Clinical trial · Interventional
The GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia
Clinical Study of GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia in Guangdong Province
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6-mercaptopurine, Methotrexate | Drug | — | UNRESOLVED |
| 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Protocol A (MM)
- interventionNames
- Drug: 6-mercaptopurine, Methotrexate
- type
- EXPERIMENTAL
- label
- Protocol B (MM/VD)
- interventionNames
- Drug: 6-mercaptopurine, Methotrexate, Vincristine, Dexamethasone
Primary outcomes (1)
- measure
- The improvement of safety in the treatment protocol
- timeFrame
- Two months
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 16 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available