Acute Myeloid LeukemiaPhase 2NCT01838395
Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients
A Phase 2 study testing Ara-C and BL-8040 in people with Acute Myeloid Leukemia, run by BioLineRx, Ltd. at 10 sites in 2 countries.
Trial summary
A study is designed to assess if BL-8040 in combination with cytarabine (Ara-C) can help controlling the disease in patients with Acute Myeloid Leukemia (AML) that have relapsed or did not respond adequately to previous treatment. The safety of the study drug combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Ara-C and BL-8040
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Apr 2013to 20 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women subjects aged 18 to 75, inclusive.
- Confirmed diagnosis of relapsed/refractory AML (WHO criteria) Refractory subjects, up to second consecutive salvage . Relapsed subjects including first and second relapse.
- AML relapse > 6 months since autologous or allogeneic stem cell transplantation, provided they are in first or second relapse and:
- No active graft-versus-host disease (GVHD > grade 1). No treatment with high dose steroids for GVHD (up to 20 mg Prednisolone or equivalent, Appendix G). No treatment with immunosuppressive drugs with the exception of low dose cyclosporine and tacrolimus (blood levels of 0.5-0.6 µg/mL).
- Clinical laboratory values should be as follows:
- White Blood Cells (WBC) < 30,000/mL Blasts in Peripheral Blood (PB) ≤ 20,000. Treatment with Hydroxyurea is permitted up to 24 hrs prior to BL-8040 administration to achieve blast counts < 20,000 prior to enrollment. Creatinine < 1.3 mg/dL; if Creatinine is > 1 mg/dL the Creatinine clearance should be > 40 mL/min as calculated using the Cockcroft-Gault formula.
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- Women of childbearing potential and all men must agree to use an approved form of contraception (e.g. oral, transdermal patch, implanted contraceptives, intrauterine device, diaphragm, condom, abstinence or surgical sterility) prior to study entry and for the duration of study participation through 30 days after the last dose of BL-8040. Confirmation that female subjects are not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Subject is able and willing to comply with the requirements of the protocol.
- Subject is able to voluntarily provide written informed consent.
Who cannot join
- Administration of conventional chemotherapy within 2 weeks of enrollment date. In the event that subjects have received chemotherapy > 2 weeks from the date of enrollment, they may be included provided they have recovered from the associated non-hematological toxicities to ≤ grade 1.
- Life expectancy of ≤ 2 months.
- Known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product.
- Use of investigational device or agents within 2 weeks of enrollment date.
- Low Performance Status (ECOG > 2; Appendix E).
- O2 saturation < 92% (on room air), evidence of Tumor Lysis Syndrome (TLS) > grade 2 (according to the Cairo-Bishop criteria (3)) or leukostasis (2).
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- Abnormal liver function tests:
- Serum aspartate transaminase (AST/SGOT) or alanine transaminase ( Alanine Transaminase (ALT)/Serum Glutamic Pyruvic Transaminase (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.
- Left ventricular ejection fraction < 40 %.
- History of myocardial infarction or cerebrovascular accident within 6 months of enrollment date.
- Presence of active, uncontrolled infection.
- Known central nervous system disease (e.g., Alzheimer's disease).
- Acute promyelocytic leukemia.
- Exposure to high dose Ara-C within 6 months of enrollment.
- 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.
- Female subjects who are pregnant or breastfeeding.
- Prior clinically significant grade 3-4 non-hematological toxicity to high dose Ara-C or grade ≥ 2 of neurological toxicity.
- Seropositive for HIV antibodies (HIV1 and HIV2), Hepatitis C antibody (Hep C Ab) or a Hepatitis B carrier (positive for Hepatitis B surface antigen [HBsAg]).
- Unable to comply with study requirements in the opinion of the Investigator.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States5 sites
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Washington University School of Medicine
St Louis, Missouri, 63110
Israel5 sites
Rambam Medical Center
Haifa, 31096
Shaare Zedek Medical Center
Jerusalem, 91031
Meir Medical Center
Kfar Saba
Chaim Sheba Medical Center
Ramat Gan, 52621
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
About this study
Official title: A Phase IIa, Multicenter, Open-Label Study Designed to Evaluate the Safety and Efficacy of Escalating Doses of BL-8040 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)
A study is designed to assess if BL-8040 in combination with cytarabine (Ara-C) can help controlling the disease in patients with Acute Myeloid Leukemia (AML) that have relapsed or did not respond adequately to previous treatment. The safety of the study drug combination will also be studied.
Read the detailed description
Open-label, multicenter, Phase IIa, dose escalating study in subjects with relapsed/refractory AML, defined according to WHO criteria, including subjects who failed chemotherapy only and those who failed previous Autologous Stem Cell Transplantation (ASCT)/ Allogeneic Stem Cell Transplantation (AlloSCT), provided at least 6 months have passed from transplant.
Eligible subjects will receive subcutaneous (SC) injections of BL-8040 ("monotherapy period") over two days (one injection per day) followed by concurrent administration of BL-8040 with standard salvage chemotherapy ("combined period") over 5 days. During the "combined period," BL-8040 will be administered 4 hours prior to chemotherapy. The chemotherapy will consist of cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age), administered intravenously (IV) over 3 hours, for 5 days and will not be escalated.
The first part of the study (Part 1) will include escalating dose groups and be considered the 'escalation phase'. Six potential 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 and evaluated for dose escalation.
At the discretion of the Sponsor, additional subjects may be enrolled into a selected dose group to confirm safety and efficacy for selected dose. the portion of this study is considered expansion phase.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Ara-C, BL-8040
- Keywords
- AML, Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ara-CDrug
Also called Cytarabine
IV (intravenous administration)
BL-8040Drug
SC (subcutaneous injection)
| Study group | Role | What they receive |
|---|---|---|
| BL-8040 0.5mg/kg + Ara-C 1.5 or 3 g/m2/d per dose (based on age) | Experimental | Arm 1: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. Receives: Drug: Ara-C; Drug: BL-8040 |
| BL-8040 0.75mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | Experimental | Arm 2: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. Receives: Drug: Ara-C; Drug: BL-8040 |
| BL-8040 1.0mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | Experimental | Arm 3: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 1 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. Receives: Drug: Ara-C; Drug: BL-8040 |
| BL-8040 1.25mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | Experimental | Arm 4: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. Receives: Drug: Ara-C; Drug: BL-8040 |
| BL-8040 1.5mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | Experimental | Arm 5: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. Receives: Drug: Ara-C; Drug: BL-8040 |
| BL-8040 2mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | Experimental | Arm 6: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 2 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. Receives: Drug: Ara-C; Drug: BL-8040 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Number of participants with Adverse event affecting the safety and tolerability of BL-8040 + Ara-C by dose level (overall, dose limiting events, related Adverse Events (AEs), Serious Adverse Events (SAEs), related SAEs, AE by severity and death) Toxicity grade was assessed according to version V4.03 of NCI-CTCAE
Measured: Participants were followed for the duration of the hospital stay and the follow-up period, an expected average of 6 weeks.
Secondary outcomes (7)
Response to Treatment by Dose
Response rate as assessed at final bone marrow evaluation based on Cheson et al 2003 criteria.
- CR defined as bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 10^9/L (1000/μL); platelet count >100 x 10^9/L (100,000/μL); independent of red cell transfusions
- CRi defined as all CR criteria except for residual neutropenia (<1.0 x 10^9/L [1000/μL]) or thrombocytopenia (<100 x 10^9/L [100,000/μL])
- Partial Response (PR) defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%
Measured: Final bone marrow evaluation - Between Day 20 and Day 44
Apoptotic Effect
Change in leukemic cell apoptosis in peripheral blood and bone marrow
Measured: Final evaluation - between Day 20 and Day 44
Assessment of the Pharmacokinetic Profile of BL-8040 - t1/2 (h)
Pharmacokinetics (PK) of BL-8040 after daily subcutaneous (SC) dosing for 2 days alone, followed by 5 days of combined administration of BL-8040 + Ara-C by dose level.
Standard Deviation is reported for N ≥ 3 t1/2 (h): The time required for plasma concentration of a drug to decrease by 50%
Measured: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.
