Back to resultsA Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
Primary Purpose
Myelodysplastic Syndromes (MDS)
Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Azacitidine
Venetoclax
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes (MDS) focused on measuring Higher-Risk (HR) Myelodysplastic Syndromes (MDS), Pharmacokinetic, Venetoclax, Azacitidine, Acute Myelogenous Leukemia, Myelodysplastic Syndromes (MDS), Treatment-Naïve Higher-Risk
Eligibility Criteria
Inclusion Criteria:
Participant must have documented diagnosis of untreated de novo MDS with:
- International Prognostic Scoring System (IPSS) risk categories Int-2 or High (minimum IPSS overall score of 1.5) OR Revised IPSS (IPSS-R) categories intermediate, high or very high (score of > 3) and
- Presence of less than 20% bone marrow blasts per bone marrow biopsy/aspirate.
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
Exclusion Criteria:
- Participant has received prior therapy for MDS. (Prior supportive care in form of transfusions or growth factors, etc., is not considered prior therapy).
- Participant has received prior therapy with a BCL-2 Homology 3 (BH3) mimetic.
Participant has a diagnosis other than previously untreated de novo MDS (as defined in the protocol) including:
- MDS with IPSS risk categories Low or Int-1 (overall IPSS score < 1.5)
- Therapy-related MDS (t-MDS).
- MDS evolving from a pre-existing myeloproliferative neoplasm (MPN).
- MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
- Participant has received allogeneic Hematopoietic Stem Cell Transplantation (HSCT) or solid organ transplantation.
- Participant has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.
Sites / Locations
- University of Arizona Cancer Center - North Campus /ID# 154155
- The University of Chicago Medical Center /ID# 153673
- University of Maryland School of Medicine /ID# 153669
- Tufts Medical Center /ID# 153672
- Dana-Farber Cancer Institute /ID# 152735
- Washington University-School of Medicine /ID# 153671
- Columbia University Medical Center /ID# 153661
- Weill Cornell Medical College /ID# 155524
- Oregon Health and Science University /ID# 152734
- University of Pittsburgh MC /ID# 153662
- Tennessee Oncology-Nashville Centennial /ID# 222769
- Vanderbilt University Medical Center /ID# 152738
- UT MD Anderson Cancer Center /ID# 153809
- Concord Repatriation General Hospital /ID# 154958
- Duplicate_St. Vincent's Hospital, Darlinghurst /ID# 222846
- St George Hospital /ID# 154954
- Liverpool Hospital /ID# 222410
- Calvary Mater Newcastle /ID# 154957
- Princess Alexandra Hospital /ID# 154990
- Austin Health /ID# 154955
- Alfred Health /ID# 154956
- Fiona Stanley Hospital /ID# 222847
- Juravinski Cancer Centre /ID# 152947
- CHU de Nantes, Hotel Dieu -HME /ID# 153828
- AP-HP - Hopital Saint-Louis /ID# 153827
- Universitatsklinikum Mannheim /ID# 153140
- Universitaetsklinikum Koeln /ID# 153141
- Duplicate_Universitaetsklinikum Carl Gus /ID# 153958
- Universitaetsklinikum Leipzig /ID# 153142
- Universitaetsklinikum Halle (Saale) /ID# 153760
- Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 153139
- Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 153764
- IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 153763
- Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 156492
- Oxford University Hospitals NHS Foundation Trust /ID# 222567
- University Hospitals Birmingham NHS Foundation Trust /ID# 158810
- King's College Hospital NHS Foundation Trust /ID# 156489
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Venetoclax + Azacitidine
Arm Description
Outcomes
Primary Outcome Measures
AUCt for Azacitidine
Area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) for azacitidine.
Cmax of venetoclax
Maximum plasma concentration (Cmax) of venetoclax.
AUCt for venetoclax
Area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) for venetoclax.
Tmax of venetoclax
Time to Cmax (peak time, Tmax) of venetoclax.
AUC[0 to infinity] for azacitidine
Area under the plasma concentration-time curve from Time 0 to infinite time.
Recommended Phase 2 dose (RPTD) and dosing schedule of venetoclax in combination with azacitidine
The RPTD of venetoclax [co-administered venetoclax and azacitidine] will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data [upon completion of the dose escalation phase].
Half-life (t[1/2]) for azacitidine
Terminal elimination half-life (t[1/2]) for azacitidine.
Cmax for azacitidine
Maximum plasma concentration (Cmax) of azacitidine.
AUC[0-24] for venetoclax
AUC over a 24-hour dose interval (AUC[0-24]) for venetoclax.
Clearance (CL) for azacitidine
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Tmax for azacitidine
Time to Cmax (peak time, Tmax) of azacitidine.
