Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation

What Was Tested

In this phase 2 trial, researchers set out to test Leuprolide.

One problem with these transplants is that the new immune cells may not work as well in the recipient as they did in the donor.

The result may be that the immune system will not work as well.

It had five arms (groups): Arm1 First Transplt/males/leuprolide/+/-FLT Imaging (active comparator), Arm2 First Transplt/males/No Leuprolide/+/- FLT Imaging (active comparator), Arm3 First Transplt/females/leuprolide+/- FLT Imaging (experimental), Arm4-Second Transplt/leuprolide and FLT Imaging (experimental) and Healthy Volunteer - Arm 5 (no intervention).

Males randomized to leuprolide for first transplant. \[18F\]fluorothymidine (FLT) imaging.

Males not receiving leuprolide for first transplant \[18F\]fluorothymidine (FLT) imaging.

Females receiving leuprolide for first transplant. \[18F\]fluorothymidine (FLT) imaging.

The registry classes the interventions as drug, procedure and radiation.

More on the Plan

All patients will undergo FLT imaging to evaluate whether this may predict BMT response or failure (relapse).

An estimated 50 patients (including subset of the 23 patients undergoing serial scanning) will be imaged approximately at 1 year for evaluation of thymus reconstitution.

The total possible numbers will include no more than 118 patients to achieve the 68 evaluable adults for the immunological primary endpoint.

However, all 23 FLT PET/CT imaged NCI patients will undergo a single 1 year FLT for evaluation of thymus reconstitution.

Who Took Part

76 actual participants took part.

It was open to people of any sex aged from 4 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: At University of Oklahoma: Age greater than or equal to 17 years old and less than or equal to 55 years for recipient. A diagnosis of a hematologic malignancy for which stem cell transplant is standard of care:. Acute Lymphocytic Leukemia (ALL). Matched sibling donor for recipient treated on adult leukemia regimen. Primary induction failure, defined as failure to achieve CR with primary induction chemotherapy.

The full record lists 38 inclusion and 28 exclusion criteria; among the exclusions: history of psychiatric disorder which may compromise compliance with transplant protocol, or which does not allow for appropriate informed consent; active infections not responding to therapy. all efforts should be made to clear the infection prior to enrollment; presence of active malignancy from an organ system other than hematopoietic.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Leuprolide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.

It started in 2011-04-19 with completion listed for 2017-12-01.

It ran at 3 sites in United States (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of B Cells at One Year Post-transplant in Participants Who Did/Did Not Receive Leuprolide Following Bone Marrow Transplant (BMT) (time frame: after first Bone Marrow Transplant, approximately 12 months post-transplant). Time to Engraftment in First Transplant Recipients Only With Median Thoracic Spine Standardized Uptake Values (SUV) of 1.4 or Greater Than Those Patients With SUV's Less Than 1.4 (time frame: 18F FLT scan done between days +5 to +12 and then time from that scan to engraftment measured). Number of Adverse Events Related to Study Drug Experienced by Participants After Second Bone Marrow Transplant (BMT) (time frame: 12 months after second BMT).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 76 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.