NCT01445535 · OUTCOME

Number of Dose-Limiting Toxicities (DLT)

Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab in T- and NK-Cell Lymphomas · Source last updated 2021-11-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Dose Limiting Toxicities
Interval / dispersion: Not reported
Time frame: First 30 days after treatment initiation.

What was measured

DLTs for siplizumab was defined as infusional grade 3 non-hematologic toxicity lasting longer than 6 hours after the infusion, any grade 4 non-hematologic toxicity, or the development of an EBV-related lymphoproliferative disorder (LPD). Expected toxicities of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH-R) and grade 3 laboratory AEs were not considered to be DLTs.

Groups in this outcome

Cohort 1 - 3.4 mg/kg

3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.

Cohort 2 - 4.8 mg/kg

4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.

Cohort 3 - 8.5 mg/kg

8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.

Cohort 4 - 15 mg/kg

15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Cohort 1 - 3.4 mg/kg	3
Cohort 2 - 4.8 mg/kg	3
Cohort 3 - 8.5 mg/kg	3
Cohort 4 - 15 mg/kg	6

Reported measurements

Source class 1

Values in Dose Limiting Toxicities · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Cohort 1 - 3.4 mg/kg	Not reported	Not reported	Not reported	Not reported
Cohort 2 - 4.8 mg/kg	Not reported	Not reported	Not reported	Not reported
Cohort 3 - 8.5 mg/kg	Not reported	Not reported	Not reported	Not reported
Cohort 4 - 15 mg/kg	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
6
units
Participants

description

groups

description
3.4 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
id
OG000
title
Cohort 1 - 3.4 mg/kg
description
4.8 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
id
OG001
title
Cohort 2 - 4.8 mg/kg
description
8.5 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
id
OG002
title
Cohort 3 - 8.5 mg/kg
description
15 mg/kg siplizumab was given on day 1 of each cycle followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab (EPOCH) (combo chemo) on days 1-5 for 21 days.
id
OG003
title
Cohort 4 - 15 mg/kg

param Type

NUMBER

reporting Status

POSTED

time Frame

First 30 days after treatment initiation.

title

Number of Dose-Limiting Toxicities (DLT)

type

OTHER_PRE_SPECIFIED

unit Of Measure

Dose Limiting Toxicities

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice