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

Gastrointestinal Stromal Tumor Clinical Trial

Official title:

Long Term Effects of Tyrosine Kinase Inhibitors on Ovarian Reserve and Fertility, A Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02734823
• Other study ID #: 0S-15-7
• Secondary ID: NCI-2016-003520S
• Status: Withdrawn
• Start date: March 1, 2016
• Est. completion date: March 14, 2024

Study information

• Verified date: March 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 14, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Premenopausal

Intervention

Other:
• Cytology Specimen Collection Procedure
Undergo collection of serum
• Laboratory Biomarker Analysis
Correlative studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Ultrasonography
Undergo transvaginal pelvic ultrasonography

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in markers of ovarian reserve in premenopausal women undergoing tyrosine kinase inhibitor therapy for cancer	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.	Baseline to up to 1 year
Secondary	Ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo IVF for fertility preservation	The results of their stimulation protocol will be recorded.	Up to 1 year