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Preleukemia clinical trials

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NCT ID: NCT06337331 Withdrawn - Clinical trials for Acute Myeloid Leukemia

Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant

Start date: August 31, 2024
Phase: Phase 2
Study type: Interventional

Patients eligible for a mismatch allogeneic stem cell transplant will receive Venetoclax daily for 7 days prior to transplant in addition to the following chemotherapy regimen: Decitabine daily for 5 days, Fludarabine daily for 5 days, and Busulfan daily for 2 days followed by 1 day of total body irradiation. Stem cell transplant will occur thereafter.

NCT ID: NCT05829434 Withdrawn - Clinical trials for Acute Myeloid Leukemia

Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed AML or HR-MDS

MAGROLIC
Start date: March 31, 2024
Phase: Phase 2
Study type: Interventional

Use of magrolimab in combination with standard intensive chemotherapy ("7+3" or CPX-351) in newly diagnosed "ELN 2022 intermediate or adverse-risk" AML or high risk MDS patients, who intend to undergo allogeneic stem cell transplantation

NCT ID: NCT05367401 Withdrawn - Clinical trials for Acute Myeloid Leukemia

A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants

Start date: December 20, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is to determine the safety and preliminary efficacy of sabatolimab in combination with magrolimab and azacitidine in adult participants with 1L unfit Acute Myeloid Leukemia (AML) or with 1L higher risk Myelodysplastic Syndromes (MDS), and sabatolimab in combination with magrolimab in participants with relapsed or refractory (R/R) AML.

NCT ID: NCT05246384 Withdrawn - Clinical trials for Acute Myeloid Leukemia

Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RP7214 in Combination With Azacitidine in Patients With Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Acute Myeloid Leukemia

Start date: January 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, open-label, non-randomized, two-part Phase I/Ib study of RP7214 in combination with azacitidine in patients with AML, MDS and CMML. Part I is a 3+3 dose-escalation study to identify the MTD/RP2D of RP7214 and azacitidine combination in patients with AML, MDS, and CMML. Part II is a dose-expansion study to evaluate the clinical activity and safety of RP7214 and azacitidine combination in AML.

NCT ID: NCT04985656 Withdrawn - Clinical trials for Myelodysplastic Syndromes (MDS)

A Study of Pevonedistat Combined With Decitabine and Cedazuridine in Adults With Higher-risk Myelodysplastic Syndromes

PEVOBINE
Start date: October 1, 2021
Phase: Phase 2
Study type: Interventional

The main aim of the study is to see if signs and symptoms of myelodysplastic syndromes disappear when treated with pevonedistat combined with decitabine and cedazuridine. Participants will receive an infusion of pevonedistat 3 times during a 28-day cycle. They will also take decitabine and cedazuridine tablets once a day for the first 5 days of the same cycle. A minimum of 6 28-day cycles is recommended, but participants can stop treatment at any time. A bone marrow biopsy, bone marrow aspirates, and blood samples will be collected during the study. Participants will attend a follow-up visit 30 days after their last dose of pevonedistat. Once treatment has ended, participants will be followed up with either monthly clinic visits or will be contacted every 3 months.

NCT ID: NCT04969367 Withdrawn - Clinical trials for Myelodysplastic Syndromes

Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome

Start date: May 10, 2021
Phase:
Study type: Observational

This study assesses feasibility and patient acceptability of using a Fitbit to monitor step count and heart rate in transfusion dependent patients with myelodysplastic syndrome. Information from this study may help researchers understand if there is any correlation between activity level and anemia.

NCT ID: NCT04395092 Withdrawn - Clinical trials for Acute Myeloid Leukemia (AML)

Haplo-identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS (NK-REALM)

Start date: November 13, 2020
Phase: Phase 2
Study type: Interventional

This study is a Phase II, single arm, open label multicenter trial designed to investigate the use of haploidentical donor derived NK cells (K-NK002) for the treatment of patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) who are undergoing haploidentical donor bone marrow transplantation (HaploBMT). K-NK002 is a NK cell product derived from peripheral blood leukocytes collected from a related donor (HLA-haploidentical matched) and enriched for NK cells with depletion of CD3+ T-lymphocytes (T-cells) followed by enriched ex-vivo expansion and administered to the patient prior to and following BMT.

NCT ID: NCT04361058 Withdrawn - Clinical trials for Myelodysplastic Syndromes

Nivolumab for High-Risk MDS/AML Patients After Allogeneic Stem Cell Transplant With Post-Transplant Cyclophosphamide

Start date: April 13, 2020
Phase: Phase 1
Study type: Interventional

There are no strategies developed post-stem cell transplant (SCT) for patients who receive allogenic SCT with a significant amount of blasts prior SCT. Novel strategies to treat relapsed AML/MDS and to reduce the incidence of relapse after allogeneic SCT are needed. This study is being done in patients with high-risk MDS or AML who undergo an allogeneic SCT. The study will have two arms, participants who receive an HLA-matched unrelated donor SCT (Arm A) or HLA- haploidentical SCT (Arm B). Following myeloablative conditioning (MAC), GVHD prophylaxis with post-transplantation cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil will be given per standard of care. At 40-60 days post SCT, If the patient has not had any evidence of Grade II-IV acute graft-versus-host-disease (aGVHD), Nivolumab will be given intravenously every 2 weeks for 4 cycles of consolidation or treatment with Nivolumab. Dose-escalation of Nivolumab will follow the standard 3+3 design where a maximum of three dose levels will be evaluated, with a maximum of 18 patients treated with nivolumab per arm. As the maximum tolerated dose (MTD) of Nivolumab may differ between Arm A and Arm B, dose escalation of nivolumab in each arm will be followed separately following allogeneic SCT. Immunosuppression with tacrolimus will be continued during the cycles of PD-1 blockade to provide a moderate level of GVHD prophylaxis during consolidation or treatment with nivolumab.

NCT ID: NCT04296214 Withdrawn - Clinical trials for Acute Myeloid Leukemia

Pharmacoeconomics in the Application of 5-azacitidine in the Treatment of Myelodysplastic Syndromes and Acute Myeloid Leukemia

Start date: January 1, 2020
Phase:
Study type: Observational

The investigators want to compare the global response rate of patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) after six months of treatment with 5-azacitidine on two different doses. First group of 50 mg/m2 for 10 days each 28 days versus 75 mg/m2 for 7 days on 28 days cycles.

NCT ID: NCT04264806 Withdrawn - Clinical trials for Myelodysplastic Syndromes

A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)

Start date: May 6, 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for Hematopoietic Stem Cell Transplantation (HSCT).