Acute Myeloid Leukemia Clinical Trial
Official title:
Phase 1b/2, Open-Label, Multicenter, Dose-Escalating, Clinical Study of the Safety, Tolerability, and PK and PD Profiles of Voreloxin Injection in Combination With Cytarabine in Patients With Relapsed or Refractory AML
This study will evaluate the safety and tolerability of voreloxin (vosaroxin) injection in combination with cytarabine in patients with relapsed or refractory acute myeloid leukemia.
An open-label, Phase 1b/2 study using a dose-escalation design with expansion at the maximum
tolerated dose (MTD) using 2 dosing schedules:
During the Schedule A dose-escalation phase, patients with relapsed or refractory acute
myeloid leukemia (AML) enrolled in cohorts of at least 3 patients to identify the MTD. Begin
with a starting dosing regimen of vosaroxin of 10 mg/m2 on Days 1 and 4 of each cycle in
combination with a 24-hour continuous intravenous (CIV) infusion of cytarabine 400 mg/m2/day
× 5 days. If none of the 3 patients or 1 of 6 patients experience a dose-limiting toxicity
(DLT) at the vosaroxin starting dose, dose-escalate vosaroxin. If 2 of 6 patients experienced
a DLT at the vosaroxin starting dose, reduce the dose of cytarabine to reduced to 200 mg/m2
(only case in which the cytarabine could have been reduced). The vosaroxin dose escalated
following a modified Fibonacci schema.
For Schedule B dose-escalation phase, patients with relapsed or refractory AML enrolled in
cohorts of at least 3 patients to identify the MTD. Begin with a starting dose regimen of
vosaroxin of 70 mg/m2 on Days 1 and 4 in combination with cytarabine as a 2-hour infusion of
1 g/m2/day × 5 days. No reductions of cytarabine allowed in Schedule B. If none of the 3
patients or 1 of 6 patients experienced a DLT in the first cohort of Schedule B, escalate the
dose of vosaroxin. If DLTs occurred in 2 of 6 patients during the starting dose, reduce the
vosaroxin dose to 50 mg/m2.
For both Schedules, the highest dose at which fewer than 2 of 6 patients experienced a DLT
during induction became the MTD and the recommended future dose.
Once the MTD of vosaroxin was determined for Schedule A, first relapse patients were enrolled
in the expansion phase at that dose level to obtain additional safety and efficacy
information. When the MTD of vosaroxin was determined for Schedule B, first relapse patients
and patients with primary refractory disease were enrolled in the expansion phase at that
dose level to characterize the safety and efficacy profile in this population.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Recruiting |
NCT04460235 -
Immunogenicity of an Anti-pneumococcal Combined Vaccination in Acute Leukemia or Lymphoma
|
Phase 4 | |
Completed |
NCT04022785 -
PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
Completed |
NCT03678493 -
A Study of FMT in Patients With AML Allo HSCT in Recipients
|
Phase 2 | |
Recruiting |
NCT05424562 -
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy Receiving Oral Venetoclax Tablets in Canada
|
||
Terminated |
NCT03224819 -
Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)
|
Early Phase 1 | |
Completed |
NCT03197714 -
Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia
|
Phase 1 | |
Active, not recruiting |
NCT04070768 -
Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) and Venetoclax in Patients With Relapsed or Refractory CD33+ Acute Myeloid Leukemia:Big Ten Cancer Research Consortium BTCRC-AML17-113
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Active, not recruiting |
NCT04107727 -
Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML)
|
Phase 2 | |
Recruiting |
NCT04920500 -
Bioequivalence of Daunorubicin Cytarabine Liposomes in Naive AML Patients
|
N/A | |
Recruiting |
NCT04385290 -
Combination of Midostaurin and Gemtuzumab Ozogamicin in First-line Standard Therapy for Acute Myeloid Leukemia (MOSAIC)
|
Phase 1/Phase 2 | |
Recruiting |
NCT03897127 -
Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics
|
Phase 3 | |
Active, not recruiting |
NCT04021368 -
RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome
|
Phase 1 | |
Recruiting |
NCT03665480 -
The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML
|
Phase 2/Phase 3 | |
Completed |
NCT02485535 -
Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant
|
Phase 1 | |
Enrolling by invitation |
NCT04093570 -
A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers
|
Phase 2 | |
Recruiting |
NCT04069208 -
IA14 Induction in Young Acute Myeloid Leukemia
|
Phase 2 | |
Recruiting |
NCT05744739 -
Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)
|
Phase 1 | |
Recruiting |
NCT04969601 -
Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings
|
Phase 1/Phase 2 |