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Preservation of Ovarian Function After Hematopoietic Cell Transplant

This study has been terminated.
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01343368
First received: March 15, 2011
Last updated: June 19, 2017
Last verified: February 2016
Results First Received: June 19, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.


Participant Flow:   Overall Study
    Interventional - Received Leuprolide   Observational Arm
STARTED   9   10 
COMPLETED   7   10 
NOT COMPLETED   2   0 
Death                1                0 
Lost to Follow-up                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

Total Total of all reporting groups

Baseline Measures
   Interventional - Received Leuprolide   Observational Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   10   17 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      7 100.0%      10 100.0%      17 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Comparison of Number of Patients With Ovarian Failure   [ Time Frame: Through Day 180 Post Transplant ]

2.  Secondary:   Comparison of Number of Patients Who Stopped Menstrual Bleeding   [ Time Frame: From Baseline Through Day 365 ]

3.  Secondary:   Comparison of Follicle Stimulating Hormone (FSH) Levels   [ Time Frame: Baseline ]

4.  Secondary:   Comparison of Follicle Stimulating Hormone (FSH) Levels   [ Time Frame: Day 100 ]

5.  Secondary:   Comparison of Follicle Stimulating Hormone (FSH) Levels   [ Time Frame: Day 180 ]

6.  Secondary:   Comparison of Follicle Stimulating Hormone (FSH) Levels   [ Time Frame: 1 year ]

7.  Secondary:   Comparison of Follicle Stimulating Hormone (FSH) Levels   [ Time Frame: 2 years ]

8.  Secondary:   Comparison of Number of Patients Who Resumed Menstrual Cycles   [ Time Frame: Day 365 Post Transplant ]

9.  Secondary:   Comparison of Lutineizing Hormone (LH) Levels   [ Time Frame: Baseline ]

10.  Secondary:   Comparison of Luteinizing Hormone (LH) Levels   [ Time Frame: Day 100 ]

11.  Secondary:   Comparison of Luteinizing Hormone (LH) Levels   [ Time Frame: Day 180 ]

12.  Secondary:   Comparison of Luteinizing Hormone (LH) Levels   [ Time Frame: 1 year ]

13.  Secondary:   Comparison of Leuprolide Hormone (LH) Levels   [ Time Frame: 2 years ]

14.  Secondary:   Comparison of Antimullerian Hormone (AMH) Levels After Transplant   [ Time Frame: Day Prior to Transplant ]

15.  Secondary:   Comparison of Antimullerian Hormone (AMH) Levels After Transplant   [ Time Frame: Day 180 after Transplant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: smith719@umn.edu



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 )
Study First Received: March 15, 2011
Results First Received: June 19, 2017
Last Updated: June 19, 2017