| CTRI Number |
CTRI/2009/091/000929 [Registered on: 11/06/2010] |
| Last Modified On: |
28/10/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the effects of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma |
|
Scientific Title of Study
|
A Randomized, Open-Label, Multicenter, Phase 2 Study of the Combination of VELCADE, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (VR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 26866138LYM2034 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinod Raina |
| Designation |
|
| Affiliation |
|
| Address |
IRCH, AIIMS
Ansari Nagar
New Delhi
DELHI
110029
India |
| Phone |
011-26593578 |
| Fax |
|
| Email |
vinodraina@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Tanuja Korde |
| Designation |
Manager Clinical Operations |
| Affiliation |
|
| Address |
Global Clinical Operations,
Janssen Pharmaceuticals Companies of Johnson & Johnson,
Johnson & Johnson Limited,
L.B.S Marg, Mulund (W), Mumbai
Ansari Nagar
Mumbai (Suburban)
MAHARASHTRA
400080
India |
| Phone |
919820208819 |
| Fax |
|
| Email |
tkorde@its.jnj.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Ravinder Tyagi |
| Designation |
Local Trial Manager |
| Affiliation |
|
| Address |
Global Clinical Operations,
Janssen Pharmaceuticals Companies of Johnson & Johnson,
Johnson & Johnson Limited,
L.B.S Marg, Mulund (W),
Mumbai 400080
Ansari Nagar
Mumbai (Suburban)
MAHARASHTRA
400080
India |
| Phone |
919910491625 |
| Fax |
|
| Email |
rtyagi1@its.jnj.com |
|
|
Source of Monetary or Material Support
|
| JOhnson and Johnson Limited |
|
|
Primary Sponsor
|
| Name |
Johnson and Johnson Limited |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SVSS Prasad |
Apollo Hospital & Research Foundation |
Jubilee Hills,-500033
Hyderabad
ANDHRA PRADESH |
040- 23607777
040 - 23543270
svss.prasad@yahoo.co.in |
| Dr Chetan Deshmukh |
Deenanath Mangeshkar Hospital |
off Curve Road,-411002
Pune
MAHARASHTRA |
020-66023000
020-66023025
drchetandeshmukh@gmail.com |
| Dr Vinod Raina |
Institute Rotary Cancer Hospital, AIIMS |
Ansari Nagar,-110029
New Delhi
DELHI |
011-2659 3679
011-26588408
vinodraina@hotmail.com |
| Dr Vijay Ramanan |
Jehangir Hospital |
32, sassoon Road,-411001
Pune
MAHARASHTRA |
020-26059318
oncologyresearch@yahoo.com
oncologyresearch@yahoo.com |
| Dr Dinesh Burani |
Rajiv Gandhi Cancer Hospital |
Sector 5,Rohini-110085
New Delhi
DELHI |
011-47022261
011-27051670
bhurani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Apollo Hospital Hyderabad |
Approved |
| Deenanath Mangeshkar Hospital, Pune |
Submittted/Under Review |
| IRCH, AIIMS, new Delhi |
Approved |
| Jehangir Hospital, Pune |
Approved |
| Rajive Gandhi Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| |
Diffused Large B Cell Lymphoma |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, prednisone (R-CHOP) |
6 cycles of 21 day each |
| Intervention |
Velcade, Rituximab, Cyclophosphamide, Doxorubicin, prednisone (VR-CAP) |
6 cycles of 21 day each |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
-Histologically confirmed non-GCB DLBCL - done by central lab
-CD20 positive disease
-At least 1 measurable or assessable site of disease |
|
| ExclusionCriteria |
| Details |
-Prior anti-neoplastic (including unconjugated therapeutic antibodies) experimental or radiation therapy
-Peripheral neuropathy or neuropathic pain of grade 2 or worse
- Prior treatment with VELCADE |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective is to determine the complete response (CR) rate following treatment with VR-CAP
(VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone) or standard R-CHOP (rituximab,
cyclophosphamide, doxorubicin, vincristine, and prednisone) therapy in subjects with newly diagnosed
non-germinal center B-like (non-GCB) diffuse large B-cell lymphoma (DLBCL). |
End of the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determine overall response rate (ORR) (CR + partial response [PR]) |
During the treatment |
| Determine duration of response (CR or PR) |
During the treatment |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
No Date Specified |
| Date of First Enrollment (Global) |
30/06/2010 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Brief Summary
|
|