Trials / Terminated
TerminatedNCT03381118
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.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- St. Petersburg State Pavlov Medical University · Academic / Other
- Sex
- All
- Age
- 55 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cytarabine | Cytarabine 500-1000 mg/m2 bid IV infusion on D-4, -3, -2 |
| DRUG | Nivolumab | Nivolumab 40 mg IV infusion on D+5 |
| DRUG | Cytarabine | Cytarabine 500-1000 mg/m2 bid IV infusion on D+1, +2, +3 |
| DRUG | Nivolumab | Nivolumab 40 mg IV infusion on D+1 |
| BIOLOGICAL | G-CSF mobilized HLA-haploidentical donor PBSC | G-CSF mobilized HLA-haploidentical donor peripheral blood stem cells IV infusion on D0 |
Timeline
- Start date
- 2017-06-30
- Primary completion
- 2018-09-30
- Completion
- 2018-09-30
- First posted
- 2017-12-21
- Last updated
- 2019-04-05
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT03381118. Inclusion in this directory is not an endorsement.