A Trial of Extracorporeal Photopheresis, Pentostatin, and Total Body Irradiation in Patients Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation for the Treatment of Malignancies
Condition: Hematologic Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to explore the use of a reduced intensity transplant conditioning regimen. A
      conditioning regimen is the treatment that is given to prepare a body for the new bone marrow
      that will be received from a donor. Reduced intensity conditioning uses lower doses of
      chemotherapy than conventional conditioning regimens. The use of lower doses of drugs and
      radiation cause fewer side effects. Reduced intensity regimens have been offered to older
      patients or patients at increased risk for transplant-related side effects and have been
      shown to be safe and effective. Reduced intensity conditioning regimens are now considered
      for many patients who are undergoing transplant.
    

Detailed description: 
      One of the complications of allogeneic stem cell transplant (ASCT) is graft versus host
      disease (GVHD). This is when the donor cells that are infused attack the body organs. This
      can cause serious illness and even death. The chance of getting serious life threatening GVHD
      with conventional transplant conditioning regimens is 25-50% depending on whether the donor
      bone marrow is from a family member or an unrelated person. The reduced intensity
      conditioning regimen used in this study involves a drug called pentostatin as well as a
      reduced dose of radiation and a treatment called photopheresis. This regimen has been
      successfully used in 106 patients. The incidence of serious GVHD in those patients was much
      less than expected: 8% for patients getting bone marrow from a family member and 23% for
      those getting bone marrow from an unrelated person. The pentostatin and radiation parts of
      this reduced intensity conditioning regimen are similar to other types of reduced intensity
      regimens, which use drugs similar to pentostatin. The unique part of this regimen compared to
      others is the use of extracorporeal photopheresis (ECP).

      While ECP has been used in 106 patients as part of a reduced intensity conditioning regimen,
      it is unknown whether adding ECP to pentostatin and radiation is what caused the reduced rate
      of GVHD that was seen in the previous study that was done. The use of ECP as part of a
      conditioning regimen is investigational. ECP is approved by the U.S. Food and Drug
      Administration (FDA) for the treatment of cutaneous T-cell lymphoma, but is not approved by
      the FDA for use prior to ASCT.

      Because it is not known whether the use of ECP in the reduced intensity conditioning regimen
      was what caused the low incidence of GVHD, this research study will look at differences in
      getting GVHD based on whether you receive ECP. Half the patients in this research study will
      receive ECP as part of their reduced intensity-conditioning regimen and the other half will
      not. Patients will be randomized (50% chance you will receive ECP and 50% chance you will
      not). Both groups will receive pentostatin and reduced dose total body irradiation. The
      primary purpose of this research study is to look at the chance of developing serious GVHD
      within the first 100 days after transplant within each group.
    

Intervention name(s): extracorporeal photopheresis; Pentostatin; Total Body Irradiation; Pentostatin; Total Body Irradiation
Intervention type(s): Procedure; Drug; Radiation; Drug; Radiation
Intervention description(s): Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.; pentostatin 8mg/m2 over 48 hours by continuous infusion; 600cGy TBI in 3 200cGy TBI fractions; pentostatin 8mg/m2 over 48 hours by continuous infusion; 600cGy TBI in 3 200cGy TBI fractions
Other intervention name(s): UVAR® XTS Photopheresis System; UVADEX®; 8-methoxypsoralen; methoxsalen; DCF; 2-Deoxycoformycin; Nipent; DCF; 2-Deoxycoformycin; Nipent
Intervention MeSH terms: Pentostatin; Methoxsalen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allogeneic Stem Cell Transplant