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Addition of Etanercept and Extracorporeal Photopheresis to Standard GVHD Prophylaxis in Patients Undergoing Reduced Intensity Unrelated Donor Hematopoietic Stem Cell Transplant


Phase 2
N/A
N/A
Open (Enrolling)
Both
Graft Versus Host Disease

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Trial Information

Addition of Etanercept and Extracorporeal Photopheresis to Standard GVHD Prophylaxis in Patients Undergoing Reduced Intensity Unrelated Donor Hematopoietic Stem Cell Transplant


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Patients who are alive, in remission, and at very low dose steroids at 6 months post-transplant

Outcome Time Frame:

180 days

Safety Issue:

Yes

Principal Investigator

John E Levine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

umcc 2008.003

NCT ID:

NCT00639717

Start Date:

March 2009

Completion Date:

September 2015

Related Keywords:

  • Graft Versus Host Disease
  • GVHD
  • Graft vs Host Disease

Name

Location

University of Michigan Cancer Center Ann Arbor, Michigan  48109