| CTRI Number |
CTRI/2025/12/099510 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the safety of test drug to treat patients with relapsed or refractory diffuse large Bcell lymphoma (DLBCL) in India |
|
Scientific Title of Study
|
A Post-Marketing Surveillance (PMS) study to monitor the safety of polatuzumab vedotin (Polivy) in India when administered as per local prescribing information in patients with relapsed or refractory diffuse large Bcell lymphoma (DLBCL) |
| Trial Acronym |
POLIVY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ML45882_V1.0_17Dec2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj Malhotra |
| Designation |
Trial Coordinator |
| Affiliation |
Postgraduate Institute of Medical Education & Research(PGIMER) |
| Address |
Clinical Hematology & Medical Oncology Department (CHMO)
Room No 18, 4th Level, F Block, Nehru Hospital
Postgraduate Institute of Medical Education & Research(PGIMER)
Chandigarh 160020, India,
Chandigarh
CHANDIGARH
160020
India |
| Phone |
7087009680 |
| Fax |
|
| Email |
malhotrapankaj@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotii Poddaar |
| Designation |
Lead- Clinical Operations |
| Affiliation |
Roche Products (India) Pvt. Ltd. |
| Address |
Roche Products (India) Pvt. Ltd.
146-B, 166 A, Unit No. 7, 8, 9, 8th Floor, R City Office,
R City Mall, Lal Bahadur Shastri Marg, Ghatkopar,
Mumbai-400086, Maharashtra, India
Mumbai
MAHARASHTRA
400086
India |
| Phone |
9136064373 |
| Fax |
|
| Email |
jyotii.poddaar@roche.com |
|
Details of Contact Person
Public Query
|
| Name |
Amol Pawar |
| Designation |
Manager- Clinical Operations |
| Affiliation |
Roche Products (India) Pvt. Ltd. |
| Address |
Roche Products (India) Pvt. Ltd.
146-B, 166 A, Unit No. 7, 8, 9, 8th Floor, R City Office,
R City Mall, Lal Bahadur Shastri Marg, Ghatkopar,
Mumbai-400086, Maharashtra, India
Mumbai
MAHARASHTRA
400086
India |
| Phone |
8080780992 |
| Fax |
|
| Email |
amol.pawar@roche.com |
|
|
Source of Monetary or Material Support
|
| Roche Products (India) Pvt. Ltd.
146B, 166A, Unit No 7, 8, 9, 8th Floor, R City Mall, Lal Bahadur Shastri Marg, Ghatkopar, MAHARASHTRA
400086 India |
|
|
Primary Sponsor
|
| Name |
Roche Products (India) Pvt. Ltd. |
| Address |
146-B, 166 A, Unit No. 7, 8, 9, 8th Floor, R City
Office, R City Mall, Lal Bahadur Shastri Marg,
Ghatkopar, Mumbai-400086, Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunu Cyriac |
Amala Institute of Medical Sciences |
Amala Hospital , SH69, Amalanagar, Thrissur,
Kerala- 680555
Thrissur
KERALA |
9778425559
drsunucyriac555@gmail.com |
| Dr Upendra Sharma |
Clinical Trial & Research Department , Mahaveer Cancer Hospital & Research Center. |
05th Floor, Bhagwan Mahaveer Cancer Hospital & Research Center, J.L.N. Marg, Malviya Nagar, Jaipur. Pin 302017
Jaipur
RAJASTHAN |
9413964612
drupendra.sharma@yahoo.in |
| Dr Asif Iqbal |
Dr. B Borooah Cancer Institute , BBCI Guwahati |
AK Azad Road,Gopinath Nagar, Guwahati-781016,Assam,India
Kamrup
ASSAM |
9706570678
asif.iqbal@bbci.in |
| Dr Pankaj Malhotra |
Postgraduate Institute of Medical Education & Research(PGIMER) |
Dept. of Clinical Hematology & Medical Oncology
Room No 18, 4th Level, F Block, Nehru Hospital
Postgraduate Institute of Medical Education & Research(PGIMER)
Chandigarh 160020, India
Chandigarh
CHANDIGARH |
7087009680
malhotrapankaj@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committeee, Bhagwan Mahaveer Cancer Hospital And Research Centre |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research |
Submittted/Under Review |
| Medical Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C833||Diffuse large B-cell lymphoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Polatuzumab vedotin |
1.8 mg/kg as an intravenous infusion every
21 days for 6 cycles. First cycle will be administered over 90 minutes, however subsequent
infusions may be administered over 30 minutes if the previous infusion is tolerated. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients with diagnosis of R R DLBCL who are not candidates for hematopoietic stem cell transplant. 2.Have received at least 1 dose of polatuzumab vedotin in R R DLBCL according to approved label. 3.Have signed the informed consent. 4.Age 18 to 80 yrs at the time of signing Informed Consent Form and willingness to comply with the study protocol requirements. |
|
| ExclusionCriteria |
| Details |
1.History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to
murine products. 2.Prior use of polatuzumab vedotin. 3.Polatuzumab vedotin containing trial or trial that include polatuzumab vedotin as an investigational agent Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis. 4.Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of polatuzumab vedotin or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the safety and tolerability of polatuzumab vedotin
in the treatment of transplant ineligible patients relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in India through the incidence of all adverse events (serious and nonserious) based on usual clinical practice |
Day 0 (baseline), Day 168 and Day 182 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Investigator assessed Complete Response (CR) & Objective Response Rate (ORR) of CR or partial response (PR) at the end of treatment, based on usual clinical practice. |
182 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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="2"
Months="5"
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
|
Prospective, non-interventional study with primary data collection. This study will evaluate the safety of polatuzumab vedotin in the treatment of transplant ineligible patients with R/R DLBCL in the real-world setting of common clinical practice in India. This study will include patients that have received at least one dose of polatuzumab vedotin according to currently approved indication in transplant ineligible R/R DLBCL in India. Patients will be treated, followed, and monitored by their physicians according to local clinical practice. There are no specific visits planned by protocol. However, baseline (first dose of study treatment) and follow up data will be gathered from the medical records at the moment of inclusion in this study up to 8 weeks after completing the treatment or receiving last dose. Data will be collected prospectively and/or retrospectively from the medical records. Patients included in the study are expected to be followed up 8 weeks after receiving last dose (observational period) unless death, lost to follow-up or withdrawal of consent, whichever occurs first. |