Preservation of Ovarian Function After Hematopoietic Cell... | NCT01343368

ID	Type	Description	Link
012M93555	Other Identifier	Institutional Review Board, University of Minnesota

Name	Class
Minnesota Medical Foundation	OTHER

Label	Type	Description	Intervention Names
Interventional - Received Leuprolide	Experimental	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.	Drug: Leuprolide Biological: hematopoietic cell transplant
Observational Arm	Active Comparator	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.	Biological: reduced intensity allogeneic HCT

Name	Type	Description	Arm Group Labels	Other Names
Leuprolide	Drug	Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days

Measure	Description	Time Frame
Comparison of Number of Patients With Ovarian Failure	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.	Through Day 180 Post Transplant

Measure	Description	Time Frame
Comparison of Number of Patients Who Stopped Menstrual Bleeding	Comparison of treatment arms; interventional versus observational. Count of patients who stopped menstrual bleeding; to determine how the effect of GnRH agonists are at suppressing menses during hematopoietic cell transplant	From Baseline Through Day 365

Name	Affiliation	Role
Angela Smith, M.D.	Masonic Cancer Center, University of Minnesota	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Masonic Cancer Center, University of Minnesota		Minneapolis	Minnesota	55455	United States

ID	Title	Description
FG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.

ID	Title	Description
BG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
BG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0007 BG00110 BG00217

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Comparison of Number of Patients With Ovarian Failure

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.

Posted

Count of Participants

Participants

Through Day 180 Post Transplant

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Units	Counts
Participants	OG0007 OG00110

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0011

Secondary

Comparison of Number of Patients Who Stopped Menstrual Bleeding

Comparison of treatment arms; interventional versus observational. Count of patients who stopped menstrual bleeding; to determine how the effect of GnRH agonists are at suppressing menses during hematopoietic cell transplant

Five patients on the Interventional arm and 10 patients on the Observational arm were lost to follow-up by Day 365.

Posted

Count of Participants

Participants

From Baseline Through Day 365

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Secondary

Comparison of Follicle Stimulating Hormone (FSH) Levels

Comparison of treatment arms; interventional versus observational average FSH levels.

Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis.

Posted

Mean

Standard Deviation

IU/L

Baseline

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Secondary

Comparison of Follicle Stimulating Hormone (FSH) Levels

Comparison of treatment arms; interventional versus observational average FSH levels.

Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.

Posted

Mean

Standard Deviation

IU/L

Day 100

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Secondary

Comparison of Follicle Stimulating Hormone (FSH) Levels

Comparison of treatment arms; interventional versus observational average FSH levels.

Posted

Mean

Standard Deviation

IU/L

Day 180

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Secondary

Comparison of Follicle Stimulating Hormone (FSH) Levels

Comparison of treatment arms; interventional versus observational average FSH levels.

Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. Three patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.

Posted

Mean

Standard Deviation

IU/L

1 year

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Secondary

Comparison of Follicle Stimulating Hormone (FSH) Levels

Comparison of treatment arms; interventional versus observational average FSH levels.

Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. All 7 patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.

Posted

Mean

Standard Deviation

IU/L

2 years

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Secondary

Comparison of Number of Patients Who Resumed Menstrual Cycles

Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant

Only 6 of the 10 patients that started on the Observational Arm were evaluable. The 2 patients were lost to follow-up.

Posted

Count of Participants

Participants

Day 365 Post Transplant

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Secondary

Comparison of Lutineizing Hormone (LH) Levels

Comparison of treatment arms; interventional versus observational average LH levels during study.

Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis.

Posted

Mean

Standard Deviation

IU/L

Baseline

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Secondary

Comparison of Luteinizing Hormone (LH) Levels

Comparison of treatment arms; interventional versus observational average LH levels during study.

Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.

Posted

Mean

Standard Deviation

IU/L

Day 100

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Secondary

Comparison of Luteinizing Hormone (LH) Levels

Comparison of treatment arms; interventional versus observational average LH levels during study.

Posted

Mean

Standard Deviation

IU/L

Day 180

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Secondary

Comparison of Luteinizing Hormone (LH) Levels

Comparison of treatment arms; interventional versus observational average LH levels during study.

Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. Three patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.

Posted

Mean

Standard Deviation

IU/L

1 year

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Secondary

Comparison of Leuprolide Hormone (LH) Levels

Comparison of treatment arms; interventional versus observational average LH levels during study.

Posted

Mean

Standard Deviation

IU/L

2 years

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Secondary

Comparison of Antimullerian Hormone (AMH) Levels After Transplant

Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.

Six patients on the Observational arm never had any follow-up AMH levels drawn and were removed from this analysis.

Posted

Mean

Standard Deviation

ng/ml

Day Prior to Transplant

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Secondary

Comparison of Antimullerian Hormone (AMH) Levels After Transplant

Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.

Four patients on the Observational and 10 patients on the Observational arm never had any follow-up AMH levels drawn and were removed from this analysis.

Posted

Mean

Standard Deviation

ng/ml

Day 180 after Transplant

ID	Title	Description
OG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.
OG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hot Flashes	Vascular disorders				EG0003 affected7 at risk EG0010 affected10 at risk
Mood Liability	Psychiatric disorders				EG0003 affected7 at risk EG0010 affected10 at risk

ID	Term
D009101	Multiple Myeloma
D008228	Lymphoma, Non-Hodgkin
D006689	Hodgkin Disease
D015470	Leukemia, Myeloid, Acute
D009196	Myeloproliferative Disorders

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006474	Hemorrhagic Disorders
D008232	Lymphoproliferative Disorders
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D008223	Lymphoma
D008206	Lymphatic Diseases
D007951	Leukemia, Myeloid
D007938	Leukemia
D001855	Bone Marrow Diseases

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D009479	Neuropeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D009842	Oligopeptides
D009419	Nerve Tissue Proteins
D011506	Proteins

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. Leuprolide: Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days hematopoietic cell transplant: Conventional bone marrow transplant regimen.			0	7	3	7
EG001	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. reduced intensity allogeneic HCT: A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.			0	10	0	10