CTRI/2025/05/087376 [Registered on: 22/05/2025] Trial Registered Prospectively
Last Modified On:
14/08/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
Acute Myeloid Leukemia: Venetoclax and Azacitidine in Indian Subjects
Scientific Title of Study
A Phase 4 Study of Venetoclax in Combination with Azacitidine in Indian Subjects with Newly
Diagnosed Acute Myeloid Leukemia Who are Ineligible for Standard Induction Therapy
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
M23-826 version 2.0 dated 04-Feb-2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Nagaraj Malipatil
Designation
Therapy Area Lead Oncology
Affiliation
AbbVie
Address
Level 6 and 7, Prestige Obelisk, Kasturba Road
Bangalore KARNATAKA 560001 India
Phone
916366547211
Fax
Email
nagaraj.malipatil@abbvie.com
Details of Contact Person Public Query
Name
Nagaraj Malipatil
Designation
Therapy Area Lead Oncology
Affiliation
AbbVie
Address
Level 6 and 7, Prestige Obelisk, Kasturba Road
Bangalore KARNATAKA 560001 India
Phone
916366547211
Fax
Email
nagaraj.malipatil@abbvie.com
Source of Monetary or Material Support
AbbVie
1 North Waukegan Road
North Chicago, IL 60064, USA
Primary Sponsor
Name
AbbVie
Address
1 North Waukegan Road
North Chicago, IL 60064
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
AbbVie Healthcare India Private Limited
Level 6 and 7, Prestige Obelisk, Kasturba Road, Bengaluru - 560001, KA, India
Countries of Recruitment
India
Sites of Study
No of Sites = 15
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Ashutosh Panigrahi
All India Institute of Medical Sciences - Bhubaneshwar
First Floor, OPD Building, Department of Hematology, Room No. 116, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar-751019, Odisha, India Khordha ORISSA
9437147517
dr.ashupanigrahi@gmail.com
Dr Jose M Easow
Apollo Cancer Centre
Room No: 44, C Block , 3rd floor, Department of Oncology, Apollo Speciality Hospital, New No.467, Old No. 320, Padma Complex, Anna Salai, Nandanam, Chennai-600035 Tamil Nadu, India Chennai TAMIL NADU
0466 6115 1292
drjose_e@apollohospitals.com
Dr Pavan Kumar Boyella
Basavatarakam Indo-American Cancer Hospital & Research Institute
OPD No 124, Block 1, First floor, Basavatarakam Indo-American Cancer Hospital & Research Institute, Road No 10, Banjara Hills, Hyderabad – 500034, Telangana, India Hyderabad TELANGANA
9656100255
drboyellapk@gmail.com
Dr Parathan Karunakaran
Cancer Institute (WIA)
Cancer Institute WIA, 4th Floor, Academic Clinical Trial Unit, Bhagawan Mahavir Vishranti Graha Building No. 38, Sardar Patel Road, Dr. S.K. Campus, Adyar, Chennai-600036, Tamil Nadu, India Chennai TAMIL NADU
22209150
k.parathan@cancerinstitutewia.org
Dr Sameer Bakhshi
Dr. B.R.A. Institute- Rotary Cancer Hospital, AIIMS
Room No. 243, Department of Medical Oncology, Second Floor, Dr. BRA institute Rotary Cancer Hospital, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi-110029, India New Delhi DELHI
011-29575237
sambakh@hotmail.com
Dr Rahul Bhargava
Fortis Memorial Research Institute
Lower Ground Floor, Department of Hematology & BMT, Fortis Memorial Research Institute, Sector-44, Opposite Millennium City Centre, Gurugram- 122002, Haryana, India Gurgaon HARYANA
0124 496 2200
rahul.bhargava@fortishealthcare.com
Dr Nataraj KS
Healthcare Global Enterprises Limited (HCGEL)
Room 512, Tower 4, 5th floor, Clinical Research Department, Healthcare Global Enterprises Limited, #8, HCG Tower, P. Kalinga Rao Road, Sampangirama nagar, Bangalore – 560027, India. Bangalore KARNATAKA
9482141773
drnatarajks@gmail.com
Dr Sameer Ramesh Melinkeri
LMMFs Deenanath Mangeshkar Hospital & Research Center
Ground Floor, Annex Building, LMMFs Deenanath Mangeshkar Hospital & Research Center, Erandawane, Pune-411004, Maharashtra, India Pune MAHARASHTRA
020 40151000
docmelinkeri@yahoo.com
Dr Sharat Damodar
Mazumdar Shaw Medical Center
Room No: F-6, Block- A, Department of Hemato-Oncology, Mazumdar Shaw Medical Center, Narayana Hrudayalaya Limited,
258/A , Bommasandra Industrial Area, Anekal Taluk, Hosur road, Bangalore - 560099, Karnataka, India Bangalore KARNATAKA
080-71222372
