| Primary | Percentage of Participants With GVHD/Relapse or Progression-free Survival (GRFS) at One Year | The primary endpoint is GRFS as a time to event endpoint from randomization. All randomized patients will be followed for one year; however, the primary endpoint will be analyzed as a time to event endpoint. The primary analysis will be done using the randomized population. An event for this time to event outcome is defined as grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, disease relapse or progression, or death by any cause, whichever comes first. Time to event analyses were conducted. An unadjusted Kaplan-Meier analysis was done. Additionally, a multivariate Cox regression model adjusting for the following pre-specified covariates: age group (< 65 vs. 65+), disease risk index (low, intermediate, high/very high), planned RIC conditioning regimen (Fludarabine/Busulfan, Fludarabine/Melphalan, Other), donor type/HLA matching score (related 6/6, unrelated 7/8, unrelated 8/8), and planned use of post-transplant maintenance therapy (Yes vs. no). | Analysis Population includes all randomized participants | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 year post randomization | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. | | OG001 | Tacrolimus/Methotrexate | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Methotrexate: Mobilized PBSC grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting on Day -3. Subsequent dosing will be based on blood levels per institutional guidelines with a suggested range of 5-15. If patients are on medications which alter the metabolism of tacrolimus, the initial starting dose and subsequent doses should be altered as per institutional practices. Tacrolimus taper can be initiated at a minimum of 90 days post HCT if there is no evidence of active GVHD. The rate of tapering will be done according institutional practices and patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Methotrexate: Methotrexate will be administered at the doses of 15 mg/m2 IV bolus on Day +1, and 10 mg/m2 IV bolus on Days +3, +6 and +11 after hematopoietic stem cell infusion. Methotrexate should be dose reduced, given with leucovorin rescue, or held for complications such as severe mucositis per institutional guidelines. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00052.3(45.2 to 58.8)
- OG00135.5(29.1 to 42.0)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| This is the result of the Cox proportional hazards analysis. The null hypothesis is that there is no difference of GRFS hazard ratio between treatment groups after adjustment for age group, donor type and HLA Matching Score, disease risk index, Planned RIC Conditioning Regimen, and Planned post-transplant maintenance therapies. | Regression, Cox | | 0.001 | Statistical significance was determined using a pre-specified threshold of 0.05 | Hazard Ratio (HR) | 0.641 | | | 2-Sided | 95 | 0.492 | 0.835 | | | | | Superiority | |
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| Secondary | Percentage of Participants With Grades II-IV and III-IV Acute GVHD at Day 100 Post-transplant | Acute GVHD was graded according to Mount Sinai aGVHD International Consortium (MAGIC) Criteria (Harris et al. 2016) with higher grade indicating worse outcomes. Grade I aGVHD is defined as Skin stage 1-2 and stage 0 for both GI and liver. Grade II is stage 3 skin, stage 1 GI, or stage 1 liver. Grade III is stage 2-3 GI or stage 2-3 liver. Grade IV is stage 4 skin or stage 4 liver. The cumulative incidence of acute GVHD grade II-IV and III-IV at Day 100 was estimated using the Aalen-Johansen estimator with 95% confidence intervals, treating death prior to aGVHD as a competing event. The cumulative incidences of Minnesota standard and high risk aGVHD at Day 100 were determined with 95% confidence intervals. Time to aGVHD is defined as time from transplant until onset of grades II-IV and III-IV aGVHD, respectively. A multivariate Cox regression model was used to compare the treatment groups, with adjustment for same baseline characteristics as for the primary endpoint. | Analysis Population includes transplanted participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 100 post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Participants With Maximum Acute GVHD at One Year Post-transplant | Acute GVHD were graded according to Mount Sinai Acute GVHD International Consortium (MAGIC) Criteria (Harris et al. Biology of Blood and Marrow Transplantation 2016; 22:4-10). The higher acute GVHD grade indicates worse outcomes. Grade 0 is no acute GVHD of any organ. Grade I acute GVHD is defined as Skin stage of 1-2 and stage 0 for both GI and liver organs. Grade II is stage 