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Imatinib and BL-8040 (Novel Anti CXCR4 Antagonist) for Improving Molecular Response in Chronic Myelogenous Leukemia | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

Imatinib and BL-8040 (Novel Anti CXCR4 Antagonist) for Improving Molecular Response in Chronic Myelogenous Leukemia

Phase I/II Study Using Imatinib and s.c. BL-8040 (Novel Anti CXCR4 Antagonist) for Improving Molecular Response in Chronic Myelogenous Leukemia (CML) Patients in First Chronic Phase Achieving Less Than Optimal Response With Imatinib.

NCT02115672•Sheba Medical Center

View on ClinicalTrials.gov

Summary

The aim of the study is to test the safety and efficacy of BL-8040 (a CXCR4 antagonist) in improving the response to imatinib in CML patients not achieving an optimal response with imatinib alone.

Detailed Description

To improve cytogenetic and molecular response of CML patients receiving Imatinib, who have not achieved an optimal response according to European LeukemiaNet (ELN) definitions , or MR4 after 24 months with Imatinib. This will be achieved by addition of the CXCR4 antagonist BL-8040, mobilizing CML leukemia stem cells from their protective bone marrow niche and exposing them to Imatinib and BL-8040-mediated apoptosis.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult men and women subjects aged 18 to 70, inclusive.
•2. Confirmed diagnosis of chronic phase CML according to the WHO criteria (WHO 2008)
•3. CML patients with sub-optimal response to Tyrosine Kinase Inhibitors, defined as "warning" in the ELN recommendations:
•Following 3 months: BCR-ABL1 \> 10%, and/or Ph+ 36-95% Following 6 months: BCR-ABL1 1-10%, and/or Ph + 1-35% Following 12 months: BCR-ABL1 0.1-1 % Following 24 months: Less than MR4
•4. Clinical laboratory values should be as follows:
•White blood cell count \< 30 X 10\*9/L Creatinine \< 1.5 ULN
•5. Women of childbearing potential and all men must agree to use approved form of contraception
•6. Subject is able and willing to comply with the requirements of the protocol.
•7. Subject is able to voluntarily provide written informed consent.

Exclusion Criteria

•1. CML patients not in chronic phase.
•2. CML patients receiving Tyrosine Kinase Inhibitors other than Imatinib.
•3. CML patients receiving Imatinib \> 400 mg/day.
•4. Patients not able to sign informed consent.
•5. Known allergy or hypersensitivity to any of the test compounds or materials or contraindication to test product.
•6. Low Performance Status (ECOG \> 2).
•7. Abnormal liver function tests:
•1. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) 2 x upper limit of normal (ULN).
•2. Serum bilirubin. Total bilirubin \> 2.0 mg/dL (34 µmol/L), conjugated bilirubin \> 0.8 mg/dL
•8. Abnormal left ventricular ejection fraction, \< 40 %.
+4 more criteria

Locations (1)

Chaim Sheba Medical Center

Tel Litwinsky, Israel

Key Dates

Start Date

November 1, 2014

Primary Completion Date

November 1, 2016

Completion Date

November 1, 2018

Last Updated

August 15, 2016

Conditions

Chronic Myeloid Leukemia

Interventions

BL-8040

DRUG

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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: August 15, 2016Data 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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Imatinib and BL-8040 (Novel Anti CXCR4 Antagonist) for Improving Molecular Response in Chronic Myelogenous Leukemia

Inclusion Criteria

Exclusion Criteria

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias

Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia

Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

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A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies