Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML

NCT04842604

CompletedPhase 3

Sponsor: Pfizer

Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia

Interventions: Glasdegib, Azacitidine

Countries: Austria, Canada, Czechia, France, Hungary, Italy, Japan, Mexico

An open-label study available to all eligible participants from Study B1371019 and participants originating from Study B1371012 continuing on study intervention with azacitidine with or without glasdegib.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Any participant who continues to demonstrate clinical benefit (as determined by the Principal Investigator) from study treatment with azacitidine with or without glasdegib in this Study or from Study B1371012.
* Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria:

* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Female participants who are pregnant or breastfeeding (if continuing to receive study intervention);
* Participant has been withdrawn from Study B1371019 and Study B1371012 for any reason (including INT cohort participants required to end study treatment)
Locations (18)
  • Salzburg, Austria
  • Salzburg, Austria
  • Winnipeg, Manitoba, Canada
  • Winnipeg, Manitoba, Canada
  • Ostrava - Poruba, Czechia
  • Ostrava-Poruba, Czechia
  • Nantes, France
  • Nantes, France
  • Debrecen, Hungary
  • Debrecen, Hungary
  • Torrette Di Ancona, Ancona, Italy
  • Torette Di Ancona, AN, Italy
  • Yoshida-gun, Fukui, Japan
  • Osaka, Osaka, Japan
  • México, MÉX, Mexico
  • Lodz, Poland
  • Valencia, Spain
  • Sutton, Surry, United Kingdom