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Phase I- II Study of in Vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus With or Without Vidaza (Azacitidine) for the Treatment of Steroid-refractory Acute Graft-versus-host Disease


Phase 1/Phase 2
18 Years
70 Years
Not Enrolling
Both
Graft Versus Host Disease

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Trial Information

Phase I- II Study of in Vivo Regulatory T Cell Enhancement With Cyclophosphamide and Sirolimus With or Without Vidaza (Azacitidine) for the Treatment of Steroid-refractory Acute Graft-versus-host Disease


Inclusion Criteria:



- Patients must have a documented clinical diagnosis of grade II-IV acute graft-versus-
host disease defined as GVHD occurring within the first 100 days of transplantation

- Patients must be steroid-refractory defines as progression after 3 days of
corticosteroid therapy or no response after 5 days of corticosteroid therapy.

- Progression is defined as up-grading

- No response is defined as no down-grading

- Progression after 3 days requires patients to have received at least 2 mg/mg/day for
a total of 6 mg/kg of methylprednisolone or its equivalent.

- No response after 5 days requires patient to have received at least 2 mg/kg/d for a
total of 10 mg/kg of methylprednisolone or its equivalent.

- Patients with exacerbation of GVHD during steroid taper will require re-treatment
with 2mg/kg/d of corticosteroids and will need to meet the criteria

- Age 18-70

- Patients must have received an allogeneic hematopoietic stem cell transplant within
100 days of study enrollment.

- Serum creatinine < 2 mg/dL

Exclusion Criteria:

- Patients cannot have active CNS disease.

- Patients must not have received cyclophosphamide for GVHD prophylaxis

- Patients must not have pneumonia requiring oxygen supplementation

- Unable or unwilling to sign informed consent.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The primary objective of this study is to determine the response rate of patients treated steroid-refractory GVHD using cyclophospahmide and sirolimus combined with 3 variations of low-dose IL 2 and low-dose Vidaza.

Outcome Time Frame:

28 days to 100 days post transplant

Safety Issue:

No

Principal Investigator

Michele Donato, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hackensack University Medical Center

Authority:

United States: Institutional Review Board

Study ID:

TREG - Pro2219

NCT ID:

NCT01453140

Start Date:

August 2011

Completion Date:

July 2012

Related Keywords:

  • Graft Versus Host Disease
  • Graft vs Host Disease

Name

Location

John Theurer Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601