MDACC Study Summary ID01-710

Study Summary
No. ID01-710:.......Other Supportive......Naoto Ueno......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	ID01-710

Study Title:	PHASE II STUDY OF GnRH ANALOGUE FOR OVARIAN FUNCTION PRESERVATION IN HEMATOPOIETIC STEM CELL TRANSPLANTATION PATIENTS

Physician

New Patient Referral



Name:	Naoto Ueno	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-794-5780 Contact us about clinical trials

General Information



Disease Group:	Other Supportive	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Allogeneic: After discharged, clinic visit 2-3/wks up to 100 days after transplant, then monthly up to 1 yr. Autologous: After discharged, clinic visit 2-3/wks up to 30 days after transplant, then every 1-2 mos up to 1 yr.

Treatment Agents:	Leuprolide Acetate	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	3-4 weeks in-patient hospitalization for the hematopoietic stem cell transplantation

Description/
Intervention:

The goals of this clinical research study are to save the fertility of the
patients who have hematopoietic stem cell transplantation and to prevent them
from suffering the side effects of early menopause. Hematopoietic stem cells
are early or parent cells that are taken from the blood. Researchers also want
to see if the study drug, leuprolide, is able to save ovarian function of the
patients when they are receiving high dose chemotherapy and/or radiation
therapy.

Study Objectives / Outcomes

1. To determine the effectiveness of the 3-month depot leuprolide in inducing and maintaining secondary amenorrhea in patients undergo hematopoietic stem cell transplantation.
2. To determine the incidence of regained ovarian function manifested as spontaneous restoration of menstruation and normalization of hormonal level in patients after transplantation and discontinuation of long-acting leuprolide.

Study Status Information



Study Activation / Registration Date:	11/18/2002

IRB Review and Approval Date:	02/20/2002

Study Type:	Therapeutic

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Hematopoietic stem cell transplantation candidate.

2) Post-menarche female less than 40 years old.

3) Premenopausal before the start of transplantation, or the start of oral contraceptive pills.

4) FSH less than or equal to 20 IU/L and LH less than or equal to 20 IU/L within 1 weeks of initiation of injection or the ovarian status is determined by Gynecology Oncology Service.

5) Agree to stop any oral contraceptive pills for a period of 3-6 months starting 1 year post-transplant

Exclusion Criteria:

1) Breast cancer

2) Ovarian cancer

3) Pregnancy

4) Hypersensitivity to any GnRH analogs

Links

Registration Number: NCT00429494
Study Information on Clinical Trials Registry (clinicaltrials.gov)