Acute Myeloid Leukemia: Venetoclax and Azacitidine in Indian Subjects
Phase 4
Not yet recruiting
- Conditions
- Acute myeloblastic leukemia,
- Registration Number
- CTRI/2025/05/087376
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety of venetoclax in combination with 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) azacitidine during the study treatment in adult Indian subjects with newly diagnosed AML ineligible for intensive 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) 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 Measures
Name Time Method 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.
Trial Locations
- Locations (15)
All India Institute of Medical Sciences - Bhubaneshwar
🇮🇳Khordha, ORISSA, India
Apollo Cancer Centre
🇮🇳Chennai, TAMIL NADU, India
Basavatarakam Indo-American Cancer Hospital & Research Institute
🇮🇳Hyderabad, TELANGANA, India
Cancer Institute (WIA)
🇮🇳Chennai, TAMIL NADU, India
Dr. B.R.A. Institute- Rotary Cancer Hospital, AIIMS
🇮🇳Delhi, DELHI, India
Fortis Memorial Research Institute
🇮🇳Gurgaon, HARYANA, India
Healthcare Global Enterprises Limited (HCGEL)
🇮🇳Bangalore, KARNATAKA, India
LMMFs Deenanath Mangeshkar Hospital & Research Center
🇮🇳Pune, MAHARASHTRA, India
Mazumdar Shaw Medical Center
🇮🇳Bangalore, KARNATAKA, India
Medanta The Medicity
🇮🇳Gurgaon, HARYANA, India
Scroll for more (5 remaining)All India Institute of Medical Sciences - Bhubaneshwar🇮🇳Khordha, ORISSA, IndiaDr Ashutosh PanigrahiPrincipal investigator9437147517dr.ashupanigrahi@gmail.com