drugset / Trial / NCT03709576
Pevonedistat and Azacitidine as Maintenance Therapy After Allogeneic Stem Cell Transplantation for Non-Remission AML
Phase 2
Terminated
3 enrolled
Milton S. Hershey Medical Center
Millennium Pharmaceuticals, Inc. · collabTakeda · collab
NaSingle-groupOpen-labelTreatment
Summary
This research is being done to find out the toxicity and efficacy of a combination of Pevonedistat and Azacitidine as post allogeneic hematopoietic stem cell transplant maintenance therapy for non-remission AML and to see the overall diseases free survival, relapse, and GVHD after treatment.
Timeline
- Start
- 2018-07-18
- Primary completion
- 2019-07-22
- Completion
- 2019-07-22
Publications
- Background Sierra J, Storer B, Hansen JA, Bjerke JW, Martin PJ, Petersdorf EW, Appelbaum FR, Bryant E, Chauncey TR, Sale G, Sanders JE, Storb R, Sullivan KM, Anasetti C. Transplantation of marrow cells from unrelated donors for treatment of high-risk acute leukemia: the effect of leukemic burden, donor HLA-matching, and marrow cell dose. Blood. 1997 Jun 1;89(11):4226-35.
- Background Giralt S, Estey E, Albitar M, van Besien K, Rondon G, Anderlini P, O'Brien S, Khouri I, Gajewski J, Mehra R, Claxton D, Andersson B, Beran M, Przepiorka D, Koller C, Kornblau S, Korbling M, Keating M, Kantarjian H, Champlin R. Engraftment of allogeneic hematopoietic progenitor cells with purine analog-containing chemotherapy: harnessing graft-versus-leukemia without myeloablative therapy. Blood. 1997 Jun 15;89(12):4531-6.
- Background Saito T, Kanda Y, Kami M, Kato K, Shoji N, Kanai S, Ohnishi T, Kawano Y, Nakai K, Ogasawara T, Matsubara H, Makimoto A, Tanosaki R, Tobinai K, Wakasugi H, Takaue Y, Mineishi S. Therapeutic potential of a reduced-intensity preparative regimen for allogeneic transplantation with cladribine, busulfan, and antithymocyte globulin against advanced/refractory acute leukemia/lymphoma. Clin Cancer Res. 2002 Apr;8(4):1014-20.
- Background Kassim AA, Chinratanalab W, Ferrara JL, Mineishi S. Reduced-intensity allogeneic hematopoietic stem cell transplantation for acute leukemias: 'what is the best recipe?'. Bone Marrow Transplant. 2005 Oct;36(7):565-74. doi: 10.1038/sj.bmt.1705075.
- Background Slavin S, Nagler A, Naparstek E, Kapelushnik Y, Aker M, Cividalli G, Varadi G, Kirschbaum M, Ackerstein A, Samuel S, Amar A, Brautbar C, Ben-Tal O, Eldor A, Or R. Nonmyeloablative stem cell transplantation and cell therapy as an alternative to conventional bone marrow transplantation with lethal cytoreduction for the treatment of malignant and nonmalignant hematologic diseases. Blood. 1998 Feb 1;91(3):756-63.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Pevonedistat | Small molecule | 20 mg/m2 | Intravenous |