Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides

Mycosis Fungoides Clinical Trial

Official title:

Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357794
• Other study ID #: 2021-0500
• Secondary ID: NCI-2022-03831
• Status: Recruiting
• Phase: Phase 2
• Start date: October 13, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: Bouthaina Dabaja, MD
• Phone: (713) 563-2406
• Email: bdabaja[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To learn if a form of radiation therapy (called ultra-low-dose - total skin electron beam therapy [ULD-TSEBT]) in combination with brentuximab vedotin can help to control mycosis fungoides

Description:

OBJECTIVES: Primary Objective: The primary objective is to determine the overall response rate (ORR), to ultra-low-dose-total-skin electron beam therapy with brentuximab vedotin (ULD-TSEBT+BV) among patients with stage I-IV mycosis fungoides/Sezary syndrome. Secondary Objective: Key secondary objective is to determine the time to treatment failure (TTF) Determine the safety of brentuximab vedotin (BV) with fractionated ultra-low-dose-total-skin electron beam therapy (ULD-TSEBT) Describe the rate and grade of neuropathy associated with lower-dose BV by using CTCAE V5.0 Assess quality of life by using the validated Skindex-29 instrument and FACT instrument Determine the complete response rate (CRR) Determine progression-free survival (PFS) Determine overall survival (OS) Note: The study follow up timeframe for CRR, PFS and OS is expected to be two and half years. Assess the relationship between ORR and CD30 expression level Exploratory Objectives: Objective: To identify tumor and peripheral blood markers that predict response to concurrent BV with fractionated ULD-TSEBT, including SS component in the history. Objective: Identification of tumor and peripheral blood markers that are predictive of response to the combination therapy. Define changes in the TCR clonotypes, phenotypes, and inflammatory cytokine levels in biopsy specimens, peripheral blood leukocytes, and serum. Correlate changes in anti-tumor immune responses with clinic-pathological variables and patient outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Biopsy-confirmed mycosis fungoides in stage I-IV (APPENDICES 3 AND 4); the presence of Sezary cells in the blood is acceptable at original diagnosis or at enrollment into the protocol, as long as the patient has current mycosis fungoides in the skin and the sesary cells in peripheral blood are < 1000 cells/ microlitre at the time of enrollment.

2. Patients with relapsed/refractory mycosis fungoides, who have ever expressed or currently express at least 1% CD30 assessed by biopsy within 6 months prior to study enrollment, are eligible.

3. Previous systemic anticancer therapy must have been discontinued at least 1 week before treatment

4. Topical or systemic steroids (equivalent to 10 mg/day of prednisone) may be considered if the dose of such steroids has been constant and their discontinuation may lead to rebound flare in disease, adrenal insufficiency, and/or unnecessary suffering, after discussion with the Principal Investigator.

5. 18 years of age or older

6. Eastern Cooperative Oncology Group (ECOG) performance status score of = 3 (APPENDIX 5)

7. No required wash-out period for prior therapies

8. HIV+ patients must be on stable antiretroviral treatment for 12 weeks before the first day of cycle 1 (C1D1), with CD4 count >200 within the 7 days before C1D1.

9. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Concurrent use of other systemic anticancer agents or treatments for mycosis fungoides or Sezary syndrome

2. Grade 2 or greater neuropathy

3. Severe renal impairment (creatinine clearance [CrCL] <30 mL/min)

4. Moderate or severe hepatic impairment (Child-Pugh B or C; see APPENDIX 6 for ChildPugh classification chart)

5. Women of reproductive potential must have a negative serum ß human chorionic gonadotropin (ß-HCG) pregnancy test within 1 week of C1D1. They should discuss contraception with the treating provider. And agree to use adequate birth control measures (oral, implanted, or barrier methods) while on study

6. Receipt of systemic therapy for another primary malignancy (other than T-cell lymphoma). Patients with more than one type of lymphoma may be enrolled after discussion with the Principal Investigator

7. Underlying medical conditions including unstable cardiac disease, or other serious illness that would impair the ability of patient to undergo treatment

8. Any other medical history, including laboratory results, deemed by the Principal Investigator to be likely to interfere with patient participation in the study

Related Conditions & MeSH terms

• Mycoses
• Mycosis Fungoides

Intervention

Drug:
• Brentuximab vedotin
Given by Vein (IV)

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Seagen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the overall response rate (ORR)		through study completion, an average of 1 year

External Links

•   M D Anderson Cancer Center