| CTRI Number |
CTRI/2009/091/000566 [Registered on: 14/09/2009] |
| Last Modified On: |
18/06/2015 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of patients with Aggressive Lymphoma following Self Stem Cell Transplantation |
|
Scientific Title of Study
|
Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Patients with Diffuse Large B-Cell Lymphoma following Autologous Stem Cell Transplantation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-2007-01 |
Other |
| NCT00532259 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Maheboob Basade |
| Designation |
|
| Affiliation |
|
| Address |
Jaslok Hospital and Research Centre
Dept. of Oncology, 15, Dr. G. Deshmukh Marg
Mumbai
MAHARASHTRA
400026
India |
| Phone |
+91-9821062692 |
| Fax |
+91-22-23520508 |
| Email |
basade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Aditi Parekh |
| Designation |
|
| Affiliation |
Associate Director - Monitoring |
| Address |
Max Neeman International
Ready Money Terrace 1st Floor, 167, Dr. A B Road, Worli Naka
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-66604446 |
| Fax |
022-24930936 |
| Email |
aparekh@neemanasia.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Aditi Parekh |
| Designation |
|
| Affiliation |
|
| Address |
Max Neeman International
Ready Money Terrace 1st Floor, 167, Dr. A B Road, Worli Naka
Mumbai
MAHARASHTRA
400018
India |
| Phone |
022-66604446 |
| Fax |
022-24930936 |
| Email |
aparekh@neemanasia.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
CureTech Ltd |
| Address |
|
| Type of Sponsor |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Sameer Melinkeri |
Deenanath Mangeshkar Hospital and Research Centre, Department of |
Deenanath Mangeshkar Hospital and Research Centre,Department of Oncology, Off Karve Road Erandawane-411004
Pune
MAHARASHTRA |
+91-9766249644
+91-20-66023012
docmelinkeri@yahoo.com |
| Dr. Sandip Abhay Kumar Shah |
Gujarat Cancer and Research Institute |
Gujarat Cancer and Research Institute,Dept. of Oncology, Clinical Trial Wing, 3 Floors, -380016
Ahmadabad
GUJARAT |
+91-9824041170
+91-79-22680662
sandip60@yahoo.com |
| Dr. Maheboob Basade |
Jaslok Hospital and Research Centre, Dept. of Oncology, 15, Dr. G. |
Jaslok Hospital and Research Centre,Dept. of Oncology, 15, Dr. G. Deshmukh Marg, -400026
Mumbai
MAHARASHTRA |
+91-9821062692
+91-22-23520508
basade@gmail.com |
| Dr. Dinesh Bhurani |
Rajiv Gandhi Cancer Institute and Research Centre, Department of |
Rajiv Gandhi Cancer Institute and Research Centre ,Department of Haemato-Oncology, Sector: 5, Rohini-110085
New Delhi
DELHI |
+91-9971500861
+91-11-27931342
dineshbhurani@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Gujarat Cancer and Research Institute/Gujarat Cancer Society Ethics Committee Asawara, Ahmedabad -380016, Gujarat. India. |
Approved |
| Institutional Ethics Committee, Deenanath Mangeshkar Hospital and Research Centre, Off Karve Road Erandawane, Pune - 411004, Maharashtra, India |
Approved |
| Institutional Review Board, Rajiv Gandhi Cancer Institute and Research Centre, Sector: 5, Rohini, Delhi: 110085, India |
Approved |
| Jaslok Hospital and Research Centre Ethics Committee, 15, Dr. G. Deshmukh Marg, Mumbai: 400026, Maharashtra, India |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with Diffuse Large B-Cell Lymphoma following Autologous Stem Cell Transplantation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CT-011 (Monoclonal Antibody) |
1.5 mg/kg parenteral for days 1, 43 & 85 |
| Comparator Agent |
Historical Control |
Historical control based on clinical publications |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
1. Patient's age is 18 years or older, both genders.
2. Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage.
3. The lymphoma is chemosensitive.
4. The lymphoma did not progress since pre-transplant chemotherapy.
5. ECOG performance status 0-1.
|
|
| ExclusionCriteria |
| Details |
1. Serious other illness.
2. Active autoimmune disease.
3. Type 1 diabetes.
4. Known immune deficiency.
5. Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma.
6. Active bacterial, fungal, or viral infection.
7. Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus viremia.
8. Pregnant or nursing (positive pregnancy test).
9. Other concurrent clinical study or investigational therapy.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the progression-free survival of the patients, defined as the proportion of patients who have not relapsed or died. |
Within 16 months following the first CT-011 treatment (18 months following autologous PBSCT). ] [Designated as safety issue: No]
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Evaluate the toxicity and safety of CT-011 in patients with DLBCL.
2. Evaluate the event free survival (events are defined as relapse, second malignancy or death) in patients treated with CT-011.
3. Evaluate the overall survival in patients treated with CT-011.
|
Within 18 months following autologous PBSCT.] [Designated as safety issue: Yes] |
|
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Target Sample Size
|
Total Sample Size="68"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
31/03/2008 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. The purpose of this study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients with DLBCL who have received autologous peripheral blood stem cell transplantation. All final eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous PBSCT. Approximately 70 patients will participate in this study. Enrolment in India started on 18, Feb 2009 with a total of 15 patients that are expected to be enrolled. |