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Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Accelerated or Blast Phase | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Accelerated or Blast Phase

A Phase II, Multicentre Study of Oral LBH589 in Patients With Accelerated Phase or Blast Phase (Blast Crisis) Chronic Myeloid Leukemia With Resistant Disease Following Treatment With at Least Two BCR-ABL Tyrosine Kinase Inhibitors

NCT00449761•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic myeloid leukemia who are in accelerated phase or blast phase (blast crisis) with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors

Detailed Description

study was designed to assess the hematologic response associated with treatment of oral panobinostat. Hematologic response is defined as the overall of complete hematologic response (CHR), and of no evidence of leukemia (NEL) and of the return to chronic phase (RTC). Hematologic responses were to be confirmed after 4 weeks, and all criteria listed below for each type of response were to be concomitantly met to result into a response.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients aged ≥ 18 years old
•Diagnosis of Philadelphia chromosome positive accelerated or blast phase chronic myeloid leukemia defined as:
•Accelerated phase - the presence of at least one of the following:
•≥15% but \<30% blasts in blood or bone marrow
•≥30% blasts plus promyelocytes in peripheral blood or bone marrow (providing that \<30% blasts present in bone marrow)
•≥ 20% basophiles in the peripheral blood
•Thrombocytopenia \<100 X 109 /L unrelated to sole therapy
•Blast phase (blast crisis) - the presence of one of the following:
•≥ 30% blasts in the blood, in bone marrow or both
•Extramedullary infiltrates of leukemic cells other than liver or spleen involvement
+15 more criteria

Exclusion Criteria

•A candidate for hematopoietic stem cell transplantation
•Prior therapy with certain medications:
•* Therapeutic doses of sodium warfarin or any other anti-vitamin K drug (low doses for line patency were allowed).
•* Candidate for hematopoietic stem cell transplantation (HSCT)
•* Prior histone deacetylase (HDAC) inhibitor treatment of Chronic Myelogenous Leukemia (CML)
•* Concomitant use of drugs with a risk of causing QT complex (QTc) prolongation or torsades de pointes, CYP3A4/5 inhibitors, anti-cancer therapy or radiation therapy, valproic acid (within 5 days prior to study drug treatment or during the study), chemotherapy (within 3 weeks), immunotherapy (within 1 week), BCR-ABL kinase inhibitor ≤ 1 week of first treatment with panobinostat
•Patients who are in chronic phase chronic myeloid leukemia
•Impaired cardiac function or clinically significant cardiac diseases
•Concomitant use of drugs with a risk of possible risk of causing QTc prolongation or torsades de pointes
•Concomitant use of certain medications
+3 more criteria

Locations (26)

City of Hope National Medical Center

Duarte, California, United States

University of Colorado Health Sciences Center/Anschutz Cancer Pavilion

Aurora, Colorado, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Northwestern University Clinical Research Office

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University Chicago Hospital

Chicago, Illinois, United States

Indiana Blood and Marrow Institute/St. Francis Hospital

Beech Grove, Indiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Hackensack University Medical Center/Oncology Research Dept.

Hackensack, New Jersey, United States

Key Dates

Start Date

February 23, 2007

Primary Completion Date

January 29, 2008

Completion Date

August 26, 2008

Last Updated

July 15, 2021

Enrollment

ACTUAL participants

Conditions

Leukemia, Myeloid, Chronic

Interventions

LBH589

DRUG

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TERMINATEDPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Accelerated or Blast Phase

Inclusion Criteria

Exclusion Criteria

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