Status:
TERMINATED
Nivolumab With Chemotherapy in Refractory MDS
Lead Sponsor:
St. Petersburg State Pavlov Medical University
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
There is evidence of involvement of checkpoint pathways, including PD-1, in the pathogenesis and resistance of myelodysplastic syndrome (MDS). However monotherapy with checkpoint inhibitors was ineffe...
Eligibility Criteria
Inclusion
- Patients with myelodysplastic syndrome (MDS) (up to 20% blasts) of any risk. Patients with lower risk MDS (low and int-1 by IPSS) should have failed prior non-hypomethylating agent therapy (ie growth factors or lenalidomide). Patients with higher risk MDS (int-2 or high by IPSS) should have failed prior at least one therapy with a hypomethylating agent or Ara-C.
- Age 18 years or older.
- No severe organ dysfunction: creatinine \<=2.5 x ULN; serum bilirubin \<=2.5 x ULN; AST and ALT \<=5 x ULN.
- Karnofsky index \>=70%
- Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception to avoid pregnancy for 24 weeks
- Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 24 weeks after the last dose of nivolumab.
Exclusion
- Another malignancy requiring treatment at the time of inclusion
- History of interstitial lung disease or pneumonitis
- Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure NYHA Class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study
- Active, known or suspected autoimmune disease requiring treatment at the time of inclusion
- Pregnancy or breastfeeding
- Patients unwilling or unable to comply with the protocol
- Somatic or psychiatric disorder making the patient unable to sign informed consent
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA4 therapy
Key Trial Info
Start Date :
May 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 25 2018
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03259516
Start Date
May 25 2017
End Date
December 25 2018
Last Update
April 5 2019
Active Locations (1)
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1
First Pavlov State Medical University of St. Petersburg
Saint Petersburg, Russia, 197089