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Risk-Adjusted 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 July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00764907
First Posted: October 2, 2008
Last Update Posted: July 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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
  • Event-free survival
  • Overall survival

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: October 1, 2008
First Posted: October 2, 2008
Last Update Posted: July 8, 2009
Last Verified: July 2009

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
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Prednisone
Liposomal doxorubicin
Cyclophosphamide
Doxorubicin
Methotrexate
Etoposide
Cytarabine
Vincristine
Ifosfamide
Daunorubicin
Asparaginase
6-Mercaptopurine
Thioguanine
Vindesine
Levoleucovorin
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs