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

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

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.

Study Overview

• Status: Withdrawn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

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic myeloid leukemia or gastrointestinal stromal tumor undergoing TKI therapy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-Correlative (ovary imaging, hormonal 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; Other: Cytology Specimen Collection Procedure; Undergo collection of serum; Other Names: Cytologic Sampling; Procedure: Ultrasonography; Undergo transvaginal pelvic ultrasonography; Other Names: Ultrasound Imaging; Ultrasound Test; Ultrasound, Medical; US; ULTRASOUND

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Irene Woo, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Estimated): March 14, 2024
• Study Completion (Estimated): March 14, 2024

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 6, 2016
• First Posted (Estimated): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Bone Marrow Diseases; Hematologic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Myeloproliferative Disorders; Neoplasms, Connective Tissue; Chronic Disease; Leukemia; Leukemia, Myeloid; Gastrointestinal Stromal Tumors; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Other Study ID Numbers: 0S-15-7 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2016-00352 (Registry Identifier: CTRP (Clinical Trial Reporting Program))