Ropeginterferon for Cutaneous T-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Ropeginterferon alfa-2b for individuals with cutaneous T-cell lymphoma (CTCL), a type of skin lymphoma. The goal is to determine the right dose for future studies. It targets those whose previous treatments were ineffective or insufficient, particularly if they have tried skin therapies like phototherapy and still experience symptoms. Ideal candidates have CTCL that has been difficult to treat with skin-directed therapies or have persistent symptoms. Participants must be able to self-administer an injection under the skin every two weeks and be willing to adhere to this schedule. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications to join the trial?
You may need to stop certain medications before joining the trial. There is a required 3-week period without other systemic anti-cancer therapies before starting the study drug, but you can continue with phototherapy or extracorporeal photopheresis if you have been on a stable schedule.
Is there any evidence suggesting that Ropeginterferon alfa-2b is likely to be safe for humans?
Research has shown that Ropeginterferon alfa-2b is generally well-tolerated. Patients did not experience any unusual safety issues, and most side effects were mild and manageable. For example, studies lasting over five years found the treatment safe without specific safety concerns.
Additionally, the FDA has approved Ropeginterferon alfa-2b for treating another condition, supporting its safety profile. However, this trial is in an early phase and aims to determine the best dose for patients with cutaneous T-cell lymphoma. Researchers will closely monitor participants' safety during the study.12345Why do researchers think this study treatment might be promising?
Researchers are excited about ropeginterferon alfa-2b for treating cutaneous T-cell lymphoma because it offers a novel approach by using interferon therapy. Unlike standard treatments like chemotherapy and radiation, which target cancer cells more broadly, ropeginterferon alfa-2b leverages the body's immune system to fight the cancer. This treatment is delivered subcutaneously, which could potentially offer a more convenient and less invasive option compared to traditional intravenous therapies. Additionally, the dosing schedule of every two weeks might improve patient compliance and quality of life.
What evidence suggests that Ropeginterferon alfa-2b might be an effective treatment for cutaneous T-cell lymphoma?
Research has shown that Ropeginterferon alfa-2b may be helpful for treating similar conditions. In patients with essential thrombocythemia, 42.9% of those treated with Ropeginterferon alfa-2b experienced lasting positive results. Early studies suggest that Ropeginterferon can work as well as other interferons, like Pegasys, in controlling the disease. For Cutaneous T-Cell Lymphoma (CTCL), evidence indicates that interferon treatments can achieve a total response rate of 56% in some stages. These findings suggest that Ropeginterferon alfa-2b could be effective for patients with CTCL. Participants in this trial will receive different dose levels of Ropeginterferon alfa-2b to evaluate its safety and efficacy.14678
Who Is on the Research Team?
Yumeng Zhang, MD
Principal Investigator
Moffitt Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with Cutaneous T-Cell Lymphoma (CTCL) who haven't fully responded to at least two skin treatments, or have stable/progressive disease after similar therapies. It's aimed at those in stages IA-IB without a complete response to certain light-based treatments or stages IIA-IIIB with little improvement after topical therapies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Ropeginterferon-alfa 2b (P1101) at varying doses every 2 weeks to determine the recommended phase II dose
Expansion Arm
Additional 20 participants are treated at the recommended phase II dose for further safety and efficacy evaluation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ropeginterferon alfa-2b
Trial Overview
The study tests Ropeginterferon alfa-2b in CTCL patients. It's a phase I/IB trial aiming to find the safest and most effective dose for future studies. Participants must have tried other skin-directed therapies before joining this single-center research.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Once the Recommended Phase 2 Dose (RP2D) is reached, an additional 20 participants will be treated at this dose for additional experience with safety and efficacy.
500 µg SQ every 2 weeks
250 µg SQ every 2 weeks
350 µg SQ every 2 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
PharmaEssentia
Industry Sponsor
Citations
1.
targetedonc.com
targetedonc.com/view/ropeginterferon-alfa-2b-succeeds-in-phase-3-essential-thrombocythemia-trialRopeginterferon Alfa-2b Succeeds in Phase 3 Essential ...
In the intent-to-treat (ITT) population, 42.9% (39/91) of patients treated with ropeginterferon alfa-2b had durable responses at 9 and 12 months ...
Ropeginterferon in Patients w/Cutaneous T-Cell ...
This is a single-center, phase I/IB study to identify the recommended phase II dose of Ropeginterferon-alfa 2b (P1101) in patients with CTCL who have failed ...
Treatment of Stage II Cutaneous T-cell Lymphoma ...
Conclusion: These results indicate that patients with CTCL stage IIa can achieve a total response rate of 56% with combined interferon alfa-2a and ...
Ropeginterferon in Patients with CTCL
This is a single-center, phase I/IB study to identify the recommended phase II dose of Ropeginterferon-alfa 2b (P1101) in patients with CTCL who have failed at ...
P159 Use of Besremi® (pegylated interferon-alfa-2b) in the ...
Early observations indicate that Besremi is at least as effective as Pegasys, with reversal of disease deterioration triggered by dose reduction of Pegasys.
BESREMI (ropeginterferon alfa-2b-njft) Review
The updated safety data provides for 60 month safety data from the CONTINUATION-PV Study. (up to 60 months of observation) whose data base lock was May 29, 2020 ...
7.
onclive.com
onclive.com/view/ropeginterferon-alfa-2b-produces-responses-safety-in-prefibrotic-primary-myelofibrosisRopeginterferon Alfa-2b Produces Responses, Safety in ...
As far as safety is concerned, [ropeginterferon alfa-2b] was tolerable without specific safety signals that were observed. The most common non- ...
8.
targetedonc.com
targetedonc.com/view/ropeginterferon-alfa-reduces-jak2-allele-burden-over-long-term-in-pvRopeginterferon Alfa Reduces JAK2 Allele Burden Over ...
According to Tremblay, there were also encouraging safety data showing that it was well tolerated over the 5-year period and patients were able ...
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