- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00846703
The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia
March 5, 2010 updated by: Sun Yat-sen University
Clinical Study of GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia in Guangdong Province
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 the protocol was mainly derived from the ALLIC-BFM 2002 protocol.
After summarizing the last six years' experience, our group revised the GZ2002 ALL protocol in the year 2008, which is named GD-2008 ALL protocol.
The diagnosis and classified criteria is according to the ALLIC-BFM 2002 protocol, and the chemotherapy protocol consists all the therapeutic phases as the ALLIC-BFM 2002 protocol prescribed.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
600
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shaoliang Huang, M.D.
- Phone Number: +8620-81332003
- Email: luhong.xu@yahoo.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- The Second Affiliated Hospital of Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 16 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Protocol A (MM)
|
6-mercaptopurine p.o. qd Methotrexate p.o. qw
Other Names:
|
EXPERIMENTAL: Protocol B (MM/VD)
|
(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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The improvement of safety in the treatment protocol
Time Frame: Two months
|
Two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (ANTICIPATED)
December 1, 2013
Study Completion (ANTICIPATED)
December 1, 2018
Study Registration Dates
First Submitted
February 17, 2009
First Submitted That Met QC Criteria
February 17, 2009
First Posted (ESTIMATE)
February 19, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
March 8, 2010
Last Update Submitted That Met QC Criteria
March 5, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Phytogenic
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Dexamethasone
- Methotrexate
- Vincristine
- Mercaptopurine
Other Study ID Numbers
- 2007016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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