NCT06855810 Newly-diagnosed Pediatric T-cell ALL Protocol
| NCT ID | NCT06855810 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 610 participants |
| Start Date | 2025-03-11 |
| Primary Completion | 2030-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 610 participants in total. It began in 2025-03-11 with a primary completion date of 2030-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, multicenter study conducted within the Chinese Children's Cancer Group (CCCG). The study aims to evaluate whether the addition of three novel agents, dasatinib, venetoclax and homoharringtonine, can improve the minimal residual disease (MRD)-negative remission rate, enhance event-free survival (EFS), and reduce the cumulative incidence of relapse (CIR) in pediatric patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL).
Eligibility Criteria
Inclusion Criteria: 1. Age older than 1 month to younger than 18 years. 2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology. 3. Diagnosis of T-ALL by immunophenotyping. Exclusion Criteria: 1. B-ALL 2. AML 3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria. 4. ALL evolved from chronic myeloid leukemia (CML). 5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction 6. Secondary leukemia 7. Known underlying congenital immunodeficiency or metabolic disease 8. Congenital heart disease with cardiac insufficiency. 9. Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression) 10. Any significant comorbidities or psychiatric disorders that may impact patient safety, compliance, informed consent, study participation, follow-up, or the interpretation of study results. In such cases, all participating sites must report directly to the PI to determine whether the patient meets exclusion criteria. 11. Severe malnutrition, active infections, heart failure, or chemotherapy intolerance.
Contact & Investigator
Xiaofan Zhu, MD
PRINCIPAL INVESTIGATOR
Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC
Frequently Asked Questions
Who can join the NCT06855810 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 18 Years, studying Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06855810 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06855810 currently recruiting?
Yes, NCT06855810 is actively recruiting participants. Contact the research team at zhangjingliao@ihcams.ac.cn for enrollment information.
Where is the NCT06855810 trial being conducted?
This trial is being conducted at Hefei, China, Hefei, China, Chongqing, China, Fuzhou, China and 11 additional locations.
Who is sponsoring the NCT06855810 clinical trial?
NCT06855810 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Xiaofan Zhu, MD at Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC. The trial plans to enroll 610 participants.
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