Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma (Fol-BRITe)

This study is currently recruiting participants.
Verified August 2013 by Dartmouth-Hitchcock Medical Center
Sponsor:
Collaborators:
Cephalon
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01234766
First received: October 6, 2010
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

The purpose of the study is to learn about the safety and effectiveness of treating follicular lymphoma with bendamustine and rituximab followed by radioimmunotherapy (RIT) using 90-yttrium (Y) ibritumomab tiuxetan.

The researchers will also test blood and bone marrow for the BCL2 gene-Jh that is a commonly found in people with follicular lymphoma (FL) and look at how the BCL2 gene-Jh responds to the study treatment.

Bendamustine is approved by the United States Food and Drug Administration (FDA) for the treatment of chronic lymphocytic leukemia and indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing treatment regimen. Bendamustine is not approved by the FDA to treat follicular lymphoma.

Rituximab is approved by the FDA for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin's lymphoma.

90-yttrium (Y) ibritumomab tiuxetan is approved by the FDA for the treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including rituximab refractory follicular NHL. It is also approved for the treatment of follicular NHL that is previously untreated with radioimmunotherapy and that achieved a partial or complete response to first-line chemotherapy.

Study participants will will receive bendamustine and rituximab for up to 16 weeks. If participants' cancer responds well to the treatment with bendamustine and rituximab, they will receive up to 12 weeks of radioimmunotherapy (RIT). After the RIT is complete, participants will be asked to return to the clinic every 3 months for a maximum of 10 years for follow-up visits.


Condition Intervention Phase
Lymphoma, Follicular
Drug: Bendamustine
Drug: Rituximab
Radiation: Y-90 ibritumomab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Phase II Study of Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma (Fol-BRITe Study)

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Complete Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    The primary endpoint is complete response (CR) rate. Historical complete response (CR) rate has been 35%. This rate will be considered as the null hypothesis.


Estimated Enrollment: 39
Study Start Date: October 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan
Drug: Bendamustine
90mg/m2, IV - Days 1 and 2 of every cycle
Other Name: Bendamustine
Drug: Rituximab
375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle
Other Name: Rituxan
Radiation: Y-90 ibritumomab
0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes
Other Name: Y-90 ibritumomab

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously untreated, histologically confirmed follicular lymphoma classification grade 1, 2 or 3a
  • Ann Arbor stages of II to IV with either symptomatic or bulky disease (>5 cm); or disease progression
  • 18 years of age or older
  • ECOG PS <2
  • Normal organ and marrow function defined as below:

Absolute neutrophil count (ANC) >= 1,000/mm3 Platelet count >=100,000/mm3 Patients with ANC less than 1,000/mm3 and/or platelets below 100,000/mm3 are still eligible for study entry as long as there is >50% bone marrow involvement with lymphoma

  • Adequate hepatic function
  • Adequate renal function
  • Measureable disease with at least one lesion measuring > 2cm in its greatest transverse diameter
  • Female subjects of childbearing potential must have a negative pregnancy test (urine or serum b-HCG) at screening and within 1 week prior to the start of treatment with Y-90 ibritumomab tiuxetan
  • Voluntary written informed consent must be given before performance of any study-related procedure

Exclusion Criteria:

  • Prior chemotherapy, immunotherapy, or monoclonal antibody therapy
  • Receiving any other investigational agents
  • Primary CNS lymphoma
  • Known HIV
  • Treatment with therapeutic doses of systemic steroids within 4 weeks of beginning study treatment (cycle 1, day -7); topical use of corticosteroids and systemic replacement of corticosteroids for adrenal insufficiency are allowed
  • Malignant pleural, pericardial or peritoneal effusions
  • Known history of myelodysplastic syndrome (MDS) or found to have MDS
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would, in the judgment of the investigator, limit compliance with study requirements
  • Pregnant or lactating female subjects
  • Concurrent active malignancy other than lymphoma or history of invasive malignancy within the past 5 years, except completely excised, non-melanoma skin cancer
  • Known Hepatitis B and/or Hepatitis C Infection
  • Any other condition, that in the judgment of the investigator places the patient at unacceptable risk if he/she were to participant in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01234766

Contacts
Contact: Frederick Lansigan, MD 800-639-6918 Cancer.Research.Nurse@Dartmouth.edu

Locations
United States, Maine
Maine Center for Cancer Medicine Recruiting
Scarborough, Maine, United States, 04074
Contact: Betsy Chase       chasee@mccm.org   
Principal Investigator: Helen Ryan, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Kara Brandariz, BS    603-653-3640    kara.l.brandariz@hitchcock.org   
Contact: Darcie Findley    603-650-4595    darcie.l.findley@hitchcock.org   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Anne Beaven, MD       anne.beaven@duke.edu   
Principal Investigator: Anne Beaven, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Eric Winer, MD    401-444-8943    EWiner@lifespan.org   
Principal Investigator: Eric Winer, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Cephalon
Spectrum Pharmaceuticals, Inc
Investigators
Principal Investigator: Frederick Lansigan, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01234766     History of Changes
Other Study ID Numbers: D1015
Study First Received: October 6, 2010
Last Updated: August 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bendamustine
Rituximab
Nitrogen Mustard Compounds
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 14, 2014