Advertisement

Topics

Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

2015-09-10 01:53:24 | BioPortfolio

Summary

A Phase I/IIa, open-label, uncontrolled study to evaluate the safety and efficacy of Astarabine (BST-236) as single agent in patients with refractory or relapsed Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) disease

Description

This is prospective, Phase I/IIa, open-label, uncontrolled, single-center, single arm study to evaluate the safety and efficacy of Astarabine given intravenously (I.V.) in escalated doses for 6 days for cycle in patients with relapsed or refractory AML or ALL who are more than 18 years of age. Patients will be screened for eligibility based on existing records and/or specific laboratory examinations performed for the screening process.

Patients will be gradually enrolled into 4 subsequent cohorts of escalating drug doses:

Cohort # Astarabine Dose Number of Patients

1. 0.5 gr/m2 (0.3 age>50) 3

2. 1.5 gr/m2 (0.8age>50) 3

3. 3.0 gr/m2 (1.5 age>50) 3

4. 4.5 gr/m2 (2.3 age>50) 6 Total number of patients: 15

De-escalation:

5. 0.3 gr/m2(0.2 age>50) 6 Maximal tolerated dose (MTD) will be defined in case 2 subjects will experience a dose limiting toxicity (DLT)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Acute Myeloid Leukemia

Intervention

Astarabine

Location

Rambam medical center hematology department
Haifa
*Not Applicable
Israel
4655202

Status

Not yet recruiting

Source

BioSight Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-09-10T01:53:24-0400

Clinical Trials [2274 Associated Clinical Trials listed on BioPortfolio]

CAR-T Cells Therapy in Relapsed/Refractory Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a group of genetically highly heterogeneous malignant disease . The disease is the most common type of adult acute leukemia. Overall survival (OS) was less ...

Metabolic Changes in Blood Samples From Patients With Acute Myeloid Leukemia

This research trial studies metabolic changes in blood samples from patients with acute myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the laborat...

Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome

RATIONALE: Vaccines made from peptides that are found on leukemia cells may make the body build an immune response and kill cancer cells. Combining vaccine therapy with the immune adjuvant...

Diagnostic Study of Gene Alterations in Patients With Acute Myeloid Leukemia

RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute myeloid leukemia and determine the extent of disease. PURPOSE: Diagnostic study to try t...

The Role of Maintenance Oral Clofarabine in Older Adults With Acute Myeloid Leukemia

The purpose of this study is to determine the side effects of the study drug, clofarabine, when given by mouth to patients with acute myeloid leukemia (AML), in remission.

PubMed Articles [6806 Associated PubMed Articles listed on BioPortfolio]

Risk of acute myeloid leukemia and myelodysplastic syndrome after autotransplants for lymphomas and plasma cell myeloma.

Exposures to DNA-damaging drugs and ionizing radiations increase risks of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

Perianal Infections in Children With Acute Myeloid Leukemia: A Report From the Canadian Infection in Acute Myeloid Leukemia Research Group.

Among 235 children with acute myeloid leukemia, 17 experienced 19 perianal infections. Among 12 episodes with definite abscess, 75% were severely neutropenic. Sixteen diagnostic imaging evaluations we...

Identification of the UBA2-WTIP fusion gene in acute myeloid leukemia.

Identifying and targeting oncogenic fusion genes have revolutionized the treatment of leukemia, such as PML-RARα fusion gene in acute promyelocytic leukemia. Here we identified an intrachromosomal fu...

MiR-425 expression profiling in acute myeloid leukemia might guide the treatment choice between allogeneic transplantation and chemotherapy.

Acute myeloid leukemia (AML) is a highly heterogeneous disease. MicroRNAs function as important biomarkers in the clinical prognosis of AML.

Outcomes of fludarabine, high dose cytarabine and granulocyte-colony stimulating factor (FLAG) as re-induction for residual acute myeloid leukemia on day 14 bone marrow.

Patients with acute myeloid leukemia (AML) treated with intensive chemotherapy may require re-induction based on the evaluation of day 14 bone marrow biopsy.

Medical and Biotech [MESH] Definitions

A pediatric acute myeloid leukemia involving both myeloid and monocytoid precursors. At least 20% of non-erythroid cells are of monocytic origin.

A rare acute myeloid leukemia characterized by abnormal EOSINOPHILS in the bone marrow.

An acute myeloid leukemia in which abnormal PROMYELOCYTES predominate. It is frequently associated with DISSEMINATED INTRAVASCULAR COAGULATION.

An acute leukemia exhibiting cell features characteristic of both the myeloid and lymphoid lineages and probably arising from MULTIPOTENT STEM CELLS.

Clonal expansion of myeloid blasts in bone marrow, blood, and other tissue. Myeloid leukemias develop from changes in cells that normally produce NEUTROPHILS; BASOPHILS; EOSINOPHILS; and MONOCYTES.

More From BioPortfolio on "Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia"

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