Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia

NCT00343369 | Unknown

• 3 other identifiers: CDR0000455738GER-COALL-07-03EU-205104
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 16

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with acute lymphoblastic leukemia.

Conditions

Leukemia

Keywords

B-cell childhood acute lymphoblastic leukemia; recurrent childhood acute lymphoblastic leukemia; T-cell childhood acute lymphoblastic leukemia; untreated childhood acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (4)

• Dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride

• Reduce therapy in low-risk patients without loss of efficacy

• Reduce neurological complications

• Reduce allergic reactions against asparaginase

Interventions

asparaginase DRUG

cyclophosphamide DRUG

cytarabine DRUG

daunorubicin hydrochloride DRUG

dexamethasone DRUG

doxorubicin hydrochloride DRUG

mercaptopurine DRUG

methotrexate DRUG

pegaspargase DRUG

prednisolone DRUG

teniposide DRUG

thioguanine DRUG

vincristine sulfate DRUG

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosed with acute B-precursor or T-cell acute lymphoblastic leukemia (ALL) * Meets 1 of the following risk criteria: * Low-risk disease, defined by any of the following: * WBC \< 25/nL * B-precursor ALL * Excluding pro-B ALL * High-risk disease, defined by any of the following: * WBC ≥ 25/nL * T-cell ALL or pro-B ALL * Chromosomal translocation 4/11 PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * More than 7 days since prior therapy with steroids, vincristine, or daunorubicin hydrochloride * More than 7 days since prior cytotoxic therapy

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (16)

Evangelisches Krankenhauus Bielfeld

Biefeld, 33617, Germany

RECRUITING

Klinikum Bremen-Mitte

Bremen, D-28205, Germany

RECRUITING

Universitaetsklinikum Duesseldorf

Düsseldorf, D-40225, Germany

RECRUITING

Universitats - Kinderklinik

Greiswald, 17487, Germany

RECRUITING

University Medical Center Hamburg - Eppendorf

Hamburg, D-20246, Germany

RECRUITING

Kreskrankenhaus Kinderabteilung

Heide, 25746, Germany

RECRUITING

Clinic for Bone Marrow Transplantation and Hematology and Oncology

Idar-Oberstein, D-55743, Germany

RECRUITING

Klinikum Krefeld GmbH

Krefeld, D-47805, Germany

RECRUITING

Universitaets - Kinderklinik

Leipzig, D-04317, Germany

RECRUITING

Johannes Gutenberg University

Mainz, D-55101, Germany

RECRUITING

Krankenhaus Neuwerk Klinik fuer Kinder und Jugendmedizin

Mönchengladbach, D-41066, Germany

RECRUITING

Dr. von Haunersches Kinderspital der Universitaet Muenchen

Munich, D-80337, Germany

RECRUITING

Staedtisches Krankenhaus Muenchen - Harlaching

Munich, D-81545, Germany

RECRUITING

Klinik St. Hedwig-Kinderklinik

Regensburg, 93049, Germany

RECRUITING

Dr. Horst-Schmidt-Kliniken

Wiesbaden, D-65199, Germany

RECRUITING

Helios Kliniken Wuppertal University Hospital

Wuppertal, D-42283, Germany

RECRUITING

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Doxorubicin; Mercaptopurine; Methotrexate; pegaspargase; Prednisolone; Teniposide; Thioguanine; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; 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; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Sulfhydryl Compounds; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aminopterin; Pterins; Pteridines; Glucosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Therapeutics

Study Officials

• Gritta Janka-Schaub

  Universitätsklinikum Hamburg-Eppendorf

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2006
• First Posted: June 23, 2006
• Study Start: January 1, 2003
• Last Updated: August 26, 2013

Record last verified: 2006-06

Locations

DE (16)