Ignite Creation Date:
2024-05-06 @ 8:47 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02822586
Status:
COMPLETED
Last Update Posted:
2019-08-30
First Post:
2016-06-30
Brief Title:
TSEB and Brentuximab for Treatment of Mycosis Fungoides Sezary Syndrome
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase 1B Trial Evaluation of the Safety of Adding Brentuximab Vedotin to Low-Dose Total Skin Electron Beam TSEB for Treatment of Patients With Mycosis Fungoides and Sézary Syndrome
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the cutaneous toxicity and treatment response associated with administering concurrent TSEB and brentuximab vedotin in patients with mycosis fungoides or Sézary Syndrome
Detailed Description:
This study is a 2-cohort open-label phase 1B trial to evaluate the cutaneous toxicity overall toxicity and treatment response associated with administering concurrent low-dose TSEB and brentuximab vedotin in patients with mycosis fungoides or Sézary Syndrome Duration of complete skin response DOCB and tumor response in lymph nodes and blood will also be evaluated Additionally skin-related QOL and neurotoxicity will be assessed
Patients will be enrolled in 1 of 2 cohorts based on disease stage
Cohort A will include patients with earlier stage disease selected Stage IB in patients who have had one previous course of therapy and Stages IIA through IIIA if N0-1
Cohort B will include patients with more advanced disease Stage IIA through IIIA if N2-3 Stage IIIB Stage IVA and transformed CTCL who are candidates for low-dose TSEB andor systemic therapy
A standard dose of brentuximab vedotin will be administered to all patients by intravenous infusion 3 weeks prior to initiation of low-dose TSEB and then every 3 weeks for a total of 3 cycles Cohort A patients will complete brentuximab vedotin after 3 cycles patients in Cohort B will continue brentuximab vedotin until disease progression or unacceptable toxicity whichever occurs first In the absence of progression or unacceptable toxicity the patient may receive brentuximab vedotin for up to 2 years as a study participant A total of 12 Gy TSEB ie low-dose TSEB will be administered to both cohorts per standard protocol in 6 fractions 2 fractions per week beginning 3 weeks after the first dose of brentuximab vedotin
The Modified Severity Weighted Assessment Tool mSWAT 16 completed by the investigator will be used to determine skin involvement at baseline and skin response to treatment beginning after administration of the 3 doses of brentuximab vedotin and low-dose TSEB Skindex-16 a patient-completed form that measures symptoms and perceptions of toxicity in patients with skin disease will be used to assess skin-related QOL Additionally Form NTX will be completed by patients in Cohort A to assess symptoms of CIPN which is a side effect of brentuximab vedotin
The sample size for this study will be a maximum of 15 patients for a total of 12 evaluable patients with no more than 6 patients in Cohort B However if the number of patients with severe toxicity exceeds the established acceptable incidence accrual will end before reaching the sample size goal of 12 evaluable patients
Patients will be enrolled in 1 of 2 cohorts based on disease stage
Cohort A will include patients with earlier stage disease selected Stage IB in patients who have had one previous course of therapy and Stages IIA through IIIA if N0-1
Cohort B will include patients with more advanced disease Stage IIA through IIIA if N2-3 Stage IIIB Stage IVA and transformed CTCL who are candidates for low-dose TSEB andor systemic therapy
A standard dose of brentuximab vedotin will be administered to all patients by intravenous infusion 3 weeks prior to initiation of low-dose TSEB and then every 3 weeks for a total of 3 cycles Cohort A patients will complete brentuximab vedotin after 3 cycles patients in Cohort B will continue brentuximab vedotin until disease progression or unacceptable toxicity whichever occurs first In the absence of progression or unacceptable toxicity the patient may receive brentuximab vedotin for up to 2 years as a study participant A total of 12 Gy TSEB ie low-dose TSEB will be administered to both cohorts per standard protocol in 6 fractions 2 fractions per week beginning 3 weeks after the first dose of brentuximab vedotin
The Modified Severity Weighted Assessment Tool mSWAT 16 completed by the investigator will be used to determine skin involvement at baseline and skin response to treatment beginning after administration of the 3 doses of brentuximab vedotin and low-dose TSEB Skindex-16 a patient-completed form that measures symptoms and perceptions of toxicity in patients with skin disease will be used to assess skin-related QOL Additionally Form NTX will be completed by patients in Cohort A to assess symptoms of CIPN which is a side effect of brentuximab vedotin
The sample size for this study will be a maximum of 15 patients for a total of 12 evaluable patients with no more than 6 patients in Cohort B However if the number of patients with severe toxicity exceeds the established acceptable incidence accrual will end before reaching the sample size goal of 12 evaluable patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2016-01509 | REGISTRY | NCI CTRP | None |
| IST2015100830 | OTHER | None | None |