Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Mucositis Graft-versus-host Disease |
Drug: Tac+MTX Drug: TAC + MMF |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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) |
- Incidence of Severe Mucositis [ Time Frame: 2 year ] [ Designated as safety issue: No ]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.
- Incidence of Acute Graft-vs-host Disease (aGVHD) [ Time Frame: 100 days post transplant ] [ Designated as safety issue: No ]incidence of aGVHD (grades 2 - 4) 100 days post allogeneic hematopoietic cell transplantation
- Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]number of participants alive at one year
| Enrollment: | 89 |
| Study Start Date: | September 2005 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
TAC + MMF
Tacrolimus and Mycophenolate
|
Drug: TAC + MMF
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:
|
|
TAC+MTX
Tacrolimus and Methotrexate
|
Drug: Tac+MTX
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:
|
Detailed Description:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| Principal Investigator: | 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00360685 History of Changes |
| Other Study ID Numbers: | MCC-14418 |
| Study First Received: | August 3, 2006 |
| Results First Received: | March 30, 2012 |
| Last Updated: | March 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
|
Tacrolimus Methotrexate Mycophenolate mofetil Mucositis |
Acute graft-versus-host disease (aGVHD) Engraftment hemolytic/uremic syndrome (HUS) Thrombotic thrombocytopenic purpura (TTP) |
Additional relevant MeSH terms:
|
Graft vs Host Disease Mucositis Immune System Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Mouth Diseases Stomatognathic Diseases Methotrexate Mycophenolic Acid Mycophenolate mofetil Tacrolimus Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Antibiotics, Antineoplastic |
ClinicalTrials.gov processed this record on May 16, 2013