Imatinib Mesylate; Leucovorin; Methotrexate; Prednisolone; Hydrocortisone; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Piperazines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Aminopterin; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Kyoo H. Lee, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 20, 2008
• Study Start: October 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: March 26, 2013

Record last verified: 2009-01

Locations

KR (1)