A Study to Analyze the Occurrence of Transformation From... | NCT02921815

Studies
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

NCT02921815

Sponsor

Celgene

Status

Completed

Last Update Posted

Jun 14, 2022Actual

Enrollment

84Actual

Phase

Not provided

Conditions

Myelodysplastic Syndromes
Leukemia, Myeloid, Acute

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2011Actual

Primary Completion Date

Aug 31, 2014Actual

Completion Date

Aug 31, 2014Actual

First Submitted Date

Sep 30, 2016

First Submission Date that Met QC Criteria

Sep 30, 2016

First Posted Date

Oct 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2022

Last Update Posted Date

Jun 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.
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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events (AEs)	Number of participants with adverse events	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shinko Hospital		Kobe	Hyōgo	651-0072	Japan

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D007951	Leukemia, Myeloid
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D009190	Myelodysplastic Syndromes
D015470	Leukemia, Myeloid, Acute
D007938	Leukemia