Status:
UNKNOWN
The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia
Lead Sponsor:
Sun Yat-sen University
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 16 years
Phase:
PHASE4
Brief Summary
The Guangdong work group of childhood acute lymphoblastic leukemia (ALL) therapy was set up in October 2002. The investigators treated the childhood ALL with a GZ2002 protocol since the year 2002, and...
Detailed Description
The modification includes: 1. In the induction phase, the agent of dexamethasone 6 mg/m2 is used instead of prednisone after prednisone prophase. 2. The phase "CAM" is 2 weeks for SR patients and 4 w...
Eligibility Criteria
Inclusion
- 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) \[MLL/AF4+\].
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00846703
Start Date
July 1 2008
End Date
December 1 2018
Last Update
March 8 2010
Active Locations (1)
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1
The second affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000