Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia
NCT ID: NCT00343369
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
550 participants
INTERVENTIONAL
2003-01-31
Brief Summary
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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.
Detailed Description
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* Determine the dose of daunorubicin hydrochloride that is equivalent to 30 mg/m² of doxorubicin hydrochloride in pediatric patients with acute lymphoblastic leukemia (ALL).
* Determine whether it is possible to reduce therapy in pediatric patients with low-risk ALL and a PVA (prednisolone-vincristine-asparaginase) score of 3+4 without loss of efficacy.
* Investigate the role of single nucleotide polymorphisms of infection defense gene for infectious complications during therapy in these patients.
* Reduce neurological complications by reducing doses of intrathecal methotrexate.
* Reduce allergic reactions against asparaginase (ASP) by using pegaspargase after E. coli ASP.
OUTLINE: This is a randomized, multicenter study.
* Prephase: Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive doxorubicin hydrochloride IV once.
* Arm II: Patients receive daunorubicin hydrochloride IV once.
* Arm III: Patients receive daunorubicin hydrochloride IV once at a higher dose than in arm II.
* Induction phase: All patients receive vincristine IV 4 times weekly, daunorubicin hydrochloride IV 3 times weekly, and oral prednisolone daily for 4 weeks.
* Intensive phase: Patients are stratified according to risk (low vs high).
* Low-risk disease\*: Patients receive 4 courses of methotrexate IV and asparaginase intramuscularly (IM).
* High-risk disease\*: Patients receive 6 courses of cyclophosphamide IV, methotrexate IV, and asparaginase IM.
All patients also receive methotrexate IV, teniposide IV, cytarabine IV, high-dose cytarabine IV, and asparaginase IM after completion of the above regimen.
* CNS phase: All patients receive intrathecal (IT) methotrexate for 3 doses and oral mercaptopurine for 4 weeks. Patients with T-cell acute lymphoblastic leukemia or patients who have blasts in cerebrospinal fluid at diagnosis or whose WBC \> 200/nL at diagnosis OR whose WBC between 100-200/nL at diagnosis and blasts \> 1/nL after prephase chemotherapy undergo cranial irradiation.
* Reinduction phase: Patients are stratified according to risk (low vs high)
* Low-risk disease\*: Patients receive 2 courses of doxorubicin hydrochloride IV, vincristine IV, and oral dexamethasone; pegaspargase IM once; and 1 course of cyclophosphamide IV, cytarabine IV, and oral thioguanine.
* High-risk disease\*: Patients receive 4 courses of doxorubicin hydrochloride IV, vincristine IV, and oral dexamethasone; pegaspargase IM twice; and 2 courses of cyclophosphamide IV, cytarabine IV, and oral thioguanine.
* Maintenance phase: All patients receive oral mercaptopurine daily and methotrexate IV once weekly for up to 2 years after diagnosis.
NOTE: \*In addition to those defined in Disease Characteristics, patients who do not achieve remission after induction phase are treated as high-risk disease, patients who achieve remission after induction phase are treated as low-risk disease
PROJECTED ACCRUAL: A total of 550 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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asparaginase
cyclophosphamide
cytarabine
daunorubicin hydrochloride
dexamethasone
doxorubicin hydrochloride
mercaptopurine
methotrexate
pegaspargase
prednisolone
teniposide
thioguanine
vincristine sulfate
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
1 Year
18 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Principal Investigators
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Gritta Janka-Schaub
Role: STUDY_CHAIR
Universitätsklinikum Hamburg-Eppendorf
Locations
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Evangelisches Krankenhauus Bielfeld
Biefeld, , Germany
Klinikum Bremen-Mitte
Bremen, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Universitats - Kinderklinik
Greiswald, , Germany
University Medical Center Hamburg - Eppendorf
Hamburg, , Germany
Kreskrankenhaus Kinderabteilung
Heide, , Germany
Clinic for Bone Marrow Transplantation and Hematology and Oncology
Idar-Oberstein, , Germany
Klinikum Krefeld GmbH
Krefeld, , Germany
Universitaets - Kinderklinik
Leipzig, , Germany
Johannes Gutenberg University
Mainz, , Germany
Krankenhaus Neuwerk Klinik fuer Kinder und Jugendmedizin
Mönchengladbach, , Germany
Dr. von Haunersches Kinderspital der Universitaet Muenchen
Munich, , Germany
Staedtisches Krankenhaus Muenchen - Harlaching
Munich, , Germany
Klinik St. Hedwig-Kinderklinik
Regensburg, , Germany
Dr. Horst-Schmidt-Kliniken
Wiesbaden, , Germany
Helios Kliniken Wuppertal University Hospital
Wuppertal, , Germany
Countries
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Facility Contacts
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N. Jorch, MD
Role: primary
Arnulf Pekrun, MD, PhD
Role: primary
Contact Person
Role: primary
James F. Beck, MD
Role: primary
Gritta Janka-Schaub
Role: primary
Streitberger
Role: primary
Wenzel Nuernberger, MD, PhD
Role: primary
P. Thomas
Role: primary
Dieter Koerholz, MD
Role: primary
P. Gutjahr, MD
Role: primary
Wolfgang Mueller, MD
Role: primary
Arndt Borkhardt
Role: primary
Papucek
Role: primary
Ove Peters
Role: primary
Gerhard Beron, MD
Role: primary
B. Dohrn, MD
Role: primary
Other Identifiers
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GER-COALL-07-03
Identifier Type: -
Identifier Source: secondary_id
EU-205104
Identifier Type: -
Identifier Source: secondary_id
CDR0000455738
Identifier Type: -
Identifier Source: org_study_id