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| ID | Type | Description | Link |
|---|---|---|---|
| CA142106 | Other Grant/Funding Number | National Cancer Institute/NIH/DHHS |
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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Massachusetts General Hospital | OTHER |
| National Cancer Institute (NCI) | NIH |
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This trial is comparing whether using a drug called sirolimus for graft versus host disease (GVHD) prevention can decrease the chance of the participant's lymphoma relapsing after transplantation, compared to using a standard GVHD prevention regimen without sirolimus. Since mTOR inhibitors have anti-lymphoma activity, their use after transplantation may lead to a decreased risk of relapse and hence better transplantation outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sirolimus-Containing Regimen | Active Comparator | The Sirolimus containing arm will consist of the following drugs: Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3. Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2. Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6. |
|
| Sirolimus-Free regimen | Active Comparator | There are two choices for the Sirolimus free arm: Control Arm 1: tacrolimus + methotrexate Tacrolimus:Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3. Methotrexate:Administered by intravenous bolus infusion at a dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11. Control Arm 2: cyclosporine + MMF Cyclosporine: administered orally at a dose of 6 mg/kg based on ABW bid starting on day -3. MMF:administered at a dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting on day 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirolimus | Drug | Taken orally for at least 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Compare 2-year Overall Survival of Patients With Lymphoma Undergoing RIC SCT Between Those Receiving Tacrolimus/Sirolimus/Methotrexate and Those Receiving Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| To Compare 2-year Progression-free Survival Between the Two Treatment Arms | 2 years | |
| To Compare the 2-year Cumulative Incidences of Disease Progression and of Non-relapse Mortality Between the Two Treatment Arms | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Armand, MD, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26729448 | Derived | Armand P, Kim HT, Sainvil MM, Lange PB, Giardino AA, Bachanova V, Devine SM, Waller EK, Jagirdar N, Herrera AF, Cutler C, Ho VT, Koreth J, Alyea EP, McAfee SL, Soiffer RJ, Chen YB, Antin JH. The addition of sirolimus to the graft-versus-host disease prophylaxis regimen in reduced intensity allogeneic stem cell transplantation for lymphoma: a multicentre randomized trial. Br J Haematol. 2016 Apr;173(1):96-104. doi: 10.1111/bjh.13931. Epub 2016 Jan 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sirolimus-Containing Regimen | The Sirolimus containing arm will consist of the following drugs: Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3. Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2. Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6. Sirolimus: Taken orally for at least 12 months Methotrexate: Given intravenously on the first, third and sixth day after transplant Tacrolimus: Taken orally or given intravenously for at least 6 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Methotrexate | Drug | Given intravenously on the first, third and sixth day after transplant |
|
|
| Tacrolimus | Drug | Taken orally or given intravenously for at least 6 months |
|
|
| Cyclosporine | Drug | Taken orally or given intravenously for at least 6 months |
|
|
| MMF | Drug | Taken orally for about 2 months |
|
|
| To Compare the 180-day Cumulative Incidence of Grades II-IV and Grades III-IV Acute GVHD Between the Two Treatment Arms | 6 months |
| To Compare the 2-year Cumulative Incidence of Chronic GVHD Between the Two Treatment Arms. | 2 years |
| To Compare the 2-year of Overall Survival, Progression-free Survival, Cumulative Incidences of Progression and Non-relapse Mortality Between the Treatment Arms for Each Histology Studied. | 2 years |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55454 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| FG001 | Sirolimus-Free Regimen | There are two choices for the Sirolimus free arm: Control Arm 1: tacrolimus + methotrexate Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11. Control Arm 2: cyclosporine + MMF Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Methotrexate: Given intravenously on the first, third and sixth day after transplant Tacrolimus: Taken orally or given intravenously for at least 6 months Cyclosporine: Taken orally or given intravenously for at least 6 months MMF: Taken orally for about 2 months |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sirolimus-Containing Regimen | The Sirolimus containing arm will consist of the following drugs: Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3. Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2. Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6. Sirolimus: Taken orally for at least 12 months Methotrexate: Given intravenously on the first, third and sixth day after transplant Tacrolimus: Taken orally or given intravenously for at least 6 months |
| BG001 | Sirolimus-Free Regimen | There are two choices for the Sirolimus free arm: Control Arm 1: tacrolimus + methotrexate Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11. Control Arm 2: cyclosporine + MMF Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Methotrexate: Given intravenously on the first, third and sixth day after transplant Tacrolimus: Taken orally or given intravenously for at least 6 months Cyclosporine: Taken orally or given intravenously for at least 6 months MMF: Taken orally for about 2 months |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | To Compare 2-year Overall Survival of Patients With Lymphoma Undergoing RIC SCT Between Those Receiving Tacrolimus/Sirolimus/Methotrexate and Those Receiving Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | To Compare 2-year Progression-free Survival Between the Two Treatment Arms | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | To Compare the 2-year Cumulative Incidences of Disease Progression and of Non-relapse Mortality Between the Two Treatment Arms | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
| ||||||||||||||||||||||||||||||||
| Secondary | To Compare the 180-day Cumulative Incidence of Grades II-IV and Grades III-IV Acute GVHD Between the Two Treatment Arms | Posted | Number | percentage of participants | 6 months |
| |||||||||||||||||||||||||||||||||
| Secondary | To Compare the 2-year Cumulative Incidence of Chronic GVHD Between the Two Treatment Arms. | Posted | Number | percentage of participants | 2 years |
| |||||||||||||||||||||||||||||||||
| Secondary | To Compare the 2-year of Overall Survival, Progression-free Survival, Cumulative Incidences of Progression and Non-relapse Mortality Between the Treatment Arms for Each Histology Studied. | Given the small number of patients within each group, we considered indolent histologies (indolent B-cell NHL, CLL and HL) together in one group (indolent group), and aggressive histologies (aggressive B-cell NHL, MCL, and T-cell NHL) in another (aggressive group). | Posted | Number | percentage of participants | 2 years |
|
Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. The study defined follow up period is 2 years.
