NCT03098589

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. 1.Planned registration period 3 years
  2. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,149

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 30, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2020

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

3.3 years

First QC Date

March 28, 2017

Last Update Submit

March 28, 2025

Conditions

Lymphoma

Keywords

Adult T-cell Leukemia LymphomaTeratogenicityMyelosuppressionHaemorrhageInfectionThromboembolismHypersensitivityTumor lysis syndromePeripheral neuropathyIschaemic heart diseaseCardiac failureArrhythmiaRenal failureInterstitial lung diseaseHepatic disorderHypothyroidismGastrointestinal perforationOrthostatic hypotensionConvulsionSomnolenceConfusionFatigueDizzinessBlurred visionSecond primary cancerCataractRevlimid capsules

Outcome Measures

Primary Outcomes (1)

  • Adverse Events (AEs)

    Number of participants with adverse events

    Up to approximately 4 years

Study Arms (1)

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

Interventions

RevlimidDRUG

Revlimid

Patients with T-cell leukemia lymphoma treated with Revlimid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • \- Relapsed or Refractory Adult T-cell Leukemia Lymphoma

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASO KK Iizuka Hospital

Iizuka, Fukuoka, 820-8505, Japan

Location

MeSH Terms

Conditions

LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaTeratogenesisHemorrhageInfectionsThromboembolismHypersensitivityTumor Lysis SyndromePeripheral Nervous System DiseasesCoronary Artery DiseaseHeart FailureArrhythmias, CardiacRenal InsufficiencyLung Diseases, InterstitialDigestive System DiseasesHypothyroidismHypotension, OrthostaticSeizuresSleepinessConfusionFatigueDizzinessNeoplasms, Second PrimaryCataract

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaHematologic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesNeuromuscular DiseasesNervous System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLung DiseasesRespiratory Tract DiseasesThyroid DiseasesEndocrine System DiseasesOrthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesHypotensionNeurologic ManifestationsSigns and SymptomsNeurobehavioral ManifestationsSensation DisordersLens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2017

First Posted

April 4, 2017

Study Start

May 30, 2017

Primary Completion

September 18, 2020

Study Completion

September 18, 2020

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations

JP(1)