Study Comparing Zevalin Regimen With no Further Treatment in Patients With Diffuse Large B-cell Lymphoma.

Stopped early · Phase 3

Conditions studied: Lymphoma, Large Cell, Diffuse

In brief

This study treats patients with diffuse large B-cell lymphoma whose disease is in complete remission due to previous treatment with Cyclophosphamide Doxorubicin hydrochloride Vincristine Prednisolone- Rituximab (CHOP-R). Half of the patients received Zevalin and the other half receive no further anti-cancer treatment. The two patient groups compared to determine if Zevalin given after CHOP-R therapy provides greater benefits than receiving no additional anti-cancer therapy after CHOP-R.

Key facts

Study ID: NCT00322218
Run by: Spectrum Pharmaceuticals, Inc
People needed: 68
Starts: 2006-05-01
Expected to finish: 2008-12-01
Last updated by the study team: 2022-01-19

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed, Ann Arbor stage II, III, or IV Diffuse large B-cell lymphoma (DLBCL) according to the Revised European American Lymphoma(REAL)/World Health Organization (WHO) classification .
Central pathology review confirming the DLBCL diagnosis and Cluster of differentiation 20 (CD20) positivity, and no evidence of DLBCL in bone marrow
First-line treatment of DLBCL must have been 6 or 8 cycles of standard CHOP chemotherapy in combination with rituximab .
Complete remission(CR) or unconfirmed complete remission(CRu) according to the International Workshop Response Criteria for Non Hodgkins Lymphoma (NHL) described by Cheson et al and modified for this study after first-line treatment with CHOP-R. Computerised Tomography (CT) scans of chest, abdomen, pelvis, and neck (if applicable) must have been performed within 6 weeks after the last dose of the last course of CHOP-R. Applicability of the neck CT means that the patient had involvement of the neck region by palpation / physical examination at first diagnosis (pre-CHOP-R).
Central radiographic review of the CT scans from before and after first-line treatment with CHOP-R fulfilling the radiological requirements for CR/CRu
Patients 60 years of age or older at time of randomization
WHO performance status (PS) of 0 to 2 within 1 week of randomization
Absolute neutrophil count greater than or equal to 1.5 x 10\^9/L within 1 week of randomization
Hemoglobin greater than or equal to 10 g/dL within 1 week of randomization
Platelets greater than or equal to 150 x 10\^9/L within 1 week of randomization
Life expectancy of 3 months or longer
Written informed consent obtained according to local guidelines

You may not qualify if…

Presence of any other malignancy or history of prior malignancy except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
Prior radioimmunotherapy, radiation therapy, or any other NHL therapy except first-line CHOP-R
Presence of gastric, central nervous system or testicular lymphoma at first diagnosis
Histological transformation of low-grade non-Hodgkin's lymphoma (NHL)
Known seropositivity for hepatitis C virus or hepatitis B surface antigen
Known history of Human Immunodeficiency virus (HIV) infection
Abnormal liver function: total bilirubin > 1.5 x upper limit of normal (ULN) or Alanine Aminotransferase > 2.5 x ULN within 1 week of randomization
Abnormal renal function: serum creatinine > 2.0 x ULN within 1 week of randomization
Nonrecovery from the toxic effects of CHOP-R therapy
Known hypersensitivity to murine or chimeric antibodies or proteins
Granulocyte Colony Stimulating Factor (G-CSF) or Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) therapy within two weeks (or four weeks if pegylated) prior to screening laboratory sampling
Concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes,congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study
Male and female patients of child-bearing potential unwilling to practice effective contraception during the study and unwilling or unable to continue contraception for 12 months after their last dose of study treatment
Female patients who are pregnant or are currently breastfeeding
Treatment with investigational drugs less than 4 weeks before the planned Day 1 or nonrecovery from the toxic effects of such therapy
Surgery less than 4 weeks before the planned Day 1 or nonrecovery from the side effects of such surgery
Concurrent systemic corticosteroid use for any reason except as premedication in case of known or suspected allergies to contrast media or as premedication for potential side effects of rituximab treatment
Unwillingness or inability to comply with the protocol

Where it is running

Research Site — Phoenix, Arizona, United States
Research Site — Scottsdale, Arizona, United States
Research site — Bakersfield, California, United States
Research Site — Berkeley, California, United States
Research Site — Beverly Hills, California, United States
Research Site — Burbank, California, United States
Research Site — Duarte, California, United States
Research site — Los Angeles, California, United States
Research site — Newport Beach, California, United States
Research Site — San Diego, California, United States
Research site — Vallejo, California, United States
Research site — Aurora, Colorado, United States
Research site — Newark, Delaware, United States
Research site — St. Petersburg, Florida, United States
Research Site — Coeur d'Alene, Idaho, United States
Research site — Chicago, Illinois, United States
Research site — Joliet, Illinois, United States
Research Site — Morris, Illinois, United States
Research site — Overland Park, Kansas, United States
Research Site — Shreveport, Louisiana, United States
Research site — Baltimore, Maryland, United States
Research site — Boston, Massachusetts, United States
Research site — Detroit, Michigan, United States
Research Site — Rochester, Minnesota, United States
Research Site — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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