All AEs grades 3-5 and SAEs whether reported by participant, discovered during questioning, directly observed, or detected by physical examination, laboratory test, etc, will be recorded in participant's medical record and appropriate study-specific forms
Only events reported in >1 patient on at least one of the arms are listed in Other AE table
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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 | Sirolimus-Containing Regimen | The Sirolimus containing arm will consist of the following drugs: Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3. Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2. Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6. Sirolimus: Taken orally for at least 12 months Methotrexate: Given intravenously on the first, third and sixth day after transplant Tacrolimus: Taken orally or given intravenously for at least 6 months | 15 | 66 | 41 | 66 | ||
| EG001 | Sirolimus-Free Regimen | There are two choices for the Sirolimus free arm: Control Arm 1: tacrolimus + methotrexate Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11. Control Arm 2: cyclosporine + MMF Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Methotrexate: Given intravenously on the first, third and sixth day after transplant Tacrolimus: Taken orally or given intravenously for at least 6 months Cyclosporine: Taken orally or given intravenously for at least 6 months MMF: Taken orally for about 2 months | 15 | 73 | 54 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other: Relapse/Progressive disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE Version 3.0 | Systematic Assessment |
| |
| GVHD | Immune system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Treatment Related Secondary Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE Version 3.0 | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Thrombotic Microangiopathy | Blood and lymphatic system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Heart Failure | Cardiac disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Supraventricular and Nodal Arrhythmia | Cardiac disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Obstuction--GI, small bowel | Gastrointestinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Edema | General disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Liver failure | Hepatobiliary disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Other- Systemic inflammatory response syndrome (SIRS) | Immune system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE Version 3.0 | Systematic Assessment |
| |
| Thrombocytopenia | Investigations | CTCAE Version 3.0 | Systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Altered mental status | Nervous system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Hemorrhage, CNS (cerebrovascular) | Nervous system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Acute Kidney Injury/Renal Failure | Renal and urinary disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Adult Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Other--Respiratory failure/lung injury | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Other--Stroke | Vascular disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Pulmonary embolism | Vascular disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE Version 3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| TMA/renal failure/hemolysis | Renal and urinary disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Thrombocytopenia | Investigations | CTCAE Version 3.0 | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE Version 3.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE Version 3.0 | Systematic Assessment |
| |
| Hyperlipidemia | Metabolism and nutrition disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Confusion/psychosis/encephalopathy | Nervous system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Respiratory | Respiratory, thoracic and mediastinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Hepatic | Hepatobiliary disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Stomatitis/mucositis | Gastrointestinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Nausea/vomiting | Gastrointestinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Weakness | Musculoskeletal and connective tissue disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Allergic Reaction | Immune system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Cardiac | Cardiac disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Pain | Nervous system disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE Version 3.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE Version 3.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Philippe Armand, MD, PhD | Dana Farber Cancer Institute | 617-632-2305 | parmand@partners.org |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D008727 | Methotrexate |
| D016559 | Tacrolimus |
| D016572 | Cyclosporine |
| D003524 | Cyclosporins |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
|
|
| OG002 | Aggressive Group: Sirolimus-Containing Regimen | Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies The Sirolimus containing arm will consist of the following drugs: Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.Taken orally or given intravenously for at least 6 months Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.Taken orally for at least 12 months Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.Given intravenously on the first, third and sixth day after transplant |
| OG003 | Aggressive Group: Sirolimus-Free Regimen | Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies There are two choices for the Sirolimus free arm: Control Arm 1: tacrolimus + methotrexate Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11. Control Arm 2: cyclosporine + MMF Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Taken orally for about 2 months. |
|
|