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Trial record 46 of 1216 for:    "Hodgkin lymphoma"

Nivolumab as Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Hodgkin Lymphoma at Risk of Relapse or Progression

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ClinicalTrials.gov Identifier: NCT03436862
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Brief Summary:
This is a Phase II single-arm open-label study of nivolumab as maintenance therapy after autologous stem cell transplantation in patients with Hodgkin lymphoma at risk of relapse or progression.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: Nivolumab Phase 2

Detailed Description:

The primary objective of this study is to evaluate safety and tolerability of nivolumab as maintenance therapy early after autologous stem cell transplant in patients with Hodgkin's Lymphoma (HL).

Eligible patients will receive nivolumab (240 mg IV) every 2 weeks (± 2 days as long as interval between doses is 12-16 days) starting 45-120 post-transplant for up to a maximum of 6 months of treatment. Response to treatment will be assessed 6 months and 1 year post-transplant using Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Single Arm Study of Nivolumab as Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Hodgkin Lymphoma at Risk of Relapse or Progression
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab
Patients will receive Nivolumab 240 mg by intravenous infusion (IV) starting Day 45-120 post-transplant (±10 days) every 2 weeks for up to a maximum of 6 months of treatment.
Drug: Nivolumab
Nivolumab 240 mg IV infusion over 60 minutes given every 2 weeks for up to 6 months.
Other Name: Opdivo




Primary Outcome Measures :
  1. The incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) as a measure of safety [ Time Frame: Up to 6 months ]
    The reported incidence of AEs and SAEs with an onset on or after the initiation of therapy will be graded according to National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE).


Secondary Outcome Measures :
  1. 12 month progression-free survival (PFS) [ Time Frame: 1 year post-transplant ]
    The number of patients who are progression-free at 12 months post-transplant.



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:

  • Patients 18 years of age and older with Hodgkin Lymphoma who have received auto-HSCT in the previous 45-120 days.
  • Complete response (CR), partial response (PR) or stable disease (SD) to salvage therapy prior to ASCT.
  • High risk of residual HL post-ASCT, as determined by 1 of the following:

    • Positive positron emission tomography (PET) scan defined by the Deauville scale 3-4 and within 2 months of start of high dose chemotherapy prior to ASCT
    • Refractory to frontline therapy
    • Relapse <12 months after frontline therapy
    • Relapse ≥12 months after frontline therapy with extra-nodal disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 - 1.
  • Adequate hematologic function defined as all of the following:

    • Absolute neutrophil count (ANC) ≥1000/μL
    • Hemoglobin (Hgb) ≥8 g/dL (transfusions to reach this point are not permitted)
    • Platelets ≥50,000/μL (transfusion is not permitted)
  • Adequate liver function defined as all of the following:

    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x the upper limit of normal (ULN)
    • Total bilirubin ≤1.5 x ULN (unless the patient has Grade 1 bilirubin elevation due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin)
  • Adequate renal function defined as serum creatinine ≤1.5 mg/dL (133 μmol/L).
  • Females of childbearing potential must have a negative serum or urine pregnancy test result within 72 hours prior to the first dose of nivolumab and must agree to follow instructions for method(s) of contraception for the duration of treatment with nivolumab and for 7 months following their last dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy.
  • Male patients with female partners of childbearing potential and women patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 7 months following last dose of study drug. Male patients must also refrain from donating sperm during their participation in the study and for 7 months following last dose of study drug.

Exclusion Criteria:

  • Patients that have received an allogenic transplant.
  • Post-ASCT or current therapy with other anti-neoplastic or investigational agents.
  • Best clinical response of progressive disease prior to ASCT.
  • Patients with any autoimmune disease or a history of autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Use of a study drug ≤ 21 days or 5 half-lives (whichever is shorter) prior to the first dose of nivolumab. For study drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the study drug and administration of nivolumab is required.
  • Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy.
  • Major surgical procedures ≤28 days of beginning study drug, or minor surgical procedures ≤7 days. No waiting required following port-a-cath placement.
  • Previously untreated brain metastases. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 2 weeks prior to study entry and there is no evidence of central nervous system disease progression, mild neurologic symptoms, and no requirement for chronic corticosteroid therapy.
  • Pregnant or lactating
  • Acute or chronic liver, renal, or pancreatic disease.
  • Uncontrolled diabetes mellitus. Patients with Type II diabetes are eligible if they require only oral hypoglycemic agents.
  • Any of the following cardiac diseases currently or within the last 6 months:

    • Left Ventricular Ejection Fraction (LVEF) <45% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO)
    • QTc interval >480 ms on screening electrocardiogram (ECG)
    • Unstable angina pectoris
    • Congestive heart failure (New York Heart Association (NYHA) ≥ Grade 2
    • Acute myocardial infarction
    • Conduction abnormality not controlled with pacemaker or medication
    • Significant ventricular or supraventricular arrhythmias (patients with chronic rate- controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible)
    • Valvular disease with significant compromise in cardiac function
  • Inadequately controlled hypertension (i.e., systolic blood pressure [SBP] >180 mmHg or diastolic blood pressure (DBP) >100 mmHg) (patients with values above these levels must have their blood pressure (BP) controlled with medication prior to starting treatment).
  • Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • Known diagnosis of human immunodeficiency virus, hepatitis B, or hepatitis C. Testing at baseline is not required.
  • Presence of other active cancers, or history of treatment for invasive cancer ≤5 years. Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e., non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.

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): NCT03436862


Contacts
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Contact: Sarah Cannon Development Innovations 844-710-6157 CANN.InnovationsMedical@sarahcannon.com

Locations
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United States, Colorado
Colorado Blood Cancer Institute Not yet recruiting
Denver, Colorado, United States, 80218
Principal Investigator: Richard Nash, MD         
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: Carlos Bachier, MD         
United States, Texas
St. David's South Austin Medical Center Recruiting
Austin, Texas, United States, 78704
Principal Investigator: Aravind Ramakrishnan, MD         
Texas Transplant Institute Not yet recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Cesar Freytes, MD         
Sponsors and Collaborators
SCRI Development Innovations, LLC
Bristol-Myers Squibb
Investigators
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Study Chair: Carlos Bachier, MD SCRI Development Innovations, LLC

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Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT03436862     History of Changes
Other Study ID Numbers: SCRI BMT 24
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

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

Keywords provided by SCRI Development Innovations, LLC:
Nivolumab
Autologous Stem Cell Transplant
Blood cancers

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
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents