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

NCT01234766 | Completed Phase 2 Results DMC

• 1 other identifier: D1015
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 4

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) 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.

Conditions

Lymphoma, Follicular

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Response at 3 Years

  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.

  3 years

Study Arms (1)

Single Arm

EXPERIMENTAL

Subjects will receive bendamustine and rituximab, followed by 90-yttrium (Y) Ibritumomab Tiuxetan

Drug: Bendamustine; Drug: Rituximab; Radiation: Y-90 ibritumomab

Interventions

Bendamustine DRUG

90mg/m2, IV - Days 1 and 2 of every cycle

Single Arm

Rituximab DRUG

375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle

Also known as: Rituxan

Single Arm

Y-90 ibritumomab RADIATION

0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Cephalon: collaborator
• Spectrum Pharmaceuticals, Inc: collaborator

Study Sites (4)

Maine Center for Cancer Medicine

Scarborough, Maine, 04074, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Bendamustine Hydrochloride; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Frederick Lansigan, MD
• Organization: Dartmouth-Hitchcock Medical Center

Frederick.Lansigan@hitchcock.org

603-650-4628

Study Officials

• Frederick Lansigan, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: November 4, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2021
• Last Updated: May 18, 2021
• Results First Posted: May 14, 2018

Record last verified: 2021-04

Locations

US (4)