High Dose Donor Hematopoietic Stem Cell Infusion for Relapsed/Refractory AML

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Leukemia, Myeloid

Treatments: Biological: hematopoietic stem cell

Study type: Interventional

Funder types: Other

Identifiers

NCT03080922

HD-DSI-AML

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia（AML）.

Full description

The relapsed/refractory AML patients will receive IA/DA/MA(I,Idamycin，D，Daunorubicin，M，Mitoxantrone，A，cytosine arabinoside) chemotherapy followed by infusion of high dose allogeneic mismatched hematopoietic stem cells.

no graft-versus-host disease (GVHD) prevention will be conducted before transplantation. Cytokine storm,GVHD snd donor graft will be detected post-transplantation.

Enrollment: 10 estimated patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with relapsed and/or refractory AML
• Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion criteria

• Previous treatment with investigational gene or cell therapy medicine products
• Any uncontrolled active medical disorder that would preclude participation as outlined

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

hematopoietic stem cell

Experimental group

Description:

high dose of donor granulocyte colony-stimulating factor（G-CSF）mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy

Treatment:

Biological: hematopoietic stem cell