Trial Outcomes & Findings for RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma (NCT NCT00667017)

NCT ID: NCT00667017

Last Updated: 2018-12-14

Results Overview

Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: Once a week for seven weeks
• Results posted on: 2018-12-14

Participant Flow

Consent Withdrawn After Treatment Started. Pt withdrew from treatment due to side effects

Participant milestones

Measure	IMTOX25 at 2mg/m²/Dose Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period. RFT5-dgA immunotoxin fluorescence activated cell sorting immunohistochemistry staining method
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	IMTOX25 at 2mg/m²/Dose Patients will receive IMTOX25 at 2mg/m²/dose, by IV administration, every other day for a total of 3 doses. A total of 6 cycles of treatment will be allowed. A cycle is equal to 6 weeks, with IMTOX25 infusion on Day 1, 3 and 5, followed by a 5 week rest period. RFT5-dgA immunotoxin fluorescence activated cell sorting immunohistochemistry staining method
Overall Study Withdrawal by Subject	1

Baseline Characteristics

RFT5-dgA Immunotoxin in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Once a week for seven weeks

Population: Consent Withdrawn After Treatment Started Pt withdrew from treatment due to side effects.

Response rate of patients with relapsed/refractory Cutaneous T Cell Lymphoma (CTCL) following treatment with IMTOX25.

Outcome measures

Outcome data not reported

Adverse Events

IMTOX25 at 2mg/m²/Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Larry Andeson, MD

University of Texas Southwestern Medical Center

Phone: 214-648-7097

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place