Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene of Cutaneous T Cell Lymphoma (TgBEX)

Rennes University Hospital

Status and phase: Completed; Phase 4

Conditions: Cutaneous T Cell Lymphoma; Hypertriglyceridemia

Treatments: Other: oral glucose tolerance test (OGTT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01569724

2010-A23465-21

Details and patient eligibility

About

Bexarotene is a RXR-selective retinoid, licensed for the treatment of cutaneous T cell lymphoma. The most frequent adverse effect is hypertriglyceridemia but its mechanism is not well known. The purpose of this study is to research a carbohydrate metabolism disorder associated in bexarotene-induced hypertriglyceridemia.

Full description

Primary cutaneous lymphomas are the second group of extra nodal lymphomas after gastrointestinal lymphomas. Bexarotene is licensed for the treatment of epidermotropic cutaneous T cell lymphoma .The most common side effect of bexarotene is hypertriglyceridemia (82%) associated with hypercholesterolemia (30 to 40%). Central hypothyroidism is also present in 40-80% of cases. These adverse effects are dose-dependent. The management of hyperlipidemia induced by bexarotene is difficult. The mechanism of lipid disorder induced by bexarotene is not well known. Associated carbohydrate metabolism disorder could be present and play a role in the bexarotene-induced hyperlipidemia.

The main objective is to estimate the frequency of a carbohydrate disorder in patients with hypertriglyceridemia (TG> 1.5 g / L) induced by bexarotene treatment of cutaneous T cell lymphoma, previously free of diabetes, thyroid dysfunction and dyslipidemia.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged over 18 years
• Diagnosis of epidermotropic CTCL confirmed by histological examination for which consideration will be given treatment with bexarotene due to the advanced stage of lymphoma (stage IIB-IV) or earlier stage if resistance to previous treatment .
• TSH, FT3 and FT4 within normal limits
• AST and ALT ≤ 2 * upper limit of normal
• Creatinine clearance ≥ 30 mL / min
• Agreement after written information and informed to participate in the study
• Patient accepting the constraints of the study
• Membership of a social security system.

Exclusion criteria

• Pregnant or lactating woman
• Women of childbearing potential without effective contraception
• Insufficient thyroid or hyperthyroidism
• Diabetes known or detected
• Hyperlipidemia known or detected
• Hepatic insufficiency
• Difficulties to understand
• Persons covered by a plan of legal protection (protection of justice, guardianship, curator) or unable to issue a consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

bexarotene

Experimental group

Treatment:

Other: oral glucose tolerance test (OGTT)