Assessment of the Pharmacokinetic Profile of BL-8040 - Tmax (h)
Pharmacokinetics (PK) of BL-8040 after daily subcutaneous (SC) dosing for 2 days alone, followed by 5 days of combined administration of BL-8040 + Ara-C by dose level.
Standard Deviation is reported for N ≥ 3 tmax (h): The time to peak concentration
Measured: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.
Assessment of the Pharmacokinetic Profile of BL-8040 - Cmax (ng/mL)
Pharmacokinetics (PK) of BL-8040 after daily subcutaneous (SC) dosing for 2 days alone, followed by 5 days of combined administration of BL-8040 + Ara-C by dose level.
Standard Deviation is reported for N ≥ 3 Cmax is the highest concentration of a drug in the blood
Measured: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.
Assessment of the Pharmacokinetic Profile of BL-8040 - AUC0-t (h*ng/mL)
Pharmacokinetics (PK) of BL-8040 after daily subcutaneous (SC) dosing for 2 days alone, followed by 5 days of combined administration of BL-8040 + Ara-C by dose level.
Standard Deviation is reported for N ≥ 3 AUC0-t is the Area Under the Curve (AUC), definite integral of the concentration of a drug in blood as a function of time.
Measured: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.
Assessment of the Pharmacokinetic Profile of BL-8040 - AUC0-24 (h*ng/mL)
Pharmacokinetics (PK) of BL-8040 after daily subcutaneous (SC) dosing for 2 days alone, followed by 5 days of combined administration of BL-8040 + Ara-C by dose level.
Standard Deviation is reported for N ≥ 3 AUC0-24 is the Area Under the Curve (AUC), definite integral of the concentration of a drug in blood from time zero to 24 hours post dose.
Measured: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2016
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study (Part 1) will include escalating dose groups and be considered the 'escalation phase'. Five potential 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 and evaluated for dose escalation. Dose escalation will be permitted until the Maximum 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 5 (1.5 mg/kg).
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioLineRx, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnon Aharon, MD, Study chair, BioLineRx, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838395
- Sponsor's protocol ID
- BL-8040.01
- Status last verified
- Aug 2024
- First submitted
- 14 Apr 2013
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Multicenter, Open-Label Study Designed to Evaluate the Safety and Efficacy of Escalating Doses of BL-8040 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT01838395
- Acronym / sponsor ID
- BL-8040.01
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- BioLineRx, Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study is designed to assess if BL-8040 in combination with cytarabine (Ara-C) can help controlling the disease in patients with Acute Myeloid Leukemia (AML) that have relapsed or did not respond adequately to previous treatment. The safety of the study drug combination will also be studied.
Detailed description
Open-label, multicenter, Phase IIa, dose escalating study in subjects with relapsed/refractory AML, defined according to WHO criteria, including subjects who failed chemotherapy only and those who failed previous Autologous Stem Cell Transplantation (ASCT)/ Allogeneic Stem Cell Transplantation (AlloSCT), provided at least 6 months have passed from transplant.
Eligible subjects will receive subcutaneous (SC) injections of BL-8040 ("monotherapy period") over two days (one injection per day) followed by concurrent administration of BL-8040 with standard salvage chemotherapy ("combined period") over 5 days. During the "combined period," BL-8040 will be administered 4 hours prior to chemotherapy. The chemotherapy will consist of cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age), administered intravenously (IV) over 3 hours, for 5 days and will not be escalated.
The first part of the study (Part 1) will include escalating dose groups and be considered the 'escalation phase'. Six potential 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 and evaluated for dose escalation.
At the discretion of the Sponsor, additional subjects may be enrolled into a selected dose group to confirm safety and efficacy for selected dose. the portion of this study is considered expansion phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- The study (Part 1) will include escalating dose groups and be considered the 'escalation phase'. Five potential 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 and evaluated for dose escalation. Dose escalation will be permitted until the Maximum 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 5 (1.5 mg/kg).
