Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma (Fol-BRITe)
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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) |
- 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 |
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| Contact: Frederick Lansigan, MD | 800-639-6918 | Cancer.Research.Nurse@Dartmouth.edu |
| 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: Darcie Findley 603-650-4595 darcie.l.findley@hitchcock.org | |
| Contact: Kara Brandariz, BS 603-653-3640 kara.l.brandariz@hitchcock.org | |
| Principal Investigator: Frederick Lansigan, MD | |
| 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 | |
| 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: | February 13, 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 May 23, 2013