NCT01998035 · OUTCOME

Phase I: Maximum Tolerated Dose (MTD) of the Combination of Oral 5-azacitidine in Combination With Romidepsin

Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies · Source last updated 2024-08-22

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

Measure: NUMBER
Unit: mg
Interval / dispersion: Not reported
Time frame: up to 1.5 years

What was measured

The highest dose of a drug or treatment that does not cause unacceptable side effects. The MTD is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found.

Analysis population: This Outcome Measure is specific for Phase 1 of the study. This Outcome Measure was NOT applied to Phase 2, therefore data was only collected and reported for Phase 1. 26 participants received the study interventions in Phase 1.

Groups in this outcome

Phase I

Phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. The safety and toxicity of this combination will be evaluated throughout the entire study.

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
Phase I	26

Reported measurements

Source class 1

Values in mg · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I	300	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
300

denoms

counts
group Id
OG000
value
26
units
Participants

description

groups

description
Phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. The safety and toxicity of this combination will be evaluated throughout the entire study.
id
OG000
title
Phase I

param Type

NUMBER

population Description

This Outcome Measure is specific for Phase 1 of the study. This Outcome Measure was NOT applied to Phase 2, therefore data was only collected and reported for Phase 1. 26 participants received the study interventions in Phase 1.

reporting Status

POSTED

time Frame

up to 1.5 years

title

Phase I: Maximum Tolerated Dose (MTD) of the Combination of Oral 5-azacitidine in Combination With Romidepsin

type

PRIMARY

unit Of Measure

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

Preserved source evidence · Not medical advice