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Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE June 22, 2006
First Posted Date  ICMJE June 23, 2006
Last Update Posted Date August 26, 2013
Study Start Date  ICMJE January 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00343369 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia
Official Title  ICMJE Multicentric Study for the Treatment of Children With Acute Lymphoblastic Leukemia
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.

Detailed Description

OBJECTIVES:

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE Leukemia
Intervention  ICMJE
  • 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 Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 8, 2006)
550
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00343369
Other Study ID Numbers  ICMJE CDR0000455738
GER-COALL-07-03
EU-205104
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Universitätsklinikum Hamburg-Eppendorf
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Gritta Janka-Schaub Universitätsklinikum Hamburg-Eppendorf
PRS Account National Cancer Institute (NCI)
Verification Date June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP