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NCT03112174 · OUTCOME

Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)

Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL) · Source last updated 2025-07-22

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
After at least 3 months of treatment, with an overall median treatment duration of 20.0 months

What was measured

DLT: any Grade (Gr) 3 or higher non-TLS adverse event (AE) at least possibly related to study drug occurring during the DLT assessment period with the following clarifications: Non-Hematologic DLTs: Gr ≥3 nausea, vomiting or diarrhea uncontrolled despite maximum medical supportive care and persisting \>5 days; Gr 3 fatigue persisting \>7 days; Gr 3 infection is not a DLT, however an infection with lifethreatening consequences or requiring urgent intervention (Gr 4) was considered a DLT; Treatment delay of any study drug \>7 days for toxicity. Hematologic DLTs: Gr 3 neutropenia is not a DLT, however, Gr 4 neutropenia (ANC \<500/mm\^3) lasting for \> 7 days is a DLT; Gr 3 or 4 neutropenia complicated by fever ≥38.5°C or infection; Gr 4 thrombocytopenia (\<25,000/mm\^3) that persists for \> 7 days; Gr 3 or 4 thrombocytopenia associated with Gr 2 or greater bleeding; Gr 3 anemia is not a DLT, however, Gr 4 anemia is a DLT; Treatment delay of any study drug \>7 days for hematologic toxicity.

Analysis population: All treated safety run-in participants

Groups in this outcome

Safety Run-in: Increased TLS Risk at Baseline

Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.

Safety Run-in: Low TLS Risk at Baseline

Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.

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

Analysis denominator · Participants

GroupSource count
Safety Run-in: Increased TLS Risk at Baseline15
Safety Run-in: Low TLS Risk at Baseline6

Reported measurements

Any TEAE/Any Grade
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run-in: Increased TLS Risk at Baseline3Not reportedNot reportedNot reportedNot reported
Safety Run-in: Low TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Any TEAE/ Grade 3+4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run-in: Increased TLS Risk at Baseline3Not reportedNot reportedNot reportedNot reported
Safety Run-in: Low TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Any TEAE/Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run-in: Increased TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Safety Run-in: Low TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Atrial fibrillation/Any Grade
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run-in: Increased TLS Risk at Baseline1Not reportedNot reportedNot reportedNot reported
Safety Run-in: Low TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Atrial fibrillation/Grade 3+4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run-in: Increased TLS Risk at Baseline1Not reportedNot reportedNot reportedNot reported
Safety Run-in: Low TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Atrial fibrillation/Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run-in: Increased TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Safety Run-in: Low TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Infection/Any Grade
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run-in: Increased TLS Risk at Baseline1Not reportedNot reportedNot reportedNot reported
Safety Run-in: Low TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Infection/Grade 3+4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run-in: Increased TLS Risk at Baseline1Not reportedNot reportedNot reportedNot reported
Safety Run-in: Low TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Infection/Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run-in: Increased TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Safety Run-in: Low TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Neutropenia/Any Grade
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run-in: Increased TLS Risk at Baseline1Not reportedNot reportedNot reportedNot reported
Safety Run-in: Low TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Neutropenia/Grade 3+4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run-in: Increased TLS Risk at Baseline1Not reportedNot reportedNot reportedNot reported
Safety Run-in: Low TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Neutropenia/Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run-in: Increased TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Safety Run-in: Low TLS Risk at Baseline0Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Any TEAE/Any Grade
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    Any TEAE/ Grade 3+4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Any TEAE/Grade 5
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Atrial fibrillation/Any Grade
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Atrial fibrillation/Grade 3+4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Atrial fibrillation/Grade 5
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Infection/Any Grade
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Infection/Grade 3+4
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Infection/Grade 5
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Neutropenia/Any Grade
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Neutropenia/Grade 3+4
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Neutropenia/Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      6
    units
    Participants
description
DLT: any Grade (Gr) 3 or higher non-TLS adverse event (AE) at least possibly related to study drug occurring during the DLT assessment period with the following clarifications: Non-Hematologic DLTs: Gr ≥3 nausea, vomiting or diarrhea uncontrolled despite maximum medical supportive care and persisting \>5 days; Gr 3 fatigue persisting \>7 days; Gr 3 infection is not a DLT, however an infection with lifethreatening consequences or requiring urgent intervention (Gr 4) was considered a DLT; Treatment delay of any study drug \>7 days for toxicity. Hematologic DLTs: Gr 3 neutropenia is not a DLT, however, Gr 4 neutropenia (ANC \<500/mm\^3) lasting for \> 7 days is a DLT; Gr 3 or 4 neutropenia complicated by fever ≥38.5°C or infection; Gr 4 thrombocytopenia (\<25,000/mm\^3) that persists for \> 7 days; Gr 3 or 4 thrombocytopenia associated with Gr 2 or greater bleeding; Gr 3 anemia is not a DLT, however, Gr 4 anemia is a DLT; Treatment delay of any study drug \>7 days for hematologic toxicity.
groups
  1. description
    Participants with an increased risk of tumor lysis syndrome (TLS) enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
    id
    OG000
    title
    Safety Run-in: Increased TLS Risk at Baseline
  2. description
    Participants with an low risk of TLS enrolled into the open-label Safety Run-in Period received concurrent ibrutinib at 560 mg once daily and venetoclax starting at 20 mg, and gradually ramped up to a target dose of 400 mg once daily over a 5-week period.
    id
    OG001
    title
    Safety Run-in: Low TLS Risk at Baseline
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated safety run-in participants
reporting Status
POSTED
time Frame
After at least 3 months of treatment, with an overall median treatment duration of 20.0 months
title
Number of Participants With Dose Limiting Toxicities (DLT) (Safety Run-in)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice