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NCT02681302 · OUTCOME

Safety of Combined Check Point Inhibition Therapy Via Assessment of Adverse Events and Lab Findings

Check Point Inhibition After Autologous Stem Cell Transplantation in Patients at High Risk of Post Transplant Recurrence · Source last updated 2026-04-03

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

Measure
NUMBER
Unit
Treatment-Related Limiting Toxicity
Interval / dispersion
Not reported
Time frame
26 weeks

What was measured

To assess the safety of combined check point inhibition with nivolumab and ipilimumab after autologous hematopoietic stem cell transplantation in patients at high risk for post-transplant recurrence including patients with persistent and recurrent high risk diffuse large B cell lymphoma, high risk and recurrent T cell lymphoma and high risk and recurrent multiple myeloma. The composite endpoint consisting of the occurrence of at least one treatment-related limiting toxicity (after combined checkpoint inhibitor treatment is initiated) defined as a ≥ grade 4 non-hematologic toxicity as specified by the CTCAE. If 3 of 7 patients in a single group experience a treatment-related limiting toxicity, that single group will be terminated.

Analysis population: Patients at high risk for post-transplant recurrence including patients with persistent and recurrent high risk diffuse large B cell lymphoma, high risk and recurrent T cell lymphoma and high risk and recurrent multiple myeloma treated with nivolumab and ipilimumab after autologous hematopoietic stem cell transplantation

Groups in this outcome

Group A

De novo diffuse large B cell lymphoma that fails to achieve a PET negative complete response to primary rituximab and anthracycline based multi-agent chemotherapy and at least maintains stable disease after salvage chemotherapy or present double/triple hit features defined by overexpression by standard immunohistochemistry of c-MYC plus BCL2 and/or BCL6 or presence of chromosomal translocations as detected by break-apart FISH involving IGH/MYC plus IGH/BCL2 and/or IGH/BCL6 and who only received standard chemoimmunotherapy with rituximab, cyclophosphamide, vincristine and prednisone (R-CHOP) for induction and present at least stable disease after consolidation or salvage chemotherapy. Stable disease (SD) for lymphoma is defined in Appendix B: Lugano Classification for Response Assessment of Non-Hodgkin Lymphoma.

Group B

Recurrent high-risk diffuse large B cell lymphoma defined as relapsing within one year of completion of rituximab and anthracycline based multi-agent chemotherapy or a sAAIPI (second-line age-adjusted International Prognostic Index) intermediate or high at relapse or acquisition of double/triple hit features upon relapse (as defined in group A) and at least stable disease after salvage chemotherapy. Patients with an initial diagnosis of low-grade/indolent non-Hodgkin lymphoma (i.e. follicular, marginal zone) who present relapse with histologic transformation to diffuse large B cell lymphoma (confirmed by biopsy) and meet the definition for high-risk as presented above, are also eligible.

Group C

De novo high-risk T cell lymphoma with at least stable disease after primary therapy. High risk T cell lymphoma is defined as Stage III or IV disease at presentation and/or failure to achieve CR after frontline chemotherapy. Patients with ALK-positive ALCL will be excluded from the trial. Patients with ALK-negative ALCL in complete response will be excluded from the trial.

Group D

Recurrent T cell lymphoma with at least stable disease after salvage therapy. Patients with ALK-positive ALCL will be excluded from the trial.

Group E

Transplant-naïve high risk multiple myeloma with at least stable disease after most recent line of therapy. High risk myeloma is defined as those carrying 1q amplifications, 1p deletions, 13q deletions by conventional cytogenetics, p53 deletions, high-risk GEP 70 scores, t(4;14), t(14;16) and t(14;20), hypodiploidy. This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.

Group F

Recurrent myeloma within 3 years after a single or tandem autologous transplant and at least stable disease after salvage therapy. Stable disease for multiple myeloma is defined in Appendix C: International Myeloma Working Group (IMWG). This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.

