NCT04886206

Injection of Lymphocytes From Haplo-identical Donor Following Chemotherapy in Patients With High-risk Acute Myeloblastic Leukemia Not Eligible for an Allogeneic Hematopoietic Stem Cell Transplantation

Phase I Study Testing the Injection of Lymphocytes From Haplo-identical Donor Following Chemotherapy in Patients With High-risk Acute Myeloblastic Leukemia Not Eligible for an Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with high risk AML non eligible for an intensive treatment and for an allogeneic transplantation will be treated with azacitidine and venetoclax. The fourth, fifth and sixth injection of azacitidine will be followed by injection of haplo-identical lymphocytes (HLI). This is a single-center phase I study to identify the dose of HLI with the most tolerable toxicity. TheBayesian continuous reassessment method (CRM) will be used

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
BIOLOGICAL	DLI	the patients will receive the injection of donor lymphocytes from haplo-identical donor (the son or daughter or possibly nephew or niece of the patient). No immunosuppressive drugs will be used. The HLI dose levels are 1) 1x107 CD3+/kg 2) 5x107 CD3+/kg 3) 7.5x107 CD3+/kg 4) 1x108 CD3+/kg.The CRM method (Continual Reassessment Method) was chosen to specify the dose of cells to be injected, each patient being assigned a dose that is believed to be associated with the target toxicity corresponding to the maximum tolerated dose (MTD). The dose-toxicity curve will be readjusted after assessing the toxicity of each patient.

Timeline

• Start date: 2021-11-10
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2021-05-13
• Last updated: 2022-05-11

Locations

1 site across 1 country: France