The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: 6-Mercaptopurine; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Mercaptopurine; Methotrexate; Vincristine

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