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Monoclonal Antibodies
Romidepsin + Brentuximab Vedotin for Cutaneous T-Cell Lymphoma
Phase 1
Waitlist Available
Led By Shazia Nakhoda, MD
Research Sponsored by Fox Chase Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically or cytologically confirmed diagnosis of mycosis fungoides (MF), Sezary syndrome (SS) or primary cutaneous CD30-positive lymphoproliferative disorder, including lymphomatoid papulosis and primary cutaneous ALCL (pc-ALCL) as defined by the WHO classification of Tumors of Hematopoietic and Lymphoid tissue.
Patients with MF/SS must have stage IB, IIA, IIB, III or IV disease; patients with primary cutaneous CD30-positive lymphoproliferative disorder must have multifocal symptomatic or extensive lesions requiring systemic treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of patient registration until death, measured every 12 weeks up to 2 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat patients with a certain type of cancer.
Who is the study for?
This trial is for adults over 18 with Cutaneous T-cell Lymphoma needing systemic therapy. Eligible patients can have had up to two prior treatments (excluding PUVA), must have certain levels of organ and marrow function, and no severe side effects from previous cancer therapies. HIV-positive patients can join if they meet specific health criteria.Check my eligibility
What is being tested?
The study tests the combination of Romidepsin and Brentuximab Vedotin in treating Cutaneous T-cell Lymphoma. It's a Phase I trial, which means it's an early-stage study focusing on the feasibility and safety of this drug combo.See study design
What are the potential side effects?
Potential side effects may include changes in blood counts, liver enzymes alterations, possible kidney function issues, fatigue, nausea, or allergic reactions related to the drugs being tested.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of skin lymphoma.
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My skin cancer is at an advanced stage or requires systemic treatment due to extensive lesions.
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I can take care of myself and am up and about more than half of my waking hours.
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I am a woman who can have children and I have a negative pregnancy test.
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I have HIV, but it's well-controlled, and I'm not on certain medications.
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My kidney function, measured by creatinine levels, is normal or nearly normal.
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I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of patient registration until death, measured every 12 weeks up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of patient registration until death, measured every 12 weeks up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicities (DLTs)
Maximum tolerated dose (MTD)
Secondary outcome measures
Estimate complete and partial response rate of the combination treatment
Overall survival (OS)
Progression free survival (PFS)
+1 moreSide effects data
From 2018 Phase 1 & 2 trial • 51 Patients • NCT01456039100%
Dysgeusia
100%
Leukopenia
100%
Thrombocytopenia
100%
Lymphopenia
100%
Neutropenia
100%
Nausea
100%
Vomiting
100%
Pyrexia
100%
Fatigue
100%
Decreased appetite
100%
Peripheral Sensory neuropathy
67%
Diarrhoea
67%
Anaemia
67%
Lip dry
67%
Haemoglobin decreased
67%
Weight decreased
67%
Blood phosphorus increased
67%
Hypotension
67%
Insomnia
33%
Hypokalaemia
33%
Alanine aminotransferase increased
33%
Akathisia
33%
Oedema peripheral
33%
Hypocalcaemia
33%
Hyperhidrosis
33%
Vitreous Floaters
33%
Cancer Pain
33%
Biliary colic
33%
Abdominal pain upper
33%
Dental caries
33%
Gastritis
33%
Hypothermia
33%
Influenza like illness
33%
Non-cardiac chest pain
33%
Hypermagnesaemia
33%
Hyperuricaemia
33%
Blood alkaline phosphatase increased
33%
Blood urea increased
33%
Somnolence
33%
Rash macular
33%
Hypoxia
33%
Arthralgia
33%
Back Pain
33%
Musculoskeletal stiffness
33%
Osteoarthritis
33%
Periarthritis
33%
Nasopharyngitis
33%
Influenza
33%
Upper respiratory tract infection
33%
Long QT syndrome
33%
Contusion
33%
Procedural Pain
33%
Phlebitis
33%
Pollakiuria
33%
Headache
33%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Romidepsin 9mg/m^2
Phase 1: Romidepsin 14mg/m^2
Phase 2: Romidepsin 14mg/m^2
Total: Romidepsin 14mg/m^2
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment2 Interventions
