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Trial record 83 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study (Optimal)

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ClinicalTrials.gov Identifier: NCT02717949
Recruitment Status : Terminated (failure to recruit)
First Posted : March 24, 2016
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

There still remains the question if hepatitis C eradication with all oral therapy will lead to a regression or cure of the low grade lymphoma. Thus, the hypothesis of this study is that oral HCV therapy will lead to a high rate of hepatitis C eradication which will correlate with a reduction of the size and extent of low-grade lymphoma. The hypothesis of this study is that subjects with hepatitis C,regardless of genotype, who have low grade lymphoma, when treated for hepatitis C without pegylated interferon will have a regression of low grade non-Hodgkin's lymphoma. In this pilot study we will evaluate the effect of Sofosbuvir/ledipasvir or sofosbuvir/ribavirin based antiviral therapy on the course of a subset of HCV-related low grade B cell non-Hodgkin's lymphoma

Primary Objective This study will assess the safety, as measured by adverse events, in subjects receiving hepatitis C treatment.

Secondary Objective The secondary objective of this study is to assess the rate of overall response of B cell non-Hodgkin's lymphoma defined as either as partial response or complete response according to revised international working group criteria for non-Hodgkin lymphoma.

Primary Endpoint Safety and tolerability of sofosbuvir/ledipasvir or sofosbuvir/ribavirin in subjects with B-cell non-Hodgkin's lymphoma will be assessed by number of adverse events and serious adverse events. In addition, the study will assess the number of subjects who had to stop treatment due to adverse events or serious adverse events. The study will also examine the number of subjects in which treatment for lymphoma had to be given due to clinical progression.

Secondary Endpoints The secondary endpoint(s) of this study is to (1) Assess the rate of overall response of B-cell Non-Hodgkin's lymphoma defined as either as partial response or complete response according to revised international working group criteria for non-Hodgkin lymphoma. (2) Determine the rate of sustained viral response in subjects with low-grade lymphoma.


Condition or disease Intervention/treatment Phase
Liver Disease Drug: sofosbuvir/ledipasvir Drug: sofosbuvir Drug: Ribavirin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study
Actual Study Start Date : February 25, 2016
Actual Primary Completion Date : June 5, 2017
Actual Study Completion Date : July 18, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sofosbuvir/ledipasvir
sofosbuvir and ledipasvir fixed dose combination given orally once a day for genotype 1 and 4.
Drug: sofosbuvir/ledipasvir
sofosbuvir ledipasvir fixed dose combination given once a day by mouth
Other Name: Harvoni

Experimental: sofosbuvir and ribavirin
Sofosbuvir 400 mg given orally once a day with weight-base ribavirin of 1200 mg for those >75 kg and 1000 mg for those <75kg given in divided dose twice a day. This intervention is for genotype 2 and 3
Drug: sofosbuvir
sofosbuvir 400 mg given one a daily orally and weight-based ribavirin given twice a day orally
Other Name: sovaldi

Drug: Ribavirin
ribavirin 1200 mg given orally in divided dose for those >75kg and 1000 mg in divided dose for those <75 kg.
Other Names:
  • copegus
  • rebetol
  • ribasphere




Primary Outcome Measures :
  1. Number Subjects Who Experience Adverse Events on HCV Treatment as Assessed by Division of AIDS (DAIDS) Adverse Event (AE) Grading Table Version 2.0. [ Time Frame: from drug dispensation until post-treatment week 36 ]
    number of subjects who experience treatment-related adverse event on HCV treatment as assessed by DAIDS AE Grading Table version 2.


Secondary Outcome Measures :
  1. Number of Subjects Who Have a Change in Lymph Node Size From Baseline After HCV Treatment [ Time Frame: from baseline to post-treament week 36 ]
    Number of subjects who have a change in the size of lymph node size from baseline



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:

  1. Willing and able to provide written informed consent.
  2. Male or female >18 years of age
  3. Serum HCV RNA levels of >1,000 IU per milliliter or higher
  4. HCV treatment experienced or naïve.

    • HCV treatment naïve: No prior exposure to any Interferon, ribavirin, or other approved or experimental HCV-specific directly acting antivirals
    • HCV Treatment-Experienced: Virologic failure after treatment with Pegylated interferon + ribavirin, Non-structural 3/4a (NS3/4A) protease inhibitor plus pegylated interferon + ribavirin, or regimen of sofosbuvir±ribavirin± pegylated interferon regimen.
  5. Chronic Hepatitis C based on the judgment of the investigator
  6. HCV genotype 1, 2, 3, 4
  7. If the patient is determined to be cirrhotic (based on criteria outlined earlier), the patient must have an ultrasound done within 6 months prior to enrollment with no evidence of hepatocellular carcinoma.
  8. Indolent Non-Hodgkin's lymphoma , which may include the following :

    • Nodal Marginal zone lymphoma
    • Extranodal marginal zone lymphoma (MALT)
    • Splenic marginal zone lymphoma
    • Follicular lymphoma Grade 1-3a with low tumor burden*, FLIPI 2 risk category of either low (i.e. no risk factors) or intermediate (1-2 risk factors), and with no B symptoms. B symptoms are defined as:

      • Fever (i.e., temperature >38°C [>100.4°F]) for 3 consecutive days
      • Weight loss exceeding 10% of body weight in 6 months
      • Drenching night sweats
    • Lymphoplasmacytic lymphoma
  9. No prior chemotherapy

    • Low tumor burden is defined as normal lactate dehydrogenase, largest nodal or extranodal mass less than 7 cm, up to three nodal sites containing nodes with a diameter greater than 3 cm, no clinically significant serous effusions detectable by physical examination or positron emission tomography (PET)/CT scan, and spleen enlargement up to 16 cm by CT without any evidence of portal hypertension.
  10. Karnofsky performance status > 70%
  11. Creatinine clearance ≥60 mL/min, as calculated by Cockcroft-Gault equation
  12. If patient will need ribavirin in their regimen then the following inclusion:

    • Hg >12 g/dL for male
    • Hg >11 g/dL for female
  13. All women of child-bearing potential who take ribavirin will need to have a negative urine pregnancy test.

Exclusion Criteria:

  1. Life expectancy < 6 months
  2. Any HCV treatment which uses pegylated interferon
  3. HCV genotype 3 Treatment experienced with cirrhosis
  4. Co-infection with hepatitis B
  5. Prior chemotherapy for lymphoma
  6. Lymphomas of other histologies other than the ones listed in section 3.3 above
  7. Follicular lymphoma with large cell transformation
  8. Decompensated liver disease in which pegylated interferon is contraindicated.
  9. Female who is pregnant or breast feeding and HCV treatment requires use of ribavirin.
  10. Solid organ transplant
  11. Any interferon- containing agent within 8 weeks prior to screening or any prior exposure to HCV-specific antivirals agent(s), other than NS3/ 4A protease inhibitor and sofosbuvir
  12. Known hypersensitivity to ledipasvir, sofosbuvir, or formulation excipients.
  13. On a prohibited medication which cannot be stopped during the duration of HCV treatment.
  14. Female subject who is pregnant or breastfeeding
  15. HIV-infection

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): NCT02717949


Locations
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United States, New York
Cornell Medical Center
New York, New York, United States, 10065
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Mamta K. Jain, MD UT Southwestern Medical Center
  Study Documents (Full-Text)

Documents provided by University of Texas Southwestern Medical Center:

Publications:

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02717949     History of Changes
Other Study ID Numbers: 042015-086
First Posted: March 24, 2016    Key Record Dates
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Texas Southwestern Medical Center:
hepatitis C
low-grade lymphoma
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Ledipasvir
Hepatitis C
Lymphoma
Hepatitis
Liver Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents