- |||||||||| RVT-1801 / Roivant
Trial completion date, Trial primary completion date: MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) - Jul 20, 2023 P1/2, N=7, Active, not recruiting, Trial completion date: Jun 2035 --> Jul 2038 | Trial primary completion date: Jun 2023 --> Jul 2037
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Enrollment closed, Enrollment change: MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) - Jul 20, 2022 P1/2, N=7, Active, not recruiting, Trial completion date: Jun 2035 --> Jul 2038 | Trial primary completion date: Jun 2023 --> Jul 2037 Recruiting --> Active, not recruiting | N=10 --> 7
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Enrollment open: MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) - Aug 26, 2021 P1/2, N=10, Recruiting, The second patient had lower HSC engraftment due to below-target melphalan exposure (likely caused by renal hyperfiltration), with 14% HbF and 5% HbA2 at three years. Active, not recruiting --> Recruiting
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[VIRTUAL] Aruvant Sciences () - May 31, 2021 - Abstract #BIO2021BIO_245; For more information on the ongoing ARU-1801 clinical study, please visit www.momentumtrials.com and for more on the company, please visit www.aruvant.com . Follow Aruvant on Facebook , Twitter @AruvantSciences and on Instagram @Aruvant_Sciences .
- |||||||||| Zarzio (filgrastim biosimilar) / Novartis, RVT-1801 / Roivant
[VIRTUAL] TOWARDS PATIENT-SPECIFIC DOSING OF MELPHALAN CONDITIONING FOR ARU-1801, A NOVEL GENE THERAPY FOR TREATMENT OF SICKLE CELL DISEASE () - May 13, 2021 - Abstract #EHA2021EHA_1410; Background Sickle cell disease (SCD) is a severe genetic disease for which the only cure is allogeneic hematopoietic stem cell transplant (HSCT), but this procedure requires myeloablative conditioning (usually with busulfan) to allow donor cell engraftment at the risk of chemotherapy-related toxicities, including short-term (e.g. neutropenia, veno-occlusive disease) and long-term (e.g. ovarian failure, secondary leukemia) effects...These data suggest individualized melphalan dosing prior to ARU-1801 infusion may be feasible; additional data will be used to refine the PK model for patients with SCD. A simple melphalan dose adjustment algorithm based on few covariate values has the potential to reduce variability and optimize melphalan exposure, which may result in improved patient outcomes after treatment with ARU-1801.
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Enrollment closed: MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) - Mar 1, 2021 P1/2, N=10, Active, not recruiting, These results are an encouraging sign of the therapeutic benefit of ARU-1801 with RIC for patients with SCD. Recruiting --> Active, not recruiting
- |||||||||| RVT-1801 / Roivant
Trial completion date, Trial primary completion date: MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) - May 8, 2020 P1/2, N=10, Recruiting, P2 had lower HSCP engraftment, which we hypothesize was due to below target melphalan exposure. Trial completion date: Dec 2035 --> Jun 2035 | Trial primary completion date: Dec 2035 --> Jun 2023
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Trial completion date, Trial primary completion date: MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) - May 6, 2019 P1/2, N=10, Recruiting, Trial completion date: Dec 2035 --> Jun 2035 | Trial primary completion date: Dec 2035 --> Jun 2023 Trial completion date: Aug 2033 --> Dec 2035 | Trial primary completion date: Aug 2032 --> Dec 2035
- |||||||||| RVT-1801 / Roivant
Trial primary completion date: MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) - Aug 30, 2017 P1/2, N=10, Recruiting, Trial completion date: Aug 2033 --> Dec 2035 | Trial primary completion date: Aug 2032 --> Dec 2035 Trial primary completion date: Jul 2017 --> Aug 2032
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