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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Cytology Specimen Collection Procedure
* Other: Laboratory Biomarker Analysis
* Other: Questionnaire Administration
* Procedure: Ultrasonography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-Correlative (ovary imaging, hormonal analysis)<br>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. | Other: Cytology Specimen Collection Procedure<br>* Undergo collection of serum<br>* Other names: Cytologic Sampling;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Ultrasonography<br>* Undergo transvaginal pelvic ultrasonography<br>* Other names: US;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |