A clinical trial to evaluate if a new combination of anticancer drugs (called inotuzumab ozogamicin and rituximab) can increase the life-span of patients with a particular type of cancer (relapsed/refractory aggressive Non-Hodgkin lymphoma)compared to other anticancer drug combinations
- Conditions
- Health Condition 1: null- Lymphoma, Non-HodgkinLymphoma, B-CellLymphoma, B-cell, Diffuse
- Registration Number
- CTRI/2011/10/002084
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 377
a. Ages Eligible for Study: 18 Years and older
b. Genders Eligible for Study: Both
c. Accepts Healthy Volunteers: No
1.relapsed/refractory/persistent CD20+/CD22+ aggressive NHL (DLBCL, transformed indolent lymphoma with DLBCL, primary mediastinal large B-cell lymphomas)
2.up to 3 prior regimens containing cytotoxic chemotherapies
3.not candidates for intensive high-dose chemotherapy, with or without an autologous stem cell transplant
Note: There is no upper limit for inclusion criteria for this trial.
1.Any prior allogeneic hematopoietic stem cell transplant; autotransplant within prior 4 months
2.anti-CD22 treatment or radioimmunotherapy within prior 6 months
3.contraindication to both investigator choice regimens
4.chronic liver disease, history of veno-occlusive disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Overall SurvivalTimepoint: 5 years
- Secondary Outcome Measures
Name Time Method 1.Safety and Tolerability: incidence of adverse events by treatment arm.Timepoint: ~every 6 months;2.Efficacy: overall response rate, progression free survival, duration of responseTimepoint: at ~3 to 6 months after start of treatment, and ~2 years after start of treatment;3.Patient-reported health-related quality of lifeTimepoint: approximately 3 to 6 months