Pembrolizumab + Gemcitabine for Cutaneous T-Cell Lymphoma
Recruiting in Palo Alto (17 mi)
+14 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Must not be taking: Immunosuppressants, Live vaccines
Disqualifiers: Pregnancy, Active infection, Autoimmune, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial is testing a combination of two drugs, pembrolizumab and gemcitabine, to treat patients with mycosis fungoides and Sézary syndrome. Pembrolizumab helps the immune system attack cancer, while gemcitabine kills cancer cells directly. The goal is to see if this combination is more effective than current treatments. IPH4102 is a new antibody specifically developed for treating cutaneous T-cell lymphoma.
Will I have to stop taking my current medications?
The trial requires that any previous systemic anti-cancer therapy be stopped at least 2 weeks before starting the study treatment. However, if you are on a stable dose of topical or systemic steroids (up to 10 mg/day of prednisone), you may continue if stopping them could cause a flare-up or other issues.
What data supports the effectiveness of the drug combination Pembrolizumab and Gemcitabine for Cutaneous T-Cell Lymphoma?
Gemcitabine has shown effectiveness as a single agent in treating cutaneous T-cell lymphoma, with studies reporting a 48% overall response rate and a 20% complete response rate in pretreated patients. Additionally, Pembrolizumab, although not extensively studied in this context, is an immune response modifier that has shown promise in treating other types of lymphomas.
12345Is the combination of Pembrolizumab and Gemcitabine safe for humans?
Gemcitabine, used alone, has shown a generally favorable safety profile in treating cutaneous T-cell lymphoma, though it can sometimes cause side effects like myelosuppression (a decrease in bone marrow activity) and infections. No severe blood or liver-related side effects were reported in some studies. Pembrolizumab's safety wasn't specifically covered in these studies, but it is generally known to be safe for use in humans.
12678How is the drug combination of Pembrolizumab and Gemcitabine unique for treating cutaneous T-cell lymphoma?
This treatment is unique because it combines Pembrolizumab, an immunotherapy drug that helps the immune system attack cancer cells, with Gemcitabine, a chemotherapy drug known for its effectiveness in treating cutaneous T-cell lymphoma, potentially offering a novel approach by using both immune and chemotherapy strategies together.
167910Eligibility Criteria
Adults over 18 with mycosis fungoides or Sézary syndrome, who have tried at least one systemic therapy before, can join this trial. They should be relatively healthy (ECOG score 0-1) and not have had certain treatments recently. People with organ transplants, other active cancers, severe infections, or immune conditions that need treatment are excluded.Inclusion Criteria
I have been treated with gemcitabine before.
Participant provides written informed consent
I have received at least one treatment for my cutaneous T-cell lymphoma.
+7 more
Exclusion Criteria
I have been diagnosed with active lymphoma in my brain or spinal cord.
I have not received a live vaccine in the last 30 days.
I have an active case of tuberculosis.
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive pembrolizumab and gemcitabine to assess efficacy in treating mycosis fungoides and Sézary syndrome
6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing if pembrolizumab combined with gemcitabine works for advanced mycosis fungoides and Sézary syndrome. Participants will receive both drugs to see how effective they are together in treating these conditions.
1Treatment groups
Experimental Treatment
Group I: Participants with confirmed mycosis fungoides/Sezary syndromeExperimental Treatment2 Interventions
Participants will have confirmed mycosis fungoides/Sezary syndrome, disease stage IB (defined as patches, plaque, or papules that involve 10% of the skin surface viscera) or higher.
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
🇺🇸 Approved in United States as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
🇨🇦 Approved in Canada as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
🇯🇵 Approved in Japan as Gemzar for:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memoral Sloan Kettering MonmouthMiddletown, NJ
Memorial Sloan Kettering Nassau (Limited protocol activities)Uniondale, NY
Memorial Sloan Kettering NassauUniondale, NY
Memorial Sloan - Kettering Cancer CenterNew York, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Phase II study of gemcitabine and bexarotene (GEMBEX) in the treatment of cutaneous T-cell lymphoma. [2022]Both gemcitabine and bexarotene are established single agents for the treatment of cutaneous T-cell lymphoma (CTCL). We investigated the feasibility and efficacy of combining these drugs in a single-arm phase II study.
Gemcitabine treatment in pretreated cutaneous T-cell lymphoma: experience in 44 patients. [2022]To evaluate the efficacy and toxicity of gemcitabine, a novel pyrimidine antimetabolite with a low-toxicity profile and activity in several solid tumors, in patients with relapsed or refractory cutaneous T-cell lymphomas.
Treatment of transformed mycosis fungoides with intermittent low-dose gemcitabine. [2022]The malignant helper T cells of mycosis fungoides, a type of cutaneous T cell lymphoma, are capable of transforming into large cerebriform cells. Large cell transformation usually renders the disease more resistant to treatment and prone to relapse. Currently investigated treatment modalities for transformed mycosis fungoides are few and include phototherapy, chemotherapy, biologic response modification, targeted molecular therapy and combinations thereof. A tolerable and reliable modality has yet to be identified. Gemcitabine, a novel purine analogue, is gaining recognition as a potent agent for advanced nontransformed cutaneous T cell lymphoma. Here we present a brief review of the literature with 3 illustrative cases that additionally reveal gemcitabine monotherapy to be a practical, safe and efficacious option for mycosis fungoides that has undergone large cell transformation.
