Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL (NCT03240211) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL
United States37 participantsStarted 2022-02-02
Plain-language summary
This is an international, multicenter, multi-arm, phase Ib, model-based dose-escalation study. The primary objectives of the study in each arm is to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), dose limiting toxicities (DLTs) and to evaluate the clinical efficacy at the MTD of various combinations of pembrolizumab, pralatrexate and decitabine.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be willing and able to provide written informed consent/assent for the trial.
. Be ≥ 18 years of age on day of signing informed consent.
. Have measurable disease as defined by the Lugano Criteria for PTCL and by the Global Response Score for CTCL.
. Patient must have histologically confirmed relapsed or refractory Peripheral T-cell lymphoma (PTCL) or cutaneous T-cell Lymphoma (CTCL) as per WHO criteria and TNMB classification and staging.
. There is no upper limit for the number of prior therapies. Patient may have relapsed after prior autologous stem cell transplant.
. Patients who had prior treatment for their disease, as long as there is radiographic evidence of refractory or relapsed disease and the patient meets all other clinical and laboratory criteria for study treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial combining three drugs — pembrolizumab, decitabine, and pralatrexate — and the main goal is to find the maximum tolerated dose rather than prove the treatment works, what does that mean for my personal safety and the uncertainty around whether it might help my specific type of T-cell lymphoma?
2The trial is listed as 'active, not recruiting,' which means they're no longer enrolling new patients — is there any way this trial or its findings might still be relevant to my care, or are there related studies I should be looking into instead?
3Given that one of the main things this study is measuring is dose-limiting toxicity, what kinds of serious side effects have been seen so far with this combination of drugs, and how would those risks compare to standard treatment options for my PTCL or CTCL?
4This trial combines an immunotherapy drug (pembrolizumab) with two chemotherapy agents — how does that multi-drug approach differ from what I'd receive on a standard treatment path, and is there a reason to consider one before the other given where my disease currently stands?
5If the overall response rate data from this trial becomes available, how will you use that information to help guide my treatment decisions, even if I'm not able to enroll directly?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Be willing to provide FNA of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
. Have a performance status of 0 or 1 on the ECOG Performance Scale.
Exclusion criteria
. Has lack of resolution of adverse events (AE) due to previously administered antineoplastic therapy to grade 1 or less according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
. Had prior therapy with PD-1 inhibitors.
. Has a diagnosis of immunodeficiency or has been receiving any immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Use of steroid equivalent to prednisone 10 mg/day does not constitute an exclusion criterion.
. Has a known history of active TB (Bacillus Tuberculosis)
. Hypersensitivity to pralatrexate, or decitabine or pembrolizumab or any of its excipients.
. Has received prior allogeneic stem cell transplant.
. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.