Ropeginterferon for Cutaneous T-Cell Lymphoma

Overseen By Richard Corona

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Chemotherapy, Immunotherapy, others

Disqualifiers: Large cell transformation, Hepatic impairment, Uncontrolled psychiatric disorders, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

38 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 4 6 7 8}

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

There is no evidence of large cell transformation on the skin biopsy at the screening visit

Ability to understand and the willingness to sign a written informed consent document

AST/ALT < 3 x upper limit of normal (ULN), and total bilirubin < 2 x ULN (unless due to Gilbert's syndrome)

Exclusion Criteria

Uncontrolled psychiatric disorders, defined as Patient Health Questionnaire-2 (PHQ-2) depression screening score equal to or above 3

Known hypersensitivity to interferons

Baseline QTcF > 470 ms

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ropeginterferon-alfa 2b (P1101) at varying doses every 2 weeks to determine the recommended phase II dose

6 weeks

3 visits (in-person)

Expansion Arm

Additional 20 participants are treated at the recommended phase II dose for further safety and efficacy evaluation

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Expansion Arm Experimental Treatment 1 Intervention

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.

Group II: Dose Level 1 Experimental Treatment 1 Intervention

500 µg SQ every 2 weeks

Group III: Dose Level -2 Experimental Treatment 1 Intervention

250 µg SQ every 2 weeks

Group IV: Dose Level -1 Experimental Treatment 1 Intervention

350 µg SQ every 2 weeks

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

PharmaEssentia

Industry Sponsor

Trials

24

Recruited

2,800+

Citations

1. targetedonc.com targetedonc.com/view/ropeginterferon-alfa-2b-succeeds-in-phase-3-essential-thrombocythemia-trial

Ropeginterferon 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07047885

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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11174383/

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 ...

4. clfoundation.org clfoundation.org/ropeginterferon-patients-ctcl

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 ...

5. academic.oup.com academic.oup.com/bjd/article/193/Supplement_1/ljaf085.187/8161873

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.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2021/761166Orig1s000MedR.pdf

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-myelofibrosis

Ropeginterferon 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-pv

Ropeginterferon 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 ...