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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/10/002084

Enrollment

377

Registered

2011-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, B-cell, Diffuse

Interventions

Intervention1: 1: Experimental Inotuzumab ozogamicin+rituximab - Drug: Inotuzumab ozogamicin and Drug: Rituximab: Drug: Inotuzumab ozogamicin 1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6

375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles. Dose: 375mg/m2. Duration: 3 to 6 cycles. Route: Intravenous infusion. Control Intervention1: Active Comparator -Investigators choice of

Drug: rituximab + gemcitabine

Drug: rituximab +bendamustine: Drug: rituximab + gemcitabine rituximab 375 mg per m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 to 6, every 28 days by IV infusion, 3 to 6 cycles

Dose: 375 mg per m2. Duration: 3 to 6 cycles. Route: Intravenous Infusion. Gemcitabine 1000 mg per m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles. Dose: 1000 mg per m2. Duration: 3 to 6 cycles.

Dose: 375mg per m2 Duration: 3 to 6 cycles. Route: Intravenous Infusion. Bendamustine 120 mg per m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles Dose: 120 mg per m2. Duration: 3 to 6

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
1. Overall SurvivalTimepoint: 5 years	—

Secondary

Measure	Time frame
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	—

Countries

Belgium, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Hungary, India, Ireland, Japan, Lithuania, Mexico, Netherlands, Other, Poland, Russian Federation, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States of America

Contacts

Public ContactPriya Dsouza

Representing Pfizer Limited

Priya.Dsouza@Pfizer.com91-9987764530

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026