NCT04440267

Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage

A Prospective, Single Arm, Open Label, Clinical Trial to Evaluate the Efficacy of Acute Lymphoblastic Leukemia-Based Therapy in Treating Patients With Acute Leukemia of Ambiguous Lineage

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

In this prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) after CR . Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. The purpose of current study is to evaluate the clinical efficacy of ALL-based chemotherapy，effect of genetic abnormality and minimal residual disease (MRD) on prognosis in patients with acute leukemia of ambiguous lineage.

Conditions

• Acute Leukemia of Ambiguous Lineage

Interventions

Type	Name	Description
DRUG	vincristine	acute lymphoblastic leukemia (ALL) -based chemotherapy
DRUG	daunorubicin	acute lymphoblastic leukemia (ALL) -based chemotherapy
DRUG	cyclophosphamide	acute lymphoblastic leukemia (ALL) -based chemotherapy
DRUG	L-Asparaginase	acute lymphoblastic leukemia (ALL) -based chemotherapy
DRUG	prednisone	acute lymphoblastic leukemia (ALL) -based chemotherapy
DRUG	mercaptopurine	acute lymphoblastic leukemia (ALL) -based chemotherapy
DRUG	methotrexate	acute lymphoblastic leukemia (ALL) -based chemotherapy
DRUG	dexamethasone	acute lymphoblastic leukemia (ALL) -based chemotherapy
DRUG	Tyrosine kinase inhibitor	acute lymphoblastic leukemia (ALL) -based chemotherapy

Timeline

• Start date: 2020-07-08
• Primary completion: 2026-06-20
• Completion: 2027-12-20
• First posted: 2020-06-19
• Last updated: 2025-08-06

Locations

1 site across 1 country: China