| CTRI Number |
CTRI/2026/03/106493 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Study of Lutetium-177 Rituximab for patients with lymphoma that has come back or not responded to treatment |
|
Scientific Title of Study
|
Phase 2 study to evaluate efficacy and safety of Lutetium-177 Rituximab in relapsed/refractory Diffuse large B cell Lymphoma and Follicular Lymphoma Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Study protocol Version 2.0 dated 06/01/2026 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sachin Punatar |
| Designation |
Professor and Medical Oncologist |
| Affiliation |
Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre |
| Address |
Department of Medical oncology Adult hematolymphoid and Bone marrow transplant unit OPD room no 103 and 307 Shanti sadan ACTREC Tata Memorial Centre sector 22 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
09833445041 |
| Fax |
|
| Email |
drsachin_punatar@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Punatar |
| Designation |
Professor and Medical Oncologist |
| Affiliation |
Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre |
| Address |
Department of Medical oncology Adult hematolymphoid and Bone marrow transplant unit OPD room no 103 and 307 Shanti sadan ACTREC Tata Memorial Centre sector 22 Kharghar Navi Mumbai
MAHARASHTRA
410210
India |
| Phone |
09833445041 |
| Fax |
|
| Email |
drsachin_punatar@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Punatar |
| Designation |
Professor and Medical Oncologist |
| Affiliation |
Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre |
| Address |
Department of Medical oncology Adult hematolymphoid and Bone marrow transplant unit OPD room no 103 and 307 Shanti sadan ACTREC Tata Memorial Centre sector 22 Kharghar Navi Mumbai
MAHARASHTRA
410210
India |
| Phone |
09833445041 |
| Fax |
|
| Email |
drsachin_punatar@yahoo.in |
|
|
Source of Monetary or Material Support
|
| 1) Intramural TRAC-TMC Dr Ernest Borges marg parel mumbai 2) Extramural Lady Tata Memorial Trust Bombay House, 24, Homi Mody Street, Mumbai 400001. |
|
|
Primary Sponsor
|
| Name |
ACTREC Tata Memorial Centre |
| Address |
Plot No. 1& 2 Sector 22 Utsav Chowk CISF Road Owe Camp Kharghar Navi Mumbai 410210 Maharashtra India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSachin Punatar |
Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre |
Department of Medical oncology Adult hematolymphoid and Bone marrow transplant unit OPD room no 103 and 307 Shanti sadan ACTREC Tata Memorial Centre Kharghar Navi Mumbai
Raigarh
MAHARASHTRA |
09833445041
drsachin_punatar@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Centre Advanced Centre for Treatment, Research and Education in Cancer Institutional Ethics Committee (TMC-IEC III) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C833||Diffuse large B-cell lymphoma, (2) ICD-10 Condition: C829||Follicular lymphoma, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lutetium-177 Radiolabeled Rituximab (177Lu-Rituximab) |
Day 1: Cold rituximab 250mg/m2 to saturate non specific receptors (This is essential to increase the binding of Lutetium177 Rituximab to tumor cells when given on day 8)
Day 8:Premedication: IV Pantoprazole 40 mg stat
Cold rituximab 250mg/m2.
Waiting period of 4-6 hours followed by IV infusion of Lutetium177 Rituximab (dose 45mCi/m2) in 100ml NS followed by Observation period of 8-10 hours to look for any treatment related events/ acute reactions.
