Clinical Study of GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia in Guangdong Province
N/A
16 Years
Both
Acute Lymphoblastic Leukemia
Trial Information
Clinical Study of GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia in Guangdong Province
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 weeks for IR and HR
patients,respectively.
3. Both the SR and IR treatments involve the protocol mM /M (8 weeks) in the phase of
consolidation. However, the folinic acid rescue starts at 36 hours instead of 42 hours.
The type of HR enters the block treatment the same with the BFM protocol.
4. There is not randomized study in delayed intensification. The GD-2008 ALL protocol uses
the same protocol II with the BFM study.
5. The randomized study focus on the phase of maintenance. The maintenance A is the same
with the BFM protocol, while the maintenance B consists of 6mp/MTX and VCR/
dexamethasone. The cycle is 8 weeks: VCR at d1, Dexamethasone at d2 to d7, 6mp from d8
to d56, and MTX at d9,d16, d23, d30, d37,d44,d51.
6. The GD-2008 ALL protocol for HR patients use the re-blocks and protocol II phases.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
The improvement of safety in the treatment protocol
Outcome Time Frame:
Two months
Safety Issue:
Yes
Principal Investigator
Jianpei Fang, M.D.
Investigator Role:
Study Director
Investigator Affiliation:
The second affiliated hospital of Sun Yat-sen University
Authority:
China: Ministry of Health
Study ID:
2007016
NCT ID:
NCT00846703
Start Date:
July 2008
Completion Date:
December 2018
Related Keywords:
- Acute Lymphoblastic Leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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