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Completed

NCT Number: NCT00803010

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

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).

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Key information

Conditions

Acute Graft Versus Host Disease Graft vs Host Disease Immune System Diseases

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

H.Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus (TAC)

Drug

Tacrolimus: administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.

Other names: FK-506, fujimycin, Prograf, Advagraf, Protopic

Methotrexate (MTX)

Drug

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.

Other names: Trexall, Rheumatrex

Rapamycin (RAPA)

Drug

Rapamycin: initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily.

Other names: Sirolimus

Primary outcomes

  1. Percentage of Participants With Evidence of Acute Graft Versus Host Disease (aGVHD), Post Transplant

    Time frame: 100 Days 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

Secondary outcomes

  1. Incidence of Increased Absolute Numbers of Regulatory T Cells (Treg)

    Time frame: 30 days and 90 days

    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).

  2. 2 Year Post Transplant Overall Survival (OS) Rate

    Time frame: 2 years

    Defined as time from transplantation (day 0 as day of stem cell infusion per standard nomenclature) to death from any cause .

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 5, 2008
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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