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

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leukemia; Multiple Myeloma; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma

Intervention: Palifermin (Biological); Lupron (Biological); peripheral blood stem cell transplantation (Procedure); Total-Body Irradiation (TBI) (Radiation); Thiotepa (Drug); Cyclophosphamide (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Miguel Perales, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

Overall contact:
Miguel Perales, MD, Phone: 212-639-8682

Summary

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. 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 leuprolide acetate can help the immune system recover faster after an allogenic transplant because experiments have shown they may be able to do this.

Clinical Details

Official title: A Phase II Study of Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: a CD4+ T cell count of greater than 200

Secondary outcome:

Overall Survival

Transplant Related Mortality

Incidence of infections

Relapse

Detailed description: 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. Patients randomized to receive Lupron will receive a three month depot dose 3-6 weeks prior to the start date of the pre-transplant conditioning regimen. 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. The preparative regimen to be used for transplants will consist of: hyperfractionated TBI administered in 11 doses over 4 days for a total of 1375 cGy, thiotepa 5 mg/kg/day IV x 2 days and cyclophosphamide with mesna prophylaxis 60 mg/kg/day IV x 2 days. All patients will receive ATG for two doses prior to transplant, except recipients of mismatched grafts (in the GVHD vector) will receive three doses. G-CSF mobilized CD34 PBSCs obtained from the HLA compatible donor will be infused on day 0. 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. Supportive care will be administered as per the BMT Service guidelines.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Treatment Portion:

- 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).

- 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

- CML failing to respond to or not tolerating imatinib, dasatinib or nilotinib in first

chronic phase of disease; CML in accelerated phase, second chronic phase, or in CR after accelerated phase or blast crisis.

- Non-Hodgkins lymphoma with chemo responsive disease in any of the following

categories: intermediate or high grade lymphomas who have failed to achieve a first CR or have relapsed following a 1st remission who are not candidates for autologous transplants. b. ii. any NHL in remission which is considered not curable with chemotherapy alone and not eligible/appropriate for autologous transplant.

- Myelodysplastic syndrome (MDS): RA/RCMD with high risk cytogenetic features or

transfusion dependence, RAEB-1 and RAEB-2

- Chronic myelomonocytic leukemia: CMML-1 and CMML-2.

- Patient's age is ≥18 or ≤60 years old

- Patients must have a Karnofsky (adult) or Lansky (pediatric) Performance Status ≥ 70%

- Patients must have adequate organ function measured by:

Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > 50% and must improve with exercise.

- Pulmonary: asymptomatic or if symptomatic, DLCO > 60% of predicted (corrected for

hemoglobin)

- Patients have a plan to receive a peripheral blood stem cell collection.

- Patients must have no change in disease status from treatment eligibility documented

by bone marrow or appropriate imaging within 30 days of transplant

- Patient's age is ≥18 or ≤60 years old Patients must have a Karnofsky (adult) or

Lansky (pediatric) Performance Status ≥ 70%

- Patients must have adequate organ function measured by:

1. Hepatic: < 3x ULN ALT and < 1. 5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia. 2. Renal: serum creatinine <1. 2 mg/dl or if serum creatinine is outside the normal range, then CrCl > 50 ml/min (measured or calculated/estimated)

- Patients must receive a peripheral blood stem cell transplant

Exclusion Criteria:

- 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.

- Pregnant or breast feeding

- HIV infection

- Patient is felt to not be a candidate for TBI by the BMT service

Donor Inclusion Criteria:

- Donor must be willing and able to undergo PBSC collection.

Locations and Contacts

Miguel Perales, MD, Phone: 212-639-8682

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting
Miguel Perales, MD, Phone: 212-639-8682
Ann Jakubowski, MD, PhD, Phone: 212-639-5013
Miguel Perales, MD, Principal Investigator
Additional Information

Memorial Sloan Kettering Cancer Center

Starting date: December 2012
Last updated: July 7, 2015

Page last updated: August 23, 2015

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