sharat.damodar.dr@narayanahealth.org
Dr Nitin Sood
Medanta The Medicity
OPD No: 13, 10th Floor, Medanta- The Medicity, Sector 38, Gurgaon -122001, Haryana, India Gurgaon HARYANA
0124-4141414
nitin.sood@medanta.org
Dr Dinesh Bhurani
Rajiv Gandhi Cancer Institute and Research Center
Room No. 3265, Department of Hemato-Oncology & BMT, Sector-5, Rohini, Delhi-110085, India. North West DELHI
011-47022261
bhurani@gmail.com
Dr Sugeeth M Thambi
Regional Cancer Centre - Thiruvananthapuram
Room No: e801 A, 8th floor, Medical Oncology Department, Regional Cancer Centre, Medical College Campus, Thiruvananthapuram-695011, Kerala, India Thiruvananthapuram KERALA
0471-2522565
sugeethmt2003@gmail.com
Dr Kannan Subramanian
Sahyadri Super Speciality Hospital
Room No. 5, Ground Floor, Sahyadri Super Speciality Hospital, Plot No. 30C, Erandawane, Karve Road, Pune-4110044, Maharashtra, India Pune MAHARASHTRA
9860335084
dockannan@gmail.com
Dr Arijit Nag
Tata Medical Center
Room no 112, LDU Building,
Department of Clinical hematology and Cellular therapies,Tata Medical Center, 14 Major Arterial road(EW), Newtown, Rajarhat, Kolkata-700160, West Bengal, India North Twentyfour Parganas WEST BENGAL
033-66057622
Arijit.nag@tmckolkata.com
Dr Manju Sengar
Tata Memorial Centre
OPD No. 81, Main Building Ground Floor, TATA Memorial Hospital, Dr. Ernest Borges Marg, Parel, Mumbai-400012, Maharashtra, India Mumbai MAHARASHTRA
This is a Phase 4, open-label, single-arm, multicenter study In India evaluating the safety and efficacy of venetoclax in combination with azacitidine (AZA) subcutaneous (SC) or intravenously (IV) in newly
diagnosed adult subjects with AML who are ineligible for intensive chemotherapy due to age or comorbidities.
Venetoclax will be administered with a 3-day dose ramp-up in an inpatient, hospital setting. Subjects will receive azacitidine for 7 days beginning on Day 1 of each 28-day cycle.
Subjects will receive venetoclax in combination with AZA for at least 6 treatment cycles or until documented disease progression, unacceptable toxicity or intolerance, withdrawal of consent, or the subject meets other criteria for discontinuation per study protocol.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
Consent
Subjects if judged by the investigator to have decision-making capacity must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
Demographic and Laboratory Assessments
Subject must be of Indian descent and reside in India.
Adult subject must be at least 18 years old.
Subject must have a projected life expectancy of at least 12 weeks
Subject must have confirmation of AML by 2016 WHO criteria, has not received previous treatment for AML, and is ineligible for treatment with intensive chemotherapy as defined by the following:
Greater than or equal to 75 years of age or between18 to 74 years of age with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3, Cardiac history of congestive heart failure requiring treatment or ejection fraction less than or equal to 50% or chronic stable angina, Diffusing capacity of the lung for carbon monoxide (DLCO) less than or equal to 65% or forced expiratory volume during the first second (FEV1) less than or equal to 65%, Creatinine clearance greater than or equal to 30 mL/min to less than 45 mL/min, Moderate hepatic impairment with total bilirubin greater than 1.5 to less than or equal to 3.0 ULN,
Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy
Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug: Creatinine clearance greater than or equal to 30 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection, Adequate liver function as demonstrated by: Serum aspartate aminotransferase (AST) less than or equal to 3.0 × upper limit of normal (ULN), Serum alanine aminotransferase (ALT) less than or equal to 3.0 × ULN, Total bilirubin less than or equal to 1.5 × ULN Unless considered due to leukemic organ involvement, White blood cell (WBC) count less than 25 × 109 /L (hydroxyurea is permitted to meet this criterion)
Subject is willing and able to comply with procedures required in this protocol.
