To evaluate the safety and feasibility of Mismatched stem cell transplantation after chemotherapy in relapsed acute myeloid leukemia (AML) patients who do not have matched sibling donor

Not Applicable

• Conditions: Health Condition 1: null- RELAPSED AND REFRACTORY AM

• Registration Number: CTRI/2018/07/015039
• Lead Sponsor: DEPARTMENT OF MEDICAL ONCOLOGY AIIMS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age 18-65 years

2. No 10/10 matched sibling and matched unrelated donor available

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, and estimated survival of at least 3 months

4. Patients must be able to understand and agree to sign an Institutional Review Board (IRB)-approved informed consent form

5)Patient has at least one medically fit first- or second-degree family member expected to be human leukocyte antigen (HLA) mismatched at 2-9/10 loci; in addition, the prospective donor is willing to voluntarily donate hematopoietic stem cells and sign consent forms

Exclusion Criteria

1. Acute promyelocytic leukemia

2. Therapy related AML/ MDS-AML

3. Chronic myeloid leukemia in accelerated phase and blastic phase

4. Previous allogeneic or autologous HSCT or solid organ transplantation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of Microtransplantation in adult patients with Relapse and Refractory AML.Timepoint: 0-6 months

Secondary Outcome Measures

Name	Time	Method
1.To assess the anti-leukemic effect of Microtransplantation. <br/ ><br> <br/ ><br>Timepoint: 0-6 months