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

NCT00360685 | Completed Results DMC

• 1 other identifier: MCC-14418
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mucositis; Graft-versus-host Disease

Keywords

Tacrolimus; Methotrexate; Mycophenolate mofetil; Mucositis; Acute graft-versus-host disease (aGVHD); Engraftment; hemolytic/uremic syndrome (HUS); Thrombotic thrombocytopenic purpura (TTP)

Outcome Measures

Primary Outcomes (1)

• Incidence of Severe Mucositis

  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.

  2 year

Secondary Outcomes (2)

• Incidence of Acute Graft-vs-host Disease (aGVHD)

  100 days post transplant

• Overall Survival

  1 year

Study Arms (2)

TAC + MMF

OTHER

Tacrolimus and Mycophenolate

Drug: TAC + MMF

TAC+MTX

OTHER

Tacrolimus and Methotrexate

Drug: Tac+MTX

Interventions

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.

Also known as: Tacrolimus, Prograf(R), Methotrexate,

TAC+MTX

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

Also known as: Tacrolimus, Prograf(R), Mycophenolate mofetil, CellCept(R)

TAC + MMF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Perkins J, Field T, Kim J, Kharfan-Dabaja MA, Fernandez H, Ayala E, Perez L, Xu M, Alsina M, Ochoa L, Sullivan D, Janssen W, Anasetti C. A randomized phase II trial comparing tacrolimus and mycophenolate mofetil to tacrolimus and methotrexate for acute graft-versus-host disease prophylaxis. Biol Blood Marrow Transplant. 2010 Jul;16(7):937-47. doi: 10.1016/j.bbmt.2010.01.010. Epub 2010 Jan 25.

  PMID: 20102746 BACKGROUND

Related Links

• Moffiitt Cancer Center Clinical Trials Website

MeSH Terms

Conditions

Mucositis; Graft vs Host Disease; Hemolytic-Uremic Syndrome; Purpura, Thrombotic Thrombocytopenic

Interventions

Tacrolimus; Methotrexate; Mycophenolic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Janelle Perkins, PharmD
• Organization: Moffitt Cancer Center

Janelle.Perkins@moffit.org

813-745-7226

Study Officials

• Janelle Perkins, PharmD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

• Teresa Field, PhD, MD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2006
• First Posted: August 7, 2006
• Study Start: September 1, 2005
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 3, 2013
• Results First Posted: May 3, 2013

Record last verified: 2013-03

Locations

US (1)