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Trial record 80 of 318 for:    ibrutinib

A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice (FIRE)

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ClinicalTrials.gov Identifier: NCT03425591
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.

Brief Summary:
The purpose of this study is to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy for chronic lymphocytic leukemia (CLL) and mantle-cell lymphoma (MCL).

Condition or disease Intervention/treatment
Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell Drug: Ibrutinib

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Retro-Prospective Observational Study of Ibrutinib Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice
Actual Study Start Date : May 11, 2016
Estimated Primary Completion Date : May 22, 2022
Estimated Study Completion Date : May 22, 2022


Group/Cohort Intervention/treatment
Cohort 1: Chronic Lymphocytic Leukemia (CLL) Participants
Participants with confirmed diagnosis of CLL will be observed to collect data on ibrutinib therapy to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy in Cohort 1. The primary data source for this observational study will be the medical records of each enrolled participant.
Drug: Ibrutinib
Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib in routine clinical practice settings will be observed for 5 years.

Cohort 2: Mantle-Cell Lymphoma (MCL) Participants
Participants with confirmed diagnosis of MCL will be observed to collect data on ibrutinib therapy to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy in Cohort 2. The primary data source for this observational study will be the medical records of each enrolled participant.
Drug: Ibrutinib
Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib in routine clinical practice settings will be observed for 5 years.




Primary Outcome Measures :
  1. Progressive-Free Survival (PFS) [ Time Frame: Approximately up to 5 years ]
    PFS in Chronic Lymphocytic Leukemia (CLL) and Mantle-Cell Lymphoma (MCL) participants will be determined. PFS is defined as the time from start of ibrutinib therapy to Progressive Disease (PD) or death from any cause. PD is defined as any new lesions or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Approximately up to 5 years ]
    ORR observed in CLL and MCL participants will be reported. ORR is defined as the proportion of participants with at least an objective response (that is, complete response or partial response, or partial response with lymphocytosis for CLL participants) as assessed by the participating physician.

  2. Time to First Response [ Time Frame: Approximately up to 5 years ]
    Time to First Response in CLL and MCL participants will be reported. Time to first response is defined as the time from start of ibrutinib therapy until first objective response.

  3. Time to Best Response [ Time Frame: Approximately up to 5 years ]
    Time to best response in CLL and MCL participants will be reported. Time to best response is defined as the time from start of ibrutinib therapy until best objective response.

  4. Duration of Response [ Time Frame: Approximately up to 5 years ]
    Duration of response in CLL and MCL participants will be reported. Duration of response is defined as the time from start of ibrutinib therapy until PD or death resulting from progression. PD is defined as any new lesions or increase by >=50% of previously involved sites from nadir.

  5. Overall survival (OS) [ Time Frame: Approximately up to 5 years ]
    Overall survival in CLL and MCL participants will be reported. Overall survival will be measured from start of ibrutinib therapy to the date of death (all-cause mortality); and from diagnosis to the date of death.

  6. Duration of Ibrutinib Therapy [ Time Frame: Approximately up to 5 years ]
    Duration of ibrutinib therapy in CLL and MCL participants will be reported.

  7. Duration of a Treatment-Free Period [ Time Frame: Every 6 months (Approximately up to 5 years) ]
    Duration of treatment-free period in CLL and MCL participants will be reported.

  8. Duration of the First Non-Ibrutinib Subsequent Therapy Period [ Time Frame: Approximately up to 5 years ]
    Duration of the first non-ibrutinib subsequent therapy period in CLL and MCL participants will be reported.

  9. Participants' Daily Dose [ Time Frame: Approximately up to 5 years ]
    Daily dose of ibrutinib taken by CLL and MCL participants will be analyzed.

  10. Number of Participants Who Require Dose Modifications [ Time Frame: Approximately up to 5 years ]
    Number of CLL and MCL participants requiring dose modifications in the ibrutinib therapy will be reported.

  11. Number of Medications Added [ Time Frame: Approximately up to 5 years ]
    Number of medications added in the CLL and MCL treatment will be reported.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population include chronic lymphocytic leukemia (CLL) or mantle-cell lymphoma (MCL) participants who were or will be treated by ibrutinib per routine clinical care on or after 21 November 2014.
Criteria

Inclusion Criteria:

  • Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:

    1. treatment of CLL/SLL in participants who have received at least 1 prior therapy; or
    2. treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or
    3. treatment of participants with relapsed or refractory MCL
  • Not currently participating in another investigational study, clinical study, or any expanded access program at study entry
  • Has not participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program
  • Participant must sign a written informed consent form (ICF) allowing data collection and source data verification

Exclusion Criteria:

  • Currently participating in another investigational study, clinical study, or any expanded access program at study entry
  • Participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program

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): NCT03425591


Contacts
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Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: 844-434-4210 JNJ.CT@sylogent.com

Locations
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France
DUMMY Recruiting
Dummy, France, 99999
Sponsors and Collaborators
Janssen-Cilag Ltd.
Investigators
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Study Director: Janssen-Cilag Ltd. Clinical Trial Janssen-Cilag Ltd.

Additional Information:
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Responsible Party: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT03425591     History of Changes
Other Study ID Numbers: CR107363
54179060CAN4001 ( Other Identifier: Janssen-Cilag Ltd. )
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lymphoma, Non-Hodgkin