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NCT03010358 · OUTCOME

Peripheral Blood B-cell Depletion and Recovery

Entospletinib and Obinutuzumab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma · Source last updated 2023-08-08

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
Up to 45 months

What was measured

Will be summarized using descriptive statistics.

Analysis population: Data for this outcome was not collected due to PI transition.

Groups in this outcome

All Research Participants

The Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol. Phase 1, Dose 1 received entospletinib at Dose Level 1: 400 mg daily (200 mg twice daily) in combination with obinutuzumab during Dose Escalation phase of study. Phase 1, Dose 2 received entospletinib at Dose Level 2: 800 mg daily (400 mg twice daily) in combination with obinutuzumab during Dose Escalation phase of study. Phase 2, MTD: Received entospletinib at Maximum Tolerated Dose (MTD) in combination with obinutuzumab during Dose Expansion phase of study. The MTD was determined to be 800 mg daily (400 mg twice daily).

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

Analysis denominator · Participants

GroupSource count
All Research Participants0

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
    units
    Participants
description
Will be summarized using descriptive statistics.
groups
  1. description
    The Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol. Phase 1, Dose 1 received entospletinib at Dose Level 1: 400 mg daily (200 mg twice daily) in combination with obinutuzumab during Dose Escalation phase of study. Phase 1, Dose 2 received entospletinib at Dose Level 2: 800 mg daily (400 mg twice daily) in combination with obinutuzumab during Dose Escalation phase of study. Phase 2, MTD: Received entospletinib at Maximum Tolerated Dose (MTD) in combination with obinutuzumab during Dose Expansion phase of study. The MTD was determined to be 800 mg daily (400 mg twice daily).
    id
    OG000
    title
    All Research Participants
population Description
Data for this outcome was not collected due to PI transition.
reporting Status
POSTED
time Frame
Up to 45 months
title
Peripheral Blood B-cell Depletion and Recovery
type
OTHER_PRE_SPECIFIED

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

Preserved source evidence · Not medical advice