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Trial record 28 of 1216 for:    "Hodgkin lymphoma"

Umbralisib and Pembrolizumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT03776864
Recruitment Status : Not yet recruiting
First Posted : December 17, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Brief Summary:
This phase II trial studies how well umbralisib and pembrolizumab work in treating patients with classical Hodgkin lymphoma that has come back or does not respond to treatment. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving umbralisib and pembrolizumab may work better in treating classical Hodgkin lymphoma.

Condition or disease Intervention/treatment Phase
Hodgkin's Lymphoma Biological: Pembrolizumab Drug: Umbralisib Phase 2

Detailed Description:

Patients receive pembrolizumab IV on day 1. Treatment repeats every 21 for up to 16 courses in the absence of disease progression or unacceptable toxicity. Patients also receive umbralisib orally (PO) daily on days 1-21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 28 days, then up to 1 year.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Umbralisib and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (pembrolizumab, umbralisib)
Patients receive pembrolizumab IV on day 1. Treatment repeats every 21 for up to 16 courses in the absence of disease progression or unacceptable toxicity. Patients also receive umbralisib PO daily on days 1-21 days in the absence of disease progression or unacceptable toxicity.
Biological: Pembrolizumab
Given IV
Other Names:
  • Immunoglobulin G4
  • Anti-(Human Programmed Cell Death 1)
  • Lambrolizumab
  • MK-3475
  • SCH 900475

Drug: Umbralisib
Given PO
Other Names:
  • TGR-1202
  • RP5264




Primary Outcome Measures :
  1. Complete response rate [ Time Frame: Up to 1 year ]
    Proportion of subjects with relapsed/ refractory classical Hodgkin Lymphoma (CHL) who achieve a complete response (CR) with a regimen of umbralisib (oral, daily) and pembrolizumab (IV, day 1 of 21-day cycles).


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: Up to 1 year ]
    Proportion of subjects with relapsed/ refractory classical Hodgkin Lymphoma (CHL) who achieve an overall response (OR) with a regimen of umbralisib (oral, daily) and pembrolizumab (IV, day 1 of 21-day cycles).

  2. Incidence of adverse events [ Time Frame: Up to 28 days post-treatment ]
    Measured via CTCAE v4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsed or refractory CHL that has received at least 3 prior lines of therapy
  • Measurable fludeoxyglucose F-18 (FDG)-avid disease defined by standard criteria (Lugano 2014) and a minimum of 1.0 cm in diameter
  • Prior treatment with anti-PD1 or anti-PDL1 therapy is allowed.

    • Patients who are currently on anti-PD1 or anti-PDL1 therapy who have failed to achieve a CR after at least 18 weeks of treatment may enroll on study. For these patients, anti-PD1 or anti-PDL1 therapy may be delayed for screening and to align pembrolizumab dosing with the expected cycle 1 day 1
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Ability to swallow and retain oral medication
  • Willingness and ability to comply with study and follow-up procedures, and give written informed consent
  • Female subjects of childbearing potential must be surgically sterile, be post-menopausal (for at least 1 year prior to screening visit), or must have a negative pregnancy test within 3 days prior to cycle 1 day 1 and agree to use medically acceptable contraception throughout the study period and for 4 months after the last dose of either study drug. Men of reproductive potential may not participate unless they agree to use medically acceptable contraception throughout the study period and for 4 months after the last dose of either study drug
  • Patients must be expected to receive at least 2 cycles of therapy
  • Patients should have a life expectancy if untreated of >= 90 days in the opinion of the investigator
  • Patients must have a FDG-positron emission tomography (PET)-computed tomography (CT) of chest, abdomen, and pelvis within 42 days of enrollment
  • Absolute neutrophil count (ANC) > 750
  • Platelet count > 40,000
  • Total bilirubin =< 1.5 times the upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (if known liver involvement then =< 5 x ULN is allowed)
  • Calculated creatinine clearance > 30 mL/min (as calculated by the Cockcroft-Gault formula)

Exclusion Criteria:

  • Patients receiving cancer therapy (i.e., chemotherapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization, prednisone > 10 mg or equivalent) or any investigational drug within 21 days of cycle 1 day 1. Patients receiving radiation therapy within 14 days from cycle 1 day 1. Anti-PD1 or anti-PDL1 therapy in patients with less than a CR after 18 weeks of such therapy is permitted to continue on schedule
  • Discontinuation from prior anti-PD1 or anti-PDL1 therapy due to immune-related adverse event or any other treatment-related adverse event
  • Autologous transplantation within 100 days
  • Prior allogeneic transplant within 12 months of initiation on study
  • Active graft versus host disease (GVHD) within 90 days prior to cycle 1 day 1
  • Evidence of active central nervous system lymphoma
  • Pregnant or nursing women
  • Evidence of chronic active hepatitis B or chronic active hepatitis C infection (hepatitis C virus [HCV]), active cytomegalovirus (CMV), or known history of human immunodeficiency virus (HIV). If hepatitis B core (HBc) antibody, HCV antibody or CMV immunoglobulin (Ig)M is positive, the patient should be evaluated for the presence of HBV, HCV or CMV by deoxyribonucleic acid (DNA) (polymerase chain reaction [PCR]) to determine presence or absence of active infection
  • Prior exposure to idelalisib (CAL-101), duvelisib (IPI-145), or any drug that specifically inhibits phosphoinositide-3-kinase (PI3K)
  • Evidence of ongoing active systemic bacterial, fungal or viral infection
  • Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:

    • Symptomatic, or history of documented congestive heart failure (New York [NY] Heart Association functional classification III-IV)
    • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of randomization
    • Concomitant use of medication known to cause QT prolongation or torsades de pointes. Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac/vascular stenting within 3 months of randomization
  • Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol principal investigator
  • Patients with an active autoimmune disorder (with the exception of autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura [ITP] or vitiligo)
  • History of non-infectious pneumonitis related to prior line of therapy

Information from the National Library of Medicine

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): NCT03776864


Contacts
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Contact: Ryan Lynch 206-606-1739 rclynch@washington.edu

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Not yet recruiting
Seattle, Washington, United States, 98109
Contact: Ryan Lynch    206-606-1739    rclynch@washington.edu   
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ryan Lynch Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03776864     History of Changes
Other Study ID Numbers: RG1003718
NCI-2018-02836 ( Other Identifier: NCI / CTRP )
10075 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pembrolizumab
Immunoglobulins
Immunoglobulin G
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs