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NCT02362997 · REGISTRY CONDITION SEARCH

Pembrolizumab After ASCT for Hodgkin Lymphoma, DLBCL and T-NHL

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2026-05-18

This phase II study is designed to determine the clinical efficacy of PD-1 blockade, using the anti-PD-1 monoclonal antibody pembrolizumab (MK-3475), administered as consolidation therapy after autologous stem cell transplant (ASCT), in patients with relapsed or refractory (R/R) Diffuse Large B Cell Lymphoma (DLBCL), classical Hodgkin Lymphoma (cHL) or peripheral T-cell lymphoma (PTCL) in 1st remission.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression-free Survival After ASCT

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outcome · POSTED

Overall Survival

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outcome · POSTED

Relapse

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outcome · POSTED

Safety and Tolerability Assessed by CTCAE v4 Grade 2 and Above Toxicity Related to Study Treatment

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outcome · POSTED

Response Rate to Pembrolizumab

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Overall Survival After ASCT by PET Status

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outcome · POSTED

Progression-free Survival After ASCT by PET Status

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outcome · POSTED

Completion Rate

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outcome · NOT POSTED

Minimal Residual Disease

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion criteria • Histologically confirmed diagnosis with review of the diagnostic pathology specimen at one of the participating institutions. Eligible histologies are: Arm A: Diffuse large B cell lymphoma; patients with a prior history of indolent B-cell NHL are eligible, as long as they have histologically confirmed DLBCL prior to their pre-transplant salvage treatment. Patients with mediastinal large B cell lymphoma are also eligible. Arm B: Classical Hodgkin lymphoma (patients with nodular lymphocyte predominant Hodgkin lymphoma \[NLPHL\] are NOT eligible) Arm C: Peripheral T cell lymphoma - eligible subtypes will include PTCL, NOS; AITL; and ALK-negative ALCL. Patients with other PTCL histologies, including ALK-positive PTCL, and cutaneous T-cell lymphoma will not be eligible.. * Age ≥ 18 at the time of enrollment. * For arms A and B, participants must have relapsed after or been refractory to first-line chemotherapy, i.e., they must have failed to achieve CR after first-line therapy or must have relapsed subsequently if they achieved CR. For arm C, participants will be eligible if transplant is performed as consolidation of first remission (partial or complete). * Participants must be planning to receive or have received autologous stem cell transplantation. Participants must have chemosensitive disease prior to ASCT, defined as achieving at least a partial remission (as determined with PET imaging) to salvage treatment. Participants with cHL or DLBCL (arms A and B) transplanted in 1st remission after only one line of treatment are not eligible. Participants with PTCL (arm C) transplanted beyond 1st remission are also not eligible. * No more than 1 line of anthracycline-containing chemotherapy prior to ASCT, and no more than 3 lines of therapy total prior to ASCT for arms A and B; no more than 1 line of therapy prior to ASCT for arm C. * Participants cannot have received any anti-neoplastic therapy (including radiotherapy, chemotherapy or immunotherapy) after ASCT * Participants must have had PET-CT for restaging after salvage therapy and before ASCT. * Participants must begin study treatment no later than 21 days from the post-ASCT discharge. Additionally, they must have recovered from ASCT toxicities at the time of first study treatment. * ECOG performance status ≤2 * Participants must have normal organ and marrow function as defined below: * absolute neutrophil count ≥ 1,000/mcL * platelets ≥ 50,000/mcL * Hemoglobin ≥ 8 g/dl * total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN), or direct bilirubin ≤ ULN in patients with Gilbert's syndrome * AST(SGOT)/ALT(SGPT) ≤ 2.5 × ULN * Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min/1.73 m2 * Resting and ambulatory oxygen saturation ≥ 94% on room air * FEV1 and DLCO (adjusted for Hemoglobin) ≥ 50% predicted * Willigness to use contraception * Ability to understand and the willingness to sign a written informed consent document. Exclusion criteria * Participants who are receiving any other investigational agents after ASCT. * Participants with active CNS involvement are excluded. * History of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents. Participants with vitiligo, resolved childhood asthma or atopy, hypothyroidism, or Sjogren's syndrome, as well as participants requiring only intranasal steroids, intermittent use of bronchodilators, local steroid injections, or physiologic replacement doses of prednisone (≤ 10 mg/d) are not excluded from this study. