Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia

Sponsor
Shanghai Jiao Tong University School of Medicine
Study ID
NCT04353479
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab(SHR-1210) — DRUG
    A humanized monoclonal immunoglobulin
  • Decitabine — DRUG
    A DNA methyltransferase inhibitor

Study Details

This is an open-label, single arm, phase 2 study to evaluate efficacy and safety of PD1 inhibitor Camrelizumab(SHR-1210) combined with DNA methyltransferase inhibitor decitabine in elderly patients with relapse and refractory acute myeloid leukemia.

Key Dates

Start date
Apr 25, 2020
Status verified
Apr 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2022

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab(SHR-1210) Combined With Decitabine
    Patients will be administered Camrelizumab(SHR-1210) at D1 and D15 and decitabine at D1-5. Treatment repeats every 28 days until disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall response rate [ Time Frame: 6 months ]

Central Contacts

Related Studies