Imatinib and BL-8040 (Novel Anti CXCR4 Antagonist) for Improving Molecular Response in Chronic Myelogenous Leukemia
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ClinicalTrials.gov Identifier: NCT02115672 |
Recruitment Status :
Withdrawn
(loss of support)
First Posted : April 16, 2014
Last Update Posted : August 15, 2016
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Condition or disease | Intervention/treatment | Phase |
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Chronic Myeloid Leukemia | Drug: BL-8040 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Study Start Date : | November 2014 |
Estimated Primary Completion Date : | November 2016 |
Estimated Study Completion Date : | November 2018 |

Arm | Intervention/treatment |
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Experimental: BL-8040
Patients with chronic phase CML on Imatinib therapy (400 mg/day) achieving less than an optimal response will be treated with sc injections of BL-8040, while continuing Imatinib. The first part of the study will include escalating dose groups. Up to 4 dose levels will be investigated starting at dose level 1. Patients will be accrued in a conventional 3+3 design. Applying this study design, the first cohort of 3 patients will be treated at dose level 1 (0.5 mg/kg) on Day 1, 15, 29 and 43. Patients will continue taking Imatinib 400 mg/day throughout the study. Dose escalation will continue until the maximal tolerated dose (MTD) is established and protocol specific stopping rules for toxicity are met. If no MTD is reached, dose escalation will continue up to dose level 4 (1.25 mg/kg).
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Drug: BL-8040
BL-8040 will be added to imatinib to improve CML response. |
- To assess the safety and tolerability of BL-8040 in combination with Imatinib in CML patients [ Time Frame: 4 months ]The investigators will assess the safety of the BL-8040 by grading of toxicities according to standard Common Toxicity Criteria for Adverse Effects (CTCAE) criteria.
- To assess the clinical efficacy of BL-8040 in combination with Imatinib [ Time Frame: 2 years ]The cytogenetic and molecular response will be assessed by standard FISH and PCR test according to established criteria.
- To assess additional pharmacodynamic parameters relevant to CXCR4 inhibition [ Time Frame: 2 months ]The investigators will test CXCR4 receptor occupancy and expression and additional pharmacodynamic endpoints relevant to CXCR4 inhibition.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult men and women subjects aged 18 to 70, inclusive.
- Confirmed diagnosis of chronic phase CML according to the WHO criteria (WHO 2008)
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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
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Clinical laboratory values should be as follows:
White blood cell count < 30 X 10*9/L Creatinine < 1.5 ULN
- Women of childbearing potential and all men must agree to use approved form of contraception
- Subject is able and willing to comply with the requirements of the protocol.
- Subject is able to voluntarily provide written informed consent.
Exclusion Criteria:
- CML patients not in chronic phase.
- CML patients receiving Tyrosine Kinase Inhibitors other than Imatinib.
- CML patients receiving Imatinib > 400 mg/day.
- Patients not able to sign informed consent.
- Known allergy or hypersensitivity to any of the test compounds or materials or contraindication to test product.
- Low Performance Status (ECOG > 2).
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Abnormal liver function tests:
- Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) 2 x upper limit of normal (ULN).
- Serum bilirubin. Total bilirubin > 2.0 mg/dL (34 µmol/L), conjugated bilirubin > 0.8 mg/dL
- Abnormal left ventricular ejection fraction, < 40 %.
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Subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to:
- Subject has been diagnosed or treated for another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy
- A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.
- Women subjects who are pregnant or breastfeeding.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115672
Israel | |
Chaim Sheba Medical Center | |
Tel-Hashomer, Israel, 52621 |
Principal Investigator: | Arnon Nagler, MD | Chaim Sheba Medical Center |
Responsible Party: | Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT02115672 |
Other Study ID Numbers: |
SHEBA-13-0575-AN-CTIL |
First Posted: | April 16, 2014 Key Record Dates |
Last Update Posted: | August 15, 2016 |
Last Verified: | December 2014 |
Chronic myeloid leukemia imatinib CXCR4 antagonist BL-8040 |
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type |
Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases |