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

NCT01746849 | Active Not Recruiting Phase 2

• 1 other identifier: 12-077
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia; Multiple Myeloma; Myelodysplastic Syndrome; Non-Hodgkin's Lymphoma

Keywords

LUPRON DEPOT; PALIFERMIN; 12-077

Outcome Measures

Primary Outcomes (1)

• a CD4+ T cell count of greater than 200

  Will be documented by flow cytometry performed in the clinical lab on peripheral blood.

  6 months

Secondary Outcomes (4)

• Overall Survival

  2 years

• Transplant Related Mortality

  6 months

• Incidence of infections

  2 years

• Relapse

  12 months

Study Arms (2)

palifermin with Lupron

EXPERIMENTAL

All patients undergo total body irradiation (TBI) on days -9 to -6 \& receive thiotepa intravenously (IV) over 2-4 hours on days -5 to -4, cyclophosphamide IV over 30-60 minutes on days -3 to -2, \& anti-thymocyte globulin infused over 12 hours on days -3 to -2 Pts undergo T-cell depleted allogeneic hematopoietic stem cell transplant on day 0. Pts will receive a three month depot dose of Lupron 3-6 weeks prior to the start date of the pre-transplant conditioning regimen. Pts will receive palifermin at 60mcg/kg/day IV on three consecutive days, 24 hours apart with the last dose administered no less than 24 \& no more than 48 hours prior to the start of cytoreduction. Pts will receive three additional daily doses of palifermin 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 \& d+2. Pts will receive a further 3-month depot injection of Lupron approximately 3 months (+/- one week) post the first dose.

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

palifermin with Degarelix

EXPERIMENTAL

Participants on the degarelix arm will receive a loading dose of degarelix 240 mcg subcutaneous 4-14 days before the start of pre-transplant conditioning. All participants will receive palifermin 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; Radiation: Total-Body Irradiation (TBI); Drug: Thiotepa; Drug: Cyclophosphamide; Drug: Degarelix

Interventions

Palifermin BIOLOGICAL

palifermin with Degarelix; palifermin with Lupron

Lupron BIOLOGICAL

palifermin with Lupron

Total-Body Irradiation (TBI) RADIATION

palifermin with Degarelix; palifermin with Lupron

peripheral blood stem cell transplantation PROCEDURE

palifermin with Degarelix; palifermin with Lupron

Thiotepa DRUG

palifermin with Degarelix; palifermin with Lupron

Cyclophosphamide DRUG

palifermin with Degarelix; palifermin with Lupron

Degarelix DRUG

palifermin with Degarelix

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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
• 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:

You may not qualify if:

• 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 must be willing and able to undergo PBSC collection.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Swedish Orphan Biovitrum: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Leukemia; Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma, Non-Hodgkin

Interventions

Fibroblast Growth Factor 7; Leuprolide; Peripheral Blood Stem Cell Transplantation; Whole-Body Irradiation; Thiotepa; Cyclophosphamide; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Lymphoma; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Fibroblast Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Oligopeptides; Nerve Tissue Proteins; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Radiotherapy; Investigative Techniques; Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Miguel Angel Perales, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 11, 2012
• Study Start: December 1, 2012
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)