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Preleukemia clinical trials

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NCT ID: NCT02323139 Completed - MDS Clinical Trials

A Study of LDE255 in Combination With Azacitidine for High Risk Myelodysplastic Syndrome Patients

LDE255
Start date: February 10, 2015
Phase: Phase 1
Study type: Interventional

This study is a phase Ib add-on study of the combination of LDE255 to azacitidine in patients without marrow response after at least 6 cycles of azacitidine.

NCT ID: NCT02308761 Completed - Clinical trials for Acute Myeloid Leukemia

A Study of RO6870810/TEN-010 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Start date: November 6, 2014
Phase: Phase 1
Study type: Interventional

RO6870810 (formerly TEN-010) is a small molecule, bromodomain and extra-terminal (BET) bromodomain inhibitor. This study is designed to characterize the safety, tolerability, and pharmacokinetics of RO6870810 monotherapy in participants with relapsed/refractory acute myeloid leukemia (RR-AML) and hypomethylating agent (HMA)-refractory myelodysplastic syndrome (MDS). The study will consist of a Screening Period, Treatment Period, and Post-Treatment Period. A standard 3+3 design will be used in which successive cohorts of three or more participants with RR-AML or HMA-refractory MDS will be treated at escalating doses until a maximum tolerated dose (MTD) is identiļ¬ed. Up to 51 adult participants with AML or MDS will be enrolled in the study.

NCT ID: NCT02296242 Completed - Clinical trials for Myelodysplastic Syndrome

Phase 1/2 Study of the ERK1/2 Inhibitor BVD-523 in Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndromes

Start date: November 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This study is being performed to assess the safety, tolerability, and preliminary clinical effects of BVD-523 given orally, twice daily for 21-day cycles, in patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS).

NCT ID: NCT02294552 Completed - Lymphoma Clinical Trials

Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT

Start date: October 2014
Phase: Phase 2
Study type: Interventional

This study evaluates the efficacy of high-dose post-transplantation cyclophosphomide as graft-versus-host disease (GVHD) prophylaxis after allogeneic stem cell transplantation in patients with different risk of GVHD. The risk-adapted strategy involves using single-agent cyclophosphomide in recipients of matched bone marrow graft, and combining cyclophosphomide with tacrolimus and mycophenolate mofetil in recipients of matched peripheral blood stem cells and mismatched bone marrow.

NCT ID: NCT02281084 Completed - Clinical trials for Myelodysplastic Syndromes

Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes

Start date: July 6, 2015
Phase: Phase 2
Study type: Interventional

Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment Reason for removing the combination arm: Due to difficulties with dose-finding, the durvalumab plus CC-486 combination arm was closed to enrollment. Extension: An Extension Phase (EP) has been added to allow subjects who are currently receiving oral azacitidine BID and who are demonstrating clinical benefit as assessed by the Investigator, to continue receiving oral azacitidine until the subject meets the criteria for study discontinuation.

NCT ID: NCT02279654 Completed - Clinical trials for Myelodysplastic Syndrome

Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)

PASS MDS del5q
Start date: December 17, 2014
Phase:
Study type: Observational [Patient Registry]

This registry is a prospective, non-interventional, post authorisation safety study for patients diagnosed with Transfusion Dependent, IPSS low or intermediate-1-Risk Myelodysplastic Syndrome (MDS), associated to a single abnormality of the chromosome 5 [del(5q)]. The purpose of this study is to collect additional data about the safety of an oral drug (lenalidomide, Revlimid®) that may have been prescribed to relieve anemia and decrease the need of blood transfusions. However, also patients affected by the MDS del(5q) who receive other treatments different from lenalidomide can be included in this study, if they agree.

NCT ID: NCT02273102 Completed - Leukemia Clinical Trials

Study of TCP-ATRA for Adult Patients With AML and MDS

TCP-ATRA
Start date: March 2, 2015
Phase: Phase 1
Study type: Interventional

Acute Myeloid Leukemia (AML) is a diverse disease that is fatal in the majority of patients. Acute promyelocytic leukemia (APL) however, a subtype of AML accounting for 5% of all cases, is very curable. APL cells are highly sensitive to the retinoid all-trans-retinoic acid (ATRA), which effectively differentiates the leukemic clone. Over 80% of APL patients can be cured with ATRA based therapies. For patients with non-APL AML, ATRA has little effect. Consequently, 85% of these patients will succumb to their disease despite conventional approaches. Little is known about mechanisms of resistance to ATRA in non-APL AML. This knowledge gap limits the use of ATRA in a disease that already has few effective therapies. The investigators' preliminary data suggest that non-APL AML cells can be re-sensitized to ATRA when combined with lysine-specific demethylase 1 (LSD 1) inhibitors. The investigators' publication in Nature Medicine showed that LSD1 inhibition with tranylcypromine (TCP), unlocked the ATRA-driven therapeutic response in non-APL AML. Notably, treatment with ATRA and TCP markedly diminished the engraftment of primary human AML cells in murine models, indicating that the combination may target leukemia-initiating cells (LIC). The investigators' data identify LSD1 as a therapeutic target and strongly suggest that it may contribute to ATRA resistance in non-APL AML. The investigators' central hypothesis is that ATRA combined with TCP will be safe and effective in a clinical population, and that this approach will suppress LICs and restore myeloid differentiation programs in patients with non-APL AML. Testing this hypothesis with the phase I clinical trial outlined in this protocol, will establish a new treatment paradigm in AML and extend the important anti-cancer effects of ATRA to all AML subtypes.

NCT ID: NCT02268383 Completed - Clinical trials for Myelodysplastic Syndromes

ACE-536 Extension Study - Myelodysplastic Syndromes

Start date: October 2014
Phase: Phase 2
Study type: Interventional

Study A536-05 is an open-label extension study for patients previously enrolled in study A536-03 (ClinicalTrials.gov Identifier NCT01749514), to evaluate the long-term safety and tolerability of ACE-536 in patients with low or intermediate-1 risk MDS.

NCT ID: NCT02264873 Completed - Clinical trials for Leukemia, Lymphoblastic, Acute

Phase I, Dose Escalation Study of Decitabine

Start date: October 2014
Phase: Phase 1
Study type: Interventional

Decitabine is a hypomethylating agent that has shown significant anti-leukemic effect in Myelodysplastic Syndrome (MDS) and Acute Myeloblastic Leukemia (AML). This study is based on the hypothesis that Decitabine delivered after allo-hematopoietic stem cell transplant (HSCT) in patients with leukemia will enhance disease control by the allogeneic immune system and lead to a longer disease free survival. The study is designed to provide safety data of low-dosing in the post-transplant setting.

NCT ID: NCT02262312 Completed - Clinical trials for Myelodysplastic Syndrome

Iron Overload and Transient Elastography in Patients With Myelodysplastic Syndrome

Start date: September 2014
Phase: Phase 0
Study type: Observational

Patients with myelodysplastic syndrome (MDS) have an ineffective hemopoiesis and often suffer from anemia. This can lead to red blood cell transfusion dependency and iron overload. Iron overload can affect the liver and lead to liver fibrosis and worst case cirrhosis. Ferritin is usually used to monitor the iron overload. In this study MDS patients will have a transient elastography performed which measures the liver's stiffness. The purpose is to investigate whether liver stiffness measurements are coherent to ferritin levels.