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A Phase II Trial of GnRH Agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)


Phase 2
50 Years
N/A
Open (Enrolling)
Female
Any Disease Requiring Hematopoietic Cell Transplant

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Trial Information

A Phase II Trial of GnRH Agonist for the Preservation of Ovarian Function After Hematopoietic Cell Transplantation (HCT)


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Comparison of Number of Patients with Ovarian Failure

Outcome Description:

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.

Outcome Time Frame:

Day 180 Post Transplant

Safety Issue:

No

Principal Investigator

Angela Smith, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2010LS053

NCT ID:

NCT01343368

Start Date:

July 2011

Completion Date:

December 2015

Related Keywords:

  • Any Disease Requiring Hematopoietic Cell Transplant
  • Post-menarchal

Name

Location

Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota  55455