Relapsed/refractory cutaneous T-cell lymphoma MedDRA version: 12.0 Level: LLT Classification code 10011678 Term: Cutaneous T-cell lymphoma recurrent MedDRA version: 12.0 Level: LLT Classification code 10011679 Term: Cutaneous T-cell lymphoma refractory
Conditions
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or non-pregnant females aged 18 years or over 2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and Sézary syndrome. 3. Patients with CTCL stages Ib, IIa, IIb, III, IVa and IVb. Staging is to take place within 1 month of obtaining full written informed consent. 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 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 7. Bexarotene naive or previous response to single-agent bexarotene, but at least 3 months since last treatment with bexarotene Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. ECOG Performance Status >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 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. To minimise the risk of pancreatitis secondary to hyperlipidaemia due to Bexarotene 12. Uncontrolled diabetes mellitus. To minimise the risk of pancreatitis secondary to hyperlipidaemia due to Bexarotene 13. Biliary tract disease. To minimise the risk of pancreatitis secondary to hyperlipidaemia due to Bexarotene 14. History of pancreatitis. To minimise the risk of pancreatitis secondary to hyperlipidaemia due to Bexarotene 15. Concomitant drug therapy with other medications that can elevate triglycerides or cause pancreatic toxicity e.g. Gemfibrozil. Due to incidence of hyperlipidaemia secondary to Bexarotene. 16. Inadequate bone marrow or other organ function, as evidenced by: Unsupported haemoglobin 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) >2.0 x ULN, serum creatinine >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 20mg for at least 3 months can be entered into the study. Local radiotherapy to isolated symptomatic tumour nodules requiring immediate treatment maybe given until 2 weeks prior to entering the study. 22. Warfarin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary research objectives are firstly to evaluate the rate of disease control. Secondly to evaluate the duration and durability of disease response and time to disease progression. Thirdly to determine the safety of combination therapy using Bexarotene and Gemcitabine in terms of physical examination, laboratory measurements, adverse events, hospital admissions and blood / platelet transfusions. Fourthly to determine the compliance with treatment. ;Primary end point(s): The primary endpoint of the trial is to confirm the safety and efficacy of the combination of gemcitabine and bexarotene in patients whose disease is no longer controlled on skin-directed therapy alone and who have failed at least one prior systemic therapy. The primary efficacy endpoint is the rate of objective response, defined as the proportion of patients with confirmed CR (Complete Remission), CCR (Clinical Complete Remission), or PR (Partial Remission)as determined by OPDREC (Objective Primary Disease Response Evaluation Criteria).;Main Objective: The primary research question is to confirm the feasibility and efficacy of using a combination of Gemcitabine and Bexarotene for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have disease that is no longer controlled by skin-directed therapy and who have had at least one prior systemic therapy. | — |
Countries
United Kingdom
Outcome results
None listed