Clinical trial · Interventional
Haploidentical Lymphocytes With Nivolumab/Ara-C as Consolidation in Elderly AML Patients
A Randomized Study of Haploidentical Lymphocytes With Nivolumab and Intermediate Dose Cytarabine Versus Nivolumab and Intermediate Dose Cytarabine as Consolidation Treatment in Older Adults With Acute Myeloid Leukemia.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unexpected toxicity
Summary
Brief summary (as posted)
A phase II trial to compare the efficacy and safety of nivolumab and intermediate dose cytarabine with or without haploidentical lymphocyte infusion. To identify the role of haploidentical lymphocytes in the treatment of acute myeloid leukemia in older adults. The patients will be stratified based on the remission number (first or second)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytarabine | Drug | Cytarabine | ALIAS |
| G-CSF mobilized HLA-haploidentical donor PBSC | Biological | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ara-C+HaploLymphocyte+Nivo
- description
- Patients treated with nivolumab, intermediate dose cytarabine and haploidentical lymphocyte infusion: \[Cytarabine 500-1000 mg/m2 bid D-4, -3, -2 + G-CSF mobilized HLA-haploidentical donor peripheral blood stem cells infusion D0 \+ Nivolumab 40 mg D+5\] х 2-3 cycles
- interventionNames
- Drug: Cytarabine
- Drug: Nivolumab
- Biological: G-CSF mobilized HLA-haploidentical donor PBSC
- type
- EXPERIMENTAL
- label
- Ara-C+ Nivo
- description
- Patients treated with nivolumab and intermediate dose cytarabine: \[Cytarabine 500-1000 mg/m2 bid D+1, +2, +3 + Nivolumab 40 mg D+1\] х 2-3 cycles
- interventionNames
- Drug: Cytarabine
- Drug: Nivolumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a diagnosis of acute myeloid leukemia with the confirmed first or second complete remission * ≥ 55 years of age * Not candidates for allogeneic stem cell transplantation as decided by the panel of hematologists at the transplant center * Patients with a HLA-haploidentical donor who should be able to provide informed consent for peripheral blood apheresis * No severe concurrent illness that limits life expectancy to less than 2 years Exclusion Criteria: * Uncontrolled bacterial or fungal infection at the time of enrollment * Karnofsky index \<70% * Acute promyelocytic leukemia * Other tumor requiring treatment at the time of enrollment * Active or prior documented autoimmune disease requiring systemic treatment * Somatic or psychiatric disorder making the patient unable to sign informed consent
References
Publications (0)
Data not yet available