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Trial record 38 of 307 for:    IBRUTINIB

Clinical Outcomes of Chronic Lymphocytic Leukemia (CCL) and Mantle Cell Lymphoma (MCL) Participants Treated With Ibrutinib: A Medical Chart Review From India

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ClinicalTrials.gov Identifier: NCT03476655
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Private Limited

Brief Summary:
The purpose of this study is to describe the effectiveness (overall response rate [ORR] and time to progression [TPP]) of Ibrutinib therapy in participants with 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 : 75 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Outcomes of CLL and MCL Patients Treated With Ibrutinib: An Observational Retrospective Medical Chart Review From India
Actual Study Start Date : April 28, 2018
Estimated Primary Completion Date : June 28, 2019
Estimated Study Completion Date : July 10, 2019


Group/Cohort Intervention/treatment
Participants with Chronic Lymphocytic Leukemia (CLL)
This study will collect retrospective data on effectiveness and outcome parameters for participants of CLL being managed with ibrutinib in the clinical practice. The primary data source for this observational study will be the medical records of each enrolled participant.
Drug: Ibrutinib
No study treatment will be administered as a part of this study. Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib treatment before 30 April 2018 in routine clinical practice settings will be observed.
Other Name: IMBRUVICA

Participants with Mantle Cell Lymphoma (MCL)
This study will collect retrospective data on effectiveness and outcome parameters for participants of MCL being managed with ibrutinib in the clinical practice. The primary data source for this observational study will be the medical records of each enrolled participant.
Drug: Ibrutinib
No study treatment will be administered as a part of this study. Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib treatment before 30 April 2018 in routine clinical practice settings will be observed.
Other Name: IMBRUVICA




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 14 months ]
    ORR is defined as achievement of complete response (CR) or partial response (PR) per International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 guidelines for Chronic Lymphocytic Leukemia (CLL) and Mantle-cell Lymphoma (MCL). CR is defined as resolution of enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/MCL detectable in the bone marrow. PR is defined as 50 percent (%) or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more reduction in the blood lymphocyte count.

  2. Time to Progression (TTP) [ Time Frame: Up to 14 months ]
    Time to progression will be reported for the observed participants receiving ibrutinib. TTP is defined as the period from study entry until objective disease progression (time from the date of randomization until disease progression or death due to progression, whichever occur first).

  3. Percentage of Participants with Complete Response (CR) [ Time Frame: Up to 14 months ]
    Percentage of participants with CR will be reported. CR is defined as resolution of enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/MCL detectable in the bone marrow.

  4. Percentage of Participants with Partial Response (PR) [ Time Frame: Up to 14 months ]
    Percentage of participants with PR will be reported. PR is defined as 50 percent (%) or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more reduction in the blood lymphocyte count.

  5. Percentage of Participants with Stable Disease (SD) [ Time Frame: Up to 14 months ]
    Percentage of participants with SD will be reported. Participants who have not achieved a CR or a PR, and who have not exhibited progressive disease will be considered to have stable disease.

  6. Percentage of Participants with Progressive Disease (PD) [ Time Frame: Up to 14 months ]
    Percentage of participants with PD will be reported. PD is defined as 50% or more increase in lymph nodes or the appearance of new enlarged lymph nodes; 50% or more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count.


Secondary Outcome Measures :
  1. Median time to Response with Ibrutinib [ Time Frame: Up to 14 months ]
    Median time to response with ibrutinib in CLL and MCL participants will be reported. Time to response is defined as the time from start of ibrutinib therapy until objective response (CR or PR assessed by the investigator, based on physical examinations, CT scans, laboratory results, and bone marrow examinations, according to the modified 2008 IWCLL response criteria).

  2. Change from Baseline in Hemoglobin Levels [ Time Frame: Baseline up to 14 months ]
    Change from baseline in blood hemoglobin level will be reported.

  3. Change from Baseline in Platelet Counts [ Time Frame: Baseline up to 14 months ]
    Change from baseline in blood platelet counts will be reported.

  4. Number of Participants with Response to Ibrutinib by Prior Lines of Therapy [ Time Frame: Up to 14 months ]
    Number of participants, who progresses on at least one prior line of therapy, with response to ibrutinib will be reported.

  5. Number of Participants with Hematological and Non-hematological Adverse Drug Reactions (ADR) [ Time Frame: Up to 14 months ]
    Number of participants with hematological and non-hematological ADR will be reported. An adverse drug reaction (ADR) is defined as a response to a medicinal (investigational or non-investigational) product that is noxious and unintended. The phrase "response to a medicinal product" means that a causal relationship between a medicinal product and an adverse event is possible, probable or very likely.



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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 treated with ibrutinib per routine clinical care before 30 April 2018 in India and who have progressed on at least one prior line of therapy or CLL participants with deletion 17p (deletions in the short arm of chromosome 17).
Criteria

Inclusion Criteria:

  • Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
  • CLL or MCL participants being newly initiated on Imbruvica treatment (ibrutinib capsule 140 mg) based on independent clinical judgment of treating physicians

Exclusion Criteria:

- Any contraindications to ibrutinib use according to the current version of the Prescribing information in India


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): NCT03476655


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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India
Apollo Hospitals International Limited Not yet recruiting
Ahmedabad, India, 382428
Healthcare Global (HCG) Hospital Not yet recruiting
Bangalore, India, 560013
Bhagwan Mahaveer Hospital & Research Centre Recruiting
Jaipur, India, 302017
Sponsors and Collaborators
Johnson & Johnson Private Limited
Investigators
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Study Director: Johnson & Johnson Private Limited Clinical Trial Johnson & Johnson Private Limited

Additional Information:
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Responsible Party: Johnson & Johnson Private Limited
ClinicalTrials.gov Identifier: NCT03476655     History of Changes
Other Study ID Numbers: CR108441
54179060LYM4007 ( Other Identifier: Johnson & Johnson Private Limited )
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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