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

This study is currently recruiting participants.
Verified January 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01569724
First received: February 24, 2012
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Hypertriglyceridemia
Cutaneous T Cell Lymphoma
Other: oral glucose tolerance test (OGTT)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Estimation of Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene Treatment of Cutaneous T Cell Lymphoma - Pilote Study

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • glucose intolerance or diabetes [ Time Frame: At 0, 2, 4, 6, 8 weeks after the administration of bexarotene. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • hypothyroidism [ Time Frame: At 0, 2, 4, 6, 8 weeks after the administration of bexarotene. ] [ Designated as safety issue: Yes ]
    hypothyroidism detection: TSH, free T3 and free T4 measured weekly during the first month and then every 15 days in the second month. Laboratory abnormalities will be evaluated according to the standards of the laboratory of each center.

  • response to bexarotene [ Time Frame: At 0, 2, 4, 6, 8 weeks after the administration of bexarotene. ] [ Designated as safety issue: No ]
    Response to bexarotene: it is considered partial if the patient has a decrease in injuries between 50% and 90% to total as if it has a lower damage of more than 90%.


Estimated Enrollment: 15
Study Start Date: January 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bexarotene Other: oral glucose tolerance test (OGTT)
patients presenting an hypertriglyceridemia will have a oral glucose tolerance test (OGTT) in order to diagnose a carbohydrate metabolism disorder
Other Name: Non applicable.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569724

Contacts
Contact: Henri ADAMSKI, MD henri.adamski@chu-rennes.fr

Locations
France
Service de dermatologie - Hôpital de Pontchaillou Recruiting
Rennes, France, 35033
Contact: Henri ADAMSKI, MD    +33-299-284-349    henri.adamski@chu-rennes.fr   
Principal Investigator: Henri ADAMSKI, MD         
Sub-Investigator: Catherine DROITCOURT, MD         
Sub-Investigator: Juliette MIQUEL, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Henri ADAMSKI, MD Rennes University Hospital
Study Chair: Emmanuel OGER, MD, PhD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01569724     History of Changes
Other Study ID Numbers: 2010-A23465-21
Study First Received: February 24, 2012
Last Updated: January 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
hypertriglyceridemia
bexarotene

Additional relevant MeSH terms:
Hypertriglyceridemia
Lymphoma
Metabolic Diseases
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bexarotene
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014