Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer

Trial Title: Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer

NCT ID: NCT06513962

Condition: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm

Conditions: Official terms:
Neoplasms
Triptorelin Pamoate

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Best Practice
Description: Receive standard chemotherapy
Arm group label: Arm B (usual care)

Other name: standard of care

Other name: standard therapy

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo blood sample collection
Arm group label: Arm A (triptorelin)
Arm group label: Arm B (usual care)

Other name: Biological Sample Collection

Other name: Biospecimen Collected

Other name: Specimen Collection

Intervention type: Other
Intervention name: Electronic Health Record Review
Description: Ancillary studies
Arm group label: Arm A (triptorelin)
Arm group label: Arm B (usual care)

Intervention type: Other
Intervention name: Survey Administration
Description: Ancillary studies
Arm group label: Arm A (triptorelin)
Arm group label: Arm B (usual care)

Intervention type: Drug
Intervention name: Triptorelin Pamoate
Description: Given IM
Arm group label: Arm A (triptorelin)

Other name: Decapeptyl

Other name: Diphereline

Other name: Pamorelin

Other name: Trelstar

Other name: Triptorelin Embonate

Summary: This phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with an alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.

Detailed description: PRIMARY OBJECTIVES: I. Determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age < 40 years (exclusive of breast cancer). II. Measure ovarian reserve via anti-Mullerian hormone (AMH) at 2-years post completion of alkylating agent-containing chemotherapy among randomized patients. SECONDARY OBJECTIVES: I. Collect information on the longitudinal trajectory of change in AMH and other ovarian hormone levels from cancer diagnosis to 2 years post cancer treatment completion among randomized patients. II. Determine the feasibility of measuring estrogen deprivation symptoms (i.e., hot flashes, sexual dysfunction) menstrual pattern, and quality of life among randomized patients. EXPLORATORY OBJECTIVE: I. Establish a unique cohort of female AYA patients treated with alkylating agent chemotherapy and randomized to receive or not receive triptorelin, that can be followed long-term to study reproductive health concerns and outcomes as well as genetic risk factors for premature menopause. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive triptorelin intramuscularly (IM) up to 14 days prior to standard chemotherapy. For patients whose chemotherapy exceeds 24 weeks, a second dose of triptorelin may be given 24 weeks after the first dose at the treating physician's discretion. Patients also undergo blood sample collection throughout the study. ARM B: Patients receive standard chemotherapy. Patients also undergo blood sample collection throughout the study. After completion of study treatment, patients are followed up at 1 and 2 years.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - < 40 years of age at the time of enrollment - Patient must be a post-menarchal female and report that their initial menstrual period occurred > 6 months prior to enrollment. (Current menstrual status is not part of the inclusion criteria.) - Newly diagnosed with first cancer, exclusive of breast cancer. - Planned treatment must include one or more of the following alkylating agents delivered with curative intent: cyclophosphamide, ifosfamide, procarbazine, chlorambucil, carmustine (BCNU), lomustine (CCNU), melphalan, thiotepa, busulfan, nitrogen mustard. - For patients < 20 years of age at enrollment, the expected alkylator dose must be ≥ 4 g/m^2 cumulative cyclophosphamide equivalent dose (CED). For patients ≥ 20 years of age at enrollment, any planned alkylator dose is permitted. Eligible patients must receive at least one of the alkylators that contribute to CED. - All patients and/or their parents or legal guardians must sign a written informed consent. - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met. Exclusion Criteria: - Any planned radiation to the pelvis; or cranial radiation ≥ 30 gray (Gy) to the hypothalamus, inclusive of any total body irradiation (TBI). - Planned bilateral oophorectomy. Note: A participant's desire to pursue alternative fertility preservation procedures (i.e., embryo, oocyte, or ovarian tissue cryopreservation) will be allowed (and in fact encouraged). - Congenital syndromes associated with infertility and decreased ovarian reserve at baseline. For example: Turner's Syndrome, Fragile X premutation carriers, Down syndrome, etc. - Pre-existing seizure disorder, congenital long QT syndrome, pseudotumor cerebri; history of pulmonary embolism, venous thrombosis, or myocardial infarction. Note: Contact study chairs if questions arise about other pre-existing conditions. - Receipt of long acting (depot) GnRH agonists within 6 months before enrollment. In contrast, subcutaneous GnRH agonist used for oocyte retrieval is not an exclusion; oral and other hormonal contraceptive use is also not an exclusion. Note: Please see protocol for the concomitant therapy restrictions for patients during the study treatment period. See protocol for information about oral and other hormonal contractive use during the study treatment period. - Prior receipt of systemic chemotherapy. However, steroids and intrathecal chemotherapy are permitted prior to study enrollment. - Any prior radiation to the pelvis; or cranial radiation ≥ 30 Gy to the hypothalamus, inclusive of any total body irradiation (TBI). - Patients who are pregnant are not eligible. A pregnancy test is required for female patients of childbearing potential. - Lactating females who plan to breastfeed their infants for the duration of triptorelin therapy (24 weeks per dose). - Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of triptorelin therapy (24 weeks per dose).

Gender: Female

Minimum age: N/A

Maximum age: 40 Years

Healthy volunteers: No

Start date: February 10, 2025

Completion date: October 30, 2029

Lead sponsor:
Agency: Children's Oncology Group
Agency class: Other

Source: Children's Oncology Group

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06513962