Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation

What Was Tested

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

The purpose of this study is to help determine if palifermin and leuprolide acetate can help the immune system recover faster following a stem cell transplant.

Blood stem cells are very young blood cells that grow in the body to become red or white blood cells or platelets.

The transplant uses stem cells in the blood from another person.

It had two arms (groups): palifermin with Lupron (experimental) and palifermin with Degarelix (experimental).

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

More on the Plan

Patients will be randomized to one of two arms: palifermin with Lupron, and control.

The control arm consists of a standard TCD allo-HSCT without the addition of palifermin or Lupron.

G-CSF mobilized CD34 PBSCs obtained from the HLA compatible donor will be infused on day 0.

Supportive care will be administered as per the BMT Service guidelines.

Who Took Part

82 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: AML in 1st remission - for patients whose AML does not have "good risk" cytogenetic features (i.e. t (8;21), t(15;17), inv 16 without c-kit mutations). Acute leukemias of ambiguous lineage in ≥ 1st remission. Secondary AML in remission. AML in ≥ 2nd remission. ALL in 1st remission with clinical or molecular features indicating a high risk for relapse; or ALL ≥ 2nd remission.

The full record lists 16 inclusion and 7 exclusion criteria; among the exclusions: active extramedullary disease; active and uncontrolled infection at time of transplantation; patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.

How the Study Was Run

Design: non-randomized, single-group and open-label.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-12 with completion listed for 2026-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: a CD4+ T cell count of greater than 200 (time frame: 6 months).

It also tracked 4 secondary outcomes, for example Overall Survival, Transplant Related Mortality, Incidence of infections and Relapse.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Leuprolide and Degarelix in 82 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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