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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


Phase 3
60 Years
N/A
Open (Enrolling)
Both
Lymphoma, Large Cell, Diffuse

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Collected until a subject dies (any cause), is lost to follow-up, or withdraws consent.

Safety Issue:

No

Principal Investigator

Biogen Idec, MD

Investigator Role:

Study Director

Investigator Affiliation:

Biogen Idec

Authority:

United States: Food and Drug Administration

Study ID:

307940/106-20

NCT ID:

NCT00322218

Start Date:

May 2006

Completion Date:

December 2009

Related Keywords:

  • Lymphoma, Large Cell, Diffuse
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteBoulder, Colorado  
Research SiteLewes, Delaware  
Research SiteBoca Raton, Florida  
Research SiteBoise, Idaho  
Research SiteArlington Heights, Illinois  
Research SiteHays, Kansas  
Research SiteBaton Rouge, Louisiana  
Research SiteBaltimore, Maryland  
Research SiteBeverly, Massachusetts  
Research SiteBattle Kreek, Michigan  
Research SiteAlexandria, Minnesota  
Research SiteHooksett, New Hampshire  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteAllentown, Pennsylvania  
Research SiteAberdeen, South Dakota  
Research SiteAbilene, Texas  
Research SiteAbington, Virginia