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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT03417154
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 13, 2018
Status verified
May 2023
Primary completion
Jan 25, 2022
Completion
Jan 25, 2022

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Nivolumab every 2 weeks and Cyclophosphamide daily
  • Experimental: Arm 2: Nivolumab every 2 weeks and Cyclophosphamide every 7 days

Primary Outcome Measure

Stage 1: Dosing Schedule of Low-dose Cyclophosphamide [ Time Frame: 4 weeks from start of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Minnesota Masonic Cancer CenterMinneapolisMinnesota55455-

Find similar trials in Minneapolis, MN

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Minnesota Masonic Cancer Center· Minneapolis, MN

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