The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia

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Brief Title

The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia

Official Title

Clinical Study of GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia in Guangdong Province

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.
    

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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

The improvement of safety in the treatment protocol


Condition

Acute Lymphoblastic Leukemia

Intervention

6-mercaptopurine, Methotrexate

Study Arms / Comparison Groups

 Protocol A (MM)
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

600

Start Date

July 2008

Completion Date

December 2018

Primary Completion Date

December 2013

Eligibility 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
      

Gender

All

Ages

N/A - 16 Years

Accepts Healthy Volunteers

No

Contacts

Jianpei Fang, M.D., +8620-81332003, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT00846703

Organization ID

2007016



Study Sponsor

Sun Yat-sen University


Study Sponsor

Jianpei Fang, M.D., Study Director, Second Affiliated Hospital, Sun Yat-Sen University


Verification Date

March 2010