Disease/Condition Activity
Subject must have ECOG performance status of: 0 to 2 for subjects greater than or equal to 75 years of age or 0 to 3 for subjects greater than or equal to18 to 74 years of age
Subject meets the following disease activity criteria: Has not received any prior treatment for AML, with the exception of hydroxyurea, May have progressed from myelodysplastic syndrome (MDS) or be considered to have secondary AML and could have been treated with growth factors only.
Contraception
Pregnancy testing in female subjects of childbearing potential: Subjects must have a negative serum pregnancy test at the Screening Visit and, if more than 7 days since obtaining the serum test, a negative urine pregnancy test at Cycle 1 Day 1, prior to the first dose of study drug.
Subjects with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test greater than or equal to 3 days later to document continued lack of a positive result (unless prohibited by local requirements).
Subjects with a urine pregnancy test at Baseline that is borderline or ambiguous must have a serum pregnancy test. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control, from Study Day 1 through at least 6 months after the last dose of study drug.
Female subjects of nonchildbearing potential do not need to use birth control.
Female subject who is not pregnant or breastfeeding, and is not considering becoming pregnant or donating eggs during the study or for approximately 6 months after the last dose of study drug.
Male subject who is sexually active with female partner(s) of childbearing potential, must agree, from Study Day 1 through 3 months after the last dose of study drug, to practice the protocol-specified contraception.
Male subject who is not considering fathering a child or donating sperm during the study or for approximately 3 months after the last dose of study drug.
ExclusionCriteria
Details
Method of Generating Random Sequence
Method of Concealment
Blinding/Masking
Primary Outcome
Outcome
TimePoints
To assess the safety of venetoclax in combination with
azacitidine during the study treatment in adult Indian subjects with newly diagnosed AML ineligible for intensive
chemotherapy.
1. Outcome (parameter to be measurable) : Treatment-emergent Adverse Event (TEAE), Time points: Dec 2027 (End of study)
2. Outcome (parameter to be measurable) : Tumor Lysis Syndrome (TLS) during cycle 1, Time points: 1 month
3. Outcome (parameter to be measurable) : Laboratory abnormalities, Time points: Dec 2027 (End of study)
Secondary Outcome
Outcome
TimePoints
1. To evaluate the efficacy of venetoclax in combination with
azacitidine including composite complete remission (complete remission [CR] & complete remission with incomplete marrow recovery [CRi]) in this population.
2. To evaluate the efficacy of venetoclax in combination with
azacitidine by CR in this population.
3. To evaluate Overall survival (OS) in this population.
1. Outcome: Composite Complete Remission (CRc), Time points: Dec 2027 (End of study)
2. Outcome: Composite Complete Remission (CRc) by initiation of Cycle 2, Time points: 1 month
3. Outcome: Complete Remission (CR), Time points: Dec 2027 (End of study)
4. Outcome: Overall Survival (OS), Time points: Dec 2027 (End of study)
Target Sample Size
Total Sample Size="100" Sample Size from India="100" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 4
Date of First Enrollment (India)
01/07/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="3" Months="4" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Acute myeloid leukemia (AML) is heterogenous malignant disorder of
bone marrow, characterized by the clonal expansion of myeloid blasts in
the bone marrow, peripheral blood, and extra medullary tissues.
Venetoclax is a selective, potent, orally bioavailable, small molecule
inhibitor of B-cell lymphoma (BCL)-2 that restores programmed cell death
in cancer cells. Venetoclax in combination with azacitidine is approved in
> 80 countries globally for patients with newly diagnosed AML who are
ineligible to receive intensive chemotherapy due to age or comorbidities.
This Phase 4, single-arm, open-label study is designed to evaluate the
safety and efficacy of venetoclax in combination with azacitidine during
study treatment in Indian subjects with newly diagnosed acute myeloid
leukemia (AML) who are ineligible for intensive chemotherapy.