Risk-Adjusted Combination Chemotherapy in Treating Young Patients With Acute Lymphoblastic Leukemia
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| Czech Republic | |
| University Hospital Motol | Recruiting |
| Prague, Czech Republic, 150 06 | |
| Contact: Jan Stary, MD 420-2-2443-6401 jan.stary@lfmotol.cuni.cz | |
| Principal Investigator: | Jan Stary, MD | University Hospital, Motol |
More Information
Additional Information:
No publications provided
| 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 May 16, 2013