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Leukemia clinical trials

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NCT ID: NCT02827617 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Identification of Biomarkers That Are Predictive of Early Ibrutinib Treatment Failure in High Risk TP53 Mutated Chronic Lymphocytic Leukemia

Start date: June 1, 2016
Phase:
Study type: Observational

The general aim of the project is the identification of dynamic molecular markers that can help the early and real time prediction of sustained benefit or no benefit from ibrutinib treatment in CLL harboring TP53 mutations. Specific aims of the project include: 1) Assess whether clearance of TP53 mutated clones translates into a predictive biomarker of long term benefit from ibrutinib treatment in CLL. 2) Assess whether plasma cell free DNA represents a sensitive tool that can early and dynamically inform on the development of ibrutinib resistant mutations in CLL.

NCT ID: NCT02825836 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Phase I/II, FIH, Dose Escalation Trial of TL-895 and Expansion of TL-895 Monotherapy and Combination Therapy With Navtemadlin in Tx-Naïve and R/R CLL/SLL Subjects

Start date: August 26, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this research study is to determine the safety and tolerability of TL-895. There are 2 parts of this study. Part 1 tested increasing doses of TL-895 to identify the recommended safe dose for participants with relapsed/refractory (R/R) B cell malignancies who failed at least 1 but no more than 3 prior therapies. Part 1 of this study is no longer enrolling participants. Arms 1 & 2 of Part 2 of this study will test different doses of TL-895 in participants with R/R CLL or SLL who have failed at least 1 prior therapy. Arms 1 & 2 of Part 2 of this study is randomized (like the flip of a coin) to receive a specific treatment dose. If someone participates in arms 1 or 2 of Part 2, the dose they receive will be either 100mg twice a day or 150mg twice a day. Arms 3 and 4 of Part 2 of this study will test the 150mg and 100mg BID dose of TL-895, respectively in treatment naïve participants with CLL/SLL. Arms 5 and 6 of Part 2 will test 150mg TL-895 BID in combination with 240 mg navtemadlin QD in participants with relapsed/refractory and treatment naïve without 17p(del). Arm 7 will test 150mg TL-895 in combination with 240 mg navtemadlin QD in participants with relapsed/refractory CLL/SLL with 17p(del). Every participant in this study will receive TL-895.

NCT ID: NCT02809092 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Interleukin-21 (IL-21)- Expanded Natural Killer Cells for Induction of Acute Myeloid Leukemia

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

Relapsed acute myeloblastic leukemia (AML) requires remission prior to allogeneic Hematopoietic Stem Cell Transplant (HSCT) for optimal survival, but is a disease with poor response to chemotherapy. Human leukocyte antigen (HLA) haploidentical, Natural killer (NK) enriched peripheral blood cell infusions have shown safety in patients with poor prognosis AML. Though not powered for such an assessment, this trial showed a promising but not statistically significant trend in remission rate. NK cell therapy was limited by small numbers of NK cells attainable through leukapheresis. We have now demonstrated that large numbers of NK cells can be propagated ex vivo from a small volume blood draw, obviating the need for donor leukapheresis. The purpose of this trial is to determine the feasibility and maximum tolerated dose of expanded NK cells and estimate the toxicity of treating relapsed/refractory AML with fludarabine + high-dose cytarabine + G-CSF (FLAG) chemotherapy followed by haploidentical expanded natural killer (NK) cells. The first NK cell dosing cohort will be well below the currently-established safe dose of pheresis-derived NK cells, as expanded NK cells may have increased toxicity because of their activated phenotype. In order to avoid accruing patients at suboptimal doses, a dose escalation schema based on the principles of an accelerated titration design is used in this study to allow expeditious advancement up to the current safe dose of NK cells.

NCT ID: NCT02787369 Active, not recruiting - Clinical trials for Recurrent Chronic Lymphoid Leukemia

ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed CLL

Start date: May 2016
Phase: Phase 1
Study type: Interventional

This research study is studying a drug called ACY-1215 in combination with ibrutinib or idelalisib as a possible treatment for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL).

NCT ID: NCT02768792 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia, in Relapse

High Dose Cytarabine Followed by Pembrolizumab in Relapsed/Refractory AML

Start date: August 22, 2016
Phase: Phase 2
Study type: Interventional

Rationale:The purpose of this research study is to test the effectiveness of the standard high dose cytarabine (HiDAC) on days 1 through 5 followed by a single dose of pembrolizumab on day 14 as induction therapy in patients with relapsed and refractory acute myeloid leukemia (AML). Patients who achieve a response to treatment will continue on the study drug (pembrolizumab) every 3 weeks for up to 2 years maintenance therapy. Purpose:This is a study about a new investigative drug, pembrolizumab (MK-3475) that is being studied in a clinical research trial together with standard chemotherapy (HiDAC) in relapsed and refractory AML. The study will also explore the association between potential immune biomarkers and clinical outcomes with pembrolizumab; therefore all patients will have blood and bone marrow samples collected before and after treatment to determine the dynamic nature of immune signatures pre and post-treatment.

NCT ID: NCT02756897 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Venetoclax and Ibrutinib in Treating Patients With Chronic or Small Lymphocytic Leukemia

Start date: July 7, 2016
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well venetoclax and ibrutinib work in treating patients with chronic or small lymphocytic leukemia. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax and ibrutinib may help control chronic or small lymphocytic leukemia.

NCT ID: NCT02752243 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

CIK-Cells in Relapsing Patients With Acute Leukemia or Myelodysplastic Syndromes After SCT.

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

Multi-site, non-randomized Phase I/II study involving children and adults.

NCT ID: NCT02752035 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy

Start date: August 1, 2016
Phase: Phase 3
Study type: Interventional

This is a clinical study for adult patients who have recently been diagnosed with acute myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood cells that are not normal. These are called leukemia cells. Some patients with AML have a mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called FLT3. This protein causes the leukemia cells to grow faster. For patients with AML who cannot receive standard chemotherapy, azacitidine (also known as Vidaza®) is a current standard of care treatment option in the United States. This clinical study is testing an experimental medicine called ASP2215, also known as gilteritinib. Gilteritinib works by stopping the leukemia cells from making the FLT3 protein. This can help stop the leukemia cells from growing faster. This study will compare two different treatments. Patients are assigned to one of these two groups by chance: a medicine called azacitidine, also known as Vidaza®, or an experimental medicine gilteritinib in combination with azacitidine. There is a twice as much chance to receive both medicines combined than azacitidine alone. The clinical study may help show which treatment helps patients live longer.

NCT ID: NCT02735291 Active, not recruiting - Leukemia Clinical Trials

Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Acute Non T Lymphocyte Leukemia

EECNTL
Start date: November 2015
Phase: N/A
Study type: Interventional

This single-arm,multicenter Phase 2 trial will treat the patients who have recurrent or refractory acute non T lymphocyte leukemia with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to tumour cells that express the EPCAM protein on the cell surface.The study will determine if these modified T cells help the body's immune system eliminate tumour cells.The trial will also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.

NCT ID: NCT02735083 Active, not recruiting - Clinical trials for Advanced Lymphoid Leukemia

A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19

Start date: March 10, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and efficacy of UCART19 administration to patients with advanced lymphoid leukemia.