Status:
TERMINATED
Study Comparing Zevalin Regimen With no Further Treatment in Patients With Diffuse Large B-cell Lymphoma.
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Collaborating Sponsors:
Bayer
Conditions:
Lymphoma, Large Cell, Diffuse
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
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-...
Detailed Description
The objectives of this study were to evaluate the efficacy and safety of the Zevalin study regimen compared with observation alone in patients with complete remission (CR or CRu) after first-line CHOP...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00322218
Start Date
May 1 2006
End Date
December 1 2008
Last Update
January 19 2022
Active Locations (90)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Mesa, Arizona, United States
2
Research Site
Phoenix, Arizona, United States
3
Research Site
Scottsdale, Arizona, United States
4
Research site
Bakersfield, California, United States