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A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.

Primary Purpose

Acute Myeloid Leukemia

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

siremadlin

venetoclax

azacitidine

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute myeloid leukemia, AML, Azacitidine, venetoclax, p53, MDM2, siremadlin, HDM201, unfit adult AML participants, newly diagnosed unfit AML, presenting with high-risk clinical features

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Age at the date of signing the informed consent form (ICF): Arm 1 and Arm 2: ≥ 18 years

- Participants diagnosed with AML based on WHO 2016 classification (Arber et al 2016) who are ineligible for standard induction chemotherapy and: Arm 1 : have received at least 2 cycles and not more than 4 cycles of first-line venetoclax plus azacitidine treatment and have not achieved a CR, CRi, CRh or MLFS.

Arm 2 : newly diagnosed AML with adverse genetic risk stratification (according to ELN 2022) (except TP53 mutation positive participants).

Participant must be considered ineligible for standard of care intensive induction chemotherapy defined by the following:
- 75 years of age; OR
- 18 to 74 years of age with at least one of the following co-morbidities: Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3; Cardiac history of congestive heart failure (CHF) requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina; DLCO ≤ 65% or FEV1 ≤ 65%.
Participants must have an ECOG performance status:
0 to 2 for participants ≥ 75 years of age. OR 0 to 3 for participants ≥ 18 to 74 years of age.
WBC < 25x109/L
AST and ALT ≤ 3 × ULN
Estimated Glomerular Filtration Rate (eGFR)≥ 60 mL/min/1.73 m2

Exclusion Criteria:

Prior exposure to MDM2-inhibitor therapy at any time.
Participants with TP53 mutation positive.
Participants with del17p.
Participants with AML-M3 / APL (Acute promyelocytic leukemia) with PML-RARA (Promyelocytic leukemia/retinoic acid receptor alpha) or with AML secondary to Down's syndrome.
Participants treated with FLT3 inhibitors
Participants who require treatment with moderate or strong CYP3A4 inducers within 14 days prior to starting study treatment, or are expected to receive moderate or strong CYP3A4 inducers during the entire study
Participants who require treatment with substrates of CYP3A4/5 with a narrow therapeutic index.

Other protocol-defined inclusion/exclusion criteria may apply at the end

Sites / Locations

University of California Los Angeles .Recruiting
Rocky Mountain Cancer Centers RMCC - AuroraRecruiting
Dana Farber Cancer Institute Harvard Cancer CenterRecruiting
Uni of Massachusetts Medical CenterRecruiting
Roswell Park Cancer InstituteRecruiting
Cleveland Clinic FoundationRecruiting
Oregon Health and Science UnivRecruiting
UPMC Cancer Centers Division Hematology-OncologyRecruiting
Texas Oncology Sammons Cancer Center Sammons Cancer Center (SC)Recruiting
University of Texas MD Anderson Cancer CenterRecruiting
Virginia Cancer Specialists .Recruiting
Medical College of Wisconsin .Recruiting
Novartis Investigative SiteRecruiting
Novartis Investigative SiteRecruiting
Novartis Investigative SiteRecruiting
Novartis Investigative SiteRecruiting
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1: Unfit adult participants with AML who responded sub-optimally to standard of care

Arm 2: Newly diagnosed unfit adult participants with high-risk AML

Arm Description

Unfit adult participants with AML who responded sub-optimally to at least 2 and not more than 4 cycles ( 1 cycle=28 days) of first-line venetoclax plus azacitidine therapy

Unfit adult participants with newly diagnosed AML and with adverse genetic risk stratification (according to ELN 2022)(Except TP53 mutation positive participants).

Outcomes

Primary Outcome Measures

Percentage of participants with Dose Limiting Toxicities (DLTs) as per investigator assessment reported during the first cycle (separately in Arm 1 & Arm 2)

Assessment of Dose Limiting Toxicity (DLT); Safety/Tolerability during the first cycle of study treatment

Percentage of participants treated at the recommended dose for expansion, achieving a complete remission (CR) as per investigator assessment (Arm 1 only)

Assessment of Complete remission (CR) in order to evaluate preliminary efficacy of siremadlin (in combination of venetoclax plus azacitidine) at the determined recommended dose for expansion

Secondary Outcome Measures

Percentage of participants treated at the recommended dose for expansion, achieving CR as per investigator assessment (Arm 2 only; for Arm 1 assessment of CR is a primary outcome measure))

Assessment of CR in order to evaluate preliminary efficacy of siremadlin (in combination of venetoclax plus azacitidine) at the determined recommended dose for expansion in participants with newly diagnosed AML having high-risk disease features.

Time of the date of the first documented CR to the date of the first documented relapse or death due to any cause, whichever occurs first (Arm 1 and Arm 2)

Assessment of duration of CR in participants who achieved a CR.

Percentage of participants achieving CR or complete remission with partial hematological recovery (CRh) and percentage of participants achieving CR or complete remission with incomplete hematological recovery (CRi) (Arm 1 and Arm 2)

CRh is defined as CR with partial hematological recovery (i.e. neutrophil >0.5 X109/L and platelet > 50X109/L) and CRi is defined as CR with incomplete hematological recovery (i.e. neutrophil <1.0X109/L and/or platelet <100X109/L)

Time from the date of the first documented CR/CRh and CR/CRi to the date of first documented relapse or death due to any cause, whichever occurs first (Arm 1 and Arm 2)

Assessment of duration of CR/CRh and duration of CR/CRi

The time from start of treatment to death due to any cause (Arm 1 and Arm 2)

Assessment of Overall Survival (OS)

Percentage of participants died due to any cause from start of treatment until 30- and 60-day (Arm 1 and Arm 2)

To assess rate of early mortality at 30 day and 60 days from start of study treatment

Pharmacokinetic (PK) parameters: AUCs of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)

PK parameters AUC and concentration vs time profiles of siremadlin, venetoclax and azacitidine. AUC0-t: The area under the concentration vs. time Curve (AUC) from time zero to specified time point. AUClast is the AUC from time zero to the last quantifiable concentration point (last) (mass x time x volume -1). AUCtau is the AUC to the end of the dosing interval as when possible PK samples will be collected up to 24 h postdose for siremadlin and venetoclax. Steady-state will be assumed on Day 5 (AUCtau, ss) in case of continuous dosing.

PK parameter: Cmax of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)

PK parameter Cmax and concentration vs time profiles of siremadlin, venetoclax and azacitidine. Cmax is the maximum (peak) observed plasma, blood, serum or other body fluid drug concentration following drug administration (mass x volume -1)

PK parameter: Tmax of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)

PK parameter Tmax and concentration vs time profiles of siremadlin, venetoclax and azacitidine. Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after drug administration (time).

Percentage of CR- Measurable Residual Disease (MRD) negative overall and in participants achieving a CR, CR/CRh, and CR/CRi (Arm 1 and Arm 2)

To assess the effect of siremadlin in combination with venetoclax plus azacitidine in MRD

Full Information

NCT ID

NCT05155709

First Posted

October 20, 2021

Last Updated

September 11, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05155709

Brief Title

A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.

Official Title

A Phase Ib/II Open Label Dose Confirmation, Proof of Concept Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Unfit Adult AML Participants Who Responded Sub-optimally to First-line Venetoclax Plus Azacitidine Treatment and in Participants With Newly Diagnosed Unfit AML Presenting With High-risk Clinical Features

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 17, 2022 (Actual)

Primary Completion Date

May 2, 2025 (Anticipated)

Study Completion Date

November 13, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A study of siremadlin in combination with venetoclax plus azacitidine in adult participants with AML who are ineligible for chemotherapy.

Detailed Description

The primary purpose of this study is to assess whether siremadlin in combination with venetoclax plus azacitidine can enhance the clinical response in unfit AML patients without unacceptable levels of treatment-emergent toxicities. The recommended dose of siremadlin in combination with venetoclax plus azacitidine will be determined to be explored further in the expansion phase and the preliminary efficacy in achieving Complete Remission (CR) will be evaluated in participants who responded sub-optimally to first-line venetoclax plus azacitidine treatment. The study will be conducted in two parts. The primary purpose of Part 1 (Safety Run-in) is to rule out excessive toxicity of siremadlin when administered in combination with venetoclax plus azacitidine while the primary purpose of Part 2 (Expansion) is to evaluate the preliminary efficacy of siremadlin when combined with venetoclax plus azacitidine in the respective patient population. The study treatment (siremadlin in combination with venetoclax plus azacitidine) will be administered in cycles with a planned duration of 28 days and will continue until the participants experience disease progression/relapse or unacceptable toxicity. In the Safety run-in part, 9-15 participants will be enrolled in each arms. Approximately 3-6 participants will be enrolled at the starting dose level of siremadlin in combination with venetoclax plus azacitidine in both arms independently. Provided the starting dose level is determined to be safe, approximately 6-9 additional participants will be enrolled at dose level +1. Safety review meetings will take place involving participating investigators and the Sponsor Team to make decisions regarding siremadlin dose and determine the recommended dose for expansion. Approximately 26 patients will be treated at the recommended dose in the expansion part.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemia, AML, Azacitidine, venetoclax, p53, MDM2, siremadlin, HDM201, unfit adult AML participants, newly diagnosed unfit AML, presenting with high-risk clinical features

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Unfit adult participants with AML who responded sub-optimally to standard of care

Arm Type

Experimental

Arm Description

Unfit adult participants with AML who responded sub-optimally to at least 2 and not more than 4 cycles ( 1 cycle=28 days) of first-line venetoclax plus azacitidine therapy

Arm Title

Arm 2: Newly diagnosed unfit adult participants with high-risk AML

Arm Type

Experimental

Arm Description

Unfit adult participants with newly diagnosed AML and with adverse genetic risk stratification (according to ELN 2022)(Except TP53 mutation positive participants).

