Advertisement

Topics

AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™

2014-08-27 03:55:20 | BioPortfolio

Summary

This is a Phase II, exploratory, open-label study of the investigational product AG-858, in patients who are cytogenetically positive after treatment with Gleevec.

The trial will consist of three independent Phase II evaluations of patient groups according to their cytogenetic status as defined in the eligibility criteria (Eligibility Criteria 4a, 4b, and 4c).

Description

The goals of this study are to determine the following:

- To estimate the proportion of patients with a complete cytogenetic response (CCR) within each patient group

- To estimate the proportion of patients with a substantial molecular response (SMR) within each patient group

- To evaluate the frequency and severity of adverse events.

- To assess the feasibility of AG-858 production.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Leukemia, Myeloid, Chronic

Intervention

Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™.

Location

Birmingham
Alabama
United States

Status

Terminated

Source

Antigenics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:20-0400

Clinical Trials [3415 Associated Clinical Trials listed on BioPortfolio]

Homoharringtonine With Oral Gleevec in Chronic, Accelerated and Blast Phase Chronic Myeloid Leukemia (CML)

This will be an open label, multi-center study of up to 77 patients with CML in chronic, accelerated or blast phase who have developed resistance to or have failed previous treatment with ...

A Study Evaluating the Effects of CLAG With Gleevec in Refractory or Relapsed Acute Myeloid Leukemia

The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG regimen) with Imatinib Mesylate (Gleevec) in patients with AML.

CLAG Gleevec in Relapsed or Refractory Acute Myeloid Leukemia (AML)

The purpose of this study is to evaluate the safety of combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate). The CLAG regimen is a combination of the chemothe...

PTK 787 and Gleevec in Patients With AML, AMM, and CML-BP

The goal of this clinical research study is to find the highest safe doses of PTK 787 (vatalanib) and Gleevec (imatinib mesylate) that can be given to treat Chronic Myelogenous Leukemia-B...

Role of Gene Variation in Effectiveness of Gleevec Treatment

This study will examine DNA from cancer patients previously treated with Gleevec to look for a variation (mutation) of the ABCG2 gene that may render the drug less effective in certain pat...

PubMed Articles [13383 Associated PubMed Articles listed on BioPortfolio]

Clinical and pathological features of myeloid leukemia cutis.

Myeloid leukemia cutis is the terminology used for cutaneous manifestations of myeloid leukemia.

Impact of FLT3 Receptor (CD135) Detection by Flow Cytometry on Clinical Outcome of Adult Acute Myeloid Leukemia Patients.

The significance of FMS-like tyrosine kinase 3 (FLT3)-ITD mutation in acute myeloid leukemia (AML) prognosis has been well established. The aims of this study were to investigate the prognostic impact...

Controversies Regarding Use of Myeloid Growth Factors in Leukemia.

This review focuses on the data supporting the use of myeloid growth factors (MGFs) in patients being treated for acute myeloid leukemia, acute lymphoblastic leukemia, chronic myeloid leukemia, and ha...

Genetic Inactivation of CD33 in Hematopoietic Stem Cells to Enable CAR T Cell Immunotherapy for Acute Myeloid Leukemia.

The absence of cancer-restricted surface markers is a major impediment to antigen-specific immunotherapy using chimeric antigen receptor (CAR) T cells. For example, targeting the canonical myeloid ma...

Widespread use of measurable residual disease in acute myeloid leukemia practice.

Measurable residual disease (MRD) has prognostic importance for patients with acute myeloid leukemia (AML). How leukemia providers incorporate MRD into routine practice remains undefined.

Medical and Biotech [MESH] Definitions

Myeloid-lymphoid leukemia protein is a transcription factor that maintains high levels of HOMEOTIC GENE expression during development. The GENE for myeloid-lymphoid leukemia protein is commonly disrupted in LEUKEMIA and combines with over 40 partner genes to form FUSION ONCOGENE PROTEINS.

Form of leukemia characterized by an uncontrolled proliferation of the myeloid lineage and their precursors (MYELOID PROGENITOR CELLS) in the bone marrow and other sites.

A member of the myeloid leukemia factor (MLF) protein family with multiple alternatively spliced transcript variants encoding different protein isoforms. In hematopoietic cells, it is located mainly in the nucleus, and in non-hematopoietic cells, primarily in the cytoplasm with a punctate nuclear localization. MLF1 plays a role in cell cycle differentiation.

The phase of chronic myeloid leukemia following the chronic phase (LEUKEMIA, MYELOID, CHRONIC-PHASE), where there are increased systemic symptoms, worsening cytopenias, and refractory LEUKOCYTOSIS.

Clonal hematopoetic disorder caused by an acquired genetic defect in PLURIPOTENT STEM CELLS. It starts in MYELOID CELLS of the bone marrow, invades the blood and then other organs. The condition progresses from a stable, more indolent, chronic phase (LEUKEMIA, MYELOID, CHRONIC PHASE) lasting up to 7 years, to an advanced phase composed of an accelerated phase (LEUKEMIA, MYELOID, ACCELERATED PHASE) and BLAST CRISIS.

More From BioPortfolio on "AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Leukemia
Leukemia is a type of cancer of the blood or bone marrow characterized by an abnormal increase of immature white blood cells called "blasts". Leukemia is a broad term covering a spectrum of diseases. In turn, it is part of the even broader grou...


Searches Linking to this Trial