Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Ms Bilyana Popova


Contact details

Cancer Research UK & UCL Trials Centre
90 Tottenham Court Road
United Kingdom

Additional identifiers

EudraCT number

2006-000591-33 number


Protocol/serial number


Study information

Scientific title

A phase II, multicentre, non-randomised, open-label, single arm trial of the efficacy of Gemcitabine and Bexarotene in patients who have developed progressive cutaneous T-cell lymphoma (CTCL)



Study hypothesis

This is a phase II, multicentre, non-randomised, open-label, single arm trial of Gemcitabine and Bexarotene for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have developed progressive disease after receiving, or have been refractory to, standard skin-directed therapy and at least one prior systemic therapy. The study aims to to evaluate the efficacy of Gemcitabine and Bexarotene as a combination therapy in patients with CTCL in terms of the rate of objective disease response and its duration, and to determine whether the combination has sufficient biological activity in CTCL to warrant more extensive investigation. This is a "two stage" study where 35 patients will be treated initially and if the response criteria are met, further 49 to a total of 84 patients will be treated on the study.

Ethics approval

Leeds (East) Research Ethics Committee, 10/05/2006, ref: 06/Q1206/65

Study design

Non-randomised multicentre interventional and observational treatment validation of investigation/therapeutic process

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: National Cancer Research Network; Subtopic: Lymphoma; Disease: Lymphoma (non-Hodgkin's)


Prophylactic fenofibrate; patients start prophylactic Fenofibrate 160 - 200 mg daily 7 days before chemotherapy. Initial chemotherapy: 4 x 21 day cycles:
Gemcitabine 1000 mg/m^2 intravenous (iv) days 1 and 8
Bexarotene 300 mg/m^2 orally (po) daily*
* Bexarotene given at a reduced dose of 150 mg/m^2 for weeks 1 and 2 of cycle 1 and, if tolerated, increased to 300 mg/m^2 as per British Dermatology Society guidelines

In patients responding after 4 cycles of Gemcitabine + Bexarotene:
Bexarotene maintenance 300 mg/m^2 daily until disease progression or patient

Study Entry: Registration only
Details: As this is a single arm study, all patients registered will recieve the same treatment.

Intervention type



Phase II

Drug names

Gemcitabine and Bexarotene (GemBex), Fenofibrate

Primary outcome measures

To confirm the feasibility and efficacy of the combination of Gemcitabine and Bexarotene in patients, assessed during time from treatment start to progression

Secondary outcome measures

Assessed during time from treatment start to progression:
1. To evaluate the rate of objective disease control
2. To evaluate the duration and durability

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Males or non-pregnant females aged greater than 18 years
2. Histologically confirmed diagnosis of cutaneous T-cell lymphoma (CTCL), including mycosis fungoides and Sézary syndrome
3. Stage Ib, IIa, IIb, III, IVa and IVb disease
4. Patients who have failed standard skin-directed therapy and have had at least 1 course of prior systemic therapy, such as interferon, chemotherapy, Denileukin diftitox (Ontak®) which they have either failed to respond to or have subsequently progressed
5. Anticipated life expectancy greater than six months
6. Written informed consent to participate in the study. vii.Bexarotene naive or previous response to single-agent bexarotene, but more than 3 months since last treatment with bexarotene

Participant type


Age group




Target number of participants

Planned Sample Size: 84; UK Sample Size: 84

Participant exclusion criteria

1. Eastern Cooperative Oncology Group (ECOG) Performance Status greater than 1
2. Patients who have not received at least 1 course of prior systemic therapy for CTCL
3. CD30 + (Ki1+ve) anaplastic large cell lymphoma
4. Patients who have failed previous treatment with Bexarotene (Targretin®)
5. Patients who have previously experienced a severe adverse reaction to Bexarotene
6. Concomitant use of any anti-cancer therapy
7. Concomitant use of any investigational agent
8. Use of any investigational agent within 4 weeks of study entry
9. Clinically significant active infection
10. Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
11. Excessive alcohol consumption
12. Uncontrolled diabetes mellitus
13. Biliary tract disease
14. History of pancreatitis
15. Concomitant drug therapy with other medications that can elevate triglycerides or cause pancreatic toxicity e.g. Gemfibrozil
16. Inadequate bone marrow or other organ function, as evidenced by: Unsupported haemoglobin less than 9.0 g/dL (transfusions and/or erythropoietin are permitted); Absolute neutrophil count (ANC) = 1.5 x 10^9/L; Platelet count less than 100 x 10^9/L
17. Total bilirubin greater than 1.25 x upper limit of normal (ULN) for institution, aspartate transaminase/glutamic oxaloacetic transaminase (AST/SGOT) and alanine transaminase/glutamic pyruvic transaminase (ALT/SGPT) greater than 2.0 x ULN, serum creatinine greater than 2 x ULN for age and sex
18. Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin or cervical epithelial neoplasm [CIN1, carcinoma in situ] that has been treated curatively)
19. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures
20. Patients who are pregnant or breast-feeding (all women of child bearing potential must use the contraceptive pill or intrauterine contraceptive device (IUCD) during the treatment period and for at least 1 month thereafter). Male patients must use a barrier method of contraception during the treatment period and for at least 1 month thereafter.
21. Any treatment for lymphoma, including photopheresis, within the 4 weeks prior to entering the study. For patients receiving long-term corticosteroid therapy, the dose should ideally be stopped and if this is not feasible reduced to as low as possible. If steroids cannot be stopped, patients who have been on stable doses less than or equal to 20 mg for at least 3 months can be entered into the study. Local radiotherapy to isolated symptomatic tumour nodules requiring immediate treatment may be given until 2 weeks prior to entering the study.
22. Warfarin

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK & UCL Trials Centre
United Kingdom

Sponsor information


University College London (UCL) (UK)

Sponsor details

Gower Street
United Kingdom

Sponsor type




Funder type


Funder name

Cancer Research UK (CRUK) (UK) (ref: C431/A6857)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in:

Publication citations

Additional files

Editorial Notes