Study Comparing Zevalin Regimen With no Further Treatment in Patients With Diffuse Large B-cell Lymphoma.
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|ClinicalTrials.gov Identifier: NCT00322218|
Recruitment Status : Terminated (due to low recruitment rate that would have led to a long study duration.)
First Posted : May 5, 2006
Results First Posted : January 19, 2022
Last Update Posted : January 19, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Large Cell, Diffuse||Drug: Zevalin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III,Open-label,Prospective,Two-armed,Multicenter Study Comparing Zevalin Regimen With no Further Treatment in Patients With Diffuse Large B-cell Lymphoma.|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Patients received Zevalin.
Zevalin Therapeutic Regimen:
Day 1: Initial administration of 250 mg/m^2 rituximab, followed immediately by administration of 185 MBq of [111In]-ibritumomab tiuxetan ,in centers where centers where biodistribution imaging or dosimetry had not been required, the first rituximab infusion was given alone.
- Day 7-9: Rituximab 250 mg/m^2, followed immediately by [90Y]-ibritumomab tiuxetan 14.8 MBq/kg given as a slow intravenous push over 10 minutes.
Two treatment days one week apart were followed by a 12-week safety period.
Zevalin study treatment regimen consisted of 2 rituximab i.v. infusions (Day 1 and Day 7-9) and one [90Y]-ibritumomab tiuxetan infusion in connection with the second rituximab infusion.
The core treatment regimen in the Zevalin arm was:
Day 1: Rituximab i.v. infusion 250 mg/m^2
Day 7-to 9: Rituximab i.v. infusion 250 mg/m^2 immediately followed by [90Y]-ibritumomab tiuxetan 14.8 MBq/kg (0.4 mCi/kg) with a maximum dose of 1184 MBq (32 mCi),administered as slow intravenous push over 10 minutes.
Other Name: Ibritumomab tiuxetan
No Intervention: Observational
Patients in this arm did not receive any reference therapy; they remained free of any anti-lymphoma therapy and were observed for relapse. This was non-interventional Stage consisting of a longterm follow-up period (until completion of a median observation period of 5 years).
- Overall Survival (OS) [ Time Frame: 5 years or until patient dies or lost to follow up ]The primary analysis was based on the full analysis set (FAS). Actually, the prominent efficacy variable OS was analysed in the FAS (identical to the safety analysis set) and Per Protocol Set using Kaplan Meier estimates by treatment group. "Overall survival" was defined as the median time interval (in months)from randomization to death from any cause.This time-to-event variable was censored at the date of the last known follow-up visit (provided that the patient was still alive at that time).
- Proportion of Participants With Disease Free Survival (DFS) [ Time Frame: 5 years or until patient disease progresses or lost to follow up ]DFS was analysed in the FAS (identical to the safety analysis set) and Per Protocol set using Kaplan Meier estimates by treatment group.Disease-free survival was defined as the median time interval (in months) from randomization to the date of relapse (as assessed by the investigator) or death from any cause. This time-to-event variable was also censored at the date of the last known follow-up visit (provided that the patient was still alive at that time).
- The Health-related Quality of Life (HRQL) [ Time Frame: Up to Month 36 ]
HRQL questionnaire consists of 27 questions each scores ranging from 0 - 4. The minimum score was 0 which is termed as 'worst imaginable health state' and the maximum score for a patient was 100 which is termed as 'best imaginable health state'.
The descriptive classification defines health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension is subdivided into 3 levels: no problem, some or moderate problems, unable or extreme problems.
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|Ages Eligible for Study:||60 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322218
|Responsible Party:||Spectrum Pharmaceuticals, Inc|
|Other Study ID Numbers:||
|First Posted:||May 5, 2006 Key Record Dates|
|Results First Posted:||January 19, 2022|
|Last Update Posted:||January 19, 2022|
|Last Verified:||January 2022|
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Immune System Diseases