Overview

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