Study Comparing the Zevalin Regimen With no Further Treatment in DLBCL Patients Who Are in Complete Remission After CHOP-R

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Cell Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
Cell Therapeutics
ClinicalTrials.gov Identifier:
NCT00322218
First received: May 4, 2006
Last updated: October 22, 2008
Last verified: October 2008
  Purpose

This study will treat patients with diffuse large B-cell lymphoma whose disease is in complete remission due to previous treatment with CHOP-R. Half of the patients will receive Zevalin and the other half will receive no further anti-cancer treatment. The two patient groups will be compared to determine if Zevalin given after CHOP-R therapy provides greater benefits than receiving no additional anti-cancer therapy after CHOP R.


Condition Intervention Phase
Lymphoma, Large Cell, Diffuse
Drug: Zevalin Therapeutic Regimen
Other: Observation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Open-Label, Prospective, Two-Armed, Multicenter, Randomized, Group Sequential Study to Evaluate the Efficacy and Safety of Subsequent Treatment With the Zevalin (Ibritumomab Tiuxetan) Study Regimen Versus Observation in Patients With Diffuse Large B-Cell Lymphoma Who Are in Complete Remission After First-Line CHOP-Rituximab (CHOP-R) Therapy

Resource links provided by NLM:


Further study details as provided by Cell Therapeutics:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Collected until a subject dies (any cause), is lost to follow-up, or withdraws consent. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: Collected until a subject relapses as assessed by an Investigator, dies (any cause), is lost to follow-up, or withdraws consent. ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: Will be assessed during the safety period and and yearly during the follow-up period for 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: May 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Zevalin Therapeutic Regimen: Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin
Drug: Zevalin Therapeutic Regimen
Zevalin Therapeutic Regimen: Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin
2
Observation
Other: Observation
Observation

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed, Ann Arbor stage II, III, or IV DLBCL according to the REAL/WHO classification (from initial diagnosis made prior to starting CHOP-R therapy)
  • Central pathology review confirming the DLBCL diagnosis and 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 (cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2 up to a maximum of 2 mg on day 1, and at least 40 mg/m2/day prednisone on Days 1 to 5 every three weeks, with generally accepted adjustments in dose or frequency due to toxicity, patient scheduling, etc.) in combination with rituximab (375 mg/m2)
  • Complete remission (CR) or unconfirmed complete remission (CRu) according to the International Workshop Response Criteria for NHL described by Cheson et al and modified for this study after first-line treatment with CHOP-R. 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 (chest, abdomen, pelvis and if applicable, neck) 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 (ANC)greater than or equal to 1.5 x 10^9/L within 1 week of randomization
  • Hemoglobin (Hgb) 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 Criteria:

  • 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 (CNS), or testicular lymphoma at first diagnosis
  • Histological transformation of low-grade NHL
  • Known seropositivity for hepatitis C virus (HCV) or hepatitis B surface antigen (HbsAg)
  • Known history of HIV infection
  • Abnormal liver function: total bilirubin > 1.5 x ULN or ALT > 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
  • G-CSF or 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322218

  Show 94 Study Locations
Sponsors and Collaborators
Cell Therapeutics
Bayer
Investigators
Study Director: Biogen Idec, MD Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00322218     History of Changes
Other Study ID Numbers: 307940/106-20
Study First Received: May 4, 2006
Last Updated: October 22, 2008
Health Authority: United States: Food and Drug Administration
South Korea: Korea Food and Drug Administration (KFDA)
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Germany: Paul-Ehrlich-Institut
Ireland: Irish Medicines Board
Singapore: Health Sciences Authority
Switzerland: Swissmedic
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Austria:AGES PharmMed / Bundesamt für Sicherheit im Gesundheitswesen
Canada: Health Canada - Health Products and Food Branch - Biologics and Genetic Therapies Directorate
Finland: National Agency for Medicines (NAM)
Hungary: Országos Gyógyszerészeti Intézet / National Institute of Pharmacy
Italy: Agenzia Italiana del Farmaco Sperimentazione Clinica
Portugal: Infarmed - Instituto Nacional da Farmácia e do Medicamento
Spain: Ministerio de Sanidad y Consumo, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
Sweden: Läkemedelsverket / Medical Products Agency (MPA)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 22, 2014