Complete Remission (CR) Rate
Complete remission rate will be defined as the proportion of participants who achieved a complete response per the International Working Group (IWG) 2006 criteria for Myelodysplastic Syndromes (MDS).
Secondary Outcome Measures
Rate of red blood cell (RBC) transfusion independence
Percentages of participants who become RBC transfusion-independent.
Progression-Free Survival (PFS)
PFS is defined as the number of days from the date of the first dose of study drug to the date of earliest disease progression or death due to disease progression or febrile neutropenia.
Overall Survival (OS)
OS is defined as number of days from the date of first dose of the study drug to the date of death of any cause.
Hematologic Improvement (HI) rate
Percentages of participants with HI (erythroid/platelet/neutrophil responses).
Rate of platelet (PLT) transfusion independence
Percentages of participants who become platelet transfusion-independent.
Event-Free Survival (EFS)
Event-free survival (EFS) will be defined as the number of days from the date of the first dose of study drug to the date of earliest disease progression or death of any cause.
Time to transformation to acute myeloid leukemia (AML)
Defined as the number of days from the date of the first dose of study drug to the date of documented AML transformation.
Overall Response Rate (ORR)
ORR (equals the rates of complete remission [CR] + partial remission [PR]) of venetoclax in combination with azacitidine.
Time to next treatment (TTNT)
Time to next treatment (TTNT) will be defined as the time from the first dose of study drug to start of new non-protocol specified MDS therapy or death from any cause.
Marrow Complete Remission (mCR) Rate
Defined as the proportion of participants who achieved a marrow complete response with or without hematological improvement per the International Working Group (IWG) 2006 criteria for Myelodysplastic Syndromes.
Modified Overall Response Rate (mORR)
mORR (equals CR + PR + mCR) of venetoclax in combination with azacitidine.
Duration of CR
Duration of CR will be defined as the number of days from the date of first response CR to the earliest documentation of progressive disease or death of any cause, whichever occurs earlier.
Duration of mORR
Duration of response (mORR) will be defined as the number of days from the date of first response (CR, PR or mCR) to the earliest documentation of progressive disease or death of any cause, whichever occurs earlier.
Duration of ORR
Duration of response (ORR) will be defined as the number of days from the date of first response (CR or PR) to the earliest documentation of progressive disease or death of any cause, whichever occurs earlier.
Rate of AML transformation
The AML transformation rate is defined as the proportion of participants transformed to Acute Myelogenous Leukemia.
Time to First Response (CR)
Time to first response (CR) will be defined as the number of days from the date of first dose of the study drug to the date of the first response of CR.
Time to First Response (mORR)
Time to first response (mORR) will be defined as the number of days from the date of first dose of the study drug to the date of the first response of (CR, PR, or mCR).
Time to First Response (ORR)
Time to first response (ORR) will be defined as the number of days from the date of first dose of the study drug to the date of the first response of (CR or PR).
Full Information
NCT ID
NCT02942290
First Posted
October 18, 2016
Last Updated
January 25, 2023
Sponsor
AbbVie
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02942290
Brief Title
A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
Official Title
A Phase 1b Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 12, 2017 (Actual)
Primary Completion Date
June 28, 2024 (Anticipated)
Study Completion Date
June 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Genentech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 1b, open-label, non-randomized, multicenter, dose-finding study evaluating venetoclax in combination with azacitidine in participants with treatment-naïve higher-risk MDS comprising a dose-escalation portion and a safety expansion portion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes (MDS)
Keywords
Higher-Risk (HR) Myelodysplastic Syndromes (MDS), Pharmacokinetic, Venetoclax, Azacitidine, Acute Myelogenous Leukemia, Myelodysplastic Syndromes (MDS), Treatment-Naïve Higher-Risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
129 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Venetoclax + Azacitidine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Powder for injection; taken subcutaneously (SC) or intravenous (IV); Administered on Days 1-7 of 28 days cycle or Days 1-5 of Week 1 & Days 1-2 of Week 2 of 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199, GDC-0199, VENCLEXTA
Intervention Description
Oral; Tablet
Primary Outcome Measure Information:
Title
AUCt for Azacitidine
Description
Area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) for azacitidine.
Time Frame
Up to 32 days
Title
Cmax of venetoclax
Description
Maximum plasma concentration (Cmax) of venetoclax.
Time Frame
Up to 32 days
Title
AUCt for venetoclax
Description
Area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) for venetoclax.
Time Frame
Up to 32 days
Title
Tmax of venetoclax
Description
Time to Cmax (peak time, Tmax) of venetoclax.
Time Frame
Up to 32 days
Title
AUC[0 to infinity] for azacitidine
Description
Area under the plasma concentration-time curve from Time 0 to infinite time.