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab. Prior hypersensitivity reactions to anti-CD20 therapy or anti-CD30 therapy is not an exclusion criterion. * Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Receipt of \> 600 mg/m2 total dose of BCNU with prior treatments including transplant conditioning regimen. * Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or pose excess risk to the participant in the opinion of the treating clinician.. * Pregnant or lactating women. * HIV-positive. * Participants with active viral hepatitis (positive HepB sAg, positive HepB core Ab with positive HepB viral load, or positive HepC antibody with positive HepC viral load). * Receipt of a live vaccine within 30 days of the start of treatment. Examples are measles, mumps, rubella, varicella, yellow fever, rabies, BCG, oral polio vaccine, and oral typhoid vaccine. * Prior treatment with an anti PD-1, anti PD-L1, or anti CTLA-4 agent. Participants who entered clinical remission with one of those agents and proceeded to ASCT without intervening relapse may be eligible after discussion with the Study Chair. Note that for patients who enter remission with checkpoint blockade therapy, this will not count towards the 3 lines of prior therapy.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
    intervention Names
    1. Drug: Pembrolizumab
    label
    Diffuse large B cell lymphoma
    type
    EXPERIMENTAL
  2. description
    Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
    intervention Names
    1. Drug: Pembrolizumab
    label
    Classical Hodgkin lymphoma
    type
    EXPERIMENTAL
  3. description
    Pembrolizumab 200mg IV every 3 weeks up to 8 cycles
    intervention Names
    1. Drug: Pembrolizumab
    label
    Peripheral T cell lymphoma
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Classical Hodgkin lymphoma
    2. Diffuse large B cell lymphoma
    3. Peripheral T cell lymphoma
    description
    Anti-PD-1 monoclonal antibody
    name
    Pembrolizumab
    other Names
    1. Keytruda
    2. MK-3475
    3. SCH 900475
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
82
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    Survival probability of patients alive 18 months from ASCT stratified by PET status before transplantation, time-to-event. Patients categorized by complete metabolic response (complete response by PET scan, assessed using the Lugano 2014 criteria), partial response (assessed using Lugano 2014 criteria) prior to transplantation.
    measure
    Overall Survival After ASCT by PET Status
    time Frame
    18 months
  2. description
    Progression-free survival probability of patients alive and disease-free 18 months from ASCT stratified by PET status before transplantation, time-to-event
    measure
    Progression-free Survival After ASCT by PET Status
    time Frame
    18 months
  3. description
    Number of patients who complete the planned treatment
    measure
    Completion Rate
    time Frame
    18 months
  4. description
    Level of MRD detected by PCR (if feasible) before and after pembrolizumab
    measure
    Minimal Residual Disease
    time Frame
    18 months
primary Outcomes
  1. description
    Proportion of patients alive and disease-free 18 months from autologous stem cell transplantation (ASCT). Progression criteria are per Lugano 2014 criteria. All patients receiving any amount of protocol treatment. Patients who have progressed or lost to follow-up prior to 18 months are counted as failures; only patients followed and progression-free for at least 18 months are counted as successes.
    measure
    Progression-free Survival After ASCT
    time Frame
    18 Months
secondary Outcomes
  1. description
    Survival probability of patients alive 18 months from ASCT, time-to-event
    measure
    Overall Survival
    time Frame
    18 Months
  2. description
    Number of patients who relapse within 18 months from autologous stem cell transplantation.
    measure
    Relapse
    time Frame
    18 Months
  3. description
    Number of patients who experienced at least a grade 2 toxicity with "definite," "probable," or "possible" attribute to study treatment, according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
    measure
    Safety and Tolerability Assessed by CTCAE v4 Grade 2 and Above Toxicity Related to Study Treatment
    time Frame
    6 months
  4. description
    In patients with measurable disease after ASCT, rate of objective response after treatment. Response was assessed using the Lugano 2014 criteria.
    measure
    Response Rate to Pembrolizumab
    time Frame
    18 months
  5. description
    Progression-free survival probability of patients who are alive and without progression 18 months from ASCT, time-to-event
    measure
    Progression-free Survival
    time Frame
    18 months
Full study description
brief Summary
This phase II study is designed to determine the clinical efficacy of PD-1 blockade, using the anti-PD-1 monoclonal antibody pembrolizumab (MK-3475), administered as consolidation therapy after autologous stem cell transplant (ASCT), in patients with relapsed or refractory (R/R) Diffuse Large B Cell Lymphoma (DLBCL), classical Hodgkin Lymphoma (cHL) or peripheral T-cell lymphoma (PTCL) in 1st remission.
detailed Description
Pembrolizumab is an antibody drug that blocks a molecule called PD-1. PD-1 is a receptor molecule on the surface of immune cells that can be used to turn off the immune response. Some cancers use this as a way to turn off the immune response against them. Blocking PD-1 with pembrolizumabmay restore an effective immune attack against the lymphoma cells. On this study, patients who undergo ASCT for R/R cHL, DLBCL or PTCL in 1st remission will receive pembrolizumab at a dose of 200mg intravenously every 3 weeks for up to 8 cycles, beginning within a few weeks of ASCT.
Source references
references
  1. citation
    Merrill MH, Dahi PB, Redd RA, McDonough MM, Chen YB, DeFilipp Z, Herrera AF, Fisher DC, LaCasce AS, Odejide OO, Ng SY, Jacobson CA, Merryman RW, Kim AI, Nieto YL, Sauter CS, Shah GL, Zain JM, Armand P, Jacobsen ED. A phase 2 study of pembrolizumab after autologous stem cell transplantation in patients with T-cell non-Hodgkin lymphoma. Blood. 2023 Aug 17;142(7):621-628. doi: 10.1182/blood.2023020244.
    pmid
    37319432
    type
    DERIVED
  2. citation
    Merryman RW, Redd RA, Taranto E, Ahmed G, Jeter E, McHugh KM, Brown JR, Crombie JL, Davids MS, Fisher DC, Freedman AS, Jacobsen E, Jacobson CA, Kim AI, LaCasce AS, Ng SY, Odejide OO, Parry EM, Jacene H, Park H, Dahi PB, Nieto Y, Joyce RM, Chen YB, Shipp MA, Herrera AF, Armand P. Minimal residual disease in patients with diffuse large B-cell lymphoma undergoing autologous stem cell transplantation. Blood Adv. 2023 Sep 12;7(17):4748-4759. doi: 10.1182/bloodadvances.2022007706.
    pmid
    36399518
    type
    DERIVED
  3. citation
    Merryman RW, Redd R, Jeter E, Wong JL, McHugh K, Reynolds C, Nazzaro M, Varden A, Brown JR, Crombie JL, Davids MS, Fisher DC, Jacobsen E, Jacobson CA, Kim AI, LaCasce AS, Ng SY, Odejide OO, Parry EM, Dahi PB, Nieto Y, Joyce RM, Chen YB, Herrera AF, Armand P, Ritz J. Immune Reconstitution following High-Dose Chemotherapy and Autologous Stem Cell Transplantation with or without Pembrolizumab Maintenance Therapy in Patients with Lymphoma. Transplant Cell Ther. 2022 Jan;28(1):32.e1-32.e10. doi: 10.1016/j.jtct.2021.10.010. Epub 2021 Oct 17.
    pmid
    34670169
    type
    DERIVED
  4. citation
    Frigault MJ, Armand P, Redd RA, Jeter E, Merryman RW, Coleman KC, Herrera AF, Dahi P, Nieto Y, LaCasce AS, Fisher DC, Ng SY, Odejide OO, Freedman AS, Kim AI, Crombie JL, Jacobson CA, Jacobsen ED, Wong JL, Bsat J, Patel SS, Ritz J, Rodig SJ, Shipp MA, Chen YB, Joyce RM. PD-1 blockade for diffuse large B-cell lymphoma after autologous stem cell transplantation. Blood Adv. 2020 Jan 14;4(1):122-126. doi: 10.1182/bloodadvances.2019000784.
    pmid
    31917843
    type
    DERIVED
  5. citation
    Armand P, Chen YB, Redd RA, Joyce RM, Bsat J, Jeter E, Merryman RW, Coleman KC, Dahi PB, Nieto Y, LaCasce AS, Fisher DC, Ng SY, Odejide OO, Freedman AS, Kim AI, Crombie JL, Jacobson CA, Jacobsen ED, Wong JL, Patel SS, Ritz J, Rodig SJ, Shipp MA, Herrera AF. PD-1 blockade with pembrolizumab for classical Hodgkin lymphoma after autologous stem cell transplantation. Blood. 2019 Jul 4;134(1):22-29. doi: 10.1182/blood.2019000215. Epub 2019 Apr 5.
    pmid
    30952672
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice