A Study to Evaluate the Ability of Lupron Depot to Enhance Immune Function Following Bone Marrow Transplantation

What Was Tested

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

It had two arms (groups): one (experimental) and Placebo Comparator (placebo comparator).

Three intramuscular injections of matched placebo administered approximately 3 months apart.

The registry classes the interventions as drug.

More on the Plan

Patients will be evaluated to determine if the rate of immunologic recovery in the LAD group is enhanced compared with the placebo group.

Who Took Part

25 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Must have Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, or mantle cell lymphoma and be considered an appropriate candidate for hematopoietic stem cell transplant. Multiple myeloma patients should have had a partial or complete response to chemotherapy. Must be seronegative for hepatitis C and HIV. Must have received prior tetanus immunization. Must not have received prior KLH immunization.

The full record lists 13 inclusion and 14 exclusion criteria; among the exclusions: must not have an uncontrolled life-threatening infection (or active infectious process requiring intravenous \[iv\] systemic medical therapy within 1 week prior to study enrollment); must not have a diagnosed or suspected schistosomiasis infection; must not have previously received hematopoietic stem cell transplantation.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received Leuprolide.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2006-02 with completion listed for 2009-02.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 25 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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