The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia

  • STATUS
    Recruiting
  • participants needed
    600
  • sponsor
    Sun Yat-sen University
Updated on 7 November 2020
lymphoid leukemia
philadelphia chromosome
methotrexate
vincristine
mercaptopurine
childhood all
dexamethasone
bcr-abl protein

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.

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.

Details
Condition childhood ALL
Treatment 6-mercaptopurine, Methotrexate, 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone, 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone
Clinical Study IdentifierNCT00846703
SponsorSun Yat-sen University
Last Modified on7 November 2020

Eligibility

Yes No Not Sure

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/L in peripheral blood (PB) on day 8
Aged 1 to < 6 years
Initial WBC < 20,000/L
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/L
Blasts < 1,000/L 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/L 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
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