CLINICAL TRIALS PROFILE FOR COAGULATION FACTOR XIII A-SUBUNIT (RECOMBINANT)
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All Clinical Trials for coagulation factor xiii a-subunit (recombinant)
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00377143 ↗ | PRospective Evaluation Comparing Initiation of Warfarin StrategiEs (PRECISE): Pharmacogenetic-guided Versus Usual Care | Withdrawn | University of Florida | Phase 4 | 2006-07-01 | Warfarin (also called Coumadin®) is an anticoagulant drug (blood thinner) given to patients to help prevent blood clots from forming or to help prevent the growth of an existing blood clot. The purpose of this study is to collect information on a possible method used to determine the best warfarin dose for people before they start warfarin. This study will focus on finding out if a person's stable dose can be better predicted by using a new approach (called "pharmacogenetic-guided dosing") compared to the current warfarin dosing method. The pharmacogenetic-guided dosing method (the new warfarin dosing method) will use a person's specific health and genetic information to calculate a patient's warfarin dose at the beginning of warfarin treatment. The hope is that through this research, we may someday be able to use an individual's genetic information to guide the selection of their specific warfarin dose at the beginning of treatment, leading to precise warfarin dosing and less need for the current trial and error process. |
| NCT06186648 ↗ | Evaluation of Treatment by Glofitamab in Combination With Rituximab or Obinutuzumab Plus CHOP in Patients With RIchter Syndrome | Recruiting | Hoffmann-La Roche | Phase 2 | 2024-03-21 | This is a national clinical trial, multicentric (28 centers), non-randomized phase 2 study. Population: Patients with previously untreated Richter's syndrome (RS), defined as the occurrence of an aggressive lymphoma (of diffuse large B-cell lymphoma histology) in a patient with chronic lymphocytic leukemia (CLL). Study treatment: The duration of each cycle is 21 days. Cycle 1: Participants will receive standard of care doses of R-CHOP in cycle 1 as follows: - Rituximab 375 mg/m² IV Day 1 - Cyclophosphamide 750 mg/m² IV Day 1 - Doxorubicin 50 mg/m² IV Day 1 - Vincristine 1.4 mg/m² [capped at 2.0 mg] IV Day 1 - Prednisone 60 mg/m2 per day PO Day 1-5 Cycle 2: In order to minimize cytokine release syndrome (CRS), participants will then receive G-CHOP as cycle 2 (with obinutuzumab) and glofitamab: - Obinutuzumab 1000 mg single dose IV Day 1 - Cyclophosphamide 750 mg/m² IV Day 1 - Doxorubicin 50 mg/m² IV Day 1 - Vincristine 1.4 mg/m² [capped at 2.0 mg] IV Day 1 - Prednisone 60 mg/m2 per day PO Day 1-5 - Glofitamab : administered intravenously (IV) as a step-up dose on Days 8 (2.5 mg) and 15 (10 mg) Cycle 3-6: Participants will receive standard of care doses of R-CHOP and Glofitamab as follows: - Rituximab 375 mg/m² IV Day 1 - Cyclophosphamide 750 mg/m² IV Day 1 - Doxorubicin 50 mg/m² IV Day 1 - Vincristine 1.4 mg/m² [capped at 2.0 mg] IV Day 1 - Prednisone 60 mg/m2 per day PO Day 1-5 - Glofitamab : 30 mg IV Day 8 Cycle 7 and 8 (only for patient in Complete Response or Partial response after Cycle 6): Cycle 7 and 8 consist of 2 infusions of glofitamab only at D8C7 and D8C8: ● Glofitamab : 30 mg IV Day 8 Primary endpoint Percentage of participants with a complete response as assessed by the investigator using the Cheson IWG 2014 Lugano Classification (i.e. Deauville scale 1-3) after 6 cycles of R/G-CHOP + glofitamab or at permanent treatment discontinuation. End of treatment is defined as after 6 cycles of R/G-CHOP + glofitamab. Permanent treatment discontinuation is defined as the discontinuation of all treatments (R/G-CHOP, glofitamab). |
| NCT06186648 ↗ | Evaluation of Treatment by Glofitamab in Combination With Rituximab or Obinutuzumab Plus CHOP in Patients With RIchter Syndrome | Recruiting | French Innovative Leukemia Organisation | Phase 2 | 2024-03-21 | This is a national clinical trial, multicentric (28 centers), non-randomized phase 2 study. Population: Patients with previously untreated Richter's syndrome (RS), defined as the occurrence of an aggressive lymphoma (of diffuse large B-cell lymphoma histology) in a patient with chronic lymphocytic leukemia (CLL). Study treatment: The duration of each cycle is 21 days. Cycle 1: Participants will receive standard of care doses of R-CHOP in cycle 1 as follows: - Rituximab 375 mg/m² IV Day 1 - Cyclophosphamide 750 mg/m² IV Day 1 - Doxorubicin 50 mg/m² IV Day 1 - Vincristine 1.4 mg/m² [capped at 2.0 mg] IV Day 1 - Prednisone 60 mg/m2 per day PO Day 1-5 Cycle 2: In order to minimize cytokine release syndrome (CRS), participants will then receive G-CHOP as cycle 2 (with obinutuzumab) and glofitamab: - Obinutuzumab 1000 mg single dose IV Day 1 - Cyclophosphamide 750 mg/m² IV Day 1 - Doxorubicin 50 mg/m² IV Day 1 - Vincristine 1.4 mg/m² [capped at 2.0 mg] IV Day 1 - Prednisone 60 mg/m2 per day PO Day 1-5 - Glofitamab : administered intravenously (IV) as a step-up dose on Days 8 (2.5 mg) and 15 (10 mg) Cycle 3-6: Participants will receive standard of care doses of R-CHOP and Glofitamab as follows: - Rituximab 375 mg/m² IV Day 1 - Cyclophosphamide 750 mg/m² IV Day 1 - Doxorubicin 50 mg/m² IV Day 1 - Vincristine 1.4 mg/m² [capped at 2.0 mg] IV Day 1 - Prednisone 60 mg/m2 per day PO Day 1-5 - Glofitamab : 30 mg IV Day 8 Cycle 7 and 8 (only for patient in Complete Response or Partial response after Cycle 6): Cycle 7 and 8 consist of 2 infusions of glofitamab only at D8C7 and D8C8: ● Glofitamab : 30 mg IV Day 8 Primary endpoint Percentage of participants with a complete response as assessed by the investigator using the Cheson IWG 2014 Lugano Classification (i.e. Deauville scale 1-3) after 6 cycles of R/G-CHOP + glofitamab or at permanent treatment discontinuation. End of treatment is defined as after 6 cycles of R/G-CHOP + glofitamab. Permanent treatment discontinuation is defined as the discontinuation of all treatments (R/G-CHOP, glofitamab). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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