NM-IL-12 in Cutaneous T-Cell Lymphoma (CTCL) Undergoing Total Skin Electron Beam Therapy (TSEBT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02542124|
Recruitment Status : Active, not recruiting
First Posted : September 4, 2015
Last Update Posted : November 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous T Cell Lymphoma (CTCL) Mycosis Fungoides Sézary Syndrome||Biological: NM-IL-12 and TSEBT||Phase 2|
This is a single arm, open-label, non-randomized study with NM-IL-12 dosed in combination with low dose TSEBT in CTCL patients. This study is planned to be conducted in 10 patients, 18 years or older in age, undergoing low dose TSEBT of 12 Gy over a 3-week period.
The study will initially enroll 4 patients and then will be expanded to enroll 6 additional patients (total 10 patients) depending on the presence or absence of Dose Modifying Criteria (DMC). Decision whether to de-escalate will be made after first 4 patients are followed up for 28 days from the first dose of NM-IL-12.
Safety monitoring will continue throughout the whole period of drug administration and the treatment will be discontinued if intolerable toxicity or disease progression occurs during this period.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm, Open-Label Study To Evaluate The Safety, Tolerability And Preliminary Efficacy Of NM-IL-12 (rHuIL-12) In Patients With Cutaneous T Cell Lymphoma (CTCL) Undergoing Low Dose Total Skin Electron Beam Therapy (TSEBT)|
|Actual Study Start Date :||December 2015|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: NM-IL-12 and TSEBT
TSEBT and subcutaneous doses of NM-IL-12
Biological: NM-IL-12 and TSEBT
The LD-TSEBT treatment will start on Day 1 of the study. NM-IL-12 will be administered subcutaneously.
Other Name: HemaMax, rHu-IL12, LD-TSEBT
- Safety and tolerability will be evaluated on the basis of the following parameters (Vital signs, physical examination,Toxicity according to the NCI CTCAE, Immunogenicity evaluated by the presence of anti-drug antibody) : [ Time Frame: 107 weeks ]
General safety: Vital signs (temperature, blood pressure, pulse rate, respiratory rate) and physical examination.
Toxicity according to the NCI CTCAE (v4.03) for AEs and clinical laboratory profile; AEs will be collected in all patients who received at least one dose of NM-IL-12 and up to four weeks post last NM-IL-12 dose.
Immunogenicity of NM-IL-12 will be evaluated by the presence of anti-drug antibody (ADA)
- Clinical Response measured by a modified severity-weighted assessment tool (mSWAT) [ Time Frame: 107 weeks ]Exploratory skin clinical responses measured by a modified severity-weighted assessment tool (mSWAT)
- Progression free survival [ Time Frame: 107 weeks ]
Progression free survival based on every 4 week follow up after the monthly dose until one of the events below occurs first:
- Progressive disease is documented
- Another treatment for CTCL is administered (topical or systemic)
- 107 weeks are completed after the patient's first dose of NM-IL-12
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02542124
|United States, California|
|Stanford Cancer Center|
|Stanford, California, United States, 94305|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Youn H Kim, MD||Stanford University|