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Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia

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. Identifier: NCT00343369
Recruitment Status : Unknown
Verified June 2006 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : June 23, 2006
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Multicentric Study for the Treatment of Children With Acute Lymphoblastic Leukemia
Study Start Date : January 2003

Primary Outcome Measures :
  1. Dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride
  2. Reduce therapy in low-risk patients without loss of efficacy
  3. Reduce neurological complications
  4. Reduce allergic reactions against asparaginase

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT00343369

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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   
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   
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   
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   
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   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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Study Chair: Gritta Janka-Schaub Universitätsklinikum Hamburg-Eppendorf
Layout table for additonal information Identifier: NCT00343369    
Other Study ID Numbers: CDR0000455738
First Posted: June 23, 2006    Key Record Dates
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:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action