Treatment consists of the combination of Romidepsin given 10mg/m2 or 14mg/m2 on days 1, 8 and 15 every 28 days and Brentuximab vedotin given 0.9mg/kg or 1.2mg/kg on days 1 and 15 every 28 days for 16 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Romidepsin
2011
Completed Phase 2
~790
Brentuximab vedotin
2012
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
Fox Chase Cancer CenterLead Sponsor
227 Previous Clinical Trials
37,493 Total Patients Enrolled
Seagen Inc.Industry Sponsor
207 Previous Clinical Trials
69,141 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,220 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions to similar types of medications called monoclonal antibodies.I do not have any serious illnesses that would stop me from following the study's requirements.My cancer has spread to my brain.I experience significant numbness or pain due to nerve damage.I have been diagnosed with a specific type of skin lymphoma.My tumor does not need to be CD30 positive for me to join.My side effects from previous cancer treatments are mild or gone.I was briefly on HDAC inhibitors or brentuximab vedotin without severe side effects or disease progression.I am not receiving active treatment for any cancer other than breast or prostate cancer, which is being treated with hormone therapy.I have had up to 2 treatments for my condition, not counting PUVA.I can take care of myself and am up and about more than half of my waking hours.My skin cancer is at an advanced stage or requires systemic treatment due to extensive lesions.I need treatment that affects my whole body.I am a woman who can have children and I have a negative pregnancy test.I am not using steroids or skin treatments while in this study, except as allowed.I have HIV, but it's well-controlled, and I'm not on certain medications.My kidney function, measured by creatinine levels, is normal or nearly normal.I am older than 18 years.My organs and bone marrow are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What have been patients' experiences with Romidepsin?
"Romidepsin receives a 1 on our safety scale because it is only in Phase 1 trials, meaning that there is limited data to support its efficacy and safety."
Answered by AI
What are the most popular reasons that Romidepsin is prescribed?
"Romidepsin is not only used to treat hodgkin disease, but also systemic anaplastic large cell lymphoma, peripheral t-cell lymphoma, and previously untreated."
Answered by AI
Are there any other drugs similar to Romidepsin that have been trialed before?
"As of right now, 79 separate trials are underway to test the efficacy of Romidepsin. Of those, 9 are in Phase 3. Most of the research is based out of Montvale, New jersey, though there are 2,123 total locations running trials for this medication."
Answered by AI
What are researchers aiming to discover through this clinical trial?
"Celgene Corporation, the sponsor of this clinical trial, reports that the primary objective of this study is to evaluate the dose-limiting toxicities (DLTs) of the combination of brentuximab vedotin and romidepsin. This will be measured over an average treatment period of 64 weeks. Secondary objectives of this trial include assessing the overall safety and tolerability of the combination therapy by monitoring adverse events, and measuring the overall survival (OS) and progression-free survival (PFS) in terms of length of time."
Answered by AI
How many patients are researchers hoping to enroll in this trial?
"That is correct. The clinical trial, which is currently recruiting participants, was originally posted on February 22nd, 2017. The most recent edit was made on July 6th, 2022. A total of 27 patients are needed for the study, which is being conducted at a single site."
Answered by AI
What sets this trial apart from others that have come before it?
"As of now, there are 79 Romidepsin trials being conducted in 649 locations and 33 countries. The first Romidepsin trial was completed in 2011 and only involved 79 patients. However, since then, 94 more studies have been completed."
Answered by AI
Are new patients being accepted into this research project currently?
"That is correct, the study is still looking for enrollees. According to the website, the clinical trial was first posted on February 22nd, 2017 and was most recently updated on July 6th, 2022. They are only admitting 27 people in total at a single location."
Answered by AI
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