Tafasitamab + Rituximab for Follicular Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of combining two drugs, tafasitamab and rituximab, to treat individuals newly diagnosed with follicular lymphoma, a type of blood cancer. Both drugs are monoclonal antibodies that assist the immune system in attacking cancer cells. Suitable candidates for this trial have been diagnosed with follicular lymphoma and experience significant symptoms such as fever, night sweats, or unexplained weight loss. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Is there any evidence suggesting that tafasitamab and rituximab are likely to be safe for humans?
Research has shown that tafasitamab, when combined with other treatments, generally has a manageable safety profile. For instance, one study found that serious side effects occurred in 71% of patients taking tafasitamab, similar to those not taking it, indicating that tafasitamab is fairly well-tolerated.
Additionally, the FDA has approved the combination of tafasitamab with other medications for treating a type of lymphoma when other treatments have failed. This approval suggests the treatment is considered safe for certain conditions. Although there is less information specifically about using tafasitamab with rituximab for newly diagnosed follicular lymphoma, the existing safety evidence remains encouraging.12345Why are researchers excited about this trial's treatments for follicular lymphoma?
Researchers are excited about using Tafasitamab in combination with Rituximab for follicular lymphoma because Tafasitamab is a monoclonal antibody that targets CD19, a protein found on the surface of B-cells, including cancerous ones. This is different from the standard treatment, which typically involves Rituximab targeting CD20. By attacking a different protein, Tafasitamab offers a new mechanism of action that could enhance the effectiveness of treatment. This dual-target approach has the potential to improve outcomes by more comprehensively attacking the cancer cells.
What evidence suggests that tafasitamab and rituximab might be an effective treatment for follicular lymphoma?
Research has shown that combining tafasitamab with other treatments, such as lenalidomide and rituximab, can significantly improve outcomes for patients with follicular lymphoma. In studies, patients receiving tafasitamab combinations achieved higher complete response rates, ranging from 43.2% to 51.1%, compared to those receiving a placebo. Overall, 84% of patients responded positively to the treatment. This trial will specifically evaluate the combination of tafasitamab and rituximab. These findings suggest that using tafasitamab and rituximab together could be a promising option for treating newly diagnosed follicular lymphoma.12356
Who Is on the Research Team?
Mengyang Di, MD, PhD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for adults who have just been diagnosed with follicular lymphoma and have not yet received treatment. Participants should be healthy enough to undergo study procedures, but specific inclusion or exclusion details are not provided here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Cycles 1-3
Patients receive rituximab IV on day 1 and tafasitamab IV on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days.
Treatment Cycles 4-6
Patients receive rituximab IV on day 1 and tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days.
Treatment Cycles 7-12
Patients receive tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, including PET scan, CT scan, bone marrow biopsy, and blood sample collection.
What Are the Treatments Tested in This Trial?
Interventions
- Rituximab
- Tafasitamab
Trial Overview
The study is testing a combination of two antibody drugs, tafasitamab and rituximab, to see how well they work together in treating newly diagnosed follicular lymphoma. Patients will also undergo scans, blood tests, bone marrow exams, and surveys as part of the research.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
CYCLES 1-3: Patients receive rituximab IV on day 1 and tafasitamab IV on days 1, 8, 15 and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. CYCLES 4-6; Patients receive rituximab IV on day 1 and tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients then undergo disease assessment. Patients with complete response undergo active surveillance. Patients with less than complete response go on to receive cycles 7-12. CYCLES 7-12: Patients receive tafasitamab IV on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET scan, CT scan, bone marrow biopsy and aspiration and blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
Citations
1.
hematologyadvisor.com
hematologyadvisor.com/reports/tafasitamab-follicular-lymphoma-improves-outcomes-treatment-risk/Tafasitamab Combo Improves Outcomes in High-Risk R/R ...
The PET complete response rate was higher with tafasitamab, ranging from 43.2% to 51.1% compared with 20.7% to 33.8% with placebo. The ORR ...
Tafasitamab, lenalidomide, and rituximab in relapsed or ...
The addition of tafasitamab to lenalidomide and rituximab resulted in significantly lower risk of progression, relapse, or death versus placebo ...
3.
ashpublications.org
ashpublications.org/ashclinicalnews/news/9146/Tafasitamab-Lenalidomide-Rituximab-CombinationTafasitamab, Lenalidomide, Rituximab Combination Improves ...
The overall response rate was 84% in the tafasitamab arm compared with 72% in the control arm (p=0.0014). The complete response rate was 45% and ...
LBA-1 Tafasitamab Plus Lenalidomide and Rituximab for ...
Conclusions: Addition of tafa to len+R resulted in significant and clinically meaningful improvement in PFS, representing a 57% reduction in ...
5.
targetedonc.com
targetedonc.com/view/tafasitamab-combo-significantly-extends-pfs-in-r-r-follicular-lymphomaTafasitamab Combo Significantly Extends PFS in R/R ...
Patients receiving the tafasitamab combination achieved a median PFS of 22.4 months, compared with 13.9 months for patients receiving placebo ...
NCT04680052 | A Phase 3 Study to Assess Efficacy and ...
A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab. Patients With Relapsed/ Follicular Lymphoma
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.