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Hodgkin LymphomaPhase 2NCT02362997

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

A Phase 2 study testing Pembrolizumab in people with Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by Dana-Farber Cancer Institute at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
6 sitesUnited States
Study dates
Apr 2015to Jun 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • City of Hope National Medical Center

    Duarte, California, 91010

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase 2 Study of Pembrolizumab (MK-3475) After Autologous Stem Cell Transplantation in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma and, Diffuse Large B Cell Lymphoma and T- Cell Non-Hodgkin Lymphoma

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.

Read the 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.

Being tested
Pembrolizumab
Keywords
Classical Hodgkin Lymphoma (cHL), Diffuse Large B Cell Lymphoma (DLBCL), Peripheral T-cell lymphoma (PTCL)
Medical subject headings
Hodgkin Disease, Lymphoma, Large B-Cell, Diffuse, Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called Keytruda, MK-3475, SCH 900475

    Anti-PD-1 monoclonal antibody

Study groups in NCT02362997
Study groupRoleWhat they receive
Diffuse large B cell lymphomaExperimentalPembrolizumab 200mg IV every 3 weeks up to 8 cycles
Receives: Drug: Pembrolizumab
Classical Hodgkin lymphomaExperimentalPembrolizumab 200mg IV every 3 weeks up to 8 cycles
Receives: Drug: Pembrolizumab
Peripheral T cell lymphomaExperimentalPembrolizumab 200mg IV every 3 weeks up to 8 cycles
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival After ASCT

    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.

    Measured: 18 Months

Secondary outcomes (5)

  1. Overall Survival

    Survival probability of patients alive 18 months from ASCT, time-to-event

    Measured: 18 Months

  2. Relapse

    Number of patients who relapse within 18 months from autologous stem cell transplantation.

    Measured: 18 Months

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

    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

    Measured: 6 months

  4. Response Rate to Pembrolizumab

    In patients with measurable disease after ASCT, rate of objective response after treatment. Response was assessed using the Lugano 2014 criteria.

    Measured: 18 months

  5. Progression-free Survival

    Progression-free survival probability of patients who are alive and without progression 18 months from ASCT, time-to-event

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2015 (estimated)
  2. Study startApr 2015
  3. Primary completion26 Oct 2021
  4. Study completionJun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02362997
Sponsor's protocol ID
14-566
Status last verified
May 2026
First submitted
5 Feb 2015
Last updated
18 May 2026
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37319432

  • 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.

    PubMed 36399518

  • 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.

    PubMed 34670169

  • 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.

    PubMed 31917843

  • 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.

    PubMed 30952672

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by Dana-Farber Cancer Institute at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival After ASCT (time frame: 18 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02362997, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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