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Leukemia, Myeloid clinical trials

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NCT ID: NCT03080922 Recruiting - Leukemia, Myeloid Clinical Trials

High Dose Donor Hematopoietic Stem Cell Infusion for Relapsed/Refractory AML

Start date: March 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficiency of high dose allogeneic mismatched hematopoietic stem cells infusions after normal chemotherapy in patients with relapsed/refractory acute myeloid leukemia(AML).

NCT ID: NCT03080766 Recruiting - Clinical trials for Acute Myeloid Leukemia

The Use of Decitabine as Induction Therapy for Acute Myeloid Leukemia With Complex and/or Monosomal Karyotype

Start date: March 1, 2017
Phase: Phase 2
Study type: Interventional

Acute myeloid leukemia (AML) is a heterogeneous group of diseases with distinct clinicopathologic features sharing in common an abnormal increase in myeloblasts in blood and bone marrow (BM). In about 5-10% patients, the myeloblasts exhibit chromosomal abnormalities (complex and/or monosomal karyotype, CK/MK*) that are associated with refractoriness to conventional chemotherapy and an extremely bad prognosis. Standard induction chemotherapy for AML comprises daunorubicin and cytarabine, the "7+3" regimen. However, treatment is largely ineffective for CK/MK AML with a temporary clearance of blasts achieved in only 30-40% cases and the cumulative toxicities resulting from repeated courses of chemotherapy have significantly increased the morbidity and mortality risks in subsequent allogeneic BMT. Therefore, standard treatment is unsatisfactory and there is an unmet clinical need for more effective and less toxic induction regimen. Both previous and recent studies showed that 10 day course of decitabine (20 mg/m2/day) induced remission in 70-100% patients with CK/MK AML, particularly those with TP53 mutations. In this study, patients with CK/MK AML will be treated with decitabine to induce remission. Bone marrow examination will be performed after each course until complete clearance of blasts or disease progression. Patients achieving CR/CRi (see below) will continue to receive 4 more courses, after which patients eligible for BMT and for whom donors are available will receive curative BMT. We reckon that the time it takes for 4 courses of decitabine will suffice for transplantation workup in HK. . Patients ineligible for BMT will continue to receive decitabine until leukemia progression. The response rate, leukemia free survival (LFS), overall survival (OS) and percentage of patients who can be bridged to BMT will be compared with historical 7+3 regimen control.

NCT ID: NCT03079505 Terminated - Clinical trials for Chronic Myeloid Leukemia - Chronic Phase

Dasatinib Versus Nilotinib for Treatment Naïve Chronic Myeloid Leukemia

DANIN
Start date: August 3, 2017
Phase: Phase 3
Study type: Interventional

DANIN study is a randomized, phase 3 clinical trial comparing 'head to head' Nilotinib versus Dasatinib as upfront therapy for patient with chronic myeloid leukemia. The efficacy of both drugs will be tested by measuring BCR/ABL (BCR-ABL = fusion gene from BCR (breakpoint cluster region gene/BCR gene product) and ABL (Abelson proto-oncogene)) using European Leukemia net recommendations the study will be conducted in NCCCR (National Center for Cancer Care & Research) sample size calculations detailed in the statistic part the clinical hematologist will recruit the patients this will include consenting process inclusion and exclusion criteria the molecular pathologist will do the molecular testing the clinical research coordinator and fellows will do the CRF (Case Report Form) as well as quality of life questionnaire and applying the protocol for evaluation of cardiac evaluation Molecular monitoring of BCR-ABL1 transcripts to assess treatment response in CML (Chronic Myeloid Leukemia).

NCT ID: NCT03075969 Active, not recruiting - Clinical trials for Chronic Myeloid Leukemia

Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia

Start date: August 3, 2017
Phase:
Study type: Observational

The objective of this study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients diagnosed with CML, and to investigate longitudinal relationship between satisfaction with information provision and QoL outcomes.

NCT ID: NCT03072043 Completed - Clinical trials for Acute Myeloid Leukemia

Phase 1b/2 Safety and Efficacy of APR-246 w/Azacitidine for tx of TP53 Mutant Myeloid Neoplasms

Start date: May 18, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The main purpose of this study is to determine the safe and recommended dose of APR-246 in combination with azacitidine as well as to see if this combination of therapy improves overall survival.

NCT ID: NCT03071276 Terminated - Clinical trials for Acute Myeloid Leukemia (AML)

Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia

Start date: January 14, 2016
Phase: Phase 2
Study type: Interventional

This study will be done in two parts: Phase I (NCT02212561) has been completed and published. The goal of the Phase I portion of this study was to find the highest tolerable dose of selinexor (KPT-330) that can be given to patients with leukemia or myelodysplastic syndrome (MDS), when it is combined with fludarabine and cytarabine. The Phase II portion of the protocol is reflected in this registration. The goal of the Phase II portion of this protocol is to give the highest dose of selinexor (KPT-330) in combination with fludarabine/cytarabine that was found in Phase I to be safe for children with acute myeloid leukemia (AML). The investigators will examine the effect of this combination treatment.

NCT ID: NCT03070093 Approved for marketing - Clinical trials for Acute Myeloid Leukemia (AML)

Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission (CRc) (complete remission [CR], complete remission with incomplete hematologic recovery [CRi], complete remission with incomplete platelet recovery [CRp]) with MRD without access to comparable or alternative therapy.

NCT ID: NCT03069352 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

Start date: May 23, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML).

NCT ID: NCT03067571 Terminated - Clinical trials for Refractory Acute Myeloid Leukemia

Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Start date: October 27, 2017
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well daratumumab works in treating patients with acute myeloid leukemia that has come back or does not respond to treatment or high-risk myelodysplastic syndrome. Immunotherapy with monoclonal antibodies, such as daratumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT03066648 Completed - Leukemia Clinical Trials

Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS

Start date: July 6, 2017
Phase: Phase 1
Study type: Interventional

To characterize the safety and tolerability of 1) MBG453 as a single agent or in combination with PDR001 or 2) PDR001 and/or MBG453 in combination with decitabine or azacitidine in AML and intermediate or high- risk MDS patients, and to identify recommended doses for future studies.