Acute Myelogenous Leukemia Clinical Trial
Official title:
A Phase 2 Trial of MLN8237, an Oral Aurora A Kinase Inhibitor, in Adult Patients With Acute Myelogenous Leukemia and High-Grade Myelodysplastic Syndrome
This is an open-label, multicenter, phase 2 study of alisertib (MLN8237) in participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested
to treat people who have acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome
(MDS). This study looked at the antitumor activity in people who received alisertib.
The study enrolled 57 patients. Participants were categorized by disease sub-types AML and
MDS. Participants received:
• Alisertib 50 mg
All participants took alisertib capsules every 12 hours each day for 7 days followed by a
14-day rest period in 21-day cycles for approximately 26 cycles.
This multi-center trial was conducted in North America and France. The overall time to
participate in this study was until there is evidence of disease progression or unacceptable
treatment-related toxicity. The participant could continue treatment beyond 12 months if it
was considered by the Sponsor and the Investigator that they would derive benefit from
continued alisertib treatment. Participants had weekly blood work and clinic visits, with
disease assessments every 2 cycles (ie. every 6 weeks) up to and including Cycle 16. Reduced
visits (every 12 weeks) were conducted for participants tolerating treatment beyond Cycle 16
and for participants off treatment without disease progression.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01200355 -
Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome
|
Phase 4 | |
| Active, not recruiting |
NCT03755414 -
Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation
|
Phase 1 | |
| Recruiting |
NCT04904588 -
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
|
Phase 2 | |
| Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
| Completed |
NCT02543879 -
Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies
|
Phase 1 | |
| Completed |
NCT01681537 -
Lenalidomide Plus Chemotherapy for AML
|
Phase 1 | |
| Completed |
NCT01385423 -
Haploidentical Donor Natural Killer Cell Infusion With IL-15 in Acute Myelogenous Leukemia (AML)
|
Phase 1 | |
| Terminated |
NCT01193400 -
Clofarabine and Low-dose Cytarabine Followed by Consolidation Therapy in AML Patients Age Greater Than or Equal to 60 Years
|
Phase 2 | |
| Completed |
NCT00981240 -
Dose Escalation, Safety and Pharmacokinetic Study of SAR103168 in Patients Refractory/ Relapsed Acute Leukemias or High-risk Myelodysplastic Syndromes
|
Phase 1 | |
| Completed |
NCT00995332 -
Disease Stabilization in AML by Treatment With ATRA, Valproic Acid and Low-dose Cytarabine
|
Phase 1/Phase 2 | |
| Completed |
NCT00975975 -
Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
|
Phase 2 | |
| Completed |
NCT00726934 -
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
|
N/A | |
| Completed |
NCT00378534 -
Methods to Enhance the Safety and Effectiveness of Stem Cell Transplants
|
Phase 2 | |
| Completed |
NCT01031498 -
Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting
|
Phase 2 | |
| Completed |
NCT00789256 -
Low Dose Melphalan and Bortezomib for AML and High-Risk MDS
|
N/A | |
| Completed |
NCT00098033 -
Investigation of Clofarabine in Acute Leukemias
|
Phase 2 | |
| Completed |
NCT01020539 -
Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Leukemia
|
Phase 1 | |
| Not yet recruiting |
NCT04709458 -
Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis
|
Phase 1 | |
| Recruiting |
NCT04024241 -
Medium Dose of Cytarabine and Mitoxantrone
|
||
| Terminated |
NCT02203773 -
Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)
|
Phase 1 |