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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAC + MMF | Other | Tacrolimus and Mycophenolate |
|
| TAC+MTX | Other | Tacrolimus and Methotrexate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Acute Graft-vs-host Disease (aGVHD) | incidence of aGVHD (grades 2 - 4) 100 days post allogeneic hematopoietic cell transplantation | 100 days post transplant |
| Overall Survival | number of participants alive at one year |
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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
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20102746 | Background | 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. |
| Label | URL |
|---|---|
| Moffiitt Cancer Center Clinical Trials Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tacrolimus And Methotrexate | All patients will receive TAC 0.03 mg/kg/24h as a continuous IV infusion beginning day -3 (day 0 being the anticipated day of hematopoietic stem cell infusion). Tacrolimus dosing should be based on ideal body weight. TAC levels should be measured on day 0 then at least twice weekly for the first month and the dose will be adjusted to maintain whole blood levels of 5-15ng/mL. When the patient is able to tolerate oral medications, the total daily dose of IV TAC will be converted to oral dosing at a 1:3 (IV:PO) ratio. The daily oral dose will be divided into twice daily dosing. Full dose TAC will be given until day +60 (+7) when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180 (+14). MTX 15 mg/m2 IV day +1 then 10 mg/m2 IV on days +3, +6, and +11. |
| FG001 | Tacrolimus And Mycophenolate Mofetil | All patients will receive TAC 0.03 mg/kg/24h as a continuous IV infusion beginning day -3. TAC levels should be measured on day 0 then at least twice weekly for the first month and the dose will be adjusted to maintain whole blood levels of 5-15ng/mL. When the patient is able to tolerate oral medications, the total daily dose of IV TAC will be converted to oral dosing. Full dose TAC will be given until day +60 (+7) when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180 (+14). MMF 30 mg/kg/day IV in 2 divided doses beginning day 0. Dosing should be based on the lesser of adjusted ideal body weight or actual body weight. The IV dose will be converted to the oral formulation when spatient is able to tolerate oral medications. Oral dosing may be capped at 1 gram twice daily. In the absence of GVHD a tapering schedule will begin on day +240 (+14) and be completed on day +360 (+14). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tacrolimus And Methotrexate | Tacrolimus (TAC) And Methotrexate (MTX) |
| BG001 | Tacrolimus And Mycophenolate Mofetil | Tacrolimus (TAC) And Mycophenolate Mofetil (MMF) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat | Posted | Number | participants | 2 year |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tacrolimus And Methotrexate | Tacrolimus (TAC) And Methotrexate (MTX) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janelle Perkins, PharmD | Moffitt Cancer Center | 813-745-7226 | Janelle.Perkins@moffit.org |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| D006086 | Graft vs Host Disease |
| D006463 | Hemolytic-Uremic Syndrome |
| D011697 | Purpura, Thrombotic Thrombocytopenic |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D008727 | Methotrexate |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000630 | Aminopterin |
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| 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 |
|
|
| 1 year |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Incidence of Acute Graft-vs-host Disease (aGVHD) | incidence of aGVHD (grades 2 - 4) 100 days post allogeneic hematopoietic cell transplantation | intent to treat | Posted | Number | participants | 100 days post transplant |
|
|
|
|
| Secondary | Overall Survival | number of participants alive at one year | intent to treat | Posted | Number | participants | 1 year |
|
|
|
|
| 25 |
| 47 |
| 0 |
| 47 |
| EG001 | Tacrolimus And Mycophenolate Mofetil | Tacrolimus (TAC) And Mycophenolate Mofetil (MMF) | 19 | 42 | 0 | 42 |
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| D009057 |
| Stomatognathic Diseases |
| D007154 | Immune System Diseases |
| D014511 | Uremia |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D019851 | Thrombophilia |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D011622 |
| Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |