| Primary | Efficacy of Combined Modality Treatment (Ruxolitinib, Decitabine, and DLI) for Relapsed AML or MDS Post Allo-HCT: Rate of Overall Survival (OS) | Rate of Overall Survival (OS) | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 6 Months | | | | ID | Title | Description |
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| OG000 | Decitabine + Ruxolitinib + DLI | Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose. Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule. Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to >100 x 10^9/L. Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle. |
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| Secondary | Efficacy of Combined Modality Treatment (Ruxolitinib, Decitabine, and DLI) for Relapsed AML or MDS Post Allo-HCT: Rate of Overall Survival (OS) | Rate of Overall Survival (OS) | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 Year | | | | ID | Title | Description |
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| OG000 | Decitabine + Ruxolitinib + DLI | Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose. Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule. Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to >100 x 10^9/L. Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle. |
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| Secondary | Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV) | Percentage of Participants with Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV) | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 3 Months | | | | ID | Title | Description |
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| OG000 | Decitabine + Ruxolitinib + DLI | Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose. Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule. Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to >100 x 10^9/L. Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle. |
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| Secondary | Progression Free Survival (PFS) | Rate of Progression Free Survival (PFS) | | Posted | | Number | 95% Confidence Interval | Percentage of participants with PFS | | 6 Months | | | | ID | Title | Description |
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| OG000 | Decitabine + Ruxolitinib + DLI | Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose. Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule. Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to >100 x 10^9/L. Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle. |
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| Secondary | Progression Free Survival (PFS) | Rate of Progression Free Survival (PFS) | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 Year | | | | ID | Title | Description |
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| OG000 | Decitabine + Ruxolitinib + DLI | Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose. Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule. Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to >100 x 10^9/L. Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle. |
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| Secondary | Relapse | Cumulative Incidence of Relapse | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 6 Months | | | | ID | Title | Description |
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| OG000 | Decitabine + Ruxolitinib + DLI | Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose. Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule. Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to >100 x 10^9/L. Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle. |
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| Secondary | Relapse | Cumulative Incidence of Relapse | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 Year | | | | ID | Title | Description |
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| OG000 | Decitabine + Ruxolitinib + DLI | Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose. Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule. Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to >100 x 10^9/L. Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle. |
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| Secondary | Complete Remission (CR) | Rate of Complete Remission (CR) | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 6 Months | | | | ID | Title | Description |
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| OG000 | Decitabine + Ruxolitinib + DLI | Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose. Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule. Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to >100 x 10^9/L. Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle. |
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| Secondary | Complete Remission (CR) | Rate of Complete Remission (CR) | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 Year | | | | ID | Title | Description |
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| OG000 | Decitabine + Ruxolitinib + DLI | Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose. Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule. Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to >100 x 10^9/L. Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle. |
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| Secondary | Non-Relapse Mortality (NRM) | Cumulative Incidence of Non-Relapse Mortality (NRM) | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 6 Months | | | | ID | Title | Description |
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| OG000 | Decitabine + Ruxolitinib + DLI | Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose. Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule. Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to >100 x 10^9/L. Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle. |
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| Secondary | Non-Relapse Mortality (NRM) | Cumulative Incidence of Non-Relapse Mortality (NRM) | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 Year | | | | ID | Title | Description |
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| OG000 | Decitabine + Ruxolitinib + DLI | Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose. Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule. Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to >100 x 10^9/L. Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle. |
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| Secondary | Best Response | Best response until next line of treatment, death, or last follow up, whichever occurs sooner | | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 Year | | | | ID | Title | Description |
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| OG000 | Decitabine + Ruxolitinib + DLI | Eligible subjects will receive up to 4 cycles of combined modality treatment. The number of cycles depends on response, toxicity, and the remaining cell dose. Decitabine: 10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule. Ruxolitinib: Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to >100 x 10^9/L. Donor Lymphocyte Infusion (DLI): DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle. |
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