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Leukemia clinical trials

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NCT ID: NCT03720366 Completed - Clinical trials for Leukemia, Myeloid, Acute

A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients

Start date: October 4, 2018
Phase: Phase 1
Study type: Interventional

This is a 2-part, open-label, interventional study conducted in approximately 42 subjects with AML harboring an IDH2 mutation. The overall study is a 3-arm investigation of the PK effects of enasidenib at steady state on the probe compounds. (Part 1), followed by treatment continuation up to 28 months (Part 2). Each arm utilizes different probe compounds; enrolls a separate cohort of approximately 14 subjects; and consists of 2 parts - investigation of the PK effects of enasidenib on the respective probe compound(s) (Part 1), followed by an enasidenib treatment extension (Part 2).

NCT ID: NCT03719534 Completed - Clinical trials for Acute Myeloid Leukemia

Haplo HCT vs Haplo-cord HCT for Patients With AML

Start date: June 1, 2017
Phase: Phase 3
Study type: Interventional

Patients who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic cell transplantation (haplo HCT) are potential candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an coinfusion of an unrelated cord blood unit (haplo-cord HCT) in addition to Arm A. Progression-free survival, overall survival, cumulative incidence of relapse and nonrelapse mortality will be recorded as endpoints.

NCT ID: NCT03719183 Completed - Clinical trials for Acute Myeloid Leukemia

Comparison of Diagnostic Yield Among M-FISH, FISH Probe Panel and Conventional Cytogenetic Analysis in AML

Start date: January 1, 2019
Phase:
Study type: Observational

Conventional cytogenetic studies have been the gold standard for more than five decades for detecting genetic alterations that are greater than 10 Mb (mega base pairs) in size. Conventional cytogenetic studies have paved the way in identifying specific chromosomal aberrations associated with clinically and morphologically definitive subsets of hematological neoplasms. Fluorescence in situ hybridization (FISH) has become a reliable and rapid complementary test in targeting critical genetic events associated with diagnostics and prognosis in hematological neoplasms. In the current health care environment, which increasingly focuses on value and efficiency, it is critical for pathologists and clinicians to effectively navigate this environment and judiciously incorporate these high-complexity and expensive techniques into routine patient care. While conventional karyotyping provides a comprehensive view of the genome, FISH can detect cryptic or submicroscopic genetic abnormalities and identify recurrent genetic abnormalities in nondividing cells. As a consequence, it is commonly extrapolated that FISH will improve the sensitivity of detecting all genetic abnormalities compared with conventional karyotyping analysis. This assumption has then been translated in clinical practice to having clinicians and pathologists routinely ordering both conventional karyotyping and FISH studies in patients with hematological neoplasms. Depending on how comprehensive the FISH panel is, the cost for this testing may be quite expensive, and its additive value remains questionable. It is common practice for laboratories to use FISH panels in conjunction with karyotyping both in diagnostic specimens and during follow-up to monitor response to therapy. Multiplex FISH (M-FISH) represents one of the most significant developments in molecular cytogenetics of the past decade. In tumor and leukemia cytogenetics, two groups have been targeted by M-FISH to identify cryptic chromosome rearrangements not detectable by conventional cytogenetic studies: those with an apparently normal karyotype (suspected of harboring small rearrangements not detectable by conventional cytogenetics) and those with a complex aberrant karyotype (which are difficult to karyotype accurately due to the sheer number of aberrations).