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with DLBCL Primary Mediastinal B cell Lymphoma PMBCL Follicular Lymphoma FL and Transformed FL with any one of the following criteria will be eligible to participate in the study
- Primary refractory showing Stable disease or Progression after 4 cycles of first line chemo immunotherapy or relapsing within 3 months of completion of treatment
-Refractory to second line or subsequent line of chemo immunotherapy showing Stable disease or Progression after 2 or more cycles of second line or subsequent line of chemotherapy
-Relapse after Autologous bone marrow transplant
Relapse Progression or Stable disease will be documented on FDG PET CT as per internationally accepted criteria and guidelines
2.Patients showing less than 25 percent marrow involvement by tumor cells on bone marrow biopsy
3.Age greater than or equal to 18 years
4.ECOG performance status less than or equal to 2
5.Normal haematological function Hb greater than 8 g per dl Platelet count greater than 75000 per cubic mm Absolute neutrophil count greater than 1000 per cubic mm Use of growth factors or transfusions to meet these requirements are permitted
6.Adequate renal function Calculated creatinine clearance greater than 30 ml per minute
7.Adequate liver function Total bilirubin less than 1.5 times institutional upper limit of normal AST SGOT or ALT SGPT less than or equal to 2.5 times institutional upper limit of normal
8.Serum albumin greater than 30 g per L or 3 g per dL
9.Patients who are not eligible for have no access to or are deemed unsuitable for standard of care therapies including CAR T cell therapy bispecific antibody therapy or salvage chemotherapy followed by autologous stem cell transplantation |
|
| ExclusionCriteria |
| Details |
1.Past history of second malignancy
2.Participants who are receiving any other investigational agents.
3.Patients who have received any cancer directed therapy within 3 weeks of screening for this study.
4.Prior radiopharmaceutical therapy
5.History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.
6.Uncontrolled intercurrent illness including or psychiatric illness or social situations that would limit compliance with study requirements.
7.Pregnant women and breastfeeding women. Breast feeding women may be eligible if they agree to stop breast feeding completely for 1 year.
8.Patient’s refusal to give informed consent and participate in the study.
9.Clinically significant or uncontrolled cardiac disease such as congestive heart failure requiring treatment (New York Heart Association more than Class 2, uncontrolled hypertension, clinically significant arrhythmia.
10. Acute coronary syndrome or acute myocardial infarction less than equal to 6 months prior to administration of study intervention.
11. Active HIV or HBV infections
12. Non-study-related minor surgical procedure less than equal to 5 days, or major surgical procedure less than equal to 21 days, prior to the administration of study intervention; in all cases, the participant must be sufficiently recovered and stable before treatment administration.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the objective response rate following Lu177-Rituximab in relapsed/ refractory DLBCL & Follicular Lymphoma Patients. |
36 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the 1 year PFS following Lu177-Rituximab therapy in relapsed/ refractory DLBCL & Follicular Lymphoma Patients.
2.To evaluate safety profile of Lu177 Rituximab therapy in relapsed/ refractory DLBCL & Follicular Lymphoma Patients in terms of incidence of more than equal to grade 3 toxicity
|
36 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 |
|
Date of First Enrollment (India)
|
06/04/2026 |
| 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="3"
Months="0"
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
|
Diffuse
large B-cell Lymphoma (DLBCL) and follicular lymphoma (FL) are common cancers. DLBCL
has a cure rate of about 55-60%. FL remains incurable, but can be controlled.
While many patients respond well to initial treatment, those whose cancer does
not respond or returns after treatment have very limited treatment options and
poor outcomes. Further treatments such as chemotherapy and stem cell
transplants often fail in these difficult cases. CART therapy is useful in some such patients
but is very expensive and remains out-of-reach for the majority of our
patients. “Radioimmunotherapy” is a treatment that uses a combination of
radiation and targeted medicines to kill cancer cells. This treatment has shown
promising outcomes in patients with FL and DLBCL in cases where chemotherapy
has not helped much. One such “radioimmunotherapy” is called “Lutetium-177
labeled Rituximab or simply Lu177-Rituximab.
This is a medicine in which Lu-177 is linked with a medicine called rituximab.
The Lu-177-Rituximab has shown encouraging results in earlier studies but its
effectiveness in relapsed DLBCL and FL is not well studied, especially when the
disease has come back after transplant. This study aims to evaluate the safety
and effectiveness of Lu177-Rituximab in such patients. Patients who have failed
standard therapies or relapsed after stem cell transplant will receive this
treatment. The study will measure how well the cancer responds and assess any
side effects of Lu-177-Rituximab. |