The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia

NCT00846703 | Unknown Phase 4 DMC

• 1 other identifier: 2007016
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• The improvement of safety in the treatment protocol

  Two months

Study Arms (2)

Protocol A (MM)

ACTIVE COMPARATOR

Drug: 6-mercaptopurine, Methotrexate

Protocol B (MM/VD)

EXPERIMENTAL

Drug: 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone

Interventions

6-mercaptopurine, Methotrexate DRUG

6-mercaptopurine p.o. qd Methotrexate p.o. qw

Also known as: For SR and IR patients (Group one)

Protocol A (MM)

6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone DRUG

(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)

Also known as: For SR and IR patients (Group two)

Protocol B (MM/VD)

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The second affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Mercaptopurine; Methotrexate; Vincristine; Dexamethasone

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jianpei Fang, M.D.

  Second Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaoliang Huang, M.D.

CONTACT

+8620-81332003; luhong.xu@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 19, 2009
• Study Start: July 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2018
• Last Updated: March 8, 2010

Record last verified: 2010-03

Locations

CN (1)