Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02356159
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — BIOLOGICAL
    Rituximab: 375 mg/m\^2 intravenous (IV) day 1 for patients with cluster of differentiation 20 (CD20)-positive disease.
  • Conditioning chemotherapy — DRUG
    Fludarabine:30 mg/m\^2 per day intravenous (IV) infusion over 30 minutes, daily on days -6, -5, -4, and -3; Cyclophosphamide:1200 mg/m\^2 per day IV infusion over 2 hours on Days 6, -5, -4, -3. Mesna: 1200 mg/m\^2 per day IV infusion, daily on days 6, -5, -4, and -3 Furosemide: 20 mg IV flat dose on days -6, -5, -4, -3; Furosemide: 20 mg IV flat dose on days -6, -5, -4, -3.
  • TMS — DRUG
    Tacrolimus: 0.02 mg/kg, start day 3. Continue intravenous (IV) or by mouth (PO). Taper will begin at day +60 if no acute graft-versus-host disease (GVHD) then at day +100 and discontinue at day +180 as tolerated. Methotrexate: 5 mg/m\^2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 60, followed by a taper if GVHD does not develop.
  • FLAG — DRUG
    Fludarabine: 25 mg/m\^2 per day intravenous (IV) over 30 minutes, daily on days 1-5 Cytarabine: 2,000 mg/m\^2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day subcutaneous (SC) beginning 24 hours PRIOR to initiation of chemotherapy.
  • EPOCH-F — DRUG
    Fludarabine: 25 mg/m\^2 per day intravenous (IV) infusion over 30 minutes, daily on days 1-4. Etoposide: 50 mg/m\^2 per day continuous IV infusion over 24 hours on days 1-4. Doxorubicin: 10 mg/m\^2/day continuous intravenous (CIV), days 1-4. Vincristine: 0.4 mg/m\^2 per day continuous IV infusion over 24 hours daily on days 1-4. Cyclophosphamide: 750 mg/m\^2 IV infusion over 30 minutes on day 5. Prednisone: 60 mg/m\^2 per day by mouth (PO) daily on days 1-5. Filgrastim: 5 mcg/kg per day SC or IV.
  • Hematopoietic stem cell transplant — PROCEDURE
    Hematopoietic stem cell transplant
  • Palifermin — DRUG
    Escalating doses of palifermin given during transplant phase.
  • Acetaminophen — DRUG
    Before each infusion of rituximab as indicated.
  • Diphenhydramine — DRUG
    Before each infusion of rituximab as indicated.
  • Prednisone — DRUG
    For engraftment syndrome.
  • Epinephrine — DRUG
    Emergency medication as indicated.
  • IV Saline — OTHER
    Before each infusion of rituximab as indicated.
  • ECG — DIAGNOSTIC_TEST
    As indicated.
  • ECHO — DIAGNOSTIC_TEST
    As indicated.
  • MUGA — DIAGNOSTIC_TEST
    As indicated.
  • DEXA — DIAGNOSTIC_TEST
    As indicated.
  • CT chest — DIAGNOSTIC_TEST
    As indicated.
  • PET — DIAGNOSTIC_TEST
    As indicated.
  • MRI — DIAGNOSTIC_TEST
    As indicated.
  • BM aspirate — PROCEDURE
    As indicated.
  • BM biopsy — PROCEDURE
    As indicated.
  • Lumbar puncture — PROCEDURE
    As indicated.

Study Details

Background: \- In allogeneic stem cell transplantation (SCT), stem cells are taken from a donor and given to a recipient. Sometimes the recipient's immune system destroys the donors' cells. Or donor immune cells attack the recipient's tissues, called graft-versus-host disease (GVHD). This is less likely when the recipient and donor have similar human leukocyte antigens (HLA). Researchers want to see if the drug palifermin improves the results of allogeneic SCT from HLA-matched unrelated donors. Objective: \- To see if high doses of palifermin before chemotherapy are safe, prevent chronic GVHD, and improve immune function after transplant. Eligibility: \- Adults 18 years of age or older with blood or bone marrow cancer with no HLA-matched sibling donor, but with a HLA-matched unrelated donor. Description of Research Study: * Participants will be screened with medical history, physical exam, and blood and urine tests. They will have scans and heart and lung exams. * Before transplant, participants will: * Have many tests and exams. These include blood tests throughout the study and bone marrow biopsy. * Get a central line catheter if they do not have one. * Have 1-3 rounds of chemotherapy. * Have more tests to make sure they can have the transplant, including medical history, physical exam, blood tests, disease specific restaging. * Get palifermin by intravenous (IV) and conditioning chemotherapy to prepare for hematopoietic stem cell transplantation (HSCT). They will get other drugs; some they will take at least 6 months. * Participants will get the HSCT. * After transplant, participants will: * Be hospitalized at least 3-4 weeks. * Monitored at least weekly for the first 100 days. * Stay near District of Columbia (D.C). for approximately 100 days post-transplant. * After 100 days post-transplant - visit National Institutes of Health (NIH) 5 times the first 2 years, then yearly until 5 years post-transplant. * Additional tests/procedures may be performed to monitor safety, response to transplant, side effects.

Key Dates

Start date
Sep 24, 2015
Status verified
Sep 2025
Primary completion
Dec 1, 2024
Completion
Mar 25, 2025

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 1/Phase 1: Dose Escalation Arm - Palifermin
    Induction chemotherapy, then palifermin at escalating doses, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.
  • Experimental: 2/Phase II Arm - Palifermin at the Recommended Phase 2 Dose
    Induction chemotherapy, then palifermin at the recommended phase 2 dose determined in Phase 1, then conditioning chemotherapy, then allogeneic stem cell transplant, then immunosuppression.

Primary Outcome Measure

Phase II: Estimated Percent of Participants Who Experienced Severe Chronic Graft Versus Host Disease (GVHD) [ Time Frame: 60 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-
National Marrow Donor ProgramMinneapolisMinnesota55401-

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