Loading clinical trials...

Safety & Efficacy Study of Combination of Pembrolizumab and Lenalidomide, in Patients With Relapsed Non-Hodgkin and Hodgkin Lymphoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Safety & Efficacy Study of Combination of Pembrolizumab and Lenalidomide, in Patients With Relapsed Non-Hodgkin and Hodgkin Lymphoma

A Phase I/II Study of the Combination of Pembrolizumab and Lenalidomide, in Patients With Relapsed Non-Hodgkin and Hodgkin Lymphoma

NCT02875067•NYU Langone Health

View on ClinicalTrials.gov

Summary

This trial is to assess the safety \& efficacy of the Combination of Pembrolizumab and Lenalidomide in the management of patients with Relapsed Hodgkin Lymphoma.

Detailed Description

There is an emerging clinical data to confirm that Programmed death-1 (PD-1)blockade is safe and viable in lymphoma. The investigators hypothesize that the novel immune platform of pembrolizumab and lenalidomide, will be safe and well tolerated in patients with Relapsed Refractory (RR) Hodgkin Lymphoma (HL) and non-Hodgkin lymphoma (NHL) and that this combination will result in a complete response (CR) rate of 50% in patients with RR HL.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be willing and able to provide written informed consent/assent for the trial.
•2. Be 18 years of age on day of signing informed consent.
•3. Have measurable or evaluable disease, as defined in 2007 Revised Response Criteria for Malignant Lymphoma24 and have received at least two prior therapies. HL patients must not be currently eligible for autologous stem cell transplant.
•4. Be willing to provide either archived tumor tissue or tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1.
•5. Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
•6. Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 14 days of treatment initiation.
•Adequate Organ Function Laboratory Values:
•* Absolute neutrophil count (ANC): ≥1,000 /microliter (mcL)
•* Platelets: ≥75,000 / mcL
•* Hemoglobin: ≥9 g/dL or ≥5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
+11 more criteria

Exclusion Criteria

•1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
•2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•3. Has a known history of active Bacillus Tuberculosis (TB)
•4. Hypersensitivity to pembrolizumab or any of its excipients.
•5. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
•* Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
•* Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•7. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
•8. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
+10 more criteria

Locations (3)

Emory University Hospital

Atlanta, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

NYU Perlmutter Cancer Center

New York, New York, United States

Key Dates

Start Date

August 29, 2016

Primary Completion Date

October 2, 2017

Completion Date

October 2, 2017

Last Updated

August 14, 2020

Enrollment

ACTUAL participants

Conditions

Relapsed Hodgkin LymphomaRelapsed Non-Hodgkin Lymphoma

Interventions

Pembrolizumab

BIOLOGICAL

Lenalidomide

DRUG

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

NCT06026319

Non-hodgkin LymphomaRelapsed Non-Hodgkin Lymphoma+8 more

View study

RECRUITINGPHASE2

A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL

NCT06484920

Relapsed Hodgkin LymphomaRefractory Hodgkin Lymphoma+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety & Efficacy Study of Combination of Pembrolizumab and Lenalidomide, in Patients With Relapsed Non-Hodgkin and Hodgkin Lymphoma

Inclusion Criteria

Exclusion Criteria

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL

Low Dose Radiation as Bridging Therapy in Relapsed B-Cell Non-Hodgkin Lymphoma

Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma

Intra-Osseous Co-Transplant of UCB and hMSC