Risk-Adjusted 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 July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00764907
First received: October 1, 2008
Last updated: July 7, 2009
Last verified: July 2009
  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. A donor stem cell transplant may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving combination chemotherapy before the transplant helps stop the growth of cancer cells and stop the patient's immune system from rejecting the donor's stem cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is studying different risk-adjusted combination chemotherapy regimens in treating young patients with acute lymphoblastic leukemia.


Condition Intervention Phase
Leukemia
Drug: asparaginase
Drug: cyclophosphamide
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: ifosfamide
Drug: leucovorin calcium
Drug: mercaptopurine
Drug: methotrexate
Drug: prednisone
Drug: thioguanine
Drug: vincristine sulfate
Drug: vindesine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Trial of the I-BFM-SG for the Management of Childhood Non-B Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: November 2002
Estimated Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
During reinduction, patients receive 1 course of protocol II.
Drug: asparaginase
Given IV during reinduction
Drug: cyclophosphamide
Given IV during reinduction
Drug: cytarabine
Given IV during reinduction
Drug: dexamethasone
Given IV or orally during reinduction
Drug: doxorubicin hydrochloride
Given IV during reinduction
Drug: methotrexate
Given orally during reinduction
Drug: thioguanine
Given orally during reinduction
Drug: vincristine sulfate
Given IV during reinduction
Experimental: Arm II
During reinduction, patients receive 2-3 course of protocol III and interim maintenance therapy.
Drug: asparaginase
Given IV during reinduction
Drug: cyclophosphamide
Given IV during reinduction
Drug: cytarabine
Given IV during reinduction
Drug: dexamethasone
Given IV or orally during reinduction
Drug: doxorubicin hydrochloride
Given IV during reinduction
Drug: mercaptopurine
Given orally during reinduction
Drug: methotrexate
Given orally during reinduction
Drug: thioguanine
Given orally during reinduction
Drug: vincristine sulfate
Given IV during reinduction
Experimental: Arm III
During reinduction, patients are receive 2 courses of protocol II and interim maintenance therapy OR 3-block consolidation regimen and 1 course of protocol II.
Drug: asparaginase
Given IV during reinduction
Drug: cyclophosphamide
Given IV during reinduction
Drug: cytarabine
Given IV during reinduction
Drug: daunorubicin hydrochloride
Given IV during reinduction
Drug: dexamethasone
Given IV or orally during reinduction
Drug: doxorubicin hydrochloride
Given IV during reinduction
Drug: etoposide
Given IV during reinduction
Drug: ifosfamide
Given IV during reinduction
Drug: leucovorin calcium
Given IV during reinduction
Drug: mercaptopurine
Given orally during reinduction
Drug: methotrexate
Given orally during reinduction
Drug: prednisone
Given intrathecally during reinduction
Drug: thioguanine
Given orally during reinduction
Drug: vincristine sulfate
Given IV during reinduction
Drug: vindesine
Given IV during reinduction

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Cytologically proven acute lymphoblastic leukemia (ALL)
  • No relapse of a previously unrecognized ALL
  • Patients must meet one of the following risk criteria:

    • Standard-risk (SR) group meeting all of the following criteria:

      • Blasts < 1,000/μL in peripheral blood (PB) on day 8
      • Aged 1 to < 6 years
      • Initial WBC < 20,000/μL
      • M1 (5%) or M2 (≥ 5% to < 25%) blasts in bone marrow on day 15
      • M1 marrow on day 33
    • Intermediate-risk (IR) group meeting all of the following criteria:

      • Aged < 1 or ≥ 6 years and/or WBC ≥ 20,000/μL
      • Blasts < 1,000/μL in PB on day 8
      • M1 or M2 marrow on day 15
      • M3 (≥ 25%) marrow on day 15 OR meets SR criteria but M3 marrow on day 15 and M1 marrow on day 33
    • High-risk (HR) group meeting ≥ 1 of the following criteria:

      • Meets IR criteria and M3 marrow on day 15 (not SR and M3 on day 15)
      • Blasts ≥ 1,000/μL in PB on day 8
      • M2 or M3 marrow on day 33
      • Translocation t(9;22) [BCR/ABL+] (Philadelphia chromosome-positive) or t(4;11) [MLL/AF4+]
  • No secondary ALL

PATIENT CHARACTERISTICS:

  • No Down syndrome
  • No other major disease that prohibits study treatment (e.g., severe congenital heart disease)
  • Not requiring significant therapy modification owing to study therapy-associated complications
  • No complications due to other interventions
  • No one with missing data that are needed for the differential diagnosis, or for selection of the proper therapy arm

PRIOR CONCURRENT THERAPY:

  • No steroids or cytostatic drugs within four weeks prior to start of study 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: NCT00764907

Locations
Czech Republic
University Hospital Motol Recruiting
Prague, Czech Republic, 150 06
Contact: Jan Stary, MD    420-2-2443-6401    jan.stary@lfmotol.cuni.cz   
Sponsors and Collaborators
University Hospital, Motol
Investigators
Principal Investigator: Jan Stary, MD University Hospital, Motol
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00764907     History of Changes
Other Study ID Numbers: CDR0000613220, MOTOL-ALL-IC-BFM-2002, EU-20871
Study First Received: October 1, 2008
Last Updated: July 7, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
T-cell childhood acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Cytarabine
Methotrexate
Thioguanine
Cyclophosphamide
Isophosphamide mustard
Asparaginase
Daunorubicin
Dexamethasone
Doxorubicin
Etoposide
Ifosfamide
Prednisone
Vincristine
Vindesine
BB 1101
Dexamethasone acetate
Dexamethasone 21-phosphate
Leucovorin
Levoleucovorin
Antimetabolites

ClinicalTrials.gov processed this record on July 22, 2014