CTRI/2025/04/085952 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On:
13/02/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Biological
Study Design
Non-randomized, Active Controlled Trial
Public Title of Study
To evaluate effect of the polatuzumab vedotin in combination with four other drugs, rituximab (R), cyclophosphamide (C), doxorubicin (H), and prednisone (P) in Lymphoma that develops from mature B-cell of patients
Scientific Title of Study
A Phase IV, Open Label, Study Evaluating the safety and efficacy of Polatuzumab Vedotin in combination with Rituximab and CHP (R-CHP) in previously untreated adult patients with diffuse large B-cell Lymphoma (DLBCL)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ML45360_Version 2.0 dated 02-May-2024
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
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, Mumbai, MAHARASHTRA, 400086 - India
Mumbai MAHARASHTRA 400086 India
Phone
9136064373
Fax
Email
jyotii.poddaar@roche.com
Details of Contact Person Public Query
Name
Sharad Junnare
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, Mumbai, MAHARASHTRA, 400086 - India
Mumbai MAHARASHTRA 400086 India
Phone
9920171414
Fax
Email
sharad.junnare@roche.com
Source of Monetary or Material Support
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 - 400 086 Maharashtra ,India
Primary Sponsor
Name
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 - INDIA
Basavatarakam Indo American Cancer Hospital & Research Institute
Medical Oncology, Basavatarakam Indo American Cancer Hospital & Research Institute, 10, Banjara Hills, Hyderabad-500034, Telangana - India
Hyderabad TELANGANA
9866154503
mvtkm@yahoo.com
Dr Sharat Damodar
Mazumdarshaw Medical Center
Adult Hematology and BMT, Mazumdarshaw Medical Center, A unit of Narayana Health
258/A, Bommasandra Industrial Area, Hosur Road, Anekkal Taluk, Bangalore - 560099 Bangalore KARNATAKA
9880437134
drsharat.damodar@gmail.com
Dr Anand Pathak
National Cancer Institute
Medical Oncology Department, National Cancer Institute Khasara No. 25, Outer Hingna Ring Road, Mouza Jamtha, Nagpur-441 108, Maharashtra, India. Nagpur MAHARASHTRA
9823038498
abpathak21@gmail.com
Dr Tuphan Kanti Dolai
NRS Medical college
Room No-1 , Department of Hematology, 4th floor, Centenary Building, N.R.S Medical College and Hospital,138 A.J.C Bose Road, Kolkata -700014, West Bengal, India Kolkata WEST BENGAL
9874890275
tkdolai75@gmail.com
Dr Dinesh Bhurani
Rajiv Gandhi Cancer Institute & Research Center
Department of Hemato-Oncology & BMT, Rajiv Gandhi Cancer Institute & Research Center (RGCIRC) - Rajiv Gandhi Cancer Institute and Research Center,
Sector-5, Rohini,New Delhi - 110085 - India New Delhi DELHI
9971500861
bhurani@gmail.com
Dr Hasmukh Jain
Tata Memorial Centre
Room No 81, Ground floor, Main Building, Tata Memorial Centre,
Tata Memorial Hospital,
E Borges Road,Mumbai 400 012
Parel (E) Mumbai - 400012 - India
Mumbai MAHARASHTRA
7718982948
dr.hkjain@gmail.com
Dr Kaushal Kalra
Vardhaman Mahavir Medical College & Safdarjung Hospital
Department of Medical Oncology, Vardhaman Mahavir Medical College & Safdarjung
Hospital, New Delhi - 110029 - India New Delhi DELHI
Institutional Ethics Committee I & II, Tata Memorial Hospital
Submittted/Under Review
Institutional Ethics Committee NRS Medical College, Kolkata
Approved
Institutional Ethics Committee VMMC and SJH
Approved
Institutional Ethics Committee, Basavatarakam Indo American Cancer Hospital & Research Institute
Approved
Institutional Review Board, Rajiv Gandhi Cancer Institute and Research Centre
Approved
Narayana Health Medical Ethics Committee
Approved
National Cancer Institute Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
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
Not Applicable
It is an open label study and there is no comparator
Intervention
R-CHP + polatuzumab vedotin
polatuzumab vedotin 1.8 mg/kg IV, rituximab 375 mg/m2 IV, cyclophosphamide 750 mg/m2 IV, and doxorubicin 50 mg/m2 IV each given on Day 1 and prednisone 100 mg/day orally (PO) given on Days 1−5 of every 21-day cycle for 6 cycles.
