Acute Myeloid Leukaemia Clinical Trial
Official title:
A Phase I, Single-arm, Open Label, Dose Escalation, Multicenter Study of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)
This is a single group, Phase 1, single-arm, dose escalation study to determine the candidate dose(s), and evaluate safety, tolerability, and preliminary anti-tumor activity of SAR445419 administered after fludarabine and cytarabine conditioning for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML). Adult participants with R/R AML will be eligible for treatment. The study is intended to assess the candidate dose(s) by the occurrence of dose-limiting toxicity (DLT) from start of chemotherapy until 28 days after the first administration of SAR445419. The duration of the study for a participant will include: - Screening period up to 21 days prior to initiating chemotherapy, - Treatment period of 5 days chemotherapy followed by SAR445419 administered for 2 weeks and end of treatment visit 56 days after first SAR445419 administration, - Survival follow-up period up to 1 year after the last participant has started treatment with SAR445419.
Participants will be followed for 28 days (for DLT evaluations) after administration of the first SAR445419 dose (Day 1) for the primary endpoint and for 1 year after the first SAR445419 dose for selected secondary endpoints. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02272478 -
Trial to Test the Effects of Adding 1 of 2 New Treatment Agents to Commonly Used Chemotherapy Combinations
|
Phase 2/Phase 3 | |
| Completed |
NCT03672695 -
Phase I Dose Escalation Study of Intravenously Administered S64315 in Combination With Orally Administered Venetoclax in Patients With Acute Myeloid Leukaemia.
|
Phase 1 | |
| Completed |
NCT01019161 -
An Open Label, Single Centre Mass Balance C14 Study in Patients With Acute Myeloid Leukaemia (AML)
|
Phase 1 | |
| Completed |
NCT00530699 -
Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)
|
Phase 1 | |
| Not yet recruiting |
NCT06326697 -
Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML)
|
Phase 1 | |
| Active, not recruiting |
NCT01597219 -
Trial of Haploidentical Stem Cell Transplantation for Haematological Cancers
|
Phase 2 | |
| Completed |
NCT01063660 -
Treosulfan Based Conditioning Acute Myeloid Leukaemia (AML)
|
Phase 2 | |
| Terminated |
NCT03217838 -
Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants.
|
Phase 1 | |
| Withdrawn |
NCT04106076 -
Phase I Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia
|
Phase 1 | |
| Active, not recruiting |
NCT04217278 -
A Trial of Treatments to Assess the Effects on Outcome of Adults With AML and MDS Undergoing Allogeneic SCT
|
Phase 2/Phase 3 | |
| Completed |
NCT02844257 -
Transfusion Dependency at Diagnosis and Transfusion Intensity During Initial Chemotherapy Are Associated With Poorer Outcomes in Adult Acute Myeloid Leukaemia
|
N/A | |
| Active, not recruiting |
NCT01716364 -
Safety Study of Anti LewisY Chimeric Antigen Receptor in Myeloma, Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
| Recruiting |
NCT06345365 -
MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
|
Phase 3 | |
| Completed |
NCT01422603 -
Clofarabine Pre-conditioning With Allogeneic Transplant for Acute Myeloid Leukaemia (AML)
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04629443 -
Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02189824 -
Chemotherapy Followed by Infusion of Partially HLA Matched Unrelated Donor Cells for Patients With AML Who Are Ineligible for Stem Cell Transplantation
|
Phase 1 | |
| Recruiting |
NCT02724163 -
International Randomised Phase III Clinical Trial in Children With Acute Myeloid Leukaemia
|
Phase 3 | |
| Completed |
NCT01621724 -
WT1 TCR Gene Therapy for Leukaemia: A Phase I/II Safety and Toxicity Study
|
Phase 1/Phase 2 | |
| Completed |
NCT01236144 -
A Trial to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.
|
Phase 1/Phase 2 | |
| Completed |
NCT01497002 -
Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a
|
Phase 3 |