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Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2006 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: June 23, 2006
Last Update Posted: August 26, 2013
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.
Information provided by:
National Cancer Institute (NCI)

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.

Condition Intervention
Leukemia Drug: 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 Radiation: radiation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Multicentric Study for the Treatment of Children With Acute Lymphoblastic Leukemia

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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

Estimated Enrollment: 550
Study Start Date: January 2003
  Show Detailed Description


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • Not specified


  • More than 7 days since prior therapy with steroids, vincristine, or daunorubicin hydrochloride
  • More than 7 days since prior cytotoxic therapy
  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): NCT00343369

Evangelisches Krankenhauus Bielfeld Recruiting
Biefeld, Germany, 33617
Contact: N. Jorch, MD    49-52-177-278-050      
Klinikum Bremen-Mitte Recruiting
Bremen, Germany, D-28205
Contact: Arnulf Pekrun, MD, PhD    49-421-497-3656    arnulf.pekrun@klinikum-bremen-mitte.de   
Universitaetsklinikum Duesseldorf Recruiting
Duesseldorf, Germany, D-40225
Contact: Contact Person    49-211-311-7990      
Universitats - Kinderklinik Recruiting
Greiswald, Germany, 17487
Contact: James F. Beck, MD    49-383-486-6325    beck@uni-greifswald.de   
University Medical Center Hamburg - Eppendorf Recruiting
Hamburg, Germany, D-20246
Contact: Gritta Janka-Schaub    49-404-2803-2580      
Kreskrankenhaus Kinderabteilung Recruiting
Heide, Germany, 25746
Contact: Streitberger    49-481-785-911      
Clinic for Bone Marrow Transplantation and Hematology and Oncology Recruiting
Idar-Oberstein, Germany, D-55743
Contact: Wenzel Nuernberger, MD, PhD    49-6781-66-1582    wnuernberger@bmt-center-io.com   
Klinikum Krefeld GmbH Recruiting
Krefeld, Germany, D-47805
Contact: P. Thomas    49-2151-322-375      
Universitaets - Kinderklinik Recruiting
Leipzig, Germany, D-04317
Contact: Dieter Koerholz, MD    49-341-9726-246    koerd@medizin.uni-leipzig.de   
Johannes Gutenberg University Recruiting
Mainz, Germany, D-55101
Contact: P. Gutjahr, MD    49-6131-17-2112      
Krankenhaus Neuwerk Klinik fuer Kinder und Jugendmedizin Recruiting
Moenchengladbach, Germany, D-41066
Contact: Wolfgang Mueller, MD    49-2161-668-2481      
Dr. von Haunersches Kinderspital der Universitaet Muenchen Recruiting
Munich, Germany, D-80337
Contact: Arndt Borkhardt    49-89-5160-4498      
Staedtisches Krankenhaus Muenchen - Harlaching Recruiting
Munich, Germany, D-81545
Contact: Papucek    49-89-6210-2710      
Klinik St. Hedwig-Kinderklinik Recruiting
Regensburg, Germany, 93049
Contact: Ove Peters    49-941-369-5404      
Dr. Horst-Schmidt-Kliniken Recruiting
Wiesbaden, Germany, D-65199
Contact: Gerhard Beron, MD    49-611-43-2564      
Helios Kliniken Wuppertal University Hospital Recruiting
Wuppertal, Germany, D-42283
Contact: B. Dohrn, MD    49-202-896-3823    bdohrn@wuppertal.helios-klinikum.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Study Chair: Gritta Janka-Schaub Universitätsklinikum Hamburg-Eppendorf
  More Information

ClinicalTrials.gov Identifier: NCT00343369     History of Changes
Other Study ID Numbers: CDR0000455738
First Submitted: June 22, 2006
First Posted: June 23, 2006
Last Update Posted: August 26, 2013
Last Verified: June 2006

Keywords provided by National Cancer Institute (NCI):
B-cell childhood acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
T-cell childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents