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NCT02332980 · OUTCOME

Overall Survival

Pembrolizumab Alone or With Idelalisib or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Non-Hodgkin Lymphomas · Source last updated 2026-06-24

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
5 years

What was measured

The distribution of overall survival will be estimated using the method of Kaplan-Meier.

Groups in this outcome

Arm A (CLL)

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.

Arm B (NHL)

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.

Arm C (CLL With Richters)

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.

Arm A (Continuation Phase)

CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.

Arm C (Continuation Phase)

CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.

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

Analysis denominator · Participants

GroupSource count
Arm A (CLL)25
Arm B (NHL)23
Arm C (CLL With Richters)17
Arm A (Continuation Phase)5
Arm C (Continuation Phase)13

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (CLL)10.6Not reported5.434.4Not reported
Arm B (NHL)48.6Not reported13.0NANot enough events to estimate upper confidence limit
Arm C (CLL With Richters)11.5Not reported4.117.6Not reported
Arm A (Continuation Phase)11.7Not reported1.9NANot enough events to estimate upper confidence limit
Arm C (Continuation Phase)13.3Not reported5.8NANot enough events to estimate upper confidence limit
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.4
        upper Limit
        34.4
        value
        10.6
      2. comment
        Not enough events to estimate upper confidence limit
        group Id
        OG001
        lower Limit
        13.0
        upper Limit
        NA
        value
        48.6
      3. group Id
        OG002
        lower Limit
        4.1
        upper Limit
        17.6
        value
        11.5
      4. comment
        Not enough events to estimate upper confidence limit
        group Id
        OG003
        lower Limit
        1.9
        upper Limit
        NA
        value
        11.7
      5. comment
        Not enough events to estimate upper confidence limit
        group Id
        OG004
        lower Limit
        5.8
        upper Limit
        NA
        value
        13.3
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    2. group Id
      OG001
      value
      23
    3. group Id
      OG002
      value
      17
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      13
    units
    Participants
description
The distribution of overall survival will be estimated using the method of Kaplan-Meier.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
    id
    OG000
    title
    Arm A (CLL)
  2. description
    Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
    id
    OG001
    title
    Arm B (NHL)
  3. description
    Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator. Patients on Arm A or Arm C experiencing stable disease without partial remission or progressive disease at 3 months of treatment with pembrolizumab proceed to the treatment continuation phase.
    id
    OG002
    title
    Arm C (CLL With Richters)
  4. description
    CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
    id
    OG003
    title
    Arm A (Continuation Phase)
  5. description
    CONTINUATION PHASE: Patients receive pembrolizumab IV over 30 minutes on day 1. Patients also receive idelalisib PO BID on days 1-21 OR ibrutinib PO QD on days 1-21. Treatment repeats every 21 days for up to 12 or 24 months in the absence of disease progression or unacceptable toxicity. Patients receiving benefit may continue to receive treatment for an additional 12 months at the discretion of the investigator.
    id
    OG004
    title
    Arm C (Continuation Phase)
param Type
MEDIAN
reporting Status
POSTED
time Frame
5 years
title
Overall Survival
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice