CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Nivolumab +2 moredrug
Likely dose
Nivolumab 3mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03417154
NCT03417154Phase 2Completed
CompareCT.gov

Nivolumab and Oral Cyclophosphamide for Relapsed/Refractory Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndrome (MDS)

Masonic Cancer Center, University of Minnesota·interventional·Posted Jan 31, 2018·Updated May 26, 2023

In Brief

A Phase 2 clinical trial evaluating Nivolumab, Low dose Cyclophosphamide (CTX) Daily, and 1 other intervention for Acute Myeloid Leukemia and Higher Risk Myelodysplastic Syndrome. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This is a phase II trial of nivolumab and low dose cyclophosphamide (CTX) when given in combination to patients with relapsed/refractory acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (MDS) who are not eligible for or decline hematopoietic stem cell transplant. It includes a randomized pilot sub-study during stage 1.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Higher Risk Myelodysplastic Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 31, 2018
Enrollment StartAug 13, 2018
Primary CompletionJan 25, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.4 years ago

Interventions

Nivolumabdrug

3mg/kg IV (or if prior alloHSCT, 1 mg/kg) over 30 minutes every 14 days on Days 1 and 15 for up to four 28-day courses.

Low dose Cyclophosphamide (CTX) Dailydrug

Oral cyclophosphamide 50mg + nivolumab 3 mg/kg IV every 2 weeks for up to 4 courses of treatment

Low dose Cyclophosphamide (CTX) Every 7 Daysdrug

Oral cyclophosphamide 350 mg every 7 days + nivolumab 3mg/kg IV every 2 weeks for up to 4 courses of treatment