3 of skin, or stage 1 of GI, or stage 1 of liver. Grade III is stage 2-3 for GI, or stage 2-3 of liver. Grade IV is stage 4 of skin, or stage 4 of liver. Max acute GVHD by one-year post-transplant was computed. | Analysis Population includes transplanted participants | Posted | | Count of Participants | | Participants | | One year post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Participants With Maximum Stage of Skin, Lower GI, and Liver at Day 100 Post-transplant | Organ stages were graded according to Mount Sinai Acute GVHD International Consortium (MAGIC) Criteria (Harris et al. 2016). Higher stage in any organ indicates worse outcomes. For skin, stage 0-no GVHD rash; 1-Maculopapular Rash <25% BSA; 2-Maculopapular Rash 25-50% BSA; 3-Maculopapular Rash >50% BSA; 4-Generalized Erythroderma Plus Bullous Formation and Desquamation >5% BSA. For Lower GI, 0-No Diarrhea or Diarrhea-Adult: <500 mL/day, <3 Episodes/day; Child: <10 mL/kg/day, <4 Episodes/day; 1-Diarrhea-Adult: 500-999 mL/day, 3-4 Episodes/day; Child: 10-19.9 mL/kg/day, 4-6 Episodes/day; 2-Diarrhea-Adult: 1000-1500 mL/day, 5-7 Episodes/day; Child: 20-30 mL/kg/day, 7-10 Episodes/day; 3-Diarrhea-Adult: >1500 mL/day, >7 Episodes/day; Child: >30 mL/kg/day, >10 Episodes/day; 4-Severe Abdominal Pain With or Without Ileus or Grossly Bloody Stool. For liver, 0-Bilirubin <2.0 mg/dL; 1-Bilirubin 2.0-3.0 mg/dL; 2-Bilirubin 3.1-6.0 mg/dL; 3-Bilirubin 6.1-15.0 mg/dL; 4-Bilirubin >15.0 mg/dL | Analysis Population includes transplanted participants | Posted | | Count of Participants | | Participants | | Day 100 post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Participants With Maximum Stage of Upper GI at Day 100 Post-transplant | Organ stages were graded according to Mount Sinai Acute GVHD International Consortium (MAGIC) Criteria (Harris et al. 2016). Higher stage in any organ indicates worse outcomes. For upper GI, stage 0 is no or intermittent nausea, vomiting, or anorexia; stage 1 is persistent nausea, vomiting, or anorexia. The maximum stages of Upper GI at patient level were summarized at Day 100. | Analysis Population includes transplanted participants | Posted | | Count of Participants | | Participants | | Day 100 post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Percentage of Participants With Chronic GVHD Post-transplant | Percentage of participants with chronic GVHD (cGVHD) at one-year will be estimated with 95% confidence intervals for each treatment group using the cumulative incidence estimate with the complementary log-log transformation, treating death prior to cGVHD as a competing event. Chronic GVHD is based on NIH Consensus Criteria (2014 NIH Consensus Criteria) and includes mild, moderate and severe chronic GVHD. Eight organs were scored on a 0-3 scale to reflect degree of cGVHD involvement. Liver and pulmonary function test results and use of systemic therapy for treatment of cGVHD were also recorded. Assessment of cGVHD occurred up to one-year post-transplant. This endpoint considers any cGVHD onset. A multivariate Cox regression model for the cause-specific hazard of cGVHD was used to compare the treatment groups, after adjustment for baseline characteristics as described for the primary endpoint. | Analysis Population includes transplanted participants | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6, 12 months post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Number of Participants Experiencing Chronic GVHD With Maximum Severity at 12 Months Post-transplant | Chronic GVHD data were collected directly from providers and chart review as defined by the NIH Consensus Conference Criteria. Eight organs were scored on a 0-3 scale to reflect degree of chronic GVHD involvement per the NIH global severity scores of mild, moderate and severe chronic GVHD. The maximum severity of chronic GVHD through 12 months post-transplant will be tabulated by treatment arm. | Analysis Population includes transplanted participants | Posted | | Count of Participants | | Participants | | 12 months post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Number of Participants With Immunosuppression-Free Survival (ISFS) at 1 Year Post-transplant | Participants who are alive, relapse-free, and do not need ongoing immune suppression (IS) to control GVHD at one year post-transplant are considered successes for the endpoint immunosuppression-free survival (ISFS). Immune suppression is defined as any systemic agents used to control or suppress GVHD. Corticosteroid doses greater than 10 mg were considered active systemic immune suppression treatment. Participants who discontinued immune suppression within 15 days or less prior to the 1-year time point was considered to be on immune suppression for this endpoint. | Analysis Population includes transplanted and evaluable participants for ISFS | Posted | | Count of Participants | | Participants | | 1 year post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Percentage of Participants With Immunosuppression-Free Survival (ISFS) at 1 Year Post-transplant | Participants who are alive, relapse-free, and do not need ongoing immune suppression to control GVHD at one year post-transplant are considered successes for the endpoint immunosuppression-free survival (ISFS). Percentage of participants alive, relapse free, and off immune suppression at 1 year post-transplant were described for each treatment group, along with 95% Clopper-Pearson confidence intervals. | Analysis Population includes transplanted and evaluable participants for ISFS. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 year post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Percentage of Participants With Neutrophil Recovery Post-transplant | Neutrophil recovery is defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/mm^3 for three consecutive measurements on three different days. The first of the three days will be designated the day of neutrophil recovery. The competing event is death without neutrophil recovery. For participants who never drop ANC below 500/mm^3, the date of neutrophil recovery will be Day +1 post-transplant. The cumulative incidence of neutrophil recovery by Day 28 and Day 100 was described for each treatment group with point estimates and 95% confidence intervals using the complementary log-log transformation and treating death as a competing event. | Analysis Population includes transplanted participants | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 28 and day 100 post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Percentage of Participants With Platelet Recovery Post-transplant | Platelet recovery is defined by two different metrics: the first day of a sustained platelet count greater than or equal to 20,000/mm^3 or greater than or equal to 50,000/mm^3 with no platelet transfusions in the preceding seven days. The first day of sustained platelet count above these thresholds will be designated the day of platelet engraftment. For participants who never drop their platelet count below 20,000/mm^3 or 50,000/mm^3, the date of platelet recovery will be Day +1 post HCT. The competing event is death without platelet recovery. The cumulative incidence estimate of platelet recovery by Day 60 and Day 100 were described by treatment group with 95% confidence intervals (complementary log-log transformation), treating death as a competing event. | Analysis Population includes transplanted participants with platelet recovery data provided | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 60 and Day 100 post-transplant | | | | ID | Title | Description |
|---|
| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Percentage of Participants With Lymphocyte Recovery Post-transplant | Lymphocyte recovery is defined as the first day of sustained absolute lymphocyte count greater than or equal to 1000/mm^3. The competing event is death without lymphocyte recovery. The cumulative incidence estimate of Lymphocyte recovery were described by treatment group with 95% confidence intervals (complementary log-log transformation), treating death as a competing event. | Analysis Population includes transplanted participants with lymphocyte recovery data provided. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 60, Day 100, 6 Months, and 1 year post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Number of Participants With Each Level of Donor Cell Engraftment Post-transplant | Donor cell engraftment were assessed with donor/recipient chimerism studies. Mixed chimerism is defined as the presence of donor cells, as a proportion of total cells to be less than 95% but at least 5% in the bone marrow or peripheral blood. Full donor chimerism is defined as greater than or equal to 95% of donor cells. Mixed and full chimerism will be evidence of donor cell engraftment. Donor cells of less than 5% will be considered as graft rejection. The number of participants with each level of chimerism described above is described as part of this outcome. | Analysis Population includes transplanted participants. | Posted | | Count of Participants | | Participants | | Day 28 and Day 100 post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Summary Statistics for Donor Chimerism | Donor cell engraftment were assessed with donor/recipient chimerism studies. Mixed chimerism is defined as the presence of donor cells, as a percentage of total cells to be less than 95% but at least 5% in the bone