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New treatment option for T-Cell Lymphoma
Official title Pembrolizumab and Brentuximab Vedotin in Subjects With Relapsed/Refractory T-cell Lymphoma
ClinicalTrials.gov ID: NCT05313243
What this study is testing
What is Brentuximab vedotin?
Brentuximab vedotin is an investigational medicine, being studied as a potential treatment for t-cell lymphoma.
Also referred to as Adcetris.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single arm, open label, multicenter study phase 2 study of pembrolizumab and brentuximab in subjects with relapsed/refractory CD30 positive T-cell lymphoma (including peripheral T-cell lymphoma and cutaneous T-cell lymphoma) who have received at least one prior therapy. We hypothesize that this combination is effective and will produce an overall response rate of \~55%.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of T-cell...
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Histologically confirmed T-cell Non-Hodgkin lymphoma (T-NHL), including:
- Peripheral T-cell lymphoma not other specified (PTCL nos)
You likely can't join if
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor...
- Patients with adult T-cell leukemia/ lymphoma (ATLL)
- Has received prior systemic anti-cancer therapy including investigational agents ≤ 4 weeks prior to first dose of study treatment on Cycle 1, Day 1...
- Pregnant or breast-feeding females. A WOCBP who has a positive urine pregnancy test at screening. If the urine test is positive or cannot be...
- Has received radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, and not...
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
See the full eligibility criteria
Who can join
- Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of T-cell Non-Hodgkin lymphoma (T-NHL) will be enrolled in this study.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Histologically confirmed T-cell Non-Hodgkin lymphoma (T-NHL), including:
- Peripheral T-cell lymphoma not other specified (PTCL nos)
- Angioimmunoblastic T-cell lymphoma (AITL)
- Anaplastic large-cell lymphoma (ALCL)
- Natural killer (NK)/T-cell lymphoma (nodal or extranodal)
- Cutaneous T-cell lymphoma (CTCL), including mycosis fungoides (MF)/sezary syndrome
- Transformed T-cell lymphoma
- Enteropathy-associated T-cell lymphoma (EATL);
- Subcutaneous panniculitis-like T-cell lymphoma (SCPTCL)
- Hepatosplenic T- cell lymphomas.
- Presence of CD30 (\>1%) by IHC on a previous biopsy sample
- Relapsed/refractory disease having failed at least one prior systemic therapy Note: Single agent Brentuximab could have been a prior line of therapy EXCEPT those with ≥ grade 2 side effects leading to treatment...
- For patients with peripheral T-cell lymphoma (PTCL): At least one measurable target lesion ≥1.5 cm
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP)
- A woman of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test during screening within 72 hours prior to receiving first dose of protocol-indicated treatment, and must agree to follow...
- A male participant must agree to use contraception during the treatment period and for at least at least 120 days (4 months) after the final dose of pembrolizumab. and refrain from donating sperm during this period.
- Adequate organ and bone marrow function resulted ≤ 10 days prior to first dose of protocol-indicated treatment:
What rules you out
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
- Patients with adult T-cell leukemia/ lymphoma (ATLL)
- Has received prior systemic anti-cancer therapy including investigational agents ≤ 4 weeks prior to first dose of study treatment on Cycle 1, Day 1. Could consider shorter interval for kinase inhibitors or other short...
- Pregnant or breast-feeding females. A WOCBP who has a positive urine pregnancy test at screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. In the event...
- Has received radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, and not have had radiation pneumonitis. A 1-week washout is permitted for...
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have...
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the...
- Has active autoimmune disease that has required systemic treatment in the past one year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine...
- Active uncontrolled infection requiring systemic therapy (patients must be afebrile for ≥ 48 hours off antibiotics prior to first protocol treatment). If fever is attributed to tumor fever (B symptom) then this criteria...
- Active myocarditis, regardless of etiology; or New York Heart Association (NYHA) functional classification III-IV heart failure.
- Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at...
- Disease free of prior malignancies for ≥ 1 year with exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. (Other malignancies will require...
- Known severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B...
- Has a history or current evidence of any condition (e.g. renal disease that would preclude treatment or obstructive pulmonary disease and history of bronchospasm), therapy, or laboratory abnormality that might confound...
- Clinically significant history of liver disease, including current alcohol abuse or cirrhosis.
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Has a known history of active TB (Bacillus Tuberculosis).
- Prior allogeneic stem cell transplant within last 5 years or active graft vs. host disease (GVHD).
- Patients with grade 2 or higher peripheral neuropathy
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.