Clinical trial NCT04353479: Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia
Official title: Combined PD1 Inhibitor and Decitabine in Elderly Patients With Relapse and Refractory Acute Myeloid Leukemia : An Open-Label, Single-Arm, Phase 2 Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: PD1 inhibitor
DNA methyltransferase inhibitor
Acute Myeloid Leukemia
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 29
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: In this single-center, open-label, nonrandomized, no control, prospective clinical trial, 29 relapsed or refractory acute myeloid leukemia patients will be enrolled. 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.

Eligibility criteria: Inclusion Criteria:

* Age: 60-75
* Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology
* ECOG：0-2
* Life expectancy ≥ 3 months
* Adequate laboratory parameters during the screening period as evidenced by the following:

  1. Creatinine clearance≥30 mL/min and serum Creatinine ≤ 160µmol/L
  2. ALT and AST ≤ 3 × upper limit of normal (ULN)
  3. FEV1,FVC,DLCO ≥ 50% predicted value
  4. Left ventricular ejection fraction (LVEF) ≥ 40%, no symptomatic arrhythmia
  5. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria:

* Treatment-related AML
* Allergic to Camrelizumab, Decitabine, other monoclonal antibody or pharmaceutical excipients
* Use of immunosuppressive drug within 2 weeks before entering the group
* Abnormal liver and kidney function(does not meet the inclusion criteria)
* Suffering from heart failure
* Active tuberculosis or HIV positive
* Active hepatitis: Hepatitis B(HBsAg positive and HBV DNA≥500IU/mL), and hepatitis C(HCV RNA positive, abnormal liver function) ,Hepatitis B and hepatitis C infection in common.
* Active, known or suspected autoimmune disease. Subjects who were in a stable state without systemic immunosuppressive therapy were admitted
* Concurrent medical condition requiring the long-term use of immunosuppressive medications, or immunosuppressive doses of systemic corticosteroids \> 10 mg/day topical prednisone or equivalent
* Suffer from other hematological neoplasm
* Known history of use other immune checkpoint inhibitor
* Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection.

Primary outcomes:
measure: Overall response rate
timeFrame: 6 months
measure: Complete remission (CR) rate
timeFrame: 6 months
Secondary outcomes:
measure: Progress-free survival (PFS)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
measure: 6-month overall survival rate
timeFrame: 6 months
measure: 12-month overall survival rate
timeFrame: 12 months
measure: Hematological and non-hematological toxicity
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Ruijin Hospital
name: Junmin Li
role: PRINCIPAL_INVESTIGATOR
References: