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Leukemia clinical trials

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NCT ID: NCT06191263 Recruiting - Clinical trials for Acute Myeloid Leukemia

Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML

RIVER-81
Start date: January 5, 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of RVU120 when administered in combination with venetoclax to adult patients with acute myeloid leukemia (AML) who are relapsed or refractory to prior therapy with venetoclax and a hypomethylating agent. The study consists of three parts. Part 1 aims to identify the doses of RVU120 and venetoclax that are considered to be safe and tolerated. Part 2 will assess the safety and efficacy of the doses selected. And Part 3 is a confirmatory cohort where patients will be treated at the same doses assessed in Part 2

NCT ID: NCT06184009 Not yet recruiting - Clinical trials for Pediatric Acute Lymphoblastic Leukemia

Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia

KPHOG_2023-02
Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

- Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD < 0.01% : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation 1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification 1. BM MRD < 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen - Difference in the number of 'interim maintenance(IM)' and 'delayed intensification(DI)' is important for chemotherapies based on MRD.

NCT ID: NCT06182592 Not yet recruiting - Clinical trials for High-risk (Secondary) Acute Myeloid Leukemia

A Bridging Study of Liposomal Cytarabine-Daunorubicin in Treating Olderly Patients With Treatment-naive High-Risk (Secondary) Acute Myeloid Leukemia

Start date: January 2024
Phase: Phase 3
Study type: Interventional

The purpose of this bridging study is to determine the efficacy of liposomal cytarabine-daunorubicin for injection compared with cytarabine and daunorubicin in older patients with high-risk (secondary) acute myeloid leukemia.

NCT ID: NCT06182163 Not yet recruiting - Clinical trials for Acute Lymphoblastic Leukemia (ALL)

Reduce Sedentary Time (ReSeT) in Acute Lymphoblastic Leukemia (ALL)

Start date: February 5, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to test if a mobile health intervention, including a wearable fitness tracker with reminders to move, individualized coaching sessions, and an app-based peer support group, can decrease sedentary time (time spent sitting/lying down and inactive) in adolescents with acute lymphoblastic leukemia (ALL) receiving maintenance chemotherapy. The main questions it aims to answer are: - Is the intervention a feasible and acceptable way to decrease sedentary time among adolescents with ALL? - Does the intervention show evidence that it may decrease sedentary time, increase quality of life, and improve blood glucose control and inflammation? Participants in the intervention group will use their fitness tracker with reminders to move as well as support from other intervention participants and coaching with study staff to gradually decrease their sedentary time over 10 weeks. Researchers will compare the intervention group to a control group that receives education only to see if the intervention may be helpful to decrease sedentary time in adolescents with ALL. All participants will wear an activity tracker on the thigh for 7 days at the beginning and end of the study as well as complete quality of life questionnaires. Study labs will be collected three times (monthly) over the course of the 12-week study. All in-person study visits and labs will occur in conjunction with Oncology clinic visits for maintenance chemotherapy.

NCT ID: NCT06180863 Withdrawn - Clinical trials for Acute Myeloid Leukemia

Oral Azacitidine (CC-486) Epigenetic Priming and Maintenance for Adult Acute Myeloid Leukemia (AML) Patients

Start date: November 2023
Phase: Phase 2
Study type: Interventional

To investigate the feasibility of delivering oral azacitidine (CC-486) as a consolidation regimen from the time of first complete remission (CR1), in patients with acute myelogenous leukemia (AML) eligible for curative intent Allogeneic Stem Cell Transplant (ASCT).

NCT ID: NCT06179524 Recruiting - Clinical trials for Relapsed B-cell Acute Lymphoblastic Leukemia

CAR-T-19 Injection in the Treatment of CD19-positive Relapsed/Refractory B-ALL

Start date: December 31, 2023
Phase: Phase 2
Study type: Interventional

This is a phase II clinical study to evaluate the safety and efficacy of CAR-T-19 injection in the treatment of CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia.

