Cutaneous T-cell Lymphoma (CTCL)Phase 1NCT02616965
A Study to Assess the Feasibility of Romidepsin Combined With Brentuximab Vedotin in Cutaneous T-cell Lymphoma
A Phase 1 study testing Romidepsin and Brentuximab vedotin in people with Cutaneous T-cell Lymphoma (CTCL), run by Fox Chase Cancer Center at 2 sites in United States.
Trial summary
This is a Phase I Trial to assess the feasibility of Romidepsin combined with Brentuximab Vedotin for patients requiring Systemic Therapy for Cutaneous T-cell Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-cell Lymphoma (CTCL)
- What is being tested?
- Romidepsin and Brentuximab vedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Feb 2017to 31 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Please note that tumor samples for patients with MF or SS can be CD30 negative and do not have to be CD30 positive on either flow cytometry or immunohistochemistry for patients to be eligible.
- 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.
- Patients must require systemic treatment.
- Patients can have received up to 2 lines of systemic treatment. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy.
- Age > 18 years.
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- ECOG performance status 0, 1 or 2.
- Patients must have acceptable organ and marrow function as defined below:
- Absolute neutrophil count > 1,500/mcL
- Platelets > 100,000/mcL
- Total bilirubin within normal institutional limits
- AST/ALT (SGOT/SGPT) < 2 times institutional normal limits
- Creatinine within normal institutional limits OR
- Creatinine clearance > 60 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal
- Women of child-bearing potential (WOCBP) must have a negative pregnancy test
- Ability to understand and willingness to sign a written informed consent and HIPAA consent document.
- Patients with HIV who are not receiving cytochrome p450 inhibitors, and who have a minimum of 300+ CD4+ cells/mm3, an undetectable viral load, and no history of AIDS indicator conditions.
Who cannot join
- Patients who have not had resolution of clinically significant toxic effects of prior anticancer therapy to ≤grade 1 as per by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0).
- Grade 2 or greater neuropathy.
- Patients may not be receiving any other investigational agents.
- Patients with known CNS involvement.
- Patients must not receive concurrent systemic or topical steroids or other skin directed therapy while on study except as outlined in 5.2.2
- Patients who have experienced allergic reactions to monoclonal antibodies.
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- Patients who have received prior HDAC inhibitors, or brentuximab vedotin, except for patients who were exposed to above drugs only for a short time (less than 8 weeks), did not progress while on treatment, and did not have intolerable toxicity but were discontinued for another reason (e.g., comorbidity) may be permitted to enter the study after discussion with the sponsor-investigator.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or breast feeding. Refer to section 4.4 for further detail.
- Second malignancies that require active treatment with the exception of breast or prostate cancer on endocrine therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania, Perelman Center
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Phase I Trial Assessing the Feasibility of Romidepsin Combined With Brentuximab Vedotin for Patients Requiring Systemic Therapy for Cutaneous T-cell Lymphoma
This is a Phase I Trial to assess the feasibility of Romidepsin combined with Brentuximab Vedotin for patients requiring Systemic Therapy for Cutaneous T-cell Lymphoma.
Read the detailed description
This is a traditional "3+3" phase 1 dose de-escalation design testing up to 3 dose levels of romidepsin in conjunction with brentuximab vedotin in patients with untreated or previously treated (up to 2 prior systemic regimens, including photopheresis) CTCL. Dose-limiting toxicities (DLT) will be determined during cycle 1. The first 3 subjects will begin at dose level 1. If no DLT is encountered another 3 subjects will be enrolled at the same dose level. The maximum tolerated dose (MTD) will be the dose level at which ≤ 1 of 6 of subjects experience DLT. If more than one subject at any one dose level encounters a DLT, the dose will be de-escalated for all subsequent subjects. Should no DLTs occur, the investigators will not escalate beyond dose level 1. Once the MTD has been confirmed, the investigators will enroll an additional 9 patients in a toxicity refinement cohort for a total of 15 evaluable patients at the MTD.
Treatment will continue for up to 16 cycles (one cycle is 28 days) or until disease progression or toxicities, whichever occurs first. Drugs can be continued after 16 cycles if a patient has derived a clinical benefit from treatment after discussion with the sponsor-investigator.
- Conditions
- Cutaneous T-cell Lymphoma (CTCL)
- Being tested
- Romidepsin, Brentuximab vedotin
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RomidepsinDrug
Romidepsin at the dosage 10mg/m2 or 14mg/m2 will be given ONCE 14 days prior to cycle one and then on days 1,8,15 in each cycle. Each cycle is 28 days and treatment will continue up to 16 cycles
Brentuximab vedotinDrug
Brentuximab vedotin at the dosage 0.9mg/kg or 1.2 mg/kg will be given on days 1 and 15 in each cycle. Each cycle is 28 days and treatment will continue up to 16 cycles
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Drug: Romidepsin; Drug: Brentuximab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
CTCAE v4.03
Measured: during treatment period which is an average of 64 weeks.
Dose-limiting toxicities (DLTs)
CTCAE v4.03
Measured: during the first 28 days (cycle 1) of treatment
Secondary outcomes (5)
overall safety and tolerability of the combination of brentuximab vedotin & romidepsin assessed by adverse events.
CTCAE v4.03
Measured: from start of treatment to 30 days post treatment period (16 cycles)
Estimate complete and partial response rate of the combination treatment
mSWAT skin assessment
Measured: 64 weeks, 30 days post treatment and every 12 weeks post-treatment, up to 2 years
Estimate complete and partial response rate of the combination treatment
Global Response Score (GRS).
Measured: 64 weeks, 30 days post treatment and every 12 weeks post-treatment, up to 2 years
Overall survival (OS)
OS is measured by length of time
Measured: From the time of patient registration until death, measured every 12 weeks up to 2 years
Progression free survival (PFS)
PFS is measured in length of time by RECIST v1.1
Measured: From the time of patient registration until disease progression, measured every 12 weeks up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study start22 Feb 2017
- Primary completion8 Aug 2022
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-cell Lymphoma (CTCL)Studies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seagen Inc., Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Shazia Nakhoda, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02616965
- Sponsor's protocol ID
- HM-085
- Other IDs
- 16-1009
- Status last verified
- Apr 2025
- First submitted
- 24 Nov 2015
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial Assessing the Feasibility of Romidepsin Combined With Brentuximab Vedotin for Patients Requiring Systemic Therapy for Cutaneous T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT02616965
- Acronym / sponsor ID
- HM-085
- Conditions
- Cutaneous T-cell Lymphoma (CTCL)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Seagen Inc., Celgene Corporation
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 30 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I Trial to assess the feasibility of Romidepsin combined with Brentuximab Vedotin for patients requiring Systemic Therapy for Cutaneous T-cell Lymphoma.
Detailed description
This is a traditional "3+3" phase 1 dose de-escalation design testing up to 3 dose levels of romidepsin in conjunction with brentuximab vedotin in patients with untreated or previously treated (up to 2 prior systemic regimens, including photopheresis) CTCL. Dose-limiting toxicities (DLT) will be determined during cycle 1. The first 3 subjects will begin at dose level 1. If no DLT is encountered another 3 subjects will be enrolled at the same dose level. The maximum tolerated dose (MTD) will be the dose level at which ≤ 1 of 6 of subjects experience DLT. If more than one subject at any one dose level encounters a DLT, the dose will be de-escalated for all subsequent subjects. Should no DLTs occur, the investigators will not escalate beyond dose level 1. Once the MTD has been confirmed, the investigators will enroll an additional 9 patients in a toxicity refinement cohort for a total of 15 evaluable patients at the MTD.
Treatment will continue for up to 16 cycles (one cycle is 28 days) or until disease progression or toxicities, whichever occurs first. Drugs can be continued after 16 cycles if a patient has derived a clinical benefit from treatment after discussion with the sponsor-investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Romidepsin, Drug: Brentuximab vedotinTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
- Please note that tumor samples for patients with MF or SS can be CD30 negative and do not have to be CD30 positive on either flow cytometry or immunohistochemistry for patients to be eligible.
- 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.
- Patients must require systemic treatment.
- Patients can have received up to 2 lines of systemic treatment. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy.
Key exclusion criteria (10 listed)
- Patients who have not had resolution of clinically significant toxic effects of prior anticancer therapy to ≤grade 1 as per by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0).
- Grade 2 or greater neuropathy.
- Patients may not be receiving any other investigational agents.
- Patients with known CNS involvement.
- Patients must not receive concurrent systemic or topical steroids or other skin directed therapy while on study except as outlined in 5.2.2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RomidepsinRomidepsin at the dosage 10mg/m2 or 14mg/m2 will be given ONCE 14 days prior to cycle one and then on days 1,8,15 in each cycle. Each cycle is 28 days and treatment will continue up to 16 cycles | Drug | Treatment |
| Brentuximab vedotinBrentuximab vedotin at the dosage 0.9mg/kg or 1.2 mg/kg will be given on days 1 and 15 in each cycle. Each cycle is 28 days and treatment will continue up to 16 cycles | Drug | Treatment |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: during treatment period which is an average of 64 weeks.
CTCAE v4.03
Dose-limiting toxicities (DLTs)
Time frame: during the first 28 days (cycle 1) of treatment
CTCAE v4.03
5 secondary outcomes
overall safety and tolerability of the combination of brentuximab vedotin & romidepsin assessed by adverse events.
Time frame: from start of treatment to 30 days post treatment period (16 cycles)
Estimate complete and partial response rate of the combination treatment
Time frame: 64 weeks, 30 days post treatment and every 12 weeks post-treatment, up to 2 years
Estimate complete and partial response rate of the combination treatment
Time frame: 64 weeks, 30 days post treatment and every 12 weeks post-treatment, up to 2 years
Overall survival (OS)
Time frame: From the time of patient registration until death, measured every 12 weeks up to 2 years
Progression free survival (PFS)
Time frame: From the time of patient registration until disease progression, measured every 12 weeks up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shazia Nakhoda, MD principal investigator
Fox Chase Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Romidepsin and Brentuximab vedotin in people with Cutaneous T-cell Lymphoma (CTCL), run by Fox Chase Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: during treatment period which is an average of 64 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.