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A Phase II CCCG-ALL Multi-center Trial of Dasatinib in Combination with Intensive Induction Therapy for Children with First Relapsed T-cell Acute Lymphoblastic Leukemia

A Phase II CCCG-ALL Multi-center Trial of Dasatinib in Combination with Intensive Induction Therapy for Children with First Relapsed T-cell Acute Lymphoblastic Leukemia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033973
Enrollment
Unknown
Registered
2020-06-19
Start date
2020-06-25
Completion date
Unknown
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with First Relapsed T-cell Acute Lymphoblastic Leukemia

Interventions

experimental group:Dasatinib in combination with intensive induction therapy

Sponsors

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 21 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with first recurrence of T-ALL. The first bone marrow relapse (with or without extramedullary infiltration) of T-ALL was necessary; 2. Patients aged 1-21 years; 3. Patients who comply with the relevant guidelines of the institutional review committee, NCI, FDA and OHRP, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Research participants or legal guardians are unable or unwilling to provide written informed consent; 3. Patients who use chemotherapy drugs other than those specified in the program; 4. Non-t-all patients; 5. Patients with etp-all; 6. Patients with abnormal liver function (direct bilirubin 3 times higher than normal upper limit); 7. Patients with abnormal renal function (EGFR = 2; 11. Patients with varicella, mumps, influenza, cytomegalovirus, active EB virus and other infectious diseases; 12. Patients with previous grade 3-4 pancreatitis.

Design outcomes

Primary

MeasureTime frame
Dasatinib window therapy;Mid-Induction MRD response;End-of-Induction MRD response;End of Consolidation-MRD response;

Countries

China

Contacts

Public ContactZhu Xiaofan

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

xfzhu@ihcams.ac.cn+86 13752090418

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026