Intervention Type

Drug

Intervention Name(s)

siremadlin

Other Intervention Name(s)

HDM201

Intervention Description

Siremadlin is a capsule taken orally once a day (QD) and comes in 10 mg, 20 mg and 30 mg strengths

Intervention Type

Drug

Intervention Name(s)

venetoclax

Intervention Description

Venetoclax is a tablet taken orally once a day (QD) and comes in 10 mg, 50 mg and 100 mg strengths.

Intervention Type

Drug

Intervention Name(s)

azacitidine

Intervention Description

Azacitidine is a powder for suspension for injection or powder for solution for infusion taken intravenously or subcutaneously according to standard local clinical practice

Primary Outcome Measure Information:

Title

Percentage of participants with Dose Limiting Toxicities (DLTs) as per investigator assessment reported during the first cycle (separately in Arm 1 & Arm 2)

Description

Assessment of Dose Limiting Toxicity (DLT); Safety/Tolerability during the first cycle of study treatment

Time Frame

From Cycle 1 Day 1 to Cycle 1 Day 28 (28 days)

Title

Percentage of participants treated at the recommended dose for expansion, achieving a complete remission (CR) as per investigator assessment (Arm 1 only)

Description

Assessment of Complete remission (CR) in order to evaluate preliminary efficacy of siremadlin (in combination of venetoclax plus azacitidine) at the determined recommended dose for expansion

Time Frame

At least 7 cycles (196 days)

Secondary Outcome Measure Information:

Title

Percentage of participants treated at the recommended dose for expansion, achieving CR as per investigator assessment (Arm 2 only; for Arm 1 assessment of CR is a primary outcome measure))

Description

Time Frame

up to 3 years

Title

Time of the date of the first documented CR to the date of the first documented relapse or death due to any cause, whichever occurs first (Arm 1 and Arm 2)

Description

Assessment of duration of CR in participants who achieved a CR.

Time Frame

up to 3 years

Title

Description

Time Frame

up to 3 years

Title

Time from the date of the first documented CR/CRh and CR/CRi to the date of first documented relapse or death due to any cause, whichever occurs first (Arm 1 and Arm 2)

Description

Assessment of duration of CR/CRh and duration of CR/CRi

Time Frame

up to 3 years

Title

The time from start of treatment to death due to any cause (Arm 1 and Arm 2)

Description

Assessment of Overall Survival (OS)

Time Frame

up to 3 years

Title

Percentage of participants died due to any cause from start of treatment until 30- and 60-day (Arm 1 and Arm 2)

Description

To assess rate of early mortality at 30 day and 60 days from start of study treatment

Time Frame

30 days & 60 days from start of study treatment

Title

Pharmacokinetic (PK) parameters: AUCs of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)

Description

Time Frame

up to 3 years

Title

PK parameter: Cmax of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)

Description

Time Frame

up to 3 years

Title

PK parameter: Tmax of siremadlin, venetoclax and azacitidine (Arm 1 and Arm 2)

Description

Time Frame

up to 3 years

Title

Percentage of CR- Measurable Residual Disease (MRD) negative overall and in participants achieving a CR, CR/CRh, and CR/CRi (Arm 1 and Arm 2)

Description

To assess the effect of siremadlin in combination with venetoclax plus azacitidine in MRD

