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Completed

NCT Number: NCT00360685

Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX

A comparative trial where all patients will receive daily doses of tacrolimus (TAC) until day +60 when tapering will begin, in the absence of graft-versus-host disease (GVHD), and discontinued by day +180. In addition patients will be randomized to methotrexate (MTX) or mycophenolate mofetil (MMF) and again, in the absence of GVHD, a tapering schedule will begin on day +240 and be completed on day +360. Doses will be adjusted to maintain blood levels.

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Key information

Conditions

Mucositis Anemia Anemia, Hemolytic Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Graft vs Host Disease Graft-Versus-Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemolytic-Uremic Syndrome Hemorrhage Immune System Diseases Kidney Diseases Male Urogenital Diseases Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombotic Thrombocytopenic Signs and Symptoms Skin Manifestations Stomatognathic Diseases Thrombocytopenia Thrombophilia Thrombotic Microangiopathies Uremia Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

About this study

The randomization for this comparative trial will be stratified by conditioning regimen and, for those patients enrolled on MCC-14178, by busulfan AUC level.

All patients will receive daily doses of TAC beginning day -3 (day 0 being the day of hematopoietic stem cell transplant (HCT)) and will be given until day +60 when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180. Doses will be adjusted to maintain blood levels.

In addition to TAC, patients will be randomized to one of the following additional anti-GVHD medications: MTX or MMF beginning day 0 at least 2 hours after the end of the HCT. In the absence of GVHD a tapering schedule will begin on day +240 and be completed on day +360.

Study participants will be extensively monitored as inpatients and then weekly as outpatients. Some tests will be conducted at least twice weekly (blood tests, toxicity data, GVHD and physical exams) one-month post-transplant and during the tapering off periods for up to 2 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient must be going through a T cell-replete allogeneic transplant

Exclusion criteria

  • A contraindication to the use of tacrolimus, mycophenolate, or methotrexate

Treatment and study plan

Tac+MTX

Drug

Tacrolimus- 0.03mg/kg/24h IV beginning day-3 Methotrexate- 15mg/m2 IV day +1 then 10mg/m2 IV on days 3, 6, 11 post transplant.

Other names: Tacrolimus, Prograf(R), Methotrexate,

TAC + MMF

Drug

Tacrolimus- 0.03 mg/kg/24h as a continuous IV infusion, beginning day -3. Mycophenolate Mofetil- 30 mg/kg/day IV in 2 divided doses (q12 hours) beginning day 0 at least 2 hours after the end of the hematopoietic stem cell transplant

Other names: Tacrolimus, Prograf(R), Mycophenolate mofetil, CellCept(R)

Primary outcomes

  1. Incidence of Severe Mucositis

    Time frame: 2 year

    Mucositis was assessed prospectively daily while the patient was hospitalized and graded retrospectively based on nurse and clinician assessments according to the clinical criteria set forth in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 3.0). Severe mucositis as defined as grade 3 or grade 4.

Secondary outcomes

  1. Incidence of Acute Graft-vs-host Disease (aGVHD)

    Time frame: 100 days post transplant

    incidence of aGVHD (grades 2 - 4) 100 days post allogeneic hematopoietic cell transplantation

  2. Overall Survival

    Time frame: 1 year

    number of participants alive at one year

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

Safety of Tacrolimus And Methotrexate (MTX) Versus Tacrolimus And Mycophenolate Mofetil (MMF) As Graft Versus Host Disease Prophylaxis In Allogeneic Hematopoietic Cell Transplants (HCT)

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Aug 7, 2006
Registry last updated
May 3, 2013

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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