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Estimation of Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene Treatment of Cutaneous T Cell Lymphoma - Pilote Study

Phase 4
18 Years
Open (Enrolling)
Hypertriglyceridemia, Cutaneous T Cell Lymphoma

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Trial Information

Estimation of Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene Treatment of Cutaneous T Cell Lymphoma - Pilote Study

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

glucose intolerance or diabetes

Outcome Description:

The presence of a carbohydrate disorder is defined by glucose intolerance or diabetes. The diagnosis of glucose intolerance is made for a fasting glucose less than 1.26 g / l glucose and 2 hours (T120mn) after taking 75 g of glucose during an oral glucose tolerance test (OGTT) between 1.4 and 2 g / l and / or a value greater than or equal to 2 g / l between T30 and T90 min. Diabetes is established for a fasting glucose greater than or equal to 1.26 g / l and / or blood glucose greater than or equal to 2 g / l to 2 hours.

Outcome Time Frame:

At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Rennes University Hospital


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

January 2012

Completion Date:

September 2014

Related Keywords:

  • Hypertriglyceridemia
  • Cutaneous T Cell Lymphoma
  • hypertriglyceridemia
  • bexarotene
  • Hypertriglyceridemia
  • Lymphoma
  • Metabolic Diseases
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous