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Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)

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ClinicalTrials.gov Identifier: NCT03098589
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)).

  1. Planned registration period 3 years
  2. Planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory ATLL

Condition or disease Intervention/treatment
Lymphoma Drug: Revlimid

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Revlimid® Capsules Drug Use-results Surveillance Relapsed or Refractory Adult T-cell Leukemia Lymphoma
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : October 2, 2021
Estimated Study Completion Date : October 2, 2021


Group/Cohort Intervention/treatment
Patients with T-cell leukemia lymphoma treated with Revlimid
Among patients with relapsed or refractory adult T-cell leukemia lymphoma, patients who received Revlimid will be targeted in this surveillance
Drug: Revlimid
Revlimid




Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Up to approximately 4 years ]
    Number of participants with adverse events



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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:   Probability Sample
Study Population
Among patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as "Adult T-cell Leukemia Lymphoma (ATLL)") who are treated with Revlimid Capsules (hereinafter referred to as "Revlimid", used by both 2.5 mg and 5 mg capsules).
Criteria

Inclusion Criteria:

- Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Exclusion Criteria:


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): NCT03098589


Contacts
Contact: Shigeru Minohara, Study manager +81-3-5224-0660 sminohara@celgene.com

Locations
Japan
ASO KK Iizuka Hospital Recruiting
Iizuka, Fukuoka, Japan, 820-8505
Sponsors and Collaborators
Celgene
Investigators
Study Director: Kyoko Matsui, MD Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03098589     History of Changes
Other Study ID Numbers: NIS-Celgene-JP-PMS-004
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Keywords provided by Celgene:
Adult T-cell Leukemia Lymphoma
Teratogenicity
Myelosuppression
Haemorrhage
Infection
Thromboembolism
Hypersensitivity
Tumor lysis syndrome
Peripheral neuropathy
Ischaemic heart disease
Cardiac failure
Arrhythmia
Renal failure
Interstitial lung disease
Hepatic disorder
Hypothyroidism
Gastrointestinal perforation
Orthostatic hypotension
Convulsion
Somnolence
Confusion
Fatigue
Dizziness
Blurred vision
Second primary cancer
Cataract
Revlimid capsules

Additional relevant MeSH terms:
Lymphoma
Leukemia-Lymphoma, Adult T-Cell
Leukemia, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents