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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00343369
First received: June 22, 2006
Last updated: August 23, 2013
Last verified: June 2006
  Purpose

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 [ 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

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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 ClinicalTrials.gov identifier: NCT00343369

Locations
Germany
Evangelisches Krankenhauus Bielfeld
Biefeld, Germany, 33617
Klinikum Bremen-Mitte
Bremen, Germany, D-28205
Universitaetsklinikum Duesseldorf
Duesseldorf, Germany, D-40225
Universitats - Kinderklinik
Greiswald, Germany, 17487
University Medical Center Hamburg - Eppendorf
Hamburg, Germany, D-20246
Kreskrankenhaus Kinderabteilung
Heide, Germany, 25746
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, Germany, D-55743
Klinikum Krefeld GmbH
Krefeld, Germany, D-47805
Universitaets - Kinderklinik
Leipzig, Germany, D-04317
Johannes Gutenberg University
Mainz, Germany, D-55101
Krankenhaus Neuwerk Klinik fuer Kinder und Jugendmedizin
Moenchengladbach, Germany, D-41066
Dr. von Haunersches Kinderspital der Universitaet Muenchen
Munich, Germany, D-80337
Staedtisches Krankenhaus Muenchen - Harlaching
Munich, Germany, D-81545
Klinik St. Hedwig-Kinderklinik
Regensburg, Germany, 93049
Dr. Horst-Schmidt-Kliniken
Wiesbaden, Germany, D-65199
Helios Kliniken Wuppertal University Hospital
Wuppertal, Germany, D-42283
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Study Chair: Gritta Janka-Schaub Universitätsklinikum Hamburg-Eppendorf
  More Information

ClinicalTrials.gov 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
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Prednisolone
Liposomal doxorubicin
Pegaspargase
Cyclophosphamide
Methotrexate
Doxorubicin
Vincristine
Cytarabine
Teniposide
Daunorubicin
Thioguanine
6-Mercaptopurine
Asparaginase
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on December 09, 2016