Trial record 50 of 88 for: "Acute Lymphoblastic Leukemia, Childhood" | "Antineoplastic Agents, Hormonal"

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Risk-Adjusted Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00764907

Recruitment Status : Unknown

Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting

First Posted : October 2, 2008

Last Update Posted : July 8, 2009

Sponsor:

Information provided by:

National Cancer Institute (NCI)

Study Description

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. 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 or disease	Intervention/treatment	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

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	4000 participants
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
Study Start Date :	November 2002
Estimated Primary Completion Date :	October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Lymphocytic Leukemia Leukemia

Genetic and Rare Diseases Information Center resources: Acute Lymphoblastic Leukemia Childhood Acute Lymphoblastic Leukemia Lymphosarcoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

Disease-free survival
Event-free survival
Overall survival

Eligibility Criteria

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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

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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

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Principal Investigator:	Jan Stary, MD	University Hospital, Motol

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zuna J, Moericke A, Arens M, Koehler R, Panzer-Grümayer R, Bartram CR, Fischer S, Fronkova E, Zaliova M, Schrauder A, Stanulla M, Zimmermann M, Trka J, Stary J, Attarbaschi A, Mann G, Schrappe M, Cario G. Implications of delayed bone marrow aspirations at the end of treatment induction for risk stratification and outcome in children with acute lymphoblastic leukaemia. Br J Haematol. 2016 Jun;173(5):742-8. doi: 10.1111/bjh.13989. Epub 2016 Feb 23.

Stary J, Zimmermann M, Campbell M, Castillo L, Dibar E, Donska S, Gonzalez A, Izraeli S, Janic D, Jazbec J, Konja J, Kaiserova E, Kowalczyk J, Kovacs G, Li CK, Magyarosy E, Popa A, Stark B, Jabali Y, Trka J, Hrusak O, Riehm H, Masera G, Schrappe M. Intensive chemotherapy for childhood acute lymphoblastic leukemia: results of the randomized intercontinental trial ALL IC-BFM 2002. J Clin Oncol. 2014 Jan 20;32(3):174-84. doi: 10.1200/JCO.2013.48.6522. Epub 2013 Dec 16.

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ClinicalTrials.gov Identifier:	NCT00764907 History of Changes
Other Study ID Numbers:	CDR0000613220 MOTOL-ALL-IC-BFM-2002 EU-20871
First Posted:	October 2, 2008 Key Record Dates
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:

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

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