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

Withdrawn

• Conditions: Gastrointestinal Stromal Tumor; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Premenopausal
• Interventions: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Procedure: Ultrasonography

• Registration Number: NCT02734823
• Lead Sponsor: University of Southern California

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-12
• Status Verified: 2024-03
• Primary Completion: 2024-03-14
• Study Completion: 2024-03-14
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (ovary imaging, hormonal analysis)	Questionnaire Administration	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.
Ancillary-Correlative (ovary imaging, hormonal analysis)	Cytology Specimen Collection Procedure	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.
Ancillary-Correlative (ovary imaging, hormonal analysis)	Laboratory Biomarker Analysis	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.
Ancillary-Correlative (ovary imaging, hormonal analysis)	Ultrasonography	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.

Primary Outcome Measures

Name	Time	Method
Changes in markers of ovarian reserve in premenopausal women undergoing tyrosine kinase inhibitor therapy for cancer	Baseline to up to 1 year	Standard descriptive statistics and scatter plots will be used to summarize patterns by cohorts at each time point. Regression methods will be used to render data compatible with the assumption of the normal distribution. Analysis will be undertaken to obtain preliminary estimates of ovarian reserve over time and to elucidate whether TKI therapy produces a clinically meaningful change in ovarian reserve marker.

Secondary Outcome Measures

Name	Time	Method
Ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo IVF for fertility preservation	Up to 1 year	The results of their stimulation protocol will be recorded.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States