Palifermin With or Without Leuprolide Acetate Versus Control for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation
The purpose of this study is to help determine if palifermin and/or 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. The donor can be a family member or a volunteer donor. This is called an allogeneic stem cell transplant.
The investigators want to see if palifermin and/or leuprolide acetate can help the immune system recover faster after an allogenic transplant because experiments have shown they may be able to do this.
Other: without the addition of palifermin or Lupron
Procedure: peripheral blood stem cell transplantation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Randomized Phase II Study of Palifermin With or Without Leuprolide Acetate Versus Control for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation|
- a CD4+ T cell count of greater than 200 [ Time Frame: 6 months ] [ Designated as safety issue: No ]Will be documented by flow cytometry performed in the clinical lab on peripheral blood.
- Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Overall survival is defined as the time from transplant to death of last follow-up.
- Transplant Related Mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]TRM is defined as death at any time from the commencement of pre-transplant conditioning due to any cause other than disease relapse with the exception of automobile or other accidents.
- Incidence of infections [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Any bacterial, viral, fungal or parasitic infection that necessitates therapy will be noted.
- Relapse [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Patients assigned to receive palifermin will receive this drug at 60mcg/kg/day IV on three consecutive days 24 hours apart with the last dose administered no less than 24 and no more than 48 hours prior to the start of cytoreduction
|Biological: Palifermin Procedure: peripheral blood stem cell transplantation|
Experimental: palifermin with Lupron
Patients assigned to receive palifermin will receive three additional daily doses of the drug, the first approximately 6 hours after the stem cell infusion on day 0, followed by two daily doses given at 24 hour intervals on d+1 and d+2. Patients assigned to receive Lupron will receive a further 3-month depot injection approximately 3 months (+/- one week) post the first dose.
|Biological: Lupron Procedure: peripheral blood stem cell transplantation|
Active Comparator: control
The control arm consists of a standard TCD (allo-HSCT) without the addition of palifermin or Lupron.
|Other: without the addition of palifermin or Lupron Procedure: peripheral blood stem cell transplantation|
|Contact: Jenna Goldberg, MD||212-639-4828|
|Contact: Miguel Perales, MD||212-639-8682|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Jenna Goldberg, MD 212-639-4828|
|Contact: Miguel Perales, MD 212-639-8682|
|Principal Investigator: Jenna Goldberg, MD|
|Principal Investigator:||Jenna Goldberg, MD||Memorial Sloan-Kettering Cancer Center|