Impact of the Inhibitors of Tyrosine Kinase on the Male Fertility

NCT01114087 | Completed

• 1 other identifier: P070131
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the possible deleterious effects of tyrosine kinase inhibitors on sperm concentration, after 6 months of therapy, which corresponds to 2 cycles of spermatogenesis and on the sperm nuclear integrity. The main comparison criterion will be the mean difference in sperm concentration before and after the 6 month treatment.

Conditions

Chronic Myeloid Leukemia; Gastrointestinal Stromal Tumors

Keywords

Spermatogenesis; Inhibitors of tyrosine kinase; Fragmentation of the spermatic DNA

Outcome Measures

Primary Outcomes (1)

• Average difference of the concentration of spermatozoa in the ejaculate measured before treatment and after 6 months of treatment.

  At the inclusion and M6 visits

Secondary Outcomes (2)

• Analysis of the fragmentation of the spermatic DNA

  At the inclusion and M6 visits

• Plasmatic concentration of the inhibitors of tyrosine kinase

  At the inclusion and M6 visits

Study Arms (1)

1

EXPERIMENTAL

Patients presenting with chronic myeloid leukaemia or malignant GIST and receiving for the first time a treatment by imatinib, a tyrosin-kinase inhibitor, preceded or not by hydroxyurea therapy for less than one month.

Drug: Imatinib treatment

Interventions

Imatinib treatment DRUG

Imatinib is a tyrosin-kinase inhibitor

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men from 18 to 60 years old
• Patients recently diagnosed CML or GIST
• Patients for whom a treatment by an inhibitor of tyrosine kinase in monotherapy is prescribed
• Patients having signed the informed consent
• Patients with social security

You may not qualify if:

• Patients already subjected to a treatment potentially sterilizing
• Patients under supervision or guardianship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Department of Biology of reproduction (TENON Hospital-APHP)

Paris, 75012, France

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Jacqueline Mandelbaum, Dr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: April 30, 2010
• Study Start: October 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 29, 2011

Record last verified: 2011-01

Locations

FR (1)