An Open-label, First-in-human, Dose Escalation Study of SAR440234 Administered as Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), or High Risk Myelodysplasia (HR-MDS)
Primary Objective: - Dose escalation: To determine the maximum tolerated dose (MTD) of SAR440234 administered as a single agent in participants with relapsed or refractory acute myeloid leukemia (R/R AML), high risk myelodysplastic syndrome (HR-MDS), or B-cell acute lymphoblastic leukemia (B-ALL), and determine the recommended phase 2 dose (RP2D) for the subsequent Expansion part. - Expansion part: To assess the activity of single agent SAR440234 at the RP2D in participants with R/R AML or HR-MDS. Secondary Objective: - To characterize the safety profile including cumulative adverse drug reactions. - To evaluate the potential immunogenicity of SAR440234. - To assess any preliminary evidence of hematologic response in the Dose Escalation Part.
NCT03594955 — Leukaemia
Status: Terminated
http://inclinicaltrials.com/leukaemia/NCT03594955/
Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-Lymphoblastic Lymphoma (T-LBL)
Primary Objective: To evaluate the efficacy of isatuximab. Secondary Objectives: - To evaluate the safety profile of isatuximab. - To evaluate the duration of response (DOR). - To evaluate progression free survival (PFS) and overall survival (OS). - To evaluate the pharmacokinetics (PK) of isatuximab in participants with T-ALL or T-LBL. - To evaluate immunogenicity of isatuximab in participants with T-ALL or T-LBL. - To assess minimal residual disease (MRD) and correlate it with clinical outcome.
NCT02999633 — T-lymphoblastic Lymphoma/Leukaemia
Status: Terminated
http://inclinicaltrials.com/t-lymphoblastic-lymphoma-leukaemia/NCT02999633/
A Two-Part Phase 1/2 Study to Determine Safety, Tolerability, Pharmacokinetics, and Activity of K0706, a Novel Tyrosine Kinase Inhibitor (TKI), in Healthy Subjects and in Subjects With Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Phase 1/2 study to determine safety, tolerability, pharmacokinetics, and anti-leukemic activity of Vodobatinib (K0706) in treatment-refractory/intolerant CML
NCT02629692 — Healthy (For Part A)
Status: Active, not recruiting
http://inclinicaltrials.com/healthy-for-part-a/NCT02629692/
A Non-randomized, Open-label Study to Characterize the Pharmacokinetics (PK) of Glivec/Gleevec® (Imatinib Mesylate) in Pediatric (Age Range 1 to Less Than 4 Years) Patients With Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) or Other Glivec/ Gleevec® Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to <4 years of age to help develop dosing regimens
NCT01066468 — Chronic Myeloid Leukemia (CML)
Status: Terminated
http://inclinicaltrials.com/chronic-myeloid-leukemia-cml/NCT01066468/
Ruxolitinib and Chidamide Intensified Bu/CY Conditioning Regimen for Patients With Acute T Cell Lymphoblast Leukemia/ Lymphoblastic Lymphoma Underwenting Haploidenticl Peripheral Blood Stem Cell Transplantation
The purpose of this study is to determine the efficacy and safety of Ruxolitinib and Chidamide intensified conditioning regimen in patients with Acute T cell Lymphoblast leukemia/ lymphoblastic lymphoma Underwenting Haploidenticl Peripheral blood Stem Cell Transplantation.
NCT05075681 — Peripheral Blood Stem Cell Transplantation
Status: Recruiting
http://inclinicaltrials.com/peripheral-blood-stem-cell-transplantation/NCT05075681/
A Phase 1 Study of ABL001 in Combination With Dasatinib, Prednisone, and Blinatumomab in Patients With BCR-ABL Positive (BCR-ABL+) B-cell Acute Lymphoblastic Leukemia (B-ALL) and Chronic Myeloid Leukemia (CML)
This research study is evaluating a drug called ABL001 taken in combination with dasatinib (Sprycel®) and prednisone (a steroid) as a possible treatment for B-cell Acute Lymphoblastic Leukemia that is BCR-ABL positive (BCR-ABL+ B-ALL) or Chronic Myeloid Leukemia (CML) in lymphoid blast crisis. BCR-ABL+ B-ALL is also called Philadelphia chromosome positive Acute Lymphoblastic Leukemia (Ph+ ALL). It is expected that 25-40 people will take part in this research study. - ABL001 - Dasatinib (Sprycel®) - Prednisone - Blinatumomab
NCT03595917 — B-cell Acute Lymphoblastic Leukemia
Status: Recruiting
http://inclinicaltrials.com/b-cell-acute-lymphoblastic-leukemia/NCT03595917/
Study of Dasatinib (BMS-354825) in Subjects With Chronic Myelogenous Leukemia With Accelerated or Myeloid or Lymphoid Blast Phase or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant to or Intolerant of Imatinib Mesylate
The purpose of this clinical research study is to provide dasatinib treatment to patients with advanced chronic myelogenous leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who no longer can tolerate treatment with imatinib. The safety of the treatment will also be studied.
NCT00298987 — Leukemia, Myeloid, Chronic
Status: Completed
http://inclinicaltrials.com/leukemia-myeloid-chronic/NCT00298987/
A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)
This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).
NCT00123487 — Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Status: Completed
http://inclinicaltrials.com/leukemia-lymphoblastic-acute-philadelphia-positive/NCT00123487/
Efficacy and Safety of Blinatumomab Maintenanceafter Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Acute B-lymphoblastic Leukemia: a Multicenter, Open-label, Randomized Controlled Study
To evaluate the safety and efficacy of Blinatumomab maintenance after allogeneic hematopoietic stem cell transplantation for high-risk acute B-lymphoblastic leukemia.
NCT06438796 — High Risk Acute Lymphoblastic Leukemia
Status: Not yet recruiting
http://inclinicaltrials.com/high-risk-acute-lymphoblastic-leukemia/NCT06438796/
Cytokine-induced Killer(CIK) Cell Therapy and Its Impact on Early Functional Exhaustion of Chimeric Antigen Receptor-T(CAR-T) Cells in Relapsed or Refractory Acute B-Lymphoblastic Leukemia: A Prospective Study
This is a single-center, double-blind, randomized trial. Patients with relapsed or refractory acute B-lymphoblastic leukemia(r/r B-ALL) experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the messenger RNA(mRNA)-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r/r B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 subjects will be enrolled.
NCT06389305 — B-cell Acute Lymphoblastic Leukemia
Status: Not yet recruiting
http://inclinicaltrials.com/b-cell-acute-lymphoblastic-leukemia/NCT06389305/