Total duration of treatment will be 18 weeks.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
1. Signed written Informed Consent Form
2. IPI score of 2 to 5
3. Previously untreated patients with CD20 positive DLBCL, including one of the following diagnoses by 2016 WHO classification of lymphoid neoplasms
a. DLBCL, not otherwise specified including germinal center B-cell type, activated B-cell type
b. DLBCL with MYC and BCL2 rearrangements
4. ECOG Performance Status of 0, 1, or 2
5. Life expectancy more than 12 months
6. At least one bidimensionally measurable lesion, defined as more than 1.5 cm in its longest dimension as measured by CT or MRI
7. Left ventricular ejection fraction (LVEF) more than equal to 50percent on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
8. Adequate hematologic function
a. Hemoglobin more than equal to 9.0 g/dL without packed RBC transfusion during 14 days before first treatment
b. ANC more than equal to 1,000 per microL
c. Platelet count more than equal to 75,000 per microL
9. For men and women of childbearing potential should be in agreement to remain abstinent.
ExclusionCriteria
Details
1. Contraindication to any of the individual components of RCHP, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products.
2. Prior organ transplantation
3. Current Grade more than 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
4. History of indolent lymphoma
5. Other histologies than those described in the inclusion criteria
6. Current diagnosis of the following: follicular lymphoma Grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma ; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; CNS lymphoma , primary effusion DLBCL, and primary cutaneous DLBCL.
7. Prior treatment with cytotoxic drugs within 5 years of screening for any condition (e.g., cancer, rheumatoid arthritis) or prior use of any anti-CD20 antibody
8. Prior use of any monoclonal antibody within 3 months of the start of Cycle 1; any investigational therapy within 28 days prior to the start of Cycle 1; vaccination with live vaccines within 28 days prior the start of Cycle 1
9. Prior radiotherapy to the mediastinal/pericardial region
10. Prior therapy for DLBCL. Corticosteroids are addressed in the next point
11. Corticosteroid use more than 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control:
-Patients receiving corticosteroid treatment with less than equal to 30 mg/day of prednisone or equivalent for reasons other than lymphoma symptom control (e.g., rheumatoid arthritis) must be documented to be on a stable dose of at least 4 weeks duration prior to the start of Cycle 1.
-Patients who require lymphoma symptom control during screening may receive steroids in the following manner:
Up to 30 mg/day of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging
If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of more than 30 to 100 mg/day of prednisone or equivalent. Prednisone more than 30 to 100 mg/day or equivalent may be given for a maximum of 7 days as a pre-phase treatment
12. History of other malignancy that could affect compliance with the protocol or interpretation of results
13. Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease
14. Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
15. History or presence of an abnormal ECG that is clinically significant in the investigators opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction.
16. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 2 weeks before the start of Cycle 1.
17. Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
18. Illicit drug or alcohol abuse within 12 months prior to screening, in the investigators judgment
19. Any of the following abnormal laboratory values:
a. INR or PT more than 1.5x upper limit of normal (ULN) in the absence of therapeutic anticoagulation
b. PTT or aPTT more than 1.5 ULN in the absence of a lupus anticoagulant
c. Serum AST and ALT more than equal to 2.5 ULN
d. Total bilirubin more than equal to 1.5 ULN
Patients with documented Gilbert disease may be enrolled if total bilirubin is less than equal to 3.0 ULN.
e. Serum creatinine clearance less than 40 mL/min
20. Patients with suspected active or latent tuberculosis, Positive test results for chronic hepatitis B infection, Positive test results for hepatitis C, Known history of HIV seropositive status, Patients with a history of progressive multifocal leukoencephalopathy, Pregnancy or lactation or intending to become pregnant during study.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
-Incidence of any adverse events
-Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to adverse events
-Dose intensities of study drugs
-Outcome will be assess at every patient visits Screening, C1D1, C2D1, C3D1, C4D1, C5D1, C6D1, and study completion visit
Secondary Outcome
Outcome
TimePoints
-ORR at end of treatment by fluorodeoxyglucose positron emission tomography (FDG-PET) as determined by the investigator
-CR rate at end of treatment by FDG-PET as determined by the investigator
Outcome will be assess at Screening & study completion visits
Target Sample Size
Total Sample Size="48" Sample Size from India="48" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Phase IV, open-label, multicenter, trial evaluating the safety and efficacy of polatuzumab vedotin in combination with R-CHP in adult patients with previously untreated CD20-positive DLBCL with International Prognostic Index (IPI) 2-5. This trial will serve as the main evidence for determining the benefit-risk of polatuzumab vedotin plus R-CHP in the target population. Primary Objective is to evaluate the safety of polatuzumab vedotin plus R-CHP. Secondary objective is To evaluate the efficacy of polatuzumab vedotin plus rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP).