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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00655668




Registration number
NCT00655668
Ethics application status
Date submitted
4/04/2008
Date registered
10/04/2008
Date last updated
25/11/2019

Titles & IDs
Public title
A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma
Scientific title
A Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid®) in Subjects With Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma
Secondary ID [1] 0 0
2007-002171-13
Secondary ID [2] 0 0
CC-5013-TCL-001
Universal Trial Number (UTN)
Trial acronym
EXPECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
T-cell Non-Hodgkin's Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lenalidomide

Experimental: Lenalidomide - Open-label, oral lenalidomide monotherapy


Treatment: Drugs: Lenalidomide
Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants Categorized by Best Response as Determined by Investigator - Participant response assessed by investigator; criteria by B. Cheson in Journal of Clinical Oncology, 1999 (see article for more detail):
Complete Response(CR): Complete disappearance of all detectable disease
Complete Response Unconfirmed(CRu): CR, but indeterminate bone marrow
Partial Response(PR): >50% decrease in six largest nodes/nodal masses
Stable Disease(SD): Less than PR, but not progressive disease
Relapsed Disease: In CR/CRu Patients, new lesions seen or increased by >=50% in previous sites
Progressive Disease(PD): >=50% increase from low in PR/Non-Responders
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Duration of Response - Kaplan-Meier Estimate of duration of response calculated as the time from first computed tomography (CT) Scan or magnetic resonance imaging (MRI) that demonstrates at least a partial response to the first documentation of disease progression, including death due to Non-Hodgkin's Lymphoma.
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Time-to-Progression - Kaplan-Meier estimate of time-to-progression is calculated as the time from the start of study drug therapy to the first documentation of progressive disease.
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Progression-Free Survival - Kaplan-Meier estimate of progression-free survival is defined as the start of study drug therapy to the first observation of disease progression or death due to any cause.
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Safety - Summary of Treatment-Emergent Events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 3: Following is the scale: Grade 1=Mild Adverse Event (AE), Grade 2=Moderate AE, Grade 3=Severe and Undesirable AE, Grade 4=Life-threatening or Disabling AE, and Grade 5=Death Related to AE.)
Timepoint [4] 0 0
Up to 24 months

Eligibility
Key inclusion criteria
- Must understand and voluntarily sign an informed consent form.

- Must be = 18 years of age at the time of signing the informed consent form.

- Must be able to adhere to the study visit schedule and other protocol requirements.

- Biopsy-proven T-cell Non-Hodgkin's Lymphoma, either:

- Peripheral T-cell Lymphoma (PTCL) whatever the subtype, or

- Cutaneous T-cell Lymphoma (CTCL), but only the subtype mycosis fungoides.

- Relapsed or refractory to previous therapy for T-cell Non-Hodgkin's Lymphoma.

- Must have received at least one prior combination chemotherapy regimen. There is no
limit on the number of prior therapies.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital Building 3, L 2 - Garran
Recruitment hospital [2] 0 0
Cancer Therapy Centre - Liverpool
Recruitment hospital [3] 0 0
Clinical Research Unit Cairns Base Hospital - Cairns
Recruitment hospital [4] 0 0
The Townsville Hospital - Douglas
Recruitment hospital [5] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [6] 0 0
Ashford Cancer Centre - Ashford
Recruitment hospital [7] 0 0
Royal Adelaide Hospital L3 East Wing - North Terrace
Recruitment hospital [8] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [9] 0 0
Box Hill Hospital, 4th Floor, Clive Ward Centre - Box Hill
Recruitment hospital [10] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [11] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [12] 0 0
St Vincents Hospital - Fitzroy
Recruitment hospital [13] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4870 - Cairns
Recruitment postcode(s) [4] 0 0
4814 - Douglas
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
5035 - Ashford
Recruitment postcode(s) [7] 0 0
5000 - North Terrace
Recruitment postcode(s) [8] 0 0
7000 - Hobart
Recruitment postcode(s) [9] 0 0
3128 - Box Hill
Recruitment postcode(s) [10] 0 0
3168 - Clayton
Recruitment postcode(s) [11] 0 0
3002 - East Melbourne
Recruitment postcode(s) [12] 0 0
3065 - Fitzroy
Recruitment postcode(s) [13] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Belgium
State/province [7] 0 0
Ottignies
Country [8] 0 0
Belgium
State/province [8] 0 0
Yvoir
Country [9] 0 0
France
State/province [9] 0 0
Cedex 01
Country [10] 0 0
France
State/province [10] 0 0
Cédex 1
Country [11] 0 0
France
State/province [11] 0 0
Cédex 9
Country [12] 0 0
France
State/province [12] 0 0
Lille
Country [13] 0 0
France
State/province [13] 0 0
Montpellier
Country [14] 0 0
France
State/province [14] 0 0
Pierre-Bénite
Country [15] 0 0
France
State/province [15] 0 0
Rue Morvan Cedex
Country [16] 0 0
France
State/province [16] 0 0
Bordeaux
Country [17] 0 0
France
State/province [17] 0 0
Clermont-Ferrand
Country [18] 0 0
France
State/province [18] 0 0
Creteil
Country [19] 0 0
France
State/province [19] 0 0
Dijon
Country [20] 0 0
France
State/province [20] 0 0
Grenoble
Country [21] 0 0
France
State/province [21] 0 0
La Roche Sur Yon
Country [22] 0 0
France
State/province [22] 0 0
Limoges
Country [23] 0 0
France
State/province [23] 0 0
Metz
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Rennes
Country [26] 0 0
France
State/province [26] 0 0
Rouen
Country [27] 0 0
France
State/province [27] 0 0
Saint Cloud
Country [28] 0 0
France
State/province [28] 0 0
Toulouse
Country [29] 0 0
France
State/province [29] 0 0
Valence

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide
monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study
will be conducted in two phases: a Treatment Phase and a Follow-up Phase.

Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive
single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles).
Subjects may continue participation in the Treatment Phase of the study for a maximum
duration of 24 months, or until disease progression or unacceptable adverse events develop.

All subjects who discontinue the Treatment Phase for any reason will continue to be followed
until progression of disease or until next lymphoma treatment is given, whichever comes
first, during the Follow-up Phase.

Objectives:

Primary:

• To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell
Non-Hodgkin's Lymphoma (NHL). Efficacy will be assessed by measuring the response rate, tumor
control rate, duration of response, time to progression and progression free survival.

Secondary:

• To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed
or refractory T-cell NHL.
Trial website
https://clinicaltrials.gov/show/NCT00655668
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kenichi Takeshita, MD
Address 0 0
Celgene Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00655668