Pembrolizumab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT03077828|
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : November 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lymphocyte-Rich Classical Hodgkin Lymphoma Recurrent Lymphocyte-Depleted Classical Hodgkin Lymphoma Recurrent Mixed Cellularity Classical Hodgkin Lymphoma Recurrent Nodular Sclerosis Classical Hodgkin Lymphoma Refractory Lymphocyte-Depleted Classical Hodgkin Lymphoma Refractory Mixed Cellularity Classical Hodgkin Lymphoma Refractory Nodular Sclerosis Classical Hodgkin Lymphoma||Drug: Carboplatin Drug: Etoposide Drug: Ifosfamide Other: Laboratory Biomarker Analysis Biological: Pembrolizumab||Phase 2|
I. To determine the complete response rate by fludeoxyglucose- positron emission tomography/computed tomography (FDG-PET/CT) prior to autologous hematopoietic stem cell transplant (AHSCT) with the combination of pembrolizumab and ifosfamide, carboplatin, etoposide (ICE) salvage chemotherapy for relapsed/refractory Hodgkin lymphoma.
I. To determine the safety and tolerability of pembrolizumab in combination with salvage high-dose chemotherapy according to Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.03.
II. To estimate the event free survival (EFS) at 2 years from start of treatment.
III. To estimate the overall survival (OS) at 2 years from start of treatment.
I. To characterize PD-1 pathway specific expression and correlate with response.
II. To characterize serum biomarkers of immune and inflammatory response during treatment.
III. To characterize levels of soluble PD-L1 related to treatment with pembrolizumab.
IV. To characterize T-lymphocyte subset changes to treatment with pembrolizumab.
V. To investigate the prevalence and clinical correlation of chromosome 9p24.1 mutations for this population.
VI. To evaluate the effect on stem cell harvest following treatment with pembrolizumab.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1, etoposide IV over 60 minutes on days 1-3 of courses 1-2, carboplatin IV over 60 minutes on day 2 of courses 1-2, and ifosfamide IV over 24 hours on day 2 of courses 1-2. Pembrolizumab in combination with ICE chemotherapy repeats every 21 days for 2 courses, patients will then receive pembrolizumab as monotherapy on course 3.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Pembrolizumab in Combination With ICE Salvage Chemotherapy for Relapsed/Refractory Hodgkin Lymphoma|
|Actual Study Start Date :||April 21, 2017|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||February 2020|
Experimental: Treatment (pembrolizumab, etoposide, carboplatin, ifosfamide)
Patients receive pembrolizumab IV over 30 minutes on day 1, etoposide IV over 60 minutes on days 1-3 of courses 1-2, carboplatin IV over 60 minutes on day 2 of courses 1-2, and ifosfamide IV over 24 hours on day 2 of courses 1-2. Pembrolizumab in combination with ICE chemotherapy repeats every 21 days for 2 courses, patients will then receive pembrolizumab as monotherapy on course 3.
Other: Laboratory Biomarker Analysis
- Complete Response Rate [ Time Frame: Up to 59 days ]Determine the complete response rate by evaluating FDG-PET/CT scans prior to Autologous Hematopoietic Stem Cell Transplant (AHSCT) with the combination of pembrolizumab and ICE salvage chemotherapy for relapsed/refractory Hodgkin lymphoma.
- Incidence of Adverse Events [ Time Frame: Up to 2 years ]Evaluate the safety and tolerability of pembrolizumab in combination with ICE salvage high-dose chemotherapy by measuring the frequency and severity of adverse events by type, severity (grade), timing, and attribution to pembrolizumab which will be assessed according the NCI-CTCAE version 4.03.
- Event Free Survival (EFS) [ Time Frame: Up to 2 years ]EFS will be defined as the length of time from treatment on protocol until the first occurrence of disease relapse, progression, re-initiation of cytotoxic chemotherapy, or death due to disease, or until last contact if the patient did not experience any of these, assessed up to 2 years.
- Overall Survival (OS) [ Time Frame: Up to 2 years ]OS will be defined as time from study enrollment until death, or until last contact if the patient did not die, assessed up to 2 years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077828
|Contact: Study Coordinator||(312)firstname.lastname@example.org|
|United States, Georgia|
|Winship Cancer Institute of Emory University||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Pamela Allen, MD, MSc 404-778-1900|
|Principal Investigator: Pamela Allen, MD, MSc|
|Augusta University Medical Center||Recruiting|
|Augusta, Georgia, United States, 30912|
|Contact: Locke J. Bryan, M.D. 706-721-2505 email@example.com|
|Principal Investigator: Locke J. Bryan, M.D.|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Jane N. Winter, M.D. 312-695-4538|
|Principal Investigator: Jane N. Winter, M.D.|
|Sub-Investigator: Leo I. Gordon, M.D.|
|Sub-Investigator: Shuo Ma, M.D., Ph.D.|
|Sub-Investigator: Barbara Pro, M.D.|
|Sub-Investigator: Jason Kaplan, M.D.|
|Loyola University Medical Center||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Scott E. Smith, M.D.,Ph.D. 708-216-9000|
|Principal Investigator: Scott E. Smith, M.D.,Ph.D.|
|United States, New Jersey|
|Hackensack University Medical Center||Not yet recruiting|
|Hackensack, New Jersey, United States, 07601|
|Contact: Andre H. Goy, M.D., M.S 210-996-4469 firstname.lastname@example.org|
|Principal Investigator: Andre H. Goy, M.D., M.S|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Carla Casulo, M.D. 585-273-3258 email@example.com|
|Principal Investigator: Carla Casulo, M.D.|
|Principal Investigator:||Jane N. Winter, M.D.||Northwestern University|