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

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ClinicalTrials.gov Identifier: NCT05357794
Recruitment Status : Recruiting
First Posted : May 3, 2022
Last Update Posted : October 17, 2022
Sponsor:
Collaborator:
Seagen Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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

Condition or disease Intervention/treatment Phase
Mycosis Fungoides Drug: Brentuximab vedotin Phase 2

Detailed Description:

OBJECTIVES:

Primary Objective:

The primary objective is to determine the overall response rate (ORR), to ultra-low-dose-totalskin 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 Assess the associations between patient prognostic factors and AEs Assess the associations of patient prognostic factors and biomarker expression level with OS/PFS

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 13, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024


Arm Intervention/treatment
Experimental: Brentuximab vedotin
Participant will receive radiation therapy to the entire skin surface over the course of 2 days. Each dose will take about 60 to 90 minutes and will vary from one patient to another
Drug: Brentuximab vedotin
Given by Vein (IV)
Other Names:
  • SGN-35
  • Adcetris




Primary Outcome Measures :
  1. To establish the overall response rate (ORR) [ Time Frame: through study completion, an average of 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT05357794


Contacts
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Contact: Bouthaina Dabaja, MD (713) 563-2406 bdabaja@mdanderson.org

Locations
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United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Bouthaina Dabaja, MD    713-563-2406    bdabaja@mdanderson.org   
Principal Investigator: Bouthaina Dabaja, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Seagen Inc.
Investigators
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Principal Investigator: Bouthaina Dabaja, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05357794    
Other Study ID Numbers: 2021-0500
NCI-2022-03831 ( Other Identifier: NCI-CTRP-Clinical Trial Reporting Registry )
First Posted: May 3, 2022    Key Record Dates
Last Update Posted: October 17, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mycoses
Mycosis Fungoides
Bacterial Infections and Mycoses
Infections
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Brentuximab Vedotin
Antineoplastic Agents, Immunological
Antineoplastic Agents