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CTRI Number  CTRI/2021/02/031578 [Registered on: 26/02/2021] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the effectiveness of 177-Lu-DOTA Rituximab drug in adult patients diagnosed with the recurrence of low-grade B-cell lymphomas (a type of blood cancer). 
Scientific Title of Study   A phase II study to evaluate the activity of 177-Lu-DOTA Rituximab in adult patients with relapsed/refractory low-grade B-cell lymphomas. 
Trial Acronym  177-Lu-DOTA Rituximab Study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manju Sengar 
Designation  Professor in Medical Oncology 
Affiliation  Tata Memorial Center 
Address  81, Main building ground floor, Tata Memorial Hospital, Dr E. Borges Road, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  9769690590  
Fax    
Email  manju.sengar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manju Sengar 
Designation  Professor in Medical Oncology 
Affiliation  Tata Memorial Center 
Address  81, Main building ground floor, Tata Memorial Hospital, Dr E. Borges Road, Parel, Mumbai.


MAHARASHTRA
400012
India 
Phone  9769690590  
Fax    
Email  manju.sengar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manju Sengar 
Designation  Professor in Medical Oncology 
Affiliation  Tata Memorial Center 
Address  81, Main building ground floor, Tata Memorial Hospital, Dr E. Borges Road, Parel, Mumbai.


MAHARASHTRA
400012
India 
Phone  9769690590  
Fax    
Email  manju.sengar@gmail.com  
 
Source of Monetary or Material Support  
Tata Research Administrative Council (TRAC), Clinical Research Secretarait (CRS) Tata Memorial Hospital  
 
Primary Sponsor  
Name  Tata Research Administrative Council TRAC  
Address  3rd floor Clinical Research Secretarait (CRS), Tata Memorial Hospital, Dr E. Borges Road, Parel, Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manju Sengar  Tata Memorial Hospital  Department of Adult Medical Oncology, opd-81, Main building ground floor, Tata Memorial Hospital, Dr E. Borges Road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 		 9769690590

manju.sengar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C851||Unspecified B-cell lymphoma, (2) ICD-10 Condition: C820||Follicular lymphoma grade I, (3) ICD-10 Condition: C821||Follicular lymphoma grade II, (4) ICD-10 Condition: C823||Follicular lymphoma grade IIIa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  177-Lu-Dota-Rituximab Drug  This drug has 3 parts- Rituximab, DOTA and Lutetium-177. Rituximab makes sure that the drug selectively targets cancer cells, Lutetium-177 is the chemical element that delivers radiation and DOTA is the agent that binds the two. The drug Rituximab (REDITUX) is made by Company Dr. Reddy’s, Lutetium is produced at Bhabha Atomic Centre and final product is made at Department of Nuclear Medicine, Tata Memorial Hospital. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Life expectancy of patients > 3 months.
2. ECOG PS 0-2
3. CD20 positive Low-grade B-cell Non-Hodgkin’s lymphoma.
a. Follicular lymphoma Grade 1-3a,
b. Marginal zone lymphoma
c. Other indolent lymphomas.
4. Relapsed disease< 2years from previous therapy or
5. Relapsed disease > 2 years from R-chemo, if a re-challenge is not feasible. (Who have received at least 2 lines of chemotherapy that includes Bendamustine/Anthracycline based regimen orcurrently ineligible for anthracyclines.)
6. No cytotoxic chemotherapy administered in the past 6 weeks, other than a prephase (steroid based).
7. Last Rituximab administration at least 6 months before the date of enrolment.
8. Hematological condition: ANC > 1500/mm3, Platelet count > 100,000/mm3, ALC < 5000/mm3 within a week from the start of treatment
9. Serum chemistry: Total Bilirubin < 1.5mg/dL, unless predominantly unconjugated hyperbilirubinemia. ALT < 2.5 times the Upper limit of normal.
10. Bone marrow biopsy- Reveals < 25% infiltration by tumor cells and >1 site of disease. 
 
ExclusionCriteria 
Details  1. Radiation to pelvis, femoral or lumbar spine in the past.
2. Active CNS lymphoma.
3. Mantle Cell Lymphoma and Large Cell Transformation of indolent lymphoma
4. Known case of Hepatitis B, C or HIV. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the Overall Response Rates to treatment with 177Lu-DOTA-Rituximab by performing PET/CECT or a Contrast enhanced CT scan chest abdomen and pelvis at 12 weeks after therapy and BM examination for those with baseline involvement.  To study the Overall Response Rates to treatment with 177Lu-DOTA-Rituximab by performing PET/CECT or a Contrast enhanced CT scan chest abdomen and pelvis at 12 weeks after therapy and BM examination for those with baseline involvement. 
 
Secondary Outcome  
Outcome  TimePoints 
2 year Progression Free Survival from the time of enrollment onto the study to progression defined as appearance of a new lesion or loss of response attained at 12 weeks, showing a more than 20% increase in the sum of longest diameters of target lesions or for small lymph nodes measuring less than 15mm post therapy, a minimum absolute increase of 5mm and the long diameter should exceed 15mm or death due to any cause whichever is earlier  2 year 
2-year Overall Survival- from the time of enrollment onto the study to death due to any cause  2 year 
The rate of hematological and non-hematological toxicities will be studied by adverse events monitoring- Duration and Severity of all adverse events as defined by Common Terminology Criteria for Adverse Events v5.0  2 years 
To study the mutational profiling especially TP53 mutation among POD 24 patients and their response to Lu-DOTA-Rituximab  2 year 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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)   05/03/2021 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Low grade B-cell lymphomas represent 25% of the Non-Hodgkin lymphoma which are controllable, but incurable. The initial treatment of symptomatic patients is with Rituximab+Bendamustine/R-CVP/R-CHOP. If remission lasts > 2 years, they are subjected to the same R-chemotherapy regimen. In our setting the options are limited for relapsed disease.

Radioimmunotherapy is a safe and effective option combining antiCD20 with radionuclide to ensure targeted delivery. Both Y90-Ibritumomab tiuxetan and I131-Tositumomab approved in relapsed setting are not available in India.

177Lu-DOTA-Rituximab is an effective radioimmunotherapy option in Low grade B cell NHL like Follicular lymphoma and Marginal zone lymphoma which has showed promising results in population who have relapsed/refractory to standard chemotherapy regimens. Relapsed Mantle Cell Lymphoma although part of the Low-Grade Lymphomas respond poorly and might affect the outcomes and hence excluded from the study.

177-Lu-DOTA-Rituximab has been tested in a phase I/II study of relapsed indolent lymphomas. We plan to evaluate the clinical activity of the effective dose.

 
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