Status:
COMPLETED
Addition of Etanercept and Extracorporeal Photopheresis (ECP) to Standard Graft-Versus-Host Disease (GVHD) Prophylaxis in Stem Cell Transplant
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Mallinckrodt
Amgen
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This research study investigates the benefits and possible risks of adding both etanercept (Enbrel) and ECP (extracorporeal photopheresis) to the conventional preventative (or prophylactic) treatments...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00639717
Start Date
March 1 2009
End Date
April 1 2016
Last Update
August 1 2017
Active Locations (1)
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1
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109