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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
The improvement of safety in the treatment protocol
Jianpei Fang, M.D.
The second affiliated hospital of Sun Yat-sen University
China: Ministry of Health