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Monoclonal Antibodies
Rituximab + Immunotherapy for Follicular Lymphoma
Phase 1
Waitlist Available
Led By Caron A. Jacobson, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients in part B, without prior anti-lymphoma therapy, must be in need of treatment as defined by any of the following criteria: Symptomatic adenopathy, Organ function impairment due to disease involvement, including cytopenias due to marrow involvement (WBC <1.5x109/L; absolute neutrophil count [ANC] <1.0x109/L, Hgb <10g/dL; platelets <100x109/L), Constitutional symptoms, Maximum diameter of disease > 7cm, 3 nodal sites of involvement, Risk of local compressive symptoms, Splenomegaly (craniocaudal diameter > 16cm on CT imaging), Clinically significant pleural or peritoneal effusion, Leukemic phase (>5x109/L circulating malignant cells), Rapid generalized disease progression, Renal infiltration, Bone lesions, Patients may have had a prior autologous stem cell transplant and may have been treated with autologous chimeric antigen receptor T-cells (CAR T-cells), Not in need of urgent cytoreductive therapy in the opinion of the investigator, Measurable disease that has not been previously irradiated on CT scans of at least 1.5 cm, OR if the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation. Imaging must be completed no greater than 6 weeks prior to study enrollment, Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (see Appendix A), Adequate hematologic and organ function: Absolute neutrophil count > 1.0x109/L unless due to marrow involvement by lymphoma in which case ANC must be >0.5x109/L, Platelets > 75 x109/L, unless due to marrow involvement by lymphoma, in which case platelets must be >50 x109/L, Creatinine < 1.5 x ULN (upper limit of normal) or estimated GFR > 40ml/min, Total bilirubin < 1.5 X ULN, unless Gilbert syndrome, in which case direct bilirubin must be < 3 x ULN, AST/ALT < 2.5 X ULN, unless documented liver involvement by lymphoma, in which case AST/ALT must be <5 x ULN, Age >18 years, Ability to understand and the willingness to sign a written informed consent document, Willingness to provide pre-treatment (or recent archival w/o intervening therapy), and on-treatment tumor samples by core needle or excisional surgical biopsy
Patients must have histologically determined follicular lymphoma, grade 1-3A, with pathologic review at the participating institutions, that has either: Relapsed or primary refractory after at least one line of therapy including anti-CD-20 monoclonal antibody treatment (part A) or; Has had no previous anti-lymphoma therapy other than corticosteroids or radiotherapy (part B). Patients with active histologic transformation are excluded. Relapsed/refractory patients with prior transformation may be included as long as there is no evidence of transformation at the time of study entry by pathology, imaging, or clinical status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing if these drugs can help treat people with follicular lymphoma.
Who is the study for?
This trial is for adults over 18 with follicular lymphoma that's relapsed after treatment or hasn't been treated yet, except those with severe allergies to monoclonal antibodies, autoimmune diseases, active infections, other cancers within the last three years (some exceptions apply), and certain heart conditions. Participants need functioning major organs and can't be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests combinations of Rituximab with new drugs Utomilumab and Avelumab as potential treatments for follicular lymphoma. It aims to find out how well these drug combos work together in patients who have had previous treatments or are newly diagnosed.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs, immune system complications potentially affecting various organs, fatigue, infusion-related reactions like fever or chills, and increased risk of infections due to a weakened immune response.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have follicular lymphoma, grade 1-3A, and have been treated with or without anti-CD-20 therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase 2 dosing
Secondary outcome measures
Complete response rate
Objective response rate
Overall Survival Rate
+8 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Rituximab+Utomilumab+PF04518600Experimental Treatment3 Interventions
Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
Utomilumab is administered intravenously over 1 hour once every 4 weeks
PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Group II: Rituximab+Avelumab+PF04518600Experimental Treatment3 Interventions
Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
Avelumab is administered intravenously over 1 hour once every 2 weeks
PF-04518600 is administered intravenously over 1 hour on day 1 and day 15
Group III: Rituximab +Utomilumab+AvelumabExperimental Treatment3 Interventions
Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
Utomilumab is administered intravenously over 1 hour once every 4 weeks
Avelumab is administered intravenously over 1 hour once every 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
Rituximab
1999
Completed Phase 4
~1880
Utomilumab
2018
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,848 Total Patients Enrolled
PfizerIndustry Sponsor
4,565 Previous Clinical Trials
10,907,213 Total Patients Enrolled
Caron A. Jacobson, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have follicular lymphoma, grade 1-3A, and have been treated with or without anti-CD-20 therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Rituximab+Avelumab+PF04518600
- Group 2: Rituximab+Utomilumab+PF04518600
- Group 3: Rituximab +Utomilumab+Avelumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare facilities are conducting this research project?
"Patients can take part in this trial at Yale New-Haven Hospital (New Haven, Connecticut), Emory University (Atlanta, Georgia) and Dana Farber Cancer Institute (Boston, Massachusetts). There are also 6 additional participating medical sites."
Answered by AI
What illnesses can be alleviated by the use of Rituximab?
"Rituximab is often used to treat the mentioned therapeutic procedure, and has also been noted as a useful treatment for merkel cell carcinoma, diffuse large b-cell lymphoma (dlbcl), and pharmacotherapy."
Answered by AI
Does Rituximab pose any substantial health hazards for those taking it?
"As this is an initial clinical trial, the safety of Rituximab was estimated to be a 1 due to limited evidence regarding its efficacy."
Answered by AI
Are there vacancies yet available to participants in this medical experiment?
"At present, this medical trial is not recruiting patients. Although initially posted on October 30th 2018 and last edited on March 17th 2022, the study has since closed its application window. However, there are an abundance of trials that still require participants - 2236 studies to be exact."
Answered by AI
Are there any comparable studies that have made use of Rituximab?
"As of now, there are 517 clinical trials researching Rituximab with 102 in their final stages. These studies take place mainly around Houston, Texas but have locations spread across 17973 other spots."
Answered by AI
What is the aggregate amount of people participating in this experiment?
"This trial is not presently accepting new participants. It was initially made public on October 30th 2018 and updated lastly on March 17th 2022. However, there are currently 1,719 trials for lymphoma, follicular recruiting patients as well as 517 concerning Rituximab still searching for individuals to join their research teams."
Answered by AI
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