NCT02287233 · OUTCOME

Post Baseline Transfusion Independence Rate Among Participants Transfusion-dependent at Baseline

A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia · Source last updated 2022-08-29

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

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: 95% Confidence Interval
Time frame: From the first dose of study drug to the last dose of study drug plus 30 days, disease progression (including clinical progression), or death, whichever was earlier; median duration of treatment was 4.2 months.

What was measured

Post baseline transfusion independence rate was estimated as the percentage of participants who achieved transfusion independence during the evaluation period. Post-baseline transfusion independence is defined as a period of at least 56 days (≥ 56 days) with no RBC or platelet transfusion during the evaluation period. The evaluation period is from the first dose of study drug to the last dose of study drug until the 30 day follow-up visit, disease progression (including clinical progression), or death, whichever was earlier. Results are reported for participants who achieved both RBC and platelet transfusion independence and for participants who received RBC transfusion independence and platelet transfusion independence.

Analysis population: Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) who received a RBC or platelet transfusion within 8 weeks prior to first dose (60), an RBC transfusion within 8 weeks prior to first dose (53) or a platelet transfusion within 8 weeks prior to first dose (23).

Groups in this outcome

Phase 1+2: 600 mg Venetoclax + LDAC

Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

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 1+2: 600 mg Venetoclax + LDAC	60

Reported measurements

RBC and platelet transfusion independence

Analysis denominator · Participants

Group	Source count
Phase 1+2: 600 mg Venetoclax + LDAC	60

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 1+2: 600 mg Venetoclax + LDAC	45.0	Not reported	32.1	58.4	Not reported

RBC transfusion independence

Analysis denominator · Participants

Group	Source count
Phase 1+2: 600 mg Venetoclax + LDAC	53

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 1+2: 600 mg Venetoclax + LDAC	45.3	Not reported	31.6	59.6	Not reported

Platelet transfusion independence

Analysis denominator · Participants

Group	Source count
Phase 1+2: 600 mg Venetoclax + LDAC	23

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Phase 1+2: 600 mg Venetoclax + LDAC	60.9	Not reported	38.5	80.3	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
32.1
upper Limit
58.4
value
45.0
denoms
counts
group Id
OG000
value
60
units
Participants
title
RBC and platelet transfusion independence
categories
measurements
group Id
OG000
lower Limit
31.6
upper Limit
59.6
value
45.3
denoms
counts
group Id
OG000
value
53
units
Participants
title
RBC transfusion independence
categories
measurements
group Id
OG000
lower Limit
38.5
upper Limit
80.3
value
60.9
denoms
counts
group Id
OG000
value
23
units
Participants
title
Platelet transfusion independence

denoms

counts
group Id
OG000
value
60
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
id
OG000
title
Phase 1+2: 600 mg Venetoclax + LDAC

param Type

NUMBER

population Description

Enrolled participants who received venetoclax with LDAC at the recommended Phase 2 dose (600 mg) who received a RBC or platelet transfusion within 8 weeks prior to first dose (60), an RBC transfusion within 8 weeks prior to first dose (53) or a platelet transfusion within 8 weeks prior to first dose (23).

reporting Status

POSTED

time Frame

From the first dose of study drug to the last dose of study drug plus 30 days, disease progression (including clinical progression), or death, whichever was earlier; median duration of treatment was 4.2 months.

title

Post Baseline Transfusion Independence Rate Among Participants Transfusion-dependent at Baseline

type

SECONDARY

unit Of Measure

percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice