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Natural killer cell treament for Blood cancer

Evaluation of efficacy of optimized natural killer cells as an adjunct to allogeneic stem cell transplantation in the treatment of refractory acute myeloid leukemia - ONKAML

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017505
Enrollment
21
Registered
2019-02-06
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: C920- Acute myeloblastic leukemia

Interventions

Intervention1: Natural Killer cells: Single Infusion of optimized natural killer cells derived from haplo- identical family donors. With unstimulated apheresis, we would expect about 109 to 1010 monon

Sponsors

Department of Biotechnology India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Signed and dated written informed consent by start date of Screening visit in accordance with GCP and local legislation Patients with refractory acute myeloid leukemia planned for allogeneic stem cell transplantation Any Age Eastern Cooperative Oncology Group (ECOG) performance score Life expectancy of 4 â?? 6 weeks

Exclusion criteria

Exclusion criteria: Hypersensitivity to chemo drugs Total bilirubin or liver enzymes greater than 3 times the upper limit of normal HIV infection

Design outcomes

Primary

MeasureTime frame
1-year relapse free survivalTimepoint: At 1 year

Secondary

MeasureTime frame
Incidence of acute and chronic graft versus host disease and 1-year overall survivalTimepoint: 30 days, 100 days and at 1 year

Countries

India

Contacts

Public ContactVikram Mathews

Christian Medical College, Vellore

vikram@cmcvellore.ac.in04162282352

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 14, 2026