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The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00846703
Recruitment Status : Recruiting
First Posted : February 19, 2009
Last Update Posted : March 8, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: 6-mercaptopurine, Methotrexate Drug: 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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


Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. The improvement of safety in the treatment protocol [ Time Frame: Two months ]

Eligibility Criteria

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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. 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
More Information

Responsible Party: Jianpei Fang,MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00846703     History of Changes
Other Study ID Numbers: 2007016
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: March 8, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Methotrexate
Vincristine
6-Mercaptopurine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal