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Trial record 14 of 52 for:    LENALIDOMIDE AND Leukemia AND Acute Myeloid Leukemia (AML)

A Study to Analyze the Occurrence of Transformation From Myelodysplastic Syndrome to Acute Myeloid Leukemia in Patients With Myelodysplastic Syndrome Who Received Revlimid® 5 mg Capsules and Who Are Continuing or no Longer Continuing Revlimid Treatment

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ClinicalTrials.gov Identifier: NCT02921815
Recruitment Status : Active, not recruiting
First Posted : October 3, 2016
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief Summary:

To analyze the occurrence of transformation from myelodysplastic syndrome (MDS) to acute myeloid leukemia (hereinafter referred to as transformation from MDS to AML) in patients with myelodysplastic syndrome with a deletion 5q cytogenetic abnormality (hereinafter referred to as del(5q)MDS) who received Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) and who are continuing or no longer continuing Revlimid treatment.

  1. Planned registration period This period started on the date of initial marketing of Revlimid and will end on the day when the appropriateness of enrollment is assessed for all del(5qMDS) patients in the all-case surveillance.
  2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid.

Condition or disease
Myelodysplastic Syndromes Leukemia, Myeloid, Acute

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Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Revlimid 5 mg Capsules Special Use-results Surveillance of Transformation to Acute Myeloid Leukemia
Actual Study Start Date : March 3, 2011
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019


Group/Cohort
Patients with myeloid leukemia
All del(5q) Myelodysplastic syndrome (MDS) patients in the all-case surveillance in whom transformation to acute myeloid leukemia has not been documented at the end of the observation period of the all-case surveillance.



Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: 3 years ]
    Number of participants with adverse events



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
Sampling Method:   Non-Probability Sample
Study Population
All del(5q) Myelodysplastic syndrome (MDS) patients in the all-case surveillance in whom transformation to acute myeloid leukemia (hereinafter referred to as Acute Myelogenous Leukemia (AML)) has not been documented at the end of the observation period of the all-case surveillance.
Criteria

Inclusion Criteria:

  • All del(5q)MDS patients in the all-case surveillance in whom transformation to acute myeloid leukemia (hereinafter referred to as AML) has not been documented at the end of the observation period of the all-case surveillance.

Exclusion Criteria:

N/A


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): NCT02921815


Locations
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Japan
Shinko Hospital
Kobe, Hyogo, Japan, 651-0072
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Jinshu Cho Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02921815     History of Changes
Other Study ID Numbers: NIS-Celgene-JP-PMS-001c
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Keywords provided by Celgene:
Leukemia
Acute Myeloid Leukemia
Revlimid
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Lenalidomide
Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents