The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT00846703|
Recruitment Status : Unknown
Verified March 2010 by Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : February 19, 2009
Last Update Posted : March 8, 2010
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Drug: 6-mercaptopurine, Methotrexate Drug: 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone||Phase 4|
The modification includes:
- In the induction phase, the agent of dexamethasone 6 mg/m2 is used instead of prednisone after prednisone prophase.
- The phase "CAM" is 2 weeks for SR patients and 4 weeks for IR and HR patients,respectively.
- 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.
- There is not randomized study in delayed intensification. The GD-2008 ALL protocol uses the same protocol II with the BFM study.
- 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.
- The GD-2008 ALL protocol for HR patients use the re-blocks and protocol II phases.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Clinical Study of GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia in Guangdong Province|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2018|
|Active Comparator: Protocol A (MM)||
Drug: 6-mercaptopurine, Methotrexate
6-mercaptopurine p.o. qd
Methotrexate p.o. qw
Other Name: For SR and IR patients (Group one)
|Experimental: Protocol B (MM/VD)||
Drug: 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone
(1)6-mercaptopurine p.o. qd x 7w Methotrexate p.o. qd x 7w
(2)Vincristine qw x 1w Dexamethasone p.o. qd x 7d
Go to (1) and (2)
Other Name: For SR and IR patients (Group two)
- The improvement of safety in the treatment protocol [ Time Frame: Two months ]
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): NCT00846703
|Contact: Shaoliang Huang, M.D.||+firstname.lastname@example.org|
|The second affiliated hospital of Sun Yat-sen University||Recruiting|
|Guangzhou, Guangdong, China, 510000|
|Contact: Jianpei Fang, M.D. +8620-81332003 email@example.com|
|Principal Investigator: Jianpei Fang, M.D.|
|Study Director:||Jianpei Fang, M.D.||Second Affiliated Hospital, Sun Yat-Sen University|
|Principal Investigator:||Xuequn Luo, M.D.||First Affiliated Hospital, Sun Yat-Sen University|
|Principal Investigator:||Jianliang Chen, M.D.||Third Affiliated Hospital, Sun Yat-Sen University|
|Principal Investigator:||Xiaofei Sun||The cancer hospital of Sun Yat-sen University|
|Principal Investigator:||Xuedong Wu||Nanfang hospital of Nanfang Medical University|
|Principal Investigator:||Liming Tu, M.D.||Guangdong Provincial People's Hospital|
|Principal Investigator:||Dongbo Lai, M.D.||Guangzhou children's hospital|
|Principal Investigator:||Changgang Li, M.D.||Shenzhen Children's Hospital|
|Principal Investigator:||Liyang Liu, M.D.||Huizhou People's Central Hospital|