Preservation of Ovarian Function After Hematopoietic Cell Transplant

University of Minnesota (UMN)

Status and phase: Terminated; Phase 2

Conditions: Multiple Myeloma; Myeloproliferative Disorders; Hodgkin Disease; Acute Myeloid Leukemia; Non-Hodgkin Lymphoma

Treatments: Drug: Leuprolide; Biological: hematopoietic cell transplant; Biological: reduced intensity allogeneic HCT

Study type: Interventional

Funder types: Other

Identifiers

NCT01343368

2010LS053

012M93555 (Other Identifier)

Details and patient eligibility

About

Women undergoing myeloablative allogeneic hematopoietic cell transplant (MA HCT) will receive GnRH agonist leuprolide. Women undergoing reduced intensity allogeneic (RIC) HCT will be observed.

Full description

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.

Enrollment: 19 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Interventional - Received Leuprolide

Experimental group

Description:

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.

Treatment:

Biological: hematopoietic cell transplant

Drug: Leuprolide

Observational Arm

Active Comparator group

Description:

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.

Treatment:

Biological: reduced intensity allogeneic HCT