Time Frame
Up to 32 days
Title
Recommended Phase 2 dose (RPTD) and dosing schedule of venetoclax in combination with azacitidine
Description
The RPTD of venetoclax [co-administered venetoclax and azacitidine] will be determined during the dose escalation phase of the study. RPTD will be determined using available safety and pharmacokinetics data [upon completion of the dose escalation phase].
Time Frame
Measured from Day 1 until Day 28 per dose level.
Title
Half-life (t[1/2]) for azacitidine
Description
Terminal elimination half-life (t[1/2]) for azacitidine.
Time Frame
Up to 32 days
Title
Cmax for azacitidine
Description
Maximum plasma concentration (Cmax) of azacitidine.
Time Frame
Up to 32 days
Title
AUC[0-24] for venetoclax
Description
AUC over a 24-hour dose interval (AUC[0-24]) for venetoclax.
Time Frame
Up to 32 days
Title
Clearance (CL) for azacitidine
Description
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Time Frame
Up to 32 days
Title
Tmax for azacitidine
Description
Time to Cmax (peak time, Tmax) of azacitidine.
Time Frame
Up to 32 days
Title
Complete Remission (CR) Rate
Description
Complete remission rate will be defined as the proportion of participants who achieved a complete response per the International Working Group (IWG) 2006 criteria for Myelodysplastic Syndromes (MDS).
Time Frame
Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent, and for an anticipated maximum duration of 24 months.
Secondary Outcome Measure Information:
Title
Rate of red blood cell (RBC) transfusion independence
Description
Percentages of participants who become RBC transfusion-independent.
Time Frame
Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent, and for an anticipated maximum duration of 24 months.
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the number of days from the date of the first dose of study drug to the date of earliest disease progression or death due to disease progression or febrile neutropenia.
Time Frame
Measured from the date of first dose of study drug to the date of earliest disease progression or death due to disease progression or febrile neutropenia, and for an anticipated maximum duration of 24 months.
Title
Overall Survival (OS)
Description
OS is defined as number of days from the date of first dose of the study drug to the date of death of any cause.
Time Frame
Measured from the date of first dose of study drug to the date of death, and for up to 5 years after the last participant is enrolled.
Title
Hematologic Improvement (HI) rate
Description
Percentages of participants with HI (erythroid/platelet/neutrophil responses).
Time Frame
Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent, and for an anticipated maximum duration of 24 months.
Title
Rate of platelet (PLT) transfusion independence
Description
Percentages of participants who become platelet transfusion-independent.
Time Frame
Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent, and for an anticipated maximum duration of 24 months.
Title
Event-Free Survival (EFS)
Description
Event-free survival (EFS) will be defined as the number of days from the date of the first dose of study drug to the date of earliest disease progression or death of any cause.
Time Frame
Measured from the date of the first dose of study drug to the date of earliest disease progression, death of any cause and for up to 5 yrs after the last participant is enrolled
Title
Time to transformation to acute myeloid leukemia (AML)
Description
Defined as the number of days from the date of the first dose of study drug to the date of documented AML transformation.
Time Frame
Measured from the date of first dose of study drug to date of documented AML transformation, defined as the presence of blast count greater than or equal to 20% in either peripheral blood or bone marrow for an anticipated maximum duration of 24 months.
Title
Overall Response Rate (ORR)
Description
ORR (equals the rates of complete remission [CR] + partial remission [PR]) of venetoclax in combination with azacitidine.
Time Frame
Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent and for an anticipated maximum duration of 24 months.
Title
Time to next treatment (TTNT)
Description
Time to next treatment (TTNT) will be defined as the time from the first dose of study drug to start of new non-protocol specified MDS therapy or death from any cause.
Time Frame
Measured from the first dose of study drug to start of new non-protocol specified MDS therapy, and for up to 5 years after the last participant is enrolled.
Title
Marrow Complete Remission (mCR) Rate
Description
Defined as the proportion of participants who achieved a marrow complete response with or without hematological improvement per the International Working Group (IWG) 2006 criteria for Myelodysplastic Syndromes.
Time Frame
Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent, and for an anticipated maximum duration of 24 months.
Title
Modified Overall Response Rate (mORR)
Description
mORR (equals CR + PR + mCR) of venetoclax in combination with azacitidine.
Time Frame
Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent and for an anticipated maximum duration of 24 months.
Title
Duration of CR
Description
Duration of CR will be defined as the number of days from the date of first response CR to the earliest documentation of progressive disease or death of any cause, whichever occurs earlier.
Time Frame
Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent, and for an anticipated maximum duration of 24 months.
