Acute Myelogenous Leukemia Clinical Trial
Official title:
A Phase 1 Study of MLN518 Given in Combination With Standard Induction Chemotherapy for the Treatment of Patients With Newly Diagnosed Acute Myelogenous Leukemia
This is a phase 1, open-label, multicenter study investigating the use of MLN518 in combination with standard chemotherapy to patients with newly diagnosed AML. Two dose levels of MLN518—200 mg and 400 mg given orally twice a day are planned for sequential evaluation in separate groups of patients. Patients assigned to the 400 mg dose level given orally twice a day of MLN518, will potentially have their dose of MLN518 adjusted on the basis of MLN518 plasma concentrations measured during the first 3 days of induction therapy. All patients will receive initial induction chemotherapy with cytarabine, 200 mg/m2/day by CIVI on Days 1 through 7, and with daunorubicin, 60 mg/m2/day by intravenous (IV) push (IV infusion if borderline cardiac function is detected) on Days 1 through 3 ("7+3"). An abbreviated cytarabine and daunorubicin regimen ("5+2") will also be used when the initial remission induction therapy fails to clear the bone marrow of blast cells (as typically detected on the Day 15 bone marrow) and a second attempt at remission induction is indicated. Patients who achieve a complete remission (CR) will receive consolidation therapy with HiDAC (standard or modified) in combination with continued MLN518 treatment. Patients remaining in continuous CR after completion of their last cycle of consolidation therapy will be permitted to continue treatment with single-agent MLN518 for 6 months thereafter.
n/a
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |