Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02356159

Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

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 donor s 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 70 with blood or bone marrow cancer with no HLA-matched sibling, but with a possible HLA-matched donor.

Design:

  • 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.
  • Take more tests to make sure they can have the transplant, including medical history, physical exam, and CT scan.
  • Get palifermin by IV and more chemotherapy. They will get other drugs, some they will take for 6 months.
  • Participants will get the SCT.
  • After transplant, participants will:
  • Be hospitalized at least 3 4 weeks.
  • Have tests for GVHD at 60 days and 6 months. These include mouth and skin photos and biopsies.
  • Stay near D.C. for 3 months.
  • Visit NIH 5 times the first 2 years, then yearly. They may have scans and biopsies.
Status: 
Recruiting
Study Date: 
Thu, 01/01/2015 to Tue, 01/01/2019
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Biological: Rituximab Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease Drug: Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 Furosemide: 20 mg IV flat dose on days -6, -5, -4, -3 Drug: TMS Tacrolimus: 0.02 mg/kg , start day 3. Continue IV or PO. Taper will begin at day +60 if no acute GVHD then at day +100 and discontinue at day +180 as tolerated. Methotrexate: 5 mg/m2 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. Drug: FLAG Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy Drug: EPOCH-F Fludarabine:25 mg/m2 per day IV infusion over 30 minutes, daily on days 1-4. Etoposide :50 mg/m2 per day continuous IV infusion over 24 hours on days 1-4. Doxorubicin:10 mg/m2/day CIV, days 1-4. Vincristine: 0.4 mg/m2 per day continuous IV infusion over 24 hours daily on days 1-4 Cyclophosphamide: 750 mg/m2 IV infusion over 30 minutes on day 5 Prednisone:60 mg/m2 per day PO daily on days 1-5. Filgrastim: 5 mcg/kg per day SC or IV. Procedure: Hematopoietic Stem Cell Transplant Hematopoietic stem cell transplant Drug: Palifermin Escalating doses of palifermin given during transplant phase