Graft-Versus-Host Disease (GVHD) Prophylaxis After Allogeneic Peripheral Blood Hematopoietic Cell Transplantation

Acute Graft Versus Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803010
• Other study ID #: MCC-15372
• Secondary ID: IRB 106591
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2008
• Last updated: July 10, 2015
• Start date: September 2008
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to compare the effectiveness of Tacrolimus and Rapamycin to Tacrolimus and Methotrexate in the prevention of severe graft-versus-host-disease. Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). An allogeneic hematopoietic cell transplant is a transplant using bone marrow and blood cells that come from someone other than the patient (a donor).

Description:

All drugs used in this study have been used in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Methotrexate used in combination are currently used as standard of care in the prevention of graft-versus-host-disease after allogeneic hematopoietic cell transplant. Tacrolimus and Rapamycin is a newer combination we are testing to see if it would be better than Tacrolimus and Methotrexate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• Tacrolimus (TAC)
Tacrolimus: administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.
• Methotrexate (MTX)
Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance.
• Rapamycin (RAPA)
Rapamycin: initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily.

Locations

Country	Name	City	State
United States	H.Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant	Incidence of acute graft versus host disease grades 2-3 according to the Common Toxicity Criteria (CTC) version 3.; Graft-versus-host-disease (GVHD) is a risk associated with allogeneic hematopoietic cell transplants (HCT). Clinical evidence of acute GVHD was recorded per standard grading scheme.; Acute GVHD classified as the following: classic acute GVHD - onset within 100 days after transplant; persistent - acute GVHD with onset prior to day 100 and without resolution beyond day 100; recurrent - acute GVHD recurrent after prior episode of acute GVHD; late acute GVHD - syndrome consistent with acute GVHD, without features of chronic GVHD, with onset occurring beyond 100 days	100 Days Post Transplant	No
Secondary	Incidence of Increased Absolute Numbers of Regulatory T Cells (Treg)	Absolute numbers of Treg at designated time points according to study arm. MTX = methotrexate/tacrolimus-treated patients; SIR = sirolimus/tacrolimus-treated patients; Treg absolute number units = number of cells/microL. A two-sided Wilcoxon's rank-sum test was employed to test differences in percent Treg (% Treg/total CD4+ cells).	30 days and 90 days	No
Secondary	2 Year Post Transplant Overall Survival (OS) Rate	Defined as time from transplantation (day 0 as day of stem cell infusion per standard nomenclature) to death from any cause .	2 years	No

External Links

•   H.Lee Moffitt Cancer Center & Research Institute