Title
Duration of mORR
Description
Duration of response (mORR) will be defined as the number of days from the date of first response (CR, PR or mCR) to the earliest documentation of progressive disease or death of any cause, whichever occurs earlier.
Time Frame
Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent and for an anticipated maximum duration of 24 months.
Title
Duration of ORR
Description
Duration of response (ORR) will be defined as the number of days from the date of first response (CR or PR) to the earliest documentation of progressive disease or death of any cause, whichever occurs earlier.
Time Frame
Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent and for an anticipated maximum duration of 24 months.
Title
Rate of AML transformation
Description
The AML transformation rate is defined as the proportion of participants transformed to Acute Myelogenous Leukemia.
Time Frame
Measured from the date of first dose of study drug to date of documented AML transformation, defined as the presence of blast count greater than or equal to 20% in either peripheral blood or bone marrow for an anticipated maximum duration of 24 months.
Title
Time to First Response (CR)
Description
Time to first response (CR) will be defined as the number of days from the date of first dose of the study drug to the date of the first response of CR.
Time Frame
Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent, and for an anticipated maximum duration of 24 months.
Title
Time to First Response (mORR)
Description
Time to first response (mORR) will be defined as the number of days from the date of first dose of the study drug to the date of the first response of (CR, PR, or mCR).
Time Frame
Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent and for an anticipated maximum duration of 24 months.
Title
Time to First Response (ORR)
Description
Time to first response (ORR) will be defined as the number of days from the date of first dose of the study drug to the date of the first response of (CR or PR).
Time Frame
Measured from Cycle 1 Day 1 as long as the participant continues to benefit, or until the occurrence of unacceptable toxicity, death, exercise of investigator discretion, or withdrawal of consent and for an anticipated maximum duration of 24 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participant must have documented diagnosis of untreated de novo MDS with:
International Prognostic Scoring System (IPSS) risk categories Int-2 or High (minimum IPSS overall score of 1.5) OR Revised IPSS (IPSS-R) categories intermediate, high or very high (score of > 3) and
Presence of less than 20% bone marrow blasts per bone marrow biopsy/aspirate.
Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
Exclusion Criteria:
Participant has received prior therapy for MDS. (Prior supportive care in form of transfusions or growth factors, etc., is not considered prior therapy).
Participant has received prior therapy with a BCL-2 Homology 3 (BH3) mimetic.
Participant has a diagnosis other than previously untreated de novo MDS (as defined in the protocol) including:
MDS with IPSS risk categories Low or Int-1 (overall IPSS score < 1.5)
Therapy-related MDS (t-MDS).
MDS evolving from a pre-existing myeloproliferative neoplasm (MPN).
MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
Participant has received allogeneic Hematopoietic Stem Cell Transplantation (HSCT) or solid organ transplantation.
Participant has received a live attenuated vaccine within 4 weeks prior to the first dose of study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Cancer Center - North Campus /ID# 154155
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719-1478
Country
United States
Facility Name
The University of Chicago Medical Center /ID# 153673
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
University of Maryland School of Medicine /ID# 153669
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1544
Country
United States
Facility Name
Tufts Medical Center /ID# 153672
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111-1552
Country
United States
Facility Name
Dana-Farber Cancer Institute /ID# 152735
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University-School of Medicine /ID# 153671
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Medical Center /ID# 153661
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Facility Name
Weill Cornell Medical College /ID# 155524
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Oregon Health and Science University /ID# 152734
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pittsburgh MC /ID# 153662
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
Tennessee Oncology-Nashville Centennial /ID# 222769
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1632
Country
United States
Facility Name
Vanderbilt University Medical Center /ID# 152738
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
UT MD Anderson Cancer Center /ID# 153809
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Concord Repatriation General Hospital /ID# 154958
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Duplicate_St. Vincent's Hospital, Darlinghurst /ID# 222846
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
St George Hospital /ID# 154954
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Liverpool Hospital /ID# 222410
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Calvary Mater Newcastle /ID# 154957
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Princess Alexandra Hospital /ID# 154990
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Austin Health /ID# 154955
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Alfred Health /ID# 154956
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Fiona Stanley Hospital /ID# 222847
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Juravinski Cancer Centre /ID# 152947
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 153828
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Facility Name
AP-HP - Hopital Saint-Louis /ID# 153827
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Universitatsklinikum Mannheim /ID# 153140
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitaetsklinikum Koeln /ID# 153141
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Duplicate_Universitaetsklinikum Carl Gus /ID# 153958
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Leipzig /ID# 153142
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitaetsklinikum Halle (Saale) /ID# 153760
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 153139
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 153764
City
Rome
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 153763
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 156492
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust /ID# 222567
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust /ID# 158810
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust /ID# 156489
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://rxabbvie.com/
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Learn more about this trial
A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)
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