Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: June 22, 2006
Last updated: August 23, 2013
Last verified: June 2006

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
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 [ Designated as safety issue: No ]
  • Reduce therapy in low-risk patients without loss of efficacy [ Designated as safety issue: No ]
  • Reduce neurological complications [ Designated as safety issue: No ]
  • Reduce allergic reactions against asparaginase [ Designated as safety issue: No ]

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


Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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   
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
Study Chair: Gritta Janka-Schaub Universitätsklinikum Hamburg-Eppendorf
  More Information Identifier: NCT00343369     History of Changes
Other Study ID Numbers: CDR0000455738  GER-COALL-07-03  EU-205104 
Study First Received: June 22, 2006
Last Updated: August 23, 2013
Health Authority: Unspecified

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:
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators processed this record on May 23, 2016