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

Analysis denominator · Participants

GroupSource count
Group A7
Group B7
Group C5
Group D4
Group E7
Group F5

Reported measurements

Source class 1
Values in Treatment-Related Limiting Toxicity · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group A2Not reportedNot reportedNot reportedNot reported
Group B0Not reportedNot reportedNot reportedNot reported
Group C0Not reportedNot reportedNot reportedNot reported
Group D2Not reportedNot reportedNot reportedNot reported
Group E1Not reportedNot reportedNot reportedNot reported
Group F2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      5
    units
    Participants
description
To assess the safety of combined check point inhibition with nivolumab and ipilimumab after autologous hematopoietic stem cell transplantation in patients at high risk for post-transplant recurrence including patients with persistent and recurrent high risk diffuse large B cell lymphoma, high risk and recurrent T cell lymphoma and high risk and recurrent multiple myeloma. The composite endpoint consisting of the occurrence of at least one treatment-related limiting toxicity (after combined checkpoint inhibitor treatment is initiated) defined as a ≥ grade 4 non-hematologic toxicity as specified by the CTCAE. If 3 of 7 patients in a single group experience a treatment-related limiting toxicity, that single group will be terminated.
groups
  1. description
    De novo diffuse large B cell lymphoma that fails to achieve a PET negative complete response to primary rituximab and anthracycline based multi-agent chemotherapy and at least maintains stable disease after salvage chemotherapy or present double/triple hit features defined by overexpression by standard immunohistochemistry of c-MYC plus BCL2 and/or BCL6 or presence of chromosomal translocations as detected by break-apart FISH involving IGH/MYC plus IGH/BCL2 and/or IGH/BCL6 and who only received standard chemoimmunotherapy with rituximab, cyclophosphamide, vincristine and prednisone (R-CHOP) for induction and present at least stable disease after consolidation or salvage chemotherapy. Stable disease (SD) for lymphoma is defined in Appendix B: Lugano Classification for Response Assessment of Non-Hodgkin Lymphoma.
    id
    OG000
    title
    Group A
  2. description
    Recurrent high-risk diffuse large B cell lymphoma defined as relapsing within one year of completion of rituximab and anthracycline based multi-agent chemotherapy or a sAAIPI (second-line age-adjusted International Prognostic Index) intermediate or high at relapse or acquisition of double/triple hit features upon relapse (as defined in group A) and at least stable disease after salvage chemotherapy. Patients with an initial diagnosis of low-grade/indolent non-Hodgkin lymphoma (i.e. follicular, marginal zone) who present relapse with histologic transformation to diffuse large B cell lymphoma (confirmed by biopsy) and meet the definition for high-risk as presented above, are also eligible.
    id
    OG001
    title
    Group B
  3. description
    De novo high-risk T cell lymphoma with at least stable disease after primary therapy. High risk T cell lymphoma is defined as Stage III or IV disease at presentation and/or failure to achieve CR after frontline chemotherapy. Patients with ALK-positive ALCL will be excluded from the trial. Patients with ALK-negative ALCL in complete response will be excluded from the trial.
    id
    OG002
    title
    Group C
  4. description
    Recurrent T cell lymphoma with at least stable disease after salvage therapy. Patients with ALK-positive ALCL will be excluded from the trial.
    id
    OG003
    title
    Group D
  5. description
    Transplant-naïve high risk multiple myeloma with at least stable disease after most recent line of therapy. High risk myeloma is defined as those carrying 1q amplifications, 1p deletions, 13q deletions by conventional cytogenetics, p53 deletions, high-risk GEP 70 scores, t(4;14), t(14;16) and t(14;20), hypodiploidy. This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
    id
    OG004
    title
    Group E
  6. description
    Recurrent myeloma within 3 years after a single or tandem autologous transplant and at least stable disease after salvage therapy. Stable disease for multiple myeloma is defined in Appendix C: International Myeloma Working Group (IMWG). This cohort has been discontinued due to updated risks provided by the FDA. These patients will be followed for safety and correlative studies only.
    id
    OG005
    title
    Group F
param Type
NUMBER
population Description
Patients at high risk for post-transplant recurrence including patients with persistent and recurrent high risk diffuse large B cell lymphoma, high risk and recurrent T cell lymphoma and high risk and recurrent multiple myeloma treated with nivolumab and ipilimumab after autologous hematopoietic stem cell transplantation
reporting Status
POSTED
time Frame
26 weeks
title
Safety of Combined Check Point Inhibition Therapy Via Assessment of Adverse Events and Lab Findings
type
PRIMARY
unit Of Measure
Treatment-Related Limiting Toxicity

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

Preserved source evidence · Not medical advice