NCT03417154

Nivolumab and Oral Cyclophosphamide for R/R AML and HIgh Risk MDS

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• Higher Risk Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Nivolumab	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.
DRUG	Low dose Cyclophosphamide (CTX) Daily	Oral cyclophosphamide 50mg + nivolumab 3 mg/kg IV every 2 weeks for up to 4 courses of treatment
DRUG	Low dose Cyclophosphamide (CTX) Every 7 Days	Oral cyclophosphamide 350 mg every 7 days + nivolumab 3mg/kg IV every 2 weeks for up to 4 courses of treatment

Timeline

• Start date: 2018-08-13
• Primary completion: 2022-01-25
• Completion: 2022-01-25
• First posted: 2018-01-31
• Last updated: 2023-05-26
• Results posted: 2023-05-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study