Status:
COMPLETED
Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Cephalon
Spectrum Pharmaceuticals, Inc
Conditions:
Lymphoma, Follicular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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) ibritu...
Detailed Description
STUDY OBJECTIVES Primary Objective \- To determine the complete response (CR) rate and overall response (OR) rate \[CR + partial response (PR) rate\] to a regimen of bendamustine and rituximab (B-R)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01234766
Start Date
October 1 2010
End Date
April 1 2021
Last Update
May 18 2021
Active Locations (4)
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1
Maine Center for Cancer Medicine
Scarborough, Maine, United States, 04074
2
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
Rhode Island Hospital
Providence, Rhode Island, United States, 02903