Back to resultsContinuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
Primary Purpose
Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Glasdegib
Azacitidine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
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- Participant has been withdrawn from Study B1371019 and Study B1371012 for any reason (including INT cohort participants required to end study treatment)
Sites / Locations
- Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU
- Uniklinikum Salzburg, Landeskrankenhaus Salzburg
- Health Sciences Centre
- CancerCare Manitoba
- Ustavni lekarna
- Klinika hematoonkologie
- CHU de Nantes
- CHU de Nantes Hotel Dieu
- Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek
- Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
- AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia
- SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi
- University of Fukui Hospital
- Osaka City University Hospital
- Instituto Nacional de Cancerología
- WWCOiT im. M. Kopemlka w Lodzl
- Hospital Universitari i Politecnic La Fe
- The Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participants from B1371019 and B1371012
Arm Description
Azacitidine will be administered 75 mg/m2/day for 7 days every 28 days on Days 1-7 (±3 days) per local label or per the IP Manual (or SPC). Azacitidine may be administered by SC injection or IV infusion. Alternate dosing schedules to administer the 7 doses to accommodate participant and treatment center availability are allowed. The starting dose regimen will be the same as the most recent regimen received on the B1371019 or B1371012 study. Glasdegib 50, 75 or 100 mg will be orally administered daily and continuously. The starting dose regimen will be the same as the most recent regimen received on the B1371012 or B1371019 study.
Outcomes
Primary Outcome Measures
Number of participants with treatment related adverse events (TEAE)
Number of participants with serious adverse events (SAE)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04842604
Brief Title
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
Official Title
A MULTI-CENTER CONTINUATION STUDY EVALUATING AZACITIDINE WITH OR WITHOUT GLASDEGIB (PF-04449913) IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA, MYELODYSPLASTIC SYNDROME OR CHRONIC MYELOMONOCYTIC LEUKEMIA
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
December 2, 2022 (Actual)
Study Completion Date
December 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants from B1371019 and B1371012
Arm Type
Experimental
Arm Description
Azacitidine will be administered 75 mg/m2/day for 7 days every 28 days on Days 1-7 (±3 days) per local label or per the IP Manual (or SPC). Azacitidine may be administered by SC injection or IV infusion. Alternate dosing schedules to administer the 7 doses to accommodate participant and treatment center availability are allowed.
The starting dose regimen will be the same as the most recent regimen received on the B1371019 or B1371012 study.
Glasdegib 50, 75 or 100 mg will be orally administered daily and continuously. The starting dose regimen will be the same as the most recent regimen received on the B1371012 or B1371019 study.
Intervention Type
Drug
Intervention Name(s)
Glasdegib
Other Intervention Name(s)
PF-04449913
Intervention Description
25 mg or 100 mg tablet
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
100 mg/vial powder for 25 mg/mL suspension for injection
Primary Outcome Measure Information:
Title
Number of participants with treatment related adverse events (TEAE)
Time Frame
Baseline through 28 days after last dose (up to approximately 20 months)
Title
Number of participants with serious adverse events (SAE)
Time Frame
Baseline through 28 days after last dose (up to approximately 20 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Landeskrankenhaus Salzburg, Universitatsklinik fur Innere Medizin III der PMU
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Uniklinikum Salzburg, Landeskrankenhaus Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Ustavni lekarna
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Klinika hematoonkologie
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
CHU de Nantes
City
Nantes cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
CHU de Nantes Hotel Dieu
City
Nantes cedex
ZIP/Postal Code
44093
Country
France
Facility Name
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika, Hematologia Tanszek
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont Belgyogyaszati Klinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi, Clinica Di Ematologia
City
Torrette Di Ancona
State/Province
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
SOD Farmacia-Dipt dei servizi -AOU Ospedali Riuniti Umberto I, G.M. Lancisi, G. Salesi
City
Torette Di Ancona
State/Province
AN
ZIP/Postal Code
60126
Country
Italy
Facility Name
University of Fukui Hospital
City
Yoshida-gun
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka-City
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Instituto Nacional de Cancerología
City
México
State/Province
MÉX
ZIP/Postal Code
14080
Country
Mexico
Facility Name
WWCOiT im. M. Kopemlka w Lodzl
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surry
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT03416179?term=B1371019&draw=2&rank=1
Description
B1371019 (NCT03416179)
Learn more about this trial
Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML
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