Phase 2 N=39 Treatment

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

Lymphoma, Follicular

Bottom Line

View on ClinicalTrials.gov: NCT01234766 ↗

Enrolled (actual)

Serious AEs

12.8%

Results posted

May 2018

Primary outcome: Primary: Number of Participants With Complete Response at 3 Years — 30 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bendamustine (Drug); Rituximab (Drug); Y-90 ibritumomab (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Dartmouth-Hitchcock Medical Center
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Complete Response at 3 Years	30	—

Summary

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.

Eligibility 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 = 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01234766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.