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Phase II Trial of Tacrolimus and Rapamycin vs. Tacrolimus and Methotrexate as GVHD Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation


Phase 2
16 Years
70 Years
Open (Enrolling)
Both
Acute Graft Versus Host Disease

Thank you

Trial Information

Phase II Trial of Tacrolimus and Rapamycin vs. Tacrolimus and Methotrexate as GVHD Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation


Inclusion Criteria:



- Age ≥ 16 and ≤ 70

- Signed informed consent

- Adequate vital organ function

- No active infection, or asymptomatic infection well controlled by antibiotic HIV
negative by ELISA or RT-PCR [if ELISA is positive and RT-PCR is negative, the ELISA
is considered false positive]

- Hepatitis B and C negative by serology or RT-PCR

- Performance status: Karnofsky Performance Status Score ≥ 60%.

Exclusion Criteria:

- Those with any Sorror's co-morbidity factors with score > 3

- 2 or more Sorror's factors with composite score of ≥ 3

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

effectiveness of TAC/RAPA vs. TAC/MTX as acute GVHD prophylaxis

Outcome Time Frame:

weekly from day 0 (day of transplant) to day +100 post transplant

Safety Issue:

No

Principal Investigator

Claudio Anasetti, MD

Investigator Role:

Study Director

Investigator Affiliation:

HLeeMoffittCancerCenter

Authority:

United States: Institutional Review Board

Study ID:

MCC 15372

NCT ID:

NCT00803010

Start Date:

September 2008

Completion Date:

September 2013

Related Keywords:

  • Acute Graft Versus Host Disease
  • aGVHD
  • GVHD
  • graft-versus-host disease
  • Graft vs Host Disease

Name

Location
H.Lee Moffitt Cancer Center Tampa, Florida  33612