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Phase 1-2 Study of Low Dose ASTX727 (ASTX727 LD) in Lower Risk MDS

Myelodysplastic Syndrome

Multicenter, open-label study of various ASTX727 LD doses and schedules to assess safety, pharmacodynamics, pharmacokinetics, and hematologic response in subjects with International Prognostic Scoring System (IPSS) risk category of low-risk or Intermediate-1 MDS. This study will be conducted in two phases. In phase 1 subjects will be randomized into 3 cohorts in a 28-day cycles. Phase 2, 80 new subjects will be randomized in a 1:1 ratio into 2 doses / schedules.
Myelodysplastic Syndrome
I/II
Mohan, Sanjay
NCT03502668
VICCHEM1967

A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)

Myelodysplastic Syndrome

This Phase 1 / 2 clinical study will evaluate evorpacept (ALX148) in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).
Myelodysplastic Syndrome
I/II
Kishtagari, Ashwin
NCT04417517
VICCHEMP2084

A Study of Engineered Donor Grafts (TregGraft / Orca-T) in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Multiple Cancer Types

This study will evaluate the safety, tolerability, and efficacy of an engineered donor graft ("TregGraft" / "Orca-T", a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.
Leukemia, Myelodysplastic Syndrome, Phase I
I
Dholaria, Bhagirathbhai
NCT04013685
VICCCTTP2086

Venetoclax and Selinexor in Treating Patients with Relapsed or Refractory High Risk Hematologic Malignancies

Multiple Cancer Types

This phase Ib trial studies the side effects and best dose of venetoclax and selinexor and how well they work in treating patients with high risk hematologic malignancies such as diffuse large B-cell lymphoma, multiple myeloma, or acute myeloid leukemia that have come back (recurrent) or do not respond to treatment (refractory). Venetoclax functions by inhibiting or slowing down a protein in the body called bcl-2, which is involved in slowing down the normal process by which old cells in the body are cleared (called apoptosis). Selinexor functions by trapping tumor suppressing proteins within the cell and causing the cancer cells to die or stop growing. This study examines the effects, if any, of selinexor and venetoclax on high risk hematologic malignancies and on the body, including any side-effects.
Hematologic, Leukemia, Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome, Phase I
I
Byrne, Michael
NCT03955783
VICCHEM1755

Active Myeloid Target Compound Decitabine and Cedazuridine in Combination with Itacitinib for the Treatment of Myelodysplastic / Myeloproliferative Neoplasm (MDS / MPN) Overlap Syndromes, ABNL-MARRO Study

Multiple Cancer Types

This phase I / II trial tests the safety, side effects, and best dose of decitabine and cedazuridine (ASTX727) in combination with itacitinib and how well they work in treating patients with myelodysplastic / myeloproliferative neoplasm. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Itacitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine and cedazuridine in combination with itacitinib may work better in treating patients with myelodysplastic / myeloproliferative neoplasm.
Hematologic, Myelodysplastic Syndrome
I/II
Savona, Michael
NCT04061421
VICCHEMP1977

A Study of ASTX030 (Cedazuridine in Combination With Azacitidine) in MDS, CMML, or AML

Multiple Cancer Types

Study ASTX030-01 is designed to move efficiently from Phase 1 to Phase 3. Phase 1 consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B) of ASTX030. Phase 2 is a randomized open-label crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 is a randomized open-label crossover study comparing the final oral ASTX030 dose to SC azacitidine. The duration of the study is expected to be approximately 48 months.
Leukemia, Myelodysplastic Syndrome, Phase I
I/II/III
Savona, Michael
NCT04256317
VICCHEMP19146

HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide

Multiple Cancer Types

This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral blood stem cell transplant in adults and bone marrow stem cell transplant in children. Post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil (MMF) will be used for for graft versus host disease (GVHD) prophylaxis. This trial will study how well this treatment works in patients with hematologic malignancies.
Hematologic, Leukemia, Lymphoma, Myelodysplastic Syndrome
II
Dholaria, Bhagirathbhai
NCT04904588
VICCCTT2171