Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)

Conditions

• Lymphoma, Follicular

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• inotuzumab ozogamicin — DRUG
  IV administration, 1.8mg/m² on day 2 of each cycle every 28 days, for up to 8 cycles.
• rituximab — DRUG
  IV administration, 375 mg/m² on day 1 of each cycle every 28 days, for up to 8 cycles.
• rituximab — DRUG
  intravenous rituximab at a dose of 375 mg/m2 on day 1
• cyclophosphamide — DRUG
  intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1
• vincristine — DRUG
  intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1
• prednisone/prednisolone — DRUG
  oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5
• mitoxantrone — DRUG
  mitoxantrone 10 mg/m2 intravenous on day 2
• fludarabine — DRUG
  fludarabine 25 mg/m2 intravenous on days 2 through 4
• dexamethasone — DRUG
  oral dexamethasone 20 mg/day on days 1-5

Study Details

This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study.

Key Dates

Start date

Nov 30, 2007

Status verified

Dec 2017

Primary completion

Apr 30, 2011

Completion

Apr 30, 2011

Study Design

Enrollment

29 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: A
  Subjects will receive rituximab intravenously at a dose level of 375 mg/m² on day 1 of each cycle followed by inotuzumab ozogamicin administered intravenously at a dose level of 1.8 mg/m2 on day 2. The sequence will be repeated every 28 days.
• Active Comparator: B
  Subjects will receive the investigator's choice from the following rituximab-containing regimens: R-CVP or R-FND. The investigator's choice of therapy will be administered every 21 days. Dosing for R-CVP will be intravenous rituximab at a dose of 375 mg/m2 on day 1, intravenous cyclophosphamide at a dose of 750 mg/m2 on day 1, intravenous vincristine at a dose of 1.4 mg/m2 (not to exceed 2 mg) on day 1, and oral prednisone/prednisolone at a dose of 40 mg/m2 on days 1 through 5. Dosing for R-FND will be as follows: rituximab 375 mg/m2 intravenous on day 1, mitoxantrone 10 mg/m2 intravenous on day 2, fludarabine 25 mg/m2 intravenous on days 2 through 4 and oral dexamethasone 20 mg/day on days 1-5.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Baseline until disease progression or death or up to 1 year after last dose of study drug ]

Locations (17)

Find similar trials in Mission Hills, CA

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