Myelodysplastic Syndrome Clinical Trial
Official title:
Haploidentical Donor Natural Killer (NK) Cell Infusion With Intravenous Recombinant Human IL-15 (rhIL-15) in Adults With Refractory or Relapsed Acute Myelogenous Leukemia (AML)
This is a single center, "modified standard design" dose escalation study designed to determine the maximum tolerated, minimum efficacious dose (MTD/MED) of IL-15 (Intravenous Recombinant Human IL-15) and incidence of donor natural killer (NK) cell expansion by day +14 when given after haploidentical donor NK cells in patients with relapse or refractory acute myelogenous leukemia (AML).
Once the MTD/MED for IL-15 is determined, this cohort will be expanded to a total of 19
patients. The primary goal of this extended phase will be to establish a correlation of the
clinical endpoint, CRp defined as leukemic clearance (< 5% marrow blast and no peripheral
blood blasts) and neutrophil recovery without platelet recovery, with in vivo expansion.
Patients achieving a complete remission and neutrophil recovery (ANC > 500) for at least 4
weeks will be considered for allogeneic transplant to prolong remission independent of this
study.
All patients, including those who go on to transplant, will be followed to determine disease
free survival, treatment related mortality, and time to relapse.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04022785 -
PLX51107 and Azacitidine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
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 |
NCT02530463 -
Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome
|
Phase 2 | |
Completed |
NCT02057185 -
Occupational Status and Hematological Disease
|
||
Completed |
NCT01682226 -
Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies
|
Phase 2 | |
Completed |
NCT02485535 -
Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant
|
Phase 1 | |
Completed |
NCT03941769 -
2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II
|
Phase 1/Phase 2 | |
Completed |
NCT00001637 -
Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
|
Phase 2 | |
Recruiting |
NCT06195891 -
Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome
|
Phase 1 | |
Active, not recruiting |
NCT04188678 -
Resiliency in Older Adults Undergoing Bone Marrow Transplant
|
N/A | |
Completed |
NCT00987480 -
Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine
|
Phase 2 | |
Recruiting |
NCT02356159 -
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
|
Phase 1/Phase 2 | |
Completed |
NCT04666025 -
SARS-CoV-2 Donor-Recipient Immunity Transfer
|
||
Completed |
NCT02756572 -
Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms
|
Phase 2 | |
Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
Completed |
NCT02543879 -
Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies
|
Phase 1 | |
Completed |
NCT02188290 -
Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation
|
N/A | |
Completed |
NCT02262312 -
Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome
|
Phase 0 | |
Recruiting |
NCT02330692 -
Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and Relapse in Myelodysplastic Syndrome
|
||
Completed |
NCT01684150 -
A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving
|
Phase 1 |