| CTRI Number |
CTRI/2023/11/060108 [Registered on: 21/11/2023] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
In patients with the cancer called Hodgkins lymphoma we are trying to see whether adding a medicine stimulating the immune system will increase the benefit of usual treatment |
|
Scientific Title of Study
|
Chemotherapy with low dose immune therapy as salvage regimen in relapsed/ refractory Hodgkins Lymphoma: A phase II study |
| Trial Acronym |
CLISH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanth Ganesan |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
DEPARTMENT OF MEDICAL ONCOLOGY SSB 3RD FLOOR Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
DEPARTMENT OF MEDICAL ONCOLOGY SSB 3RD FLOOR Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132296000 |
| Fax |
|
| Email |
p.ganesan@jipmer.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasanth Ganesan |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
DEPARTMENT OF MEDICAL ONCOLOGY SSB 3RD FLOOR Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
DEPARTMENT OF MEDICAL ONCOLOGY SSB 3RD FLOOR Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
PONDICHERRY
605006
India |
| Phone |
04132296000 |
| Fax |
|
| Email |
p.ganesan@jipmer.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prasanth Ganesan |
| Designation |
Professor of Medical Oncology |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
DEPARTMENT OF MEDICAL ONCOLOGY SSB 3RD FLOOR Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
DEPARTMENT OF MEDICAL ONCOLOGY SSB 3RD FLOOR Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
PONDICHERRY
605006
India |
| Phone |
04132296000 |
| Fax |
|
| Email |
p.ganesan@jipmer.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER |
| Address |
Dhanvantri Nagar
Gorimedu
Puducherry 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Deepam Pushpam |
All India Institute of Medical Sciences, New Delhi |
Department of Medical Oncology
1st Floor
Dr BRA IRCH AIIMS Ansari Nagar New Delhi 110029
New Delhi
DELHI |
9650629370
deepampushpam@gmail.com |
| Dr Venkatraman Radhakrishnan |
Cancer Institute WIA |
Head of the Department
Medical Oncology
Mahaveen Jain Block
Dr Krishnamurthy Campus
Sardar Patel Road
Guindy Chennai
Chennai
TAMIL NADU |
9498082771
venkymd@googlemail.com |
| Prasanth Ganesan |
JIPMER Puducherry |
Medical Oncology 3rd Floor
SS Block
JIPMER
Pondicherry
PONDICHERRY |
9940339189
pg1980@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Cancer Institute Institute Review Board |
Approved |
| IEC AIIMS |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C819||Hodgkin lymphoma, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Salvage chemotherapy with low dose nivolumab |
3 cycles of salvage chemotherapy (investigators choice from the list) with low-dose nivolumab (40 mg X 2 doses givne 6 weeks apart). |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Relapsed/ refractory Hodgkins Lymphoma having previously received at least 1-2 lines of standard chemotherapy.
2. Demonstrated disease recurrence or progression or refractoriness by clear evidence on PET-CT or other imaging studies with or without biopsy confirmation
3. ECOG performance status 0 to 1
4. Written informed consent for adults over 18 years of age and consent from parents/ legal guardians for those below 18. Written assent for those 12-18 years and verbal assent for those 7-12 years old.
5. Negative urine/ serum pregnancy test in women of childbearing potential (WOCBP)
6. Female patients in the reproductive age group MUST AGREE TO use suitable contraception during therapy
7. Acceptable bone marrow and organ function at screening
8. Measurable disease must be present either on physical examination or imaging studies
|
|
| ExclusionCriteria |
| Details |
1. Any anti-cancer therapy (other than palliative radiation and steroids) within the last three weeks
2. CNS involvement by disease
3. Inter-current severe illness or medical condition such as active uncontrolled infection, uncontrolled diabetes, or significant cardiac dysfunction would preclude safe administration of the protocol treatment.
4. Prior therapy with immune checkpoint inhibitors
5. Prior therapy with auto SCT/ alloSCT
6. Human Immunodeficiency Virus (HIV) infection/and/or Anti-retroviral therapy and/or HCV infection (patients who are anti-HCV positive but have been treated and have undetectable viral load would be permitted to be part of the study).
7. Active Hepatitis B infection (in patients who are Hepatitis B carriers, the markers of active infection such as HBeAg and HBV DNA titers must be negative, and patients would be continued on appropriate prophylaxis with antivirals throughout the study).
8. Uncontrolled medical conditions, including but not limited to uncontrolled diabetes mellitus and hypertension which may interfere with the safe delivery of salvage chemotherapy or immune therapy.
9. History of significant autoimmune or connective tissue disorders, which may be exacerbated by the use of nivolumab
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| complete response rate in all evaluable patients |
9 weeks from start of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Progression Free survival |
1 year |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/12/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a trial of salvage chemotherapy in patients with relapsed Hodgkins lymphoma. Patients will receive therapy with salvage chemotherapy (physician’s choice from one of the following regimens: (ICE, GVDex, DHAP, GDP, BeGEV) along with low dose nivolumab 40mg with first and 3rd cycles. Response will be assessed after 3 cycles. |