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Recruitment Status : Withdrawn (loss of support)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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: BL-8040||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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).
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.
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
|Chaim Sheba Medical Center|
|Tel-Hashomer, Israel, 52621|
|Principal Investigator:||Arnon Nagler, MD||Chaim Sheba Medical Center|