NCT ID: NCT06177561 Recruiting - Leukemia Clinical Trials

Safety and Efficacy of LPE in Clearing DSA in Patients Who Received Allo-HSCT

Start date: November 9, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to prospectively explore the effectiveness and safety of LPE in clearing DSA, and to investigate the clinical efficacy of a combination therapy with LPE in patients undergoing genetic hematopoietic stem cell transplantation.

NCT ID: NCT06177067 Recruiting - Clinical trials for Refractory Acute Myeloid Leukemia

Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

Start date: April 19, 2024
Phase: Phase 1
Study type: Interventional

This is a research study to find out if adding a new study drug called revumenib to commonly used chemotherapy drugs is safe and if they have beneficial effects in treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that did not go into remission after treatment (refractory) or has come back after treatment (relapsed), and to determine the total dose of the 3-drug combination of revumenib, azacitidine and venetoclax that can be given safely in participants also taking an anti-fungal drug. Primary Objective - To determine the safety and tolerability of revumenib + azacitidine + venetoclax in pediatric patients with relapsed or refractory AML or ALAL. Secondary Objectives - Describe the rates of complete remission (CR), complete remission with incomplete count recovery (CRi), and overall survival for patients treated with revumenib + azacitidine + venetoclax at the recommended phase 2 dose (RP2D).

NCT ID: NCT06175923 Not yet recruiting - Clinical trials for Myelodysplastic Syndromes

Role of BMP Pathway in MDS Progression

BMP-MDS
Start date: January 27, 2024
Phase:
Study type: Observational

Myelodysplastic syndromes (MDS) are hematological cancers that can progress to acute myelogenous leukemia (AML). The involvement of the microenvironment in the maintenance, resistance and evolution of MDS is increasingly described. The Bone Morphogenetic Protein (BMP) pathway is involved in numerous functions, including self-renewal of the hematopoietic stem cell compartment and the regulation of hematopoiesis, via interaction with bone marrow stromal cells. Investigators have demonstrated its involvement in chronic myeloid leukemia (CML) and AML, in particular via the activation of TWIST1, ΔNp73, NANOG; it is responsible for an increased state of quiescence of certain cancer stem cells and their resistance. Preliminary results based on the analysis of large databases suggest that the BMP pathway is also altered early in MDS. This study explores the alteration of this pathway in MDS and its involvement in the transformation into AML. If appropriate, the BMP pathway could constitute a very promising therapeutic target to combat transformation into AML.

NCT ID: NCT06175702 Not yet recruiting - Clinical trials for Lymphoblastic Leukemia

Treatment Protocol for Newky Diagnosed Adult Ph Positive ALL

LALPh2022
Start date: December 25, 2023
Phase:
Study type: Observational

The goal of this prospective, multicenter, open observational study is to assess the efficacy and safety of the treatment for acute lymphoblastic leukemia Ph' positive adult patients with approved combinations of chemotherapy and tyrosine kinase inhibitor (TKI). Efficay refers to the rate of Complete Molecular Response (BCR::ABL1/ABL1 ratio 0.01%) in eah treatment arm. Safety refers to measurement of i) Adverse events (AEs) and serious adverse events (SAEs) according to standard clinical and laboratory tests (hematology and chemistry, physical examination, vital sign measurements, and diagnostic tests), ii) incidence and degree of cytopenias and iii) incidence and degree of infections. Low-dose chemotherapy will be given together with the TKI imatinib to patients of all ages as induction to remission phase. Consolidation treatment will continue with low-dose chemotherapy with imatinib if the patient fullfills both criteria: to show a measurable residual disease (MRD) value lower than 0,01% at 3 month of therapy, and not showing IKZF1plus genetics Those patients have any of these 2 conditions will be considered high-risk patients and will recieve consolidation treatment intensification with low-dose chemotherapy plus ponatinib as TKI and allogeneic stem cell transplantation (allo SCT). The remaining patients (standard-risk) will receive maintenance chemotherapy together with imatinib or ponatinib and will not be submitted to alloSCT.