Clinical trial NCT00639717 (phase 2, status: completed)
Conditions: graft versus host disease
ICD codes: D89.810, D89.811, D89.813, D89.812
Drugs: tacrolimus (standard gvhd prophylaxis), mycophenolate (standard gvhd prophylaxis), etanercept, methoxsalen
SMILES: CO[C@@H]1C[C@@H](CC[C@H]1O)\C=C(/C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@]2(O)O[C@@H]([C@H](C[C@H]2C)OC)[C@H](C[C@@H](C)C\C(C)=C\[C@@H](CC=C)C(=O)C[C@H](O)[C@H]1C)OC, COC1=C(C\C=C(/C)CCC(O)=O)C(O)=C2C(=O)OCC2=C1C, [O-][N+](=O)OC[C@@H](O[N+]([O-])=O)[C@H](CO[N+]([O-])=O)O[N+]([O-])=O, COC1=C2OC(=O)C=CC2=CC2=C1OC=C2
Eligibility criteria:

        Inclusion Criteria:

          -  Candidate for unrelated donor (allogeneic) HSCT for hematologic conditions, either
             malignant or non-malignant.

          -  Donor can be unrelated marrow, blood or cord blood.

          -  Any disease for which unrelated donor transplant is appropriate is eligible except:

               -  Progressive or poorly controlled malignancies for which the likelihood of durable
                  disease control [i.e., patients expected to have at least 6 months PFS from date
                  of transplant] is <25%.

               -  This determination of likelihood of durable disease control must take into
                  account the patient's disease status and consideration of the agents and doses
                  used in the reduced intensity conditioning regimen.

               -  The determination of adequate disease control will be certified by the PI or
                  designee on the eligibility checklist.

               -  Patients may be consented to this trial based on disease control at the time of
                  consent, but later removed from the trial prior to initiation of transplant
                  conditioning regimen if disease status confirmation between consenting and
                  transplant changes. In the event this occurs these patients will be replaced.

          -  Must be receiving a recognized reduced intensity transplant as determined by the
             University of Michigan Blood and Marrow Transplantation Program.

          -  Patients age 50 or older are eligible based on age.

          -  Patients may be <50 years old if they are eligible for a reduced intensity
             conditioning regimen based on disease type (eg, indolent lymphoma) or if comorbidities
             preclude a full-intensity transplant.

          -  Patients must have adequate venous access by either peripheral vein or central line so
             that ECP can be performed.

          -  Patients must be expected to tolerate the fluid shifts associated with ECP. The
             primary reason for expected intolerance of ECP is small size (ie, <30kg weight), but
             other factors may also be considered in this determination.

        Exclusion Criteria:

          -  Not a candidate for a reduced intensity transplant conditioning regimen (based on the
             current U-M BMT program clinical guidelines).

          -  Patient has a suitable related donor available for transplant.

          -  Karnofsky or Lansky performance status of < 50% at the time of admission for HSCT

          -  Patients with evidence of HIV infection or other opportunistic infection including but
             not limited to Tuberculosis and Histoplasmosis.

          -  Patients with active bacterial, fungal or viral infection not responding to treatment.

          -  Any medical or psychological conditions that would keep the patient from complying
             with the protocol and/or would markedly increase the morbidity and mortality from the
             procedure.

          -  Pregnancy.

          -  T-cell depleted allograft