Long-term outcome of patients with advanced-stage cutaneous T cell lymphoma treated with gemcitabine. [2022]The choice of treatment for cutaneous T cell lymphoma (CTCL) is often determined by institutional experience, particularly as there is a paucity of data from phase III trials and a lack of consensus concerning treatment of the advanced stages. Among the several second-line and experimental drugs, gemcitabine could be considered one of the most suitable options for pretreated CTCL. Since it is difficult to find in literature the long-term outcome regarding the efficacy of a single-agent drug in pretreated patients and, in particular, in rare diseases such as CTCL, a retrospective observational study was conducted with the aim of evaluating the long-term outcome of CTCL patients treated with gemcitabine. Twenty-five patients with at least one therapy (range 1-8) performed prior to gemcitabine were found. After gemcitabine treatment, the overall response was 48 % with a 20 % of complete responses. At 15 years, the estimated overall survival is 47 %, progression-free survival 8.8 %, and disease-free survival 40 % (median reached at 2.9 years). All patients received at least three cycles and no grade 3-4 hematological adverse events occurred. At the latest follow-up, two patients are still in continuous complete response. This long-term update on the role of gemcitabine as a single agent in pretreated advanced-stage CTCL confirms this monotherapy as effective and safe.
Retrospective Analysis of 118 Patients With Cutaneous T-Cell Lymphomas: A Single-Center Experience. [2022]Cutaneous T-cell lymphomas (CTCL) represent rare non-Hodgkin lymphomas (NHL) with an incidence less than 1 per 100,000 inhabitants. The most common type of CTCL is mycosis fungoides (MF), which represents approximately 60% of all CTCL, followed by Sézary syndrome (SS), approximately 5%. We retrospectively analyzed the outcome of 118 patients with MF (n=96) and SS (n=22) treated between the years 1998 and 2021 at the Charles University General Hospital in Prague, Czech Republic. The ratio between men and women was 1.2:1 (62 men, and 56 women). The median age at diagnosis was 62 years (23 to 92 years). From the MF cohort 48 patients (50% out of MF cohort) presented with advanced stage disease. Ninety patients (77%) received a systemic treatment at any time from the diagnosis; the median number of therapy lines was two. At the time of database lock, the overall survival (OS) of 96 patients with MF reached 17.7 years with the median follow-up 4.0 years. With the median follow-up 2.6 years, the median OS of 22 patients with SS was 3.5 years. The most common type of systemic therapy for MF included low-dose methotrexate (61%), interferon-alpha (58%), bexarotene (28%), and chlorambucil (25%). The most common type of therapy for SS included bexarotene (64%), extracorporeal photopheresis (50%), and interferon-alpha (45%). Only the minority of patients received innovative targeted agents including brentuximab vedotin, mogamulizumab, or pembrolizumab. Besides the retrospective analysis of the CTCL cohort, current standards and future perspectives of selected innovative agents are summarized and discussed. The analyzed cohort represents the largest cohort of CTCL patients in the Czech Republic. Overall, the survival parameters of our CTCL cohort are comparable to those previously published by other groups. In conclusion, our analysis of 118 real world cohort of consecutive CTCL patients treated at the single center confirmed the efficacy of immune response modifiers and underlines the urgent need for ample implementation of innovative agents and their combinations into earlier lines of therapy.
Clinical Outcomes of Advanced-Stage Cutaneous Lymphoma under Low-Dose Gemcitabine Treatment: Real-Life Data from the German Cutaneous Lymphoma Network. [2022]Gemcitabine is an effective single-agent chemotherapy used in advanced stages of cutaneous T-cell lymphoma (CTCL). However, gemcitabine used in the current standard regimen is frequently associated with adverse events (AE), such as an increased risk for myelosuppression and severe infections.
Gemcitabine treatment in cutaneous T-cell lymphoma: a multicentre study of 23 cases. [2022]Primary cutaneous T-cell lymphomas (CTCLs) are malignancies characterized by a clonal T-cell infiltrate involving the skin. CTCLs often show resistance to conventional antineoplastic chemotherapy. Gemcitabine is a pyrimidine analogue which has shown efficacy and a favourable safety profile in solid tumours and haematological malignancies.
[Gemcitabine Monotherapy for Advanced Mycosis Fungoides--Two Case Reports and a Literature Review]. [2022]Gemcitabine, a pyrimidine nucleoside analogue, is gaining recognition as a potential therapeutic agent for advanced-stage and refractory cutaneous T-cell lymphoma (CTCL). We report of 2 patients whose advanced-stage mycosis fungoides was not sufficiently controlled by prior CHOP therapy. Both patients showed great improvement in the skin lesions with weekly gemcitabine therapy (1,000-1,200 mg/m2). The patients received four and 8 cycles of gemcitabine monotherapy, respectively, and no grade 3-4 hematological or hepatic adverse events occurred. This is the first report of the efficacy of gemcitabine for CTCL in Japan. Gemcitabine is well tolerated and is an effective monotherapy for CTCL.
Gemcitabine and vinorelbine treatment in cutaneous T-cell lymphoma in four patients. [2022]Treatment options for advanced stage cutaneous T-cell lymphoma (CTCL) are limited by the their efficacy and side-effects profile. Gemcitabine, a pyrimidine analogue, has been reported to be efficacious in CTCL. Most of the studies published used gemcitabine as a single agent in treating advanced CTCL. Our small case series demonstrated that a combination of gemcitabine and vinorelbine induced partial remission in all four patients with refractory or advanced CTCL, although the effects were not sustained for a long duration (2-6 months). Two patients had neutropenia and one had acute hepatitis, requiring discontinuation of treatment.
Gemcitabine as frontline treatment for cutaneous T-cell lymphoma: phase II study of 32 patients. [2022]Based on the activity of gemcitabine in heavily pretreated patients with cutaneous T-cell lymphoma (CTCL), the objective of the current study was to determine the role of gemcitabine in the treatment of patients with advanced, untreated CTCL.