Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL)

Sponsor
Spectrum Pharmaceuticals, Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT00384111
Collaborator
CTI BioPharma (Industry)
26
6
2
25
4.3
0.2

Study Details

Study Description

Brief Summary

This study will treat follicular lymphoma patients who have not received previous treatment with R-CVP. Half of the patients will receive Zevalin after R-CVP and the other half will receive only R-CVP. The two patient groups will be compared to determine if Zevalin given after R-CVP therapy provides greater benefits than receiving no additional anti-cancer therapy after R-CVP.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Open Label Multicenter, Randomized Study to Compare the Efficacy and Safety of the Zevalin (Ibritumomab Tiuxetan) Therapeutic Regimen Following Cyclophosphamide, Vincristine, Prednisone, and Rituximab (R-CVP) With R-CVP Alone in High-Risk Subjects With Previously Untreated CD20-Positive Follicular Non-Hodgkin's Lymphoma
Actual Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Nov 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Participants will receive standard R-CVP followed by 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
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: R-CVP
Standard R-CVP

Active Comparator: 2

Participants will receive standard R-CVP.

Drug: R-CVP
Standard R-CVP

Outcome Measures

Primary Outcome Measures

  1. Number of Participants With Adverse Events [18 months]

Secondary Outcome Measures

  1. Number of Participants With Serious and Non-serious Adverse Events [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information).

  • Age greater than or equal to 18 years at the time of informed consent.

  • Histologically confirmed follicular NHL according to the Revised European American Lymphoma (REAL)/World Health Organization (WHO)classification (from initial diagnosis); grades 1, 2, or 3.

  • Bi-dimensionally measurable lesion(s) in at least one site.

  • High risk NHL as defined by a follicular lymphoma international prognostic index (FLIPI) of 3, 4, or 5 assessed within 3 months prior to randomization.

  • NHL requires treatment as determined by the investigator.

  • Confirmed CD20+ lymphoma cells.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1,or 2.

  • Expected survival of greater than or equal to 3 months.

  • Male subjects and female subjects of child bearing potential willing to practice effective contraception during the study and willing and able to continue contraception for 1 year after their last dose of study treatment (R CVP for subjects in the observation arm and the Zevalin therapeutic regimen for subjects in the Zevalin arm).

Exclusion Criteria:
  • Previous anticancer treatment for NHL, including chemotherapy, immunotherapy, radiation (locoregional or extended field), radioimmunotherapy, or investigational therapy.

  • Known seropositivity for hepatitis C virus, hepatitis B virus (surface antigen-positive), or other active infection uncontrolled by treatment.

  • Known diagnosis of human immunodeficiency virus infection.

  • Presence of primary gastric, central nervous system (CNS), or testicular lymphoma, or transformed lymphoma, or chronic lymphocytic leukemia (CLL).

  • Active therapy within previous 5 years for other malignancy, except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.

  • Abnormal liver function: total bilirubin >1.5 X upper limit of normal (ULN) or ALT

2.5 X ULN.

  • Impairment of renal function (serum creatinine >1.5 X ULN) not due to lymphoma.

  • 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) that could compromise participation in the study.

  • Known hypersensitivity to murine and/or chimeric proteins.

  • History of severe allergic or anaphylactic reactions.

  • Known allergy to any components present in rituximab, cyclophosphamide, vincristine, and prednisone (CVP), or Zevalin.

  • Treatment with another study treatment or approved therapy for investigational use within the 12 weeks prior to randomization.

  • Exposure to monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins.

  • Females with a positive pregnancy test result at screening or who are currently breastfeeding.

  • Inability to comply with study requirements.

  • Major surgery within 28 days except for diagnosis.

  • In need of immediate intervention to treat life threatening complications.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Integrated Community Oncology Network Jacksonville Florida United States 32256
2 Gulfcoast Oncology Associates Saint Petersburg Florida United States 33705
3 Wellstar-Northwest Georgia Oncology Centers Marietta Georgia United States 30060
4 Oncology Hematology Care Inc. Cincinnati Ohio United States 45242
5 Chattanooga Oncology Hematology Care Chattanooga Tennessee United States 37404
6 Tennessee Oncology Nashville Tennessee United States 37203

Sponsors and Collaborators

  • Spectrum Pharmaceuticals, Inc
  • CTI BioPharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00384111
Other Study ID Numbers:
  • 106NH301
First Posted:
Oct 5, 2006
Last Update Posted:
Jan 14, 2022
Last Verified:
Dec 1, 2021
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail It was planned to randomized the enrolled subjects to receive R-CVP followed by Zevalin Therapeutic Regimen or R-CVP. However, due to low enrollment and early termination, participants were not randomized and received any treatment. The data for the Participant flow and Baseline sections is reported for all enrolled participants in one arm.
Arm/Group Title All Enrolled Participants
Arm/Group Description Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study.
Period Title: Overall Study
STARTED 26
COMPLETED 0
NOT COMPLETED 26

Baseline Characteristics

Arm/Group Title All Enrolled Participants
Arm/Group Description Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study.
Overall Participants 26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
63
(9)
Sex: Female, Male (Count of Participants)
Female
9
34.6%
Male
17
65.4%

Outcome Measures

1. Primary Outcome
Title Number of Participants With Adverse Events
Description
Time Frame 18 months

Outcome Measure Data

Analysis Population Description
Data for this outcome measure was not collected and summarized as the study was terminated early by the sponsor.
Arm/Group Title All Enrolled Participants
Arm/Group Description Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study.
Measure Participants 0
2. Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events
Description
Time Frame 18 months

Outcome Measure Data

Analysis Population Description
Data for this outcome measure was not collected and summarized as the study was terminated early by the sponsor.
Arm/Group Title All Enrolled Participants
Arm/Group Description Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study.
Measure Participants 0

Adverse Events

Time Frame Up to end of study (approximately up to 4 years)
Adverse Event Reporting Description Safety data were not collected as the study was terminated early by the sponsor.
Arm/Group Title All Enrolled Participants
Arm/Group Description Participants with follicular lymphoma who have not received previous treatment with R-CVP were enrolled in the study.
All Cause Mortality
All Enrolled Participants
Affected / at Risk (%) # Events
Total 0/0 (NaN)
Serious Adverse Events
All Enrolled Participants
Affected / at Risk (%) # Events
Total 0/0 (NaN)
Other (Not Including Serious) Adverse Events
All Enrolled Participants
Affected / at Risk (%) # Events
Total 0/0 (NaN)

Limitations/Caveats

Outcome measures and safety data were not collected and summarized as the study was terminated early by the sponsor.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Gajanan Bhat
Organization Spectrum Pharmaceuticals, Inc, Research and Development Office 157 Technology Drive Irvine, CA 92618
Phone 949-743-9219
Email gajanan.bhat@sppirx.com
Responsible Party:
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00384111
Other Study ID Numbers:
  • 106NH301
First Posted:
Oct 5, 2006
Last Update Posted:
Jan 14, 2022
Last Verified:
Dec 1, 2021