The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2010 by Sun Yat-sen University
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00846703
First received: February 17, 2009
Last updated: March 5, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Drug: 6-mercaptopurine, Methotrexate
Drug: 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study of GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia in Guangdong Province

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • The improvement of safety in the treatment protocol [ Time Frame: Two months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: July 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846703

Contacts
Contact: Shaoliang Huang, M.D. +8620-81332003 luhong.xu@yahoo.com

Locations
China, Guangdong
The second affiliated hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Jianpei Fang, M.D.    +8620-81332003    jpfang2005@163.com   
Principal Investigator: Jianpei Fang, M.D.         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Jianpei Fang, M.D. The Second Affiliated Hospital of 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
  More Information

No publications provided

Responsible Party: Jianpei Fang,MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00846703     History of Changes
Other Study ID Numbers: 2007016
Study First Received: February 17, 2009
Last Updated: March 5, 2010
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
6-Mercaptopurine
Methotrexate
Dexamethasone
Vincristine
BB 1101
Dexamethasone acetate
Dexamethasone 21-phosphate
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on August 27, 2014