Study of Zevalin Versus Observation in Participants at Least 60 Years Old With Newly Diagnosed Diffuse Large B-cell Lymphoma in Positron Emission Tomography (PET)-Negative Complete Remission After Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like Therapy

Conditions

• Diffuse Large B-cell Lymphoma
• Follicle Center Lymphoma

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zevalin — DRUG
  Zevalin administered intravenous infusion.
• Y-90-Zevalin — DRUG
  Y-90-Zevalin administered by intravenous infusion.
• Rituximab — DRUG
  Rituximab administered by intravenous infusion.
• In-111 Zevalin — DRUG
  In-111-Zevalin administered by intravenously.

Study Details

The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy.

Key Dates

Start date

Apr 19, 2012

Status verified

Nov 2021

Primary completion

Oct 23, 2014

Completion

Oct 23, 2014

Study Design

Enrollment

79 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Zevalin
  Participants received rituximab 250 milligram per meter square (mg/m\^2) by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 millicurie (mCi) on Day 1. And on Days 7-9: participants received rituximab 250 mg/m\^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 millicurie/kilogram (mCi/kg) 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/ microliter \[μL\] to 149,000/μL).
• No Intervention: Observation
  Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease.

Primary Outcome Measure

Overall Survival (OS) for Living Participants [ Time Frame: From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years) ]

Locations (28)

Find similar trials in Casa Grande, AZ

Related Studies

• A Long-term Extension Study of PCI-32765 (Ibrutinib)
  PHASE3 · Recruiting · Janssen Research & Development, LLC · Duarte, California
• Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
  PHASE2 · Recruiting · New York Medical College · Valhalla, New York
• Evaluation of Human Immune Responses Vaccination in Patients With Lymphoma
  Recruiting · Emory University · Atlanta, Georgia
• Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
  EARLY_PHASE1 · Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey