|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 March 2024 |
|
Main ID: |
NCT02616965 |
|
Date of registration:
|
24/11/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Study to Assess the Feasibility of Romidepsin Combined With Brentuximab Vedotin in Cutaneous T-cell Lymphoma
|
|
Scientific title:
|
A Phase I Trial Assessing the Feasibility of Romidepsin Combined With Brentuximab Vedotin for Patients Requiring Systemic Therapy for Cutaneous T-cell Lymphoma |
|
Date of first enrolment:
|
February 22, 2017 |
|
Target sample size:
|
16 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT02616965 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Shazia Nakhoda, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Fox Chase Cancer Center |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. 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.
2. 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.
3. Patients must require systemic treatment.
4. 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.
5. Age > 18 years.
6. ECOG performance status 0, 1 or 2.
7. 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
8. Women of child-bearing potential (WOCBP) must have a negative pregnancy test
9. Ability to understand and willingness to sign a written informed consent and HIPAA
consent document.
10. 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.
Exclusion Criteria:
1. 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).
2. Grade 2 or greater neuropathy.
3. Patients may not be receiving any other investigational agents.
4. Patients with known CNS involvement.
5. Patients must not receive concurrent systemic or topical steroids or other skin
directed therapy while on study except as outlined in 5.2.2
6. Patients who have experienced allergic reactions to monoclonal antibodies.
7. 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.
8. 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.
9. Pregnant or breast feeding. Refer to section 4.4 for further detail.
10. Second malignancies that require active treatment with the exception of breast or
prostate cancer on endocrine therapy.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cutaneous T-cell Lymphoma (CTCL)
|
|
Intervention(s)
|
|
Drug: Romidepsin
|
|
Drug: Brentuximab vedotin
|
|
Primary Outcome(s)
|
|
Maximum tolerated dose (MTD)
[Time Frame: during treatment period which is an average of 64 weeks.]
|
|
Dose-limiting toxicities (DLTs)
[Time Frame: during the first 28 days (cycle 1) of treatment]
|
|
Secondary Outcome(s)
|
|
Overall survival (OS)
[Time Frame: From the time of patient registration until death, measured every 12 weeks 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]
|
|
Progression free survival (PFS)
[Time Frame: From the time of patient registration until disease progression, measured every 12 weeks up to 2 years]
|
|
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)]
|
|
Secondary ID(s)
|
|
16-1009
|
|
HM-085
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|