| Arm | Type | Receives |
|---|---|---|
| BL-8040 0.5mg/kg + Ara-C 1.5 or 3 g/m2/d per dose (based on age) | Experimental | Drug: Ara-C, Drug: BL-8040Arm 1: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. |
| BL-8040 0.75mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | Experimental | Drug: Ara-C, Drug: BL-8040Arm 2: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. |
| BL-8040 1.0mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | Experimental | Drug: Ara-C, Drug: BL-8040Arm 3: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 1 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. |
| BL-8040 1.25mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | Experimental | Drug: Ara-C, Drug: BL-8040Arm 4: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. |
| BL-8040 1.5mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | Experimental | Drug: Ara-C, Drug: BL-8040Arm 5: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. |
| BL-8040 2mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | Experimental | Drug: Ara-C, Drug: BL-8040Arm 6: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 2 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult men and women subjects aged 18 to 75, inclusive.
- Confirmed diagnosis of relapsed/refractory AML (WHO criteria) Refractory subjects, up to second consecutive salvage . Relapsed subjects including first and second relapse.
- AML relapse > 6 months since autologous or allogeneic stem cell transplantation, provided they are in first or second relapse and:
- No active graft-versus-host disease (GVHD > grade 1). No treatment with high dose steroids for GVHD (up to 20 mg Prednisolone or equivalent, Appendix G). No treatment with immunosuppressive drugs with the exception of low dose cyclosporine and tacrolimus (blood levels of 0.5-0.6 µg/mL).
- Clinical laboratory values should be as follows:
Key exclusion criteria (21 listed)
- Administration of conventional chemotherapy within 2 weeks of enrollment date. In the event that subjects have received chemotherapy > 2 weeks from the date of enrollment, they may be included provided they have recovered from the associated non-hematological toxicities to ≤ grade 1.
- Life expectancy of ≤ 2 months.
- Known allergy or hypersensitivity to any of the test compounds, materials or contraindication to test product.
- Use of investigational device or agents within 2 weeks of enrollment date.
- Low Performance Status (ECOG > 2; Appendix E).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ara-CAlso: CytarabineIV (intravenous administration) | Drug | BL-8040 0.5mg/kg + Ara-C 1.5 or 3 g/m2/d per dose (based on age), BL-8040 0.75mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age), BL-8040 1.0mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age), BL-8040 1.25mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age), BL-8040 1.5mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age), BL-8040 2mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) |
| BL-8040SC (subcutaneous injection) | Drug | BL-8040 0.5mg/kg + Ara-C 1.5 or 3 g/m2/d per dose (based on age), BL-8040 0.75mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age), BL-8040 1.0mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age), BL-8040 1.25mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age), BL-8040 1.5mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age), BL-8040 2mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) |
Primary outcome
Safety and Tolerability
Time frame: Participants were followed for the duration of the hospital stay and the follow-up period, an expected average of 6 weeks.
Number of participants with Adverse event affecting the safety and tolerability of BL-8040 + Ara-C by dose level (overall, dose limiting events, related Adverse Events (AEs), Serious Adverse Events (SAEs), related SAEs, AE by severity and death) Toxicity grade was assessed according to version V4.03 of NCI-CTCAE
7 secondary outcomes
Response to Treatment by Dose
Time frame: Final bone marrow evaluation - Between Day 20 and Day 44
Apoptotic Effect
Time frame: Final evaluation - between Day 20 and Day 44
Assessment of the Pharmacokinetic Profile of BL-8040 - t1/2 (h)
Time frame: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.
Assessment of the Pharmacokinetic Profile of BL-8040 - Tmax (h)
Time frame: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.
Assessment of the Pharmacokinetic Profile of BL-8040 - Cmax (ng/mL)
Time frame: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.
Assessment of the Pharmacokinetic Profile of BL-8040 - AUC0-t (h*ng/mL)
Time frame: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.
Assessment of the Pharmacokinetic Profile of BL-8040 - AUC0-24 (h*ng/mL)
Time frame: Blood samples for the determination of BL-8040 were collected before dosing and at 0.25, 0.5, 1, 2, 4, 8, and 24 hours after BL-8040 administration on Day 1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnon Aharon, MD study chair
BioLineRx, Ltd.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ara-C and BL-8040 in people with Acute Myeloid Leukemia, run by BioLineRx, Ltd. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Participants were followed for the duration of the hospital stay and the follow-up period, an expected average of 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.