Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Infections

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Mycoses

Mycosis Fungoides

Lymphoma, T-Cell, Cutaneous

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Bexarotene

Patients will be initiated on bexarotene 150 mg daily on Day 1, with dose increase to 300 mg daily on Day 15. Patients will receive Cycle 1 of TSEB on Day 22 (with 2 Gy given on two consecutive days -Day 22 and 23), with safety assessment on Day 52. Efficacy will first be assessed on Day 52 and then again on Day 82 by global response assessment, including mSWAT. Patients who have less than 70% reduction from baseline mSWAT score will be eligible for subsequent cycles of TSEB (administered as 4 Gy over 2 consecutive days), until mSWAT score reduction of ≥ 70%, and up to a total of 6 cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by treating physician, or termination of the study.

Orally every day starting at the dose of 150 mg/day flat dose. At Day 15, if the treatment is tolerated, patients will escalate the dose of bexarotene to 300 mg/day, and that dose will remain constant during the rest of the study.

At Day 21, if the bexarotene has shown to be tolerated, patients will receive the first dose of TSEB (2 Gy x 2).

Total Skin Electron Beam (TSEB)

Brandon Imber, MD, MS

Shamir Geller

Brandon Imber, MD

The researchers are doing this study to test the safety of combining bexarotene with TSEB radiotherapy in people who have a common form of CTCL called mycosis fungoides (MF).

Bexarotene is a form of vitamin A that activates proteins called retinoid X receptors, which may stop the growth of cancer cells and kill them. TSEB radiotherapy is a type of radiation therapy that treats the entire surface of the skin with very low doses of radiation to kill cancer cells and shrink tumors. This type of radiation does not pass through the outer layers of the skin into the tissues and organs below the skin.

The study researchers think that giving bexarotene treatment at the same time as treatment with TSEB radiotherapy may be more effective against MF than either treatment given alone or in sequence (one after the other).

This is a Phase I, single-arm therapeutic study for patients with diffuse cutaneous T-cell lymphomas (CTCL).

A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides

A Phase Ib Trial Combining Bexarotene With Ultra-Low Dose Total Skin Electron Beam (Tseb) Radiotherapy For The Treatment Of Diffuse Cutaneous T-Cell Lymphomas

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

as defined by number of patients who develop CTCAE, v. 5, grade 3+ toxicities at 1 month post-treatment.

For patients with mycosis fungoides without blood involvement, the response criteria will be based upon modified international consensus guidelines.26 Specifically, skin response will be assessed by the Modified Severity Weighted Assessment Tool (mSWAT). For the purposes of this protocol, overall skin response will be considered to be either CR or PR.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides	NCT05296304	Cutaneous T-cel...	Bexarotene Total Skin Elec...	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides	NCT05296304	Cutaneous T-cel...	Bexarotene Total Skin Elec...	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoides	NCT05296304	Cutaneous T-cel...	Bexarotene Total Skin Elec...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for total skin electron beam (tseb)