The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia
NCT ID: NCT00846703
Last Updated: 2010-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
600 participants
INTERVENTIONAL
2008-07-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Protocol A (MM)
6-mercaptopurine, Methotrexate
6-mercaptopurine p.o. qd
Methotrexate p.o. qw
Protocol B (MM/VD)
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)
Interventions
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6-mercaptopurine, Methotrexate
6-mercaptopurine p.o. qd
Methotrexate p.o. qw
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
16 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Sun Yat-sen University
Principal Investigators
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Jianpei Fang, M.D.
Role: STUDY_DIRECTOR
Second Affiliated Hospital, Sun Yat-Sen University
Xuequn Luo, M.D.
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Jianliang Chen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Third Affiliated Hospital, Sun Yat-Sen University
Xiaofei Sun
Role: PRINCIPAL_INVESTIGATOR
The cancer hospital of Sun Yat-sen University
Xuedong Wu
Role: PRINCIPAL_INVESTIGATOR
Nanfang hospital of Nanfang Medical University
Liming Tu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Guangdong Provincial People's Hospital
Dongbo Lai, M.D.
Role: PRINCIPAL_INVESTIGATOR
Guangzhou children's hospital
Changgang Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Children's Hospital
Liyang Liu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Huizhou People's Central Hospital
Locations
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The second affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2007016
Identifier Type: -
Identifier Source: org_study_id
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