test

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

Conditions

Follicular Lymphoma

Trial Phase

Trial Purpose and Description

Trial 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 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 wil 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.


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

Previously untreated, histologically confirmed follicular lymphoma classification grade 1, 2 or 3a (>15 centroblasts per high power field with centrocytes present)

 

Ann Arbor stages of II to IV with either symptomatic or bulky disease (>5 cm); or disease progression

 

Male or female subject 18 years of age or older

 

ECOG performance status <2

 

Patients must have normal organ and marrow function as defined below:

Adequate hematologic function

- Absolute neutrophil count (ANC) >1,000/mm3

- Platelet count >100,000/mm3

- Patients with an 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

- Total bilirubin within normal institutional limits

- AST(SGOT) <2.5 X institutional upper limit of normal

- ALT(SGPT) <2.5 X institutional upper limit of normal

Adequate renal function

- Calculated creatinine clearance >40 mL/min/1.73m2

Creatinine clearance should be calculated using the Cockcroft-Gault Equation (Appendix F) or per institutional standard

 

Measureable disease with at least one lesion measuring > 2 cm in its greatest transverse diameter

 

Female subjects of childbearing potential must have a negative pregnancy

test (urine or serum b-HCG) at screening. Both male and female subjects must employ effective contraceptive measures prior to the start of therapy until 12 months after the last dose of study drug. Men must agree not to father a child and agree to use effective birth control during therapy and for 12 months after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential.

 

Voluntary written informed consent must be given before performance of any study-related procedure, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. The subject must have the ability to understand and the willingness to sign a written informed consent document.

Fol-BRITe study

 

Exclusion Criteria:

 

Patients who have had prior chemotherapy or immunotherapy

 

Patients receiving any other investigational agents

 

Prior chemotherapy or monoclonal antibody therapy; prior radiation will be allowed if <25% of active bone marrow was exposed

 

Patients with primary CNS lymphoma

 

Patients with 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

 

Patients who have had malignant pleural, pericardial or peritoneal effusions at any time

 

Patients with a known history of myelodysplastic syndrome (MDS) or found to have MDS on review of the staging bone marrow aspirate and biopsy

 

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. The only exception is 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

Sponsor:
Cephalon
Dartmouth-Hitchcock Medical Center
Spectrum Pharmaceuticals, Inc
Dates:
October 2012
Last Updated:
Study HIC#:
1207010545

Clinicaltrials.gov ID: Yale2349468