NCT ID: NCT03702231 Completed - Clinical trials for Chronic Lymphocytic Leukemia (CLL)

Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's Tyrosine Kinase Inhibitor (BTK-I)

Start date: December 7, 2018
Phase: Phase 2
Study type: Interventional

Background: People who have cancer tend to get sick more often. This is in part because of the cancer treatments they get. Because of this, they may get shingles. Scientists had thought people with chronic lymphocytic leukemia (CLL) should not get the shingles vaccine. Now there is a new shingles vaccine that is not live and cannot cause shingles. The new shingles vaccine may protect people with weak immune systems from getting shingles. This is currently shown to be safe to give people 50 years and older to prevent shingles. Researchers want to test how safe the vaccine is and how it works in people with CLL. Objective: To learn how a new shingles vaccine works in people who have chronic lymphocytic leukemia or small lymphocytic lymphoma (SLL). Eligibility: Adults ages 18 years and older with CLL or SLL who are not being treated for CLL or who are getting certain treatments. Design: Participants will be screened with a chart review or through another protocol. Visit 1 At visit 1, participants may have a pregnancy test, blood test, or physical exam. Pregnant participants cannot be in the study. Eligible participants will get the shingles vaccine as an injection. Participants will receive a diary and write down any symptoms they have for 7 days after the vaccines. Visit 2 Visit 2 will be 3 months later. Participants will have blood taken and get another dose of the vaccine. Participants will receive a diary and write down any symptoms they have for 7 days after the vaccines. Visit 3 Visit 3 will be 3 months after visit 2. Participants will have blood taken. Participants may be able to get an additional vaccine the same day as the shingles vaccine.

NCT ID: NCT03701295 Completed - Clinical trials for Refractory Acute Myeloid Leukemia

Pinometostat and Azacitidine in Treating Patients With Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia With 11q23 Rearrangement

Start date: March 6, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This phase Ib/II trial studies the side effects and best dose of pinometostat when given together with azacitidine and to see how well it works in treating patients with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or is newly diagnosed, with an 11q23 rearrangement. Pinometostat and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT03678493 Completed - Clinical trials for Acute Myeloid Leukemia

A Study of FMT in Patients With AML Allo HSCT in Recipients

Start date: September 9, 2019
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients). Participants in each cohort will be randomized in a 2:1 ratio to receive up to 3 treatments of FMT vs. placebo after each exposure to antibacterial antibiotics until 3 months after randomization.

NCT ID: NCT03678454 Completed - Clinical trials for Chronic Myeloid Leukemia

Iclusig® (Ponatinib) in Clinical Practice for the Treatment of Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia in Belgium

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

This prospective registry is initiated to follow up on the use of Iclusig® in patients with CML or Ph+ ALL in routine practice in Belgium.

NCT ID: NCT03677596 Completed - Leukemia Clinical Trials

A Study Of Two Inotuzumab Ozogamicin Doses in Relapsed/ Refractory Acute Lymphoblastic Leukemia Transplant Eligible Patients

Start date: July 1, 2019
Phase: Phase 4
Study type: Interventional

This study will explore 2 different doses of inotuzumab ozogamicin including the dose that is approved and a lower dose. The main purpose of this study is to evaluate whether a dose of inotuzumab ozogamicin, lower than the approved dose, could be recommended for adult patient with relapsed or refractory ALL who may be at higher risk for severe liver problems after inotuzumab ozogamicin treatment and stem cell transplant (a potentially curative therapy that can replace cancer cells with healthy cells). Efficacy and safety of the 2 doses will be evaluated.

NCT ID: NCT03672695 Completed - Clinical trials for Acute Myeloid Leukaemia

Phase I Dose Escalation Study of Intravenously Administered S64315 in Combination With Orally Administered Venetoclax in Patients With Acute Myeloid Leukaemia.

Start date: November 28, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety profile, tolerability and the Recommended Phase 2 Dose of the combination S64315 with venetoclax in patients with Acute Myeloid Leukaemia.

NCT ID: NCT03671564 Completed - Clinical trials for Acute Myeloid Leukemia

Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Start date: August 23, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia. The milademetan initial dose will be Level 1: 90 mg. No increase in the milademetan dose will be made in the same participant. Dose-limiting toxicity associated with milademetan occurring at each level will be assessed, and the maximum tolerated dose (MTD) will be decided using a modified continuous reassessment method (mCRM).