Clinical trial · Interventional
Two Combination Chemotherapy Regimens in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia
A Multicenter Study of Treatment Protocol for Childhood Acute Lymphoblastic Leukemia in China, 2008.
- 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)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia. PURPOSE: This randomized clinical trial is studying the side effects of two combination chemotherapy regimens and to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| mercaptopurine | Drug | Mercaptopurine | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard- or Intermediate-Risk Maintenance Arm I
- description
- Patients receive oral mercaptopurine and oral methotrexate on days 1-56, dexamethasone IV on days 1-5 and 29-33, vincristine IV on days 1 and 29, and methotrexate IT on day 50. Treatment repeats every 8 weeks for up to 8 (girls)-11 (boys) courses.
- interventionNames
- Drug: dexamethasone
- Drug: mercaptopurine
- Drug: methotrexate
- Drug: vincristine sulfate
- type
- EXPERIMENTAL
- label
- Standard- or Intermediate-Risk Maintenance Arm II
- description
- Patients receive oral mercaptopurine once daily on days 8-28 and 36-56; oral methotrexate once on days 8,15, 22, 36, 43, and 50; dexamethasone IV on days 1-5 and 29-33; and vincristine IV on days 1 and 29. Patients also receive methotrexate IT on day 1, every 8 weeks, for 8 courses.
- interventionNames
- Drug: dexamethasone
- Drug: mercaptopurine
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Newly diagnosed acute lymphoblastic leukemia meeting 1 of the following risk definitions:
* Standard-risk disease:
* Age 1 to 9 years
* White blood cell (WBC) \< 50/mm\^3 OR t(12;21) or molecular fusion product -positive disease
* Good response to prior prednisone (day 8 peripheral blood blast \< 1,000/mm\^3)
* None of the following subtypes:
* T-cell
* t(9;22)
* t(4;11)
* t(1;19)
* Molecular
* Bone marrow (BM) M1 or M2 on day 15, BM remission (\< 5% blast) on day 33
* Intermediate-risk disease:
* Good response to prior prednisone
* BM M1/M2 on day 15
* Meets 1 of the following criteria:
* At least 10 years old
* WBC \> 50/mm\^3
* Under 1 year old without Mixed Lineage Leukemia (MLL) gene rearrangement
* T-cell OR t(1;19) or molecular fusion product positive.
* Standard-risk patient with BM M3 on day 15
* If minimal residual disease (MRD) available, day 33 MRD \< 10\^-2
* High-risk disease, meeting 1 of the following criteria:
* Poor response to prior prednisone
* t(9;22) or molecular fusion product (BCR/ABL1), t(4;11) or molecular fusion product (MLL/AF4)
* Intermediate-risk patient with BM M3 on day 15
* BM M2/M3 on day 33
* If MRD available, flow cytometry/polymerase chain reaction (PCR) \> 10% on days 15 OR MRD \> 10\^-2 on day 33 OR MRD (before mini-M phase or M phase) \> 10\^-3 on day 84
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (1)
- DERIVEDLiu X, Zou Y, Chen X, Wang S, Guo Y, Yang W, Zhang L, Chen Y, Zhang Y, Zhu X. Minimal residual disease surveillance at day 90 predicts long-term survival in pediatric patients with T-cell acute lymphoblastic leukemia. Leuk Lymphoma. 2020 Dec;61(14):3460-3467. doi: 10.1080/10428194.2020.1805739. Epub 2020 Aug 11. PMID 32779947