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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 CTI BioPharma.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
CTI BioPharma
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 CTI BioPharma:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322218

  Show 94 Study Locations
Sponsors and Collaborators
CTI BioPharma
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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 25, 2014