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NCT03593915 · OUTCOME

Determination of the Complete Response Rate

A Phase 1b/2 Study of Alvocidib Plus Decitabine or Azacitidine in Patients With MDS · Source last updated 2023-11-09

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
From the date of first treatment, every 8 weeks, for the first 6 cycles, for an average of 26 weeks

What was measured

The calculation for Complete Response Rate is as follows: complete response \[CR\] / complete response with incomplete blood count recovery \[CRi\] / CRmarrow / partial response \[PR\] / hematologic improvement \[HI\]

Analysis population: Sponsor's decision to terminate further development of the alvocidib program. Data collection and analysis were therefore not conducted as planned.

Groups in this outcome

ALV-DEC: Cohort 1

Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 20mg/m2 (4 hr IVI)

ALV-DEC: Cohort 2

Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 30mg/m2 (4 hr IVI)

ALV-DEC: Cohort 3

Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 45mg/m2 (4 hr IVI)

ALV-DEC: Cohort 4

Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 60mg/m2 (4 hr IVI)

ALV-AZA: Cohort 5

Azacitidine (AZA) administered on either a 7-day schedule or a 5-2-2 schedule (once daily for 5 days followed by 2 drug-free days with 2 more days of treatment) at 75mg/m2 per day subcutaneously or via IVI. Alvocidib (ALV) administered on day 10 at 75mg/m2 as a 30-60 minute IVI.

ALV-AZA: Cohort 6

Azacitidine (AZA) administered on either a 7-day schedule or a 5-2-2 schedule (once daily for 5 days followed by 2 drug-free days with 2 more days of treatment) at 75mg/m2 per day subcutaneously or via IVI. Alvocidib (ALV) administered on day 10 at 90mg/m2 as a 30-60 minute IVI.

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

Analysis denominator · Participants

GroupSource count
ALV-DEC: Cohort 10
ALV-DEC: Cohort 20
ALV-DEC: Cohort 30
ALV-DEC: Cohort 40
ALV-AZA: Cohort 50
ALV-AZA: Cohort 60

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    units
    Participants
description
The calculation for Complete Response Rate is as follows: complete response \[CR\] / complete response with incomplete blood count recovery \[CRi\] / CRmarrow / partial response \[PR\] / hematologic improvement \[HI\]
groups
  1. description
    Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 20mg/m2 (4 hr IVI)
    id
    OG000
    title
    ALV-DEC: Cohort 1
  2. description
    Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 30mg/m2 (4 hr IVI)
    id
    OG001
    title
    ALV-DEC: Cohort 2
  3. description
    Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 45mg/m2 (4 hr IVI)
    id
    OG002
    title
    ALV-DEC: Cohort 3
  4. description
    Decitabine is administered as a 1-hour intravenous (IV) infusion (IVI) daily days 1-5 at 20mg/m2; followed on day 8 by Alvocidib 20mg/m2 (30min bolus) and Alvocidib 60mg/m2 (4 hr IVI)
    id
    OG003
    title
    ALV-DEC: Cohort 4
  5. description
    Azacitidine (AZA) administered on either a 7-day schedule or a 5-2-2 schedule (once daily for 5 days followed by 2 drug-free days with 2 more days of treatment) at 75mg/m2 per day subcutaneously or via IVI. Alvocidib (ALV) administered on day 10 at 75mg/m2 as a 30-60 minute IVI.
    id
    OG004
    title
    ALV-AZA: Cohort 5
  6. description
    Azacitidine (AZA) administered on either a 7-day schedule or a 5-2-2 schedule (once daily for 5 days followed by 2 drug-free days with 2 more days of treatment) at 75mg/m2 per day subcutaneously or via IVI. Alvocidib (ALV) administered on day 10 at 90mg/m2 as a 30-60 minute IVI.
    id
    OG005
    title
    ALV-AZA: Cohort 6
population Description
Sponsor's decision to terminate further development of the alvocidib program. Data collection and analysis were therefore not conducted as planned.
reporting Status
POSTED
time Frame
From the date of first treatment, every 8 weeks, for the first 6 cycles, for an average of 26 weeks
title
Determination of the Complete Response Rate
type
SECONDARY

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Preserved source evidence · Not medical advice