| CTRI Number |
CTRI/2026/03/105926 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
22/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study of venetoclax treatment in patients with acute myeloid leukemia to see if it helps prevent the disease from coming back after initial therapy |
|
Scientific Title of Study
|
Centre for Advanced Research on Innovation in Diagnosis, Prognostication, and Monitoring of Acute Myeloid Leukemia: VENCON STUDY: A Phase II-III study of Venetoclax- Based Consolidation in AML Patients in CR After Azacitidine + Venetoclax Induction |
| Trial Acronym |
VENCON |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lingaraj Nayak |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Room No. 1005, 10th floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167294976 |
| Fax |
|
| Email |
lingarajnayak86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lingaraj Nayak |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Room No. 1005, 10th floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167294976 |
| Fax |
|
| Email |
lingarajnayak86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lingaraj Nayak |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Tata Memorial Centre |
| Address |
Room No. 1005, 10th floor, Homi Bhabha Block, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9167294976 |
| Fax |
|
| Email |
lingarajnayak86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Extramural: ICMR CAR grants |
| Intramural: Tata Memorial Centre |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai, 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ICMR |
V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi - 110029, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anant Gokarn |
Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) |
ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai - 410210, Maharashtra.
Mumbai (Suburban)
MAHARASHTRA |
27405000-8694
anantgokarn@gmail.com |
| Dr Lingaraj Nayak |
Tata Memorial Hospital |
Room Number-81 Main Building Dr. E Borges Road, Parel, Mumbai - 400 012 India
MAHARASHTRA
Mumbai
MAHARASHTRA |
02224177210
lingarajnayak86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee III, TMC ACTREC |
Approved |
| Tata Memorial Centre, Institutional Ethics Committee-I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C920||Acute myeloblastic leukemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Phase II single-arm component |
Azacitidine-venetoclax (10 cycles) |
| Intervention |
Phase III
Arm A (Experimental) |
High-Dose Cytarabine (9 g per m² total per cycle over 3 days) + Venetoclax 100 mg orally once daily (Days 1–10)
Three cycles |
| Comparator Agent |
Phase III
Arm B (Control) |
High-Dose Cytarabine (9 g per m² total per cycle over 3 days)
Three cycles |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Denovo AML in morphological remission after azacitidine venetoclax based induction therapy
Age 15 to 60 years
ECOG performance status 0 to 1
A patient who can give informed consent for the study
The patient does not have any contraindications to receive chemotherapy
Adequate hematological hepatic and renal function parameters
a Hematological Hb more than 80 g per L ANC more than or equal to 1.5 x 10 9 per L platelets more than or equal to 100 x 10 9 per L
b Liver functions bilirubin less than or equal to 2 times upper limit normal ULN AST ALT less than or equal to 5 times ULN alkaline phosphatase less than or equal to 6 times ULN serum albumin more than or equal to 30 g per L
c Renal function creatinine less than or equal to 1.5 ULN creatinine clearance more than or equal to 60 mL per min
Written patient consent form |
|
| ExclusionCriteria |
| Details |
Very high risk AML TP53 mutated AML Complex karyotype Monosomal karyotype
AML with FLT3 mutation VAF greater than 5 percent
Complete remission with incomplete hematologic recovery CRi
More than 6 weeks since the last azacitidine venetoclax
Active infection requiring IV antibiotics or antifungals
Clinically significant active coronary heart disease cardiomyopathy or congestive heart failure NYHA III IV clinically significant valvular defect
ECOG PS 2 or more |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Event-Free Survival (EFS) |
Participants will be followed for 24 months after completion of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Progression-Free Survival (PFS) |
Time from randomization to relapse, progression, or death from any cause. |
| Overall Survival (OS) |
Time from randomization to relapse, progression, or death from any cause. |
| Incidence of Grade 3–4 toxicities (CTCAE v5.0) |
Time from randomization to relapse, progression, or death from any cause. |
| MRD clearance kinetics (NGS-based) |
Time from randomization to relapse, progression, or death from any cause. |
|
|
Target Sample Size
|
Total Sample Size="256"
Sample Size from India="256"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/03/2026 |
| 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="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study evaluates optimal consolidation therapy in patients with acute myeloid leukemia who achieve complete remission after induction treatment with azacitidine and venetoclax. Although azacitidine and venetoclax is an effective lower intensity induction regimen, the most appropriate consolidation strategy after remission is not well established, particularly in resource limited settings where stem cell transplantation may not be feasible for many patients. The study is designed as a combined phase II and phase III clinical trial conducted at Tata Memorial Centre. The objective is to assess the safety and efficacy of venetoclax based consolidation strategies in patients who have achieved remission following azacitidine and venetoclax induction therapy. In the phase III component, patients aged 15 to 60 years who are considered fit for intensive chemotherapy will be randomized to receive high dose cytarabine consolidation with venetoclax or high dose cytarabine alone. The aim is to determine whether the addition of venetoclax to cytarabine consolidation improves treatment outcomes including relapse free survival and overall survival. In the phase II component, patients aged 15 to 70 years who are not considered fit for intensive chemotherapy will receive venetoclax based consolidation therapy after achieving remission with azacitidine and venetoclax induction. This phase will evaluate the feasibility safety and clinical outcomes of this consolidation approach in patients who are not eligible for intensive chemotherapy. The overall study aims to generate evidence on effective post remission treatment strategies following azacitidine and venetoclax induction in acute myeloid leukemia and to improve long term disease control in this patient population. |