|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
29 April 2013 |
|
Main ID: |
NCT01232556 |
|
Date of registration:
|
27/10/2010 |
|
Primary sponsor: |
|
|
Public title:
|
A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy
|
|
Scientific title:
|
An Open-Label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin Administered In Combination With Rituximab Compared To Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma Who Are Not Candidates For Intensive High-Dose Chemotherapy |
|
Date of first enrolment:
|
April 2011 |
|
Target sample size:
|
377 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01232556 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Belgium
|
Bulgaria
|
Canada
|
Croatia
|
Czech Republic
|
France
|
Germany
|
Hungary
|
|
India
|
Ireland
|
Japan
|
Lithuania
|
Mexico
|
Poland
|
Puerto Rico
|
Russian Federation
|
|
Singapore
|
Slovakia
|
Spain
|
Sweden
|
Taiwan
|
Thailand
|
Turkey
|
Ukraine
|
|
United Kingdom
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Pfizer CT.gov Call Center |
|
Address:
|
|
|
Telephone:
|
1-800-718-1021 |
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Pfizer CT.gov Call Center |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pfizer |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- relapsed/refractory/persistent CD20+/CD22+ aggressive NHL (DLBCL, transformed
indolent lymphoma with DLBCL, primary mediastinal large B-cell lymphomas)
- up to 3 prior regimens containing cytotoxic chemotherapies
- not candidates for intensive high-dose chemotherapy, with or without an autologous
stem cell transplant
Exclusion Criteria:
- Any prior allogeneic hematopoietic stem cell transplant; autotransplant within prior
4 months
- anti-CD22 treatment or radioimmunotherapy within prior 6 months
- contraindication to both investigator choice regimens
- chronic liver disease, history of veno-occlusive disease
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Lymphoma, Non-Hodgkin
|
|
Intervention(s)
|
|
Drug: Inotuzumab ozogamicin
|
|
Drug: Rituximab
|
|
Drug: rituximab + gemcitabine
|
|
Drug: rituximab +bendamustine
|
|
Primary Outcome(s)
|
|
Overall Survival
[Time Frame: 5 years]
|
|
Secondary Outcome(s)
|
|
Efficacy: overall response rate, progression free survival, duration of response
[Time Frame: at ~3 to 6 months after start of treatment, and ~2 years after start of treatment]
|
|
Patient-reported health-related quality of life
[Time Frame: approximately 3 to 6 months]
|
|
Safety and Tolerability: incidence of adverse events by treatment arm.
[Time Frame: ~every 6 months]
|
|
Secondary ID(s)
|
|
3129K5-3303
|
|
B1931008
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|