A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

Conditions

• Lymphoma, Non-Hodgkin

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Inotuzumab ozogamicin — DRUG
  1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles
• Rituximab — DRUG
  375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles
• rituximab + gemcitabine — DRUG
  rituximab 375 mg/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; gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles
• rituximab +bendamustine — DRUG
  rituximab 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles; bendamustine 120 mg/m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles

Study Details

The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.

Key Dates

Start date

Apr 4, 2011

Status verified

Dec 2018

Primary completion

Mar 28, 2014

Completion

Mar 28, 2014

Study Design

Enrollment

338 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 1
  Inotuzumab ozogamicin+rituximab
• Active Comparator: 2
  Investigator's choice of (1) rituximab+gemcitabine, or (2) rituximab+bendamustine

Primary Outcome Measure

Overall Survival [ Time Frame: From randomization up to 5 years after last dose or up to final study visit, whichever occurs first. ]

Locations (82)

Find similar trials in Burbank, CA

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