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Age at the date of signing the informed consent form (ICF): Arm 1 and Arm 2: ≥ 18 years - Participants diagnosed with AML based on WHO 2016 classification (Arber et al 2016) who are ineligible for standard induction chemotherapy and: Arm 1 : have received at least 2 cycles and not more than 4 cycles of first-line venetoclax plus azacitidine treatment and have not achieved a CR, CRi, CRh or MLFS. Arm 2 : newly diagnosed AML with adverse genetic risk stratification (according to ELN 2022) (except TP53 mutation positive participants). Participant must be considered ineligible for standard of care intensive induction chemotherapy defined by the following: 75 years of age; OR 18 to 74 years of age with at least one of the following co-morbidities: Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or 3; Cardiac history of congestive heart failure (CHF) requiring treatment or Ejection Fraction ≤ 50% or chronic stable angina; DLCO ≤ 65% or FEV1 ≤ 65%. Participants must have an ECOG performance status: 0 to 2 for participants ≥ 75 years of age. OR 0 to 3 for participants ≥ 18 to 74 years of age. WBC < 25x109/L AST and ALT ≤ 3 × ULN Estimated Glomerular Filtration Rate (eGFR)≥ 60 mL/min/1.73 m2 Exclusion Criteria: Prior exposure to MDM2-inhibitor therapy at any time. Participants with TP53 mutation positive. Participants with del17p. Participants with AML-M3 / APL (Acute promyelocytic leukemia) with PML-RARA (Promyelocytic leukemia/retinoic acid receptor alpha) or with AML secondary to Down's syndrome. Participants treated with FLT3 inhibitors Participants who require treatment with moderate or strong CYP3A4 inducers within 14 days prior to starting study treatment, or are expected to receive moderate or strong CYP3A4 inducers during the entire study Participants who require treatment with substrates of CYP3A4/5 with a narrow therapeutic index. Other protocol-defined inclusion/exclusion criteria may apply at the end

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

1-888-669-6682

novartis.email@novartis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Novartis Pharmaceuticals

Phone

+41613241111

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

University of California Los Angeles .

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Individual Site Status

Recruiting

Facility Contact:

Phone

310-825-9111

First Name & Middle Initial & Last Name & Degree

Caspian Oliai

Facility Name

Rocky Mountain Cancer Centers RMCC - Aurora

City

Longmont

State/Province

Colorado

ZIP/Postal Code

80501

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Therese Jones

Phone

303-418-7600

therese.jones@usoncology.com

First Name & Middle Initial & Last Name & Degree

Christopher Benton

Facility Name

Dana Farber Cancer Institute Harvard Cancer Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephanie Silva

Phone

617-632-3985

Stephanief_Silva@dfci.harvard.edu

First Name & Middle Initial & Last Name & Degree

Daniel J DeAngelo

Facility Name

Uni of Massachusetts Medical Center

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kelvin Adu Ntoso

Phone

508-856-1767

Kelvin.AduNtoso@umassmed.edu

First Name & Middle Initial & Last Name & Degree

Jonathan Gerber

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katherine Collins

Phone

716-845-3221

Katherine.Collins@RoswellPark.org

First Name & Middle Initial & Last Name & Degree

Amanda Przespolewski

Facility Name

Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Lee

Phone

216-444-0441

leel5@ccf.org

First Name & Middle Initial & Last Name & Degree

Hetty Carraway

Facility Name

Oregon Health and Science Univ

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicole Tong

Phone

503-346-7894

tongni@ohsu.edu

First Name & Middle Initial & Last Name & Degree

Elie Traer

Facility Name

UPMC Cancer Centers Division Hematology-Oncology

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Abigail Holmes

Phone

412-648-6575

holmesam6@upmc.edu

First Name & Middle Initial & Last Name & Degree

Jing Zhou Hou

Facility Name

Texas Oncology Sammons Cancer Center Sammons Cancer Center (SC)

City

Dallas

State/Province

Texas

ZIP/Postal Code

78246

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maner Jessica

jessica.maner@usoncology.com

First Name & Middle Initial & Last Name & Degree

Moshe Levy

Facility Name

University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4099

Country

United States

Individual Site Status

Recruiting

Facility Contact:

Phone

713-794-5783

First Name & Middle Initial & Last Name & Degree

Naval Daver

Facility Name

Virginia Cancer Specialists .

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hunfa Asghar

Phone

703-280-5390

hunfa.asghar@usoncology.com

First Name & Middle Initial & Last Name & Degree

Mitul Gandhi

Facility Name

Medical College of Wisconsin .

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristin Komnick

Phone

123

kkomnick@mcw.edu

First Name & Middle Initial & Last Name & Degree

Ravi Narra

Facility Name

Novartis Investigative Site

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6000

Country

Australia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Hong Kong

Country

Hong Kong

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Beer-Sheva

ZIP/Postal Code

8457108

Country

Israel

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20162

Country

Italy

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Alor Setar

State/Province

Kedah

ZIP/Postal Code

05460

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Selangor

ZIP/Postal Code

68000

Country

Malaysia

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Hospitalet de LLobregat

State/Province

Catalunya

ZIP/Postal Code

08907

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46010

Country

Spain

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Ankara

State/Province

Yenimahalle

ZIP/Postal Code

06200

Country

Turkey

Individual Site Status

Recruiting

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

IPD Sharing URL

https://www.clinicalstudydatarequest.com

Learn more about this trial

A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.

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