marrow or peripheral blood. Full donor chimerism is defined as greater than or equal to 95% of donor cells. Mixed and full chimerism will be evidence of donor cell engraftment. Donor cells of less than 5% will be considered as graft rejection. Donor chimerism at Day 28 and Day 100 after transplant in each of the randomized treatment arms will be described numerically as median and range for those evaluable. | Analysis Population includes transplanted participants who submitted post-transplant assessments. | Posted | | Median | Full Range | percentage of donor cells | | Day 28 and Day 100 post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Percentage of Participants With Disease Relapse at 1 Year Post-transplant | Disease relapse/progression is defined as being alive and free of relapse/progression of the primary disease. The time from transplant until relapse/progression of the primary disease, or cumulative incidence, was estimated at one-year post-transplant along with 95% CIs computed using the complementary log-log transformation, treating death prior to disease relapse as a competing event. A multivariate Cox regression model for the cause-specific hazard of relapse or progression will be used to compare the treatment groups, after adjustment for baseline characteristics as described for the primary endpoint. | Analysis Population includes transplanted participants | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 year post-transplant | | | | ID | Title | Description |
|---|
| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Percentage of Participants With Treatment-related Mortality (TRM) Post-transplant | An event for this endpoint TRM is death without evidence of disease progression or recurrence. Disease progression or recurrence will be considered a competing event. The time from transplant until TRM, or cumulative incidence, estimated at specific time points along with 95% CIs computed using the complementary log-log transformation, treating relapse/progression of the primary disease as a competing risk. A multivariate Cox regression model for the cause-specific hazard of TRM was used to compare the treatment groups, after adjustment for baseline characteristics as described for the primary endpoint. | Analysis Population includes transplanted participants | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 100, 180 and 1 year post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Number of Participants Reporting Grade 3-5 Toxicities by 1 Year Post-transplant | All Grade 3-5 toxicities will be tabulated by grade for each randomized treatment arm, by type of toxicity as well as the peak grade overall. Toxicities were evaluated using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | Analysis Population includes transplanted participants | Posted | | Count of Participants | | Participants | | 1 year post-transplant | | | | ID | Title | Description |
|---|
| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Frequencies of Infections Categorized by Infection Type | All Grade 2 and 3 infections were reported according to the BMT CTN Technical Manual of Procedures (MOP) up to 1 year post-transplant. The frequency of Grade 2-3 infections and the number of participants experiencing infections occurring within 1 year post-transplant, are tabulated by treatment arm, organism, time period of infection onset, and severity, with Grade defined per the BMT CTN Technical MOP. | Analysis Population includes transplanted participants | Posted | | Number | | infections | | 1 year post-transplant | | | | ID | Title | Description |
|---|
| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Number of Participants With Grade 2 and 3 Infections | All Grade 2 and 3 infections were reported according to the BMT CTN Technical Manual of Procedures (MOP) up to 1 year post-transplant. The frequency of Grade 2-3 infections and the number of participants experiencing infections occurring within 1 year post-transplant, are tabulated by treatment arm, organism, time period of infection onset, and severity, with Grade defined per the BMT CTN Technical MOP. | Analysis Population includes transplanted participants | Posted | | Count of Participants | | Participants | | 1 year post-transplant | | | | ID | Title | Description |
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| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Percentage of Participants With Grade 2 and 3 Infections | Grade 2 and 3 infections, as defined by the BMT CTN Technical Manual of Procedures (MOP), are reported on the study. The cumulative incidence of infections post transplantation, treating death as a competing risk, were compared between the treatment groups using the Gray's test. | Analysis Population includes transplanted participants | Posted | | Number | 95% Confidence Interval | percentage of participants | | 6 months and 1 year post-transplant | | | | ID | Title | Description |
