A Phase II Trial of GnRH Agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Comparison of Number of Patients With Ovarian Failure
研究概览
简要总结
Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed.
详细描述
This study is to use gonadotropin releasing hormone (GnRH) agonist leuprolide prior myeloablative hematopoietic cell transplantation to prevent ovarian dysfunction in post-menarchal women.
The primary objective is to determine the effect of GnRH agonists on the incidence of ovarian failure.
The secondary objectives are
- to determine how effective GnRH agonists are at suppressing menses during
- to determine the incidence and timing of resumption of menstrual cycles after HCT
- to determine the incidence and timing of resumption of normal FSH and LH levels after HCT
- to determine the incidence of normal AMH levels after HCT
- to determine the effect of GnRH agonists on immune reconstitution after HCT
- to assess the safety and tolerability of GnRH agonists in the context of HCT
A total of 47 patients will be accrued in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Interventional Arm:
- •Eligible for myeloablative allogenic or autologous hematopoietic cell transplant (HCT)
- •Post-menarchal female < or = 50 years of age
- •Normal antimullerian hormone (AMH) level and/or follicle stimulating hormone (FSH)/leuprolide (LH) levels for age/stage of puberty
- •Those women who have an FSH > 40 IU/L and whose diagnosis of malignancy and whose chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis.
- •Observational Arm:
- •Eligible for reduced intensity allogeneic HCT
- •Post-menarchal female ≤ 50 years of age
- •Normal AMH level and/or FSH/LH for age/stage of puberty
- •Those women who an FSH >40 IU/L and whose diagnosis of malignancy and chemotherapy treatment was within 12 weeks of enrollment are still eligible if they had normal menstrual cycles pre-diagnosis.
排除标准
- •All Arms:
- •History of ovarian cancer
- •Surgical resection of one or both ovaries. Prior hysterectomy is allowed as long as the ovaries are intact.
- •Use of GnRH agonist in last 12 months will exclude patients if lab results are not available to demonstrate adequate ovarian function prior to initiation of GnRH therapy.
研究组 & 干预措施
Interventional - Received Leuprolide
Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
干预措施: Leuprolide (Drug)
Interventional - Received Leuprolide
Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-HCT and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days for patients who undergo myeloablative allogeneic or autologous hematopoietic cell transplantation.
干预措施: hematopoietic cell transplant (Biological)
Observational Arm
Women undergoing reduced intensity allogeneic HCT will be observed. Progestin contraceptives, Norethindrone acetate, and any other hormone methods can be used according to the prescription guidelines except for GnRH agonists to suppress menses.
干预措施: reduced intensity allogeneic HCT (Biological)
结局指标
主要结局
Comparison of Number of Patients With Ovarian Failure
时间窗: Through Day 180 Post Transplant
Comparison of treatment arms; interventional versus observational. Ovarian failure rate is based on FSH measured at 180 days after HCT; to determine the effect of GnRH agonists on the incidence of ovarian failure (i.e. FSH \>40 IU/L) after transplant.
次要结局
- Comparison of Number of Patients Who Resumed Menstrual Cycles(Day 365 Post Transplant)
- Comparison of Luteinizing Hormone (LH) Levels(1 year)
- Comparison of Antimullerian Hormone (AMH) Levels After Transplant(Day 180 after Transplant)
- Comparison of Number of Patients Who Stopped Menstrual Bleeding(From Baseline Through Day 365)
- Comparison of Leuprolide Hormone (LH) Levels(2 years)
- Comparison of Follicle Stimulating Hormone (FSH) Levels(2 years)
- Comparison of Lutineizing Hormone (LH) Levels(Baseline)