Long Term Effects of Tyrosine Kinase Inhibitor Therapy on Ovarian Reserve and Fertility in Patients With Chronic Myeloid Leukemia or Gastrointestinal Stromal Tumor

University of Southern California

Status: Withdrawn

Conditions: Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Gastrointestinal Stromal Tumor; Premenopausal

Treatments: Other: Laboratory Biomarker Analysis; Procedure: Ultrasonography; Other: Cytology Specimen Collection Procedure; Other: Questionnaire Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02734823

NCI-2016-00352 (Registry Identifier)

0S-15-7 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This pilot research trial studies the long term effects of tyrosine kinase inhibitor therapy on ovarian reserve and fertility in patients with chronic myeloid leukemia or gastrointestinal stromal tumor. Studying ovary imaging, ovarian reserve markers, and hormone levels from patients receiving tyrosine kinase inhibitor therapy may help doctors learn more about the effects of tyrosine kinase inhibitor therapy on ovarian function and fertility.

Full description

PRIMARY OBJECTIVES:

I. To collect preliminary information to help design a study to look at longitudinal changes in markers of ovarian reserve and menstruation in premenopausal women undergoing tyrosine kinase inhibitors (TKI) therapy.

SECONDARY OBJECTIVES:

I. Evaluate ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo in vitro fertilization (IVF) for fertility preservation.

OUTLINE:

Patients undergo transvaginal ultrasound for antral follicles analysis and collection of serum for ovarian reserve markers and hormonal analysis before TKI therapy and at 12, 24, and 48 weeks.

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with chronic myeloid leukemia (CML), gastrointestinal stromal tumor (GIST), non metastatic cancer where TKI is the first line agent
• Premenopausal (has had menses at any time in the preceding 12 consecutive months)
• Has not undergone a hysterectomy or bilateral oophorectomy
• Willing to use non-hormonal (ie: barrier method or abstinence) as form of contraception during the one year of study

Exclusion criteria

• Patients who have had chemotherapy or radiotherapy in the past
• Patients may not be receiving any other investigational agents
• Patients must not be pregnant or nursing
• Other medical conditions or treatments that affect hormonal levels (potentially confounding interpretation of results)
• Patients with ongoing hormonal contraception or unwilling or unable to discontinue will not eligible

Trial design

0 participants in 1 patient group

Ancillary-Correlative (ovary imaging, hormonal analysis)

Description:

Patients undergo transvaginal ultrasound for antral follicles analysis and collection of serum for ovarian reserve markers and hormonal analysis before TKI therapy and at 12, 24, and 48 weeks.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Cytology Specimen Collection Procedure

Procedure: Ultrasonography

Other: Questionnaire Administration