|---|
| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Percentage of Participants With CMV at Day 100 Post-transplant | The cumulative incidence of initiation of systemic treatment for CMV was compared between the treatment groups using the Gray's test, with death treated as a competing risk. Estimates of the cumulative incidence of CMV reactivation are provided at Day 100 post-transplant. | Analysis Population includes transplanted participants | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 100 post-transplant | | | | ID | Title | Description |
|---|
| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Percentage of Participants With Disease-Free Survival (DFS) at 1 Year Post-transplant | DFS is defined as being alive and free of relapse/progression of the primary disease. The time from transplant until death or relapse/progression (DFS failure) was described for each treatment arm using the Kaplan-Meier estimator, with numbers of subjects at risk at specific time points presented for each treatment group. A multivariate Cox regression model for the hazard of death will be used to compare the treatment groups, after adjustment for baseline characteristics as described for the primary endpoint. | Analysis Population includes transplanted participants | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 year post-transplant | | | | ID | Title | Description |
|---|
| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Percentage of Participants With Overall Survival (OS) at 1 Year Post-transplant | The event for this endpoint OS is death from any cause post-transplant. Time to overall survival is defined as the time interval between date of transplant and date of death from any cause. Surviving participants will be censored at last follow-up or 1 year post-transplant, whichever comes first. The time from transplant until death from any cause was described graphically for each treatment arm using the Kaplan-Meier estimator, with numbers of subjects at risk at specific time points presented for each treatment group. A multivariate Cox regression model for the hazard of death will be used to compare the treatment groups, after adjustment for baseline characteristics as described for the primary endpoint. | Analysis Population includes transplanted participants | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 year post-transplant | | | | ID | Title | Description |
|---|
| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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| Secondary | Percentage of Participants With Lymphoproliferative Disease (PTLD) at 1 Year Post-Transplant | The cumulative incidence of lymphoproliferative disease at 1-year post-transplant is described with 95% confidence intervals for each treatment group using the Aalen-Johansen estimator, treating death as a competing event. | Analysis Population includes transplanted participants | Posted | | Number | 95% Confidence Interval | percentage of participants | | 1 year Post-Transplant | | | | ID | Title | Description |
|---|
| OG000 | PTCY/Tacrolimus/MMF | Mobilized Peripheral Blood Stem Cell graft with Tacrolimus/Mycophenolate Mofetil/Post-Transplant Cyclophosphamide: Mobilized PBSC grafts will be administered on Day 0 to all patients. Stem cells are administered through an indwelling central venous catheter. Tacrolimus: Tacrolimus will be given per institutional practices, orally at a dose of 0.05-0.06 mg/kg/day or intravenously at a dose of 0.02-0.03 mg/kg/day starting Day +5. Serum levels of tacrolimus will be measured at Day +7 and then should be checked weekly thereafter, the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at 90 days post HCT if there is no evidence of active GVHD. The tapering rate will be based on institutional practices, patients should be off tacrolimus by Day 180 post HCT if there is no evidence of active GVHD. Mycophenolate Mofetil: MMF will be given at a dose of 15 mg/kg/dose ter in die (TID) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and discontinue after the last dose on Day +35, or may be continued if active GVHD is present. Cyclophosphamide: Cyclophosphamide [50 mg/kg ideal body weight (IBW); if actual body weight (ABW) < IBW, use ABW] will be given on Day +3 (between 60 and 72 hours after the start of the PBSC infusion) and on Day +4 post-transplant (approximately 24 hours after Day +3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours. |
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