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Preservation of Ovarian Function After Hematopoietic Cell Transplant

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ClinicalTrials.gov Identifier: NCT01343368
Recruitment Status : Terminated
First Posted : April 28, 2011
Results First Posted : July 17, 2017
Last Update Posted : December 5, 2017
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Multiple Myeloma
Non-Hodgkin Lymphoma
Hodgkin Disease
Acute Myeloid Leukemia
Myeloproliferative Disorders
Interventions Drug: Leuprolide
Biological: hematopoietic cell transplant
Biological: reduced intensity allogeneic HCT
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Period Title: Overall Study
Started 9 10
Completed 7 10
Not Completed 2 0
Reason Not Completed
Death             1             0
Lost to Follow-up             1             0
Arm/Group Title Interventional - Received Leuprolide Observational Arm Total
Hide Arm/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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 7 10 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
<=18 years
2
  28.6%
6
  60.0%
8
  47.1%
Between 18 and 65 years
5
  71.4%
4
  40.0%
9
  52.9%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
Female
7
 100.0%
10
 100.0%
17
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Comparison of Number of Patients With Ovarian Failure
Hide 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.
Time Frame Through Day 180 Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 7 10
Measure Type: Count of Participants
Unit of Measure: Participants
3
  42.9%
1
  10.0%
2.Secondary Outcome
Title Comparison of Number of Patients Who Stopped Menstrual Bleeding
Hide Description 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
Time Frame From Baseline Through Day 365
Hide Outcome Measure Data
Hide Analysis Population Description
Five patients on the Interventional arm and 10 patients on the Observational arm were lost to follow-up by Day 365.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 2 0
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
0
3.Secondary Outcome
Title Comparison of Follicle Stimulating Hormone (FSH) Levels
Hide Description Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: IU/L
9.3  (8.0) 4.4  (1.7)
4.Secondary Outcome
Title Comparison of Follicle Stimulating Hormone (FSH) Levels
Hide Description Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: IU/L
18.4  (19.5) 9.1  (12.7)
5.Secondary Outcome
Title Comparison of Follicle Stimulating Hormone (FSH) Levels
Hide Description Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: IU/L
47.0  (40.1) 4.7  (4.7)
6.Secondary Outcome
Title Comparison of Follicle Stimulating Hormone (FSH) Levels
Hide Description Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 4 2
Mean (Standard Deviation)
Unit of Measure: IU/L
61.5  (97.6) 48.8  (84.5)
7.Secondary Outcome
Title Comparison of Follicle Stimulating Hormone (FSH) Levels
Hide Description Comparison of treatment arms; interventional versus observational average FSH levels.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 0 2
Mean (Standard Deviation)
Unit of Measure: IU/L
7.1  (4.6)
8.Secondary Outcome
Title Comparison of Number of Patients Who Resumed Menstrual Cycles
Hide Description Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant
Time Frame Day 365 Post Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Only 6 of the 10 patients that started on the Observational Arm were evaluable. The 2 patients were lost to follow-up.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 7 6
Measure Type: Count of Participants
Unit of Measure: Participants
2
  28.6%
4
  66.7%
9.Secondary Outcome
Title Comparison of Lutineizing Hormone (LH) Levels
Hide Description Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: IU/L
19.8  (30.2) 6.8  (7.6)
10.Secondary Outcome
Title Comparison of Luteinizing Hormone (LH) Levels
Hide Description Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: IU/L
2.4  (2.7) 6.4  (7.7)
11.Secondary Outcome
Title Comparison of Luteinizing Hormone (LH) Levels
Hide Description Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: IU/L
31.1  (32.0) 4.3  (3.0)
12.Secondary Outcome
Title Comparison of Luteinizing Hormone (LH) Levels
Hide Description Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 4 2
Mean (Standard Deviation)
Unit of Measure: IU/L
31.9  (36.1) 27.8  (41.6)
13.Secondary Outcome
Title Comparison of Leuprolide Hormone (LH) Levels
Hide Description Comparison of treatment arms; interventional versus observational average LH levels during study.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 0 2
Mean (Standard Deviation)
Unit of Measure: IU/L
5.6  (4.3)
14.Secondary Outcome
Title Comparison of Antimullerian Hormone (AMH) Levels After Transplant
Hide Description Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.
Time Frame Day Prior to Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Six patients on the Observational arm never had any follow-up AMH levels drawn and were removed from this analysis.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 7 4
Mean (Standard Deviation)
Unit of Measure: ng/ml
0.6  (0.9) 6.4  (7.7)
15.Secondary Outcome
Title Comparison of Antimullerian Hormone (AMH) Levels After Transplant
Hide Description Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.
Time Frame Day 180 after Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

Overall Number of Participants Analyzed 3 0
Mean (Standard Deviation)
Unit of Measure: ng/ml
0.08  (0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Interventional - Received Leuprolide Observational Arm
Hide Arm/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.

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.

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.

All-Cause Mortality
Interventional - Received Leuprolide Observational Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Interventional - Received Leuprolide Observational Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Interventional - Received Leuprolide Observational Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   3/7 (42.86%)   0/10 (0.00%) 
Psychiatric disorders     
Mood Liability  3/7 (42.86%)  0/10 (0.00%) 
Vascular disorders     
Hot Flashes  3/7 (42.86%)  0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Angela Smith
Organization: Masonic Cancer Center, University of Minnesota
Phone: 612-626-8094
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01343368     History of Changes
Other Study ID Numbers: 2010LS053
012M93555 ( Other Identifier: Institutional Review Board, University of Minnesota )
First Submitted: March 15, 2011
First Posted: April 28, 2011
Results First Submitted: June 19, 2017
Results First Posted: July 17, 2017
Last Update Posted: December 5, 2017