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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

To evaluate the safety and feasibility of HLA-mismatched stem cell microtransplantation in relapsed and refractory acute myeloid leukemia (AML)patients who do not have matched sibling donor : A single arm prospective,interventional, pilot study â??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/015039
Enrollment
5
Registered
2018-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- RELAPSED AND REFRACTORY AML

Interventions

Intervention1: Microtransplantation: Eligible patients will receive induction chemotherapy with 3+ 7 induction (Cytarabine 100 mg/m2 /day by continuous intravenous infusion (CIVI) on days 1-7 andDau

Sponsors

DEPARTMENT OF MEDICAL ONCOLOGY AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To evaluate the safety of Microtransplantation in adult patients with Relapse and Refractory AML.Timepoint: 0-6 months—

Secondary

MeasureTime frame
1.To assess the anti-leukemic effect of Microtransplantation. Timepoint: 0-6 months—

Countries

India

Contacts

Public ContactDR RANJIT KUMAR SAHOO

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

drranjitmd@gmail.com

Outcome results

None listed

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