Clinical Trial DRUG BL-8040.01
- A Phase IIa, Multicenter, Open-Label Study Designed to Evaluate the Safety and Efficacy of Escalating Doses of BL-8040 in Adult Subjects with Relapsed/Refractory Acute Myeloid Leukemia
- Principal Investigator
- Jessica Altman
- Status: COMPLETED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG BL-8040.01
- The main purpose of the study is to examine the safety and tolerability of BL-8040 when given once daily for two days, followed by five days of combined treatment with BL-8040 and Ara-C.
- This study is for patients with acute myelogenous leukemia (AML). AML is a cancer of the blood and bone marrow, characterized by rapid growth of abnormal blood cells that accumulate in the bone marrow and interfere with production of normal blood cells. The standard treatment in patients with AML that has either returned or did not respond adequately to previous treatment is chemotherapy with either a single drug (e.g., Ara-C) or combination chemotherapy with 2 or 3 different drugs. These treatments are often associated with unpleasant side effects and there remains a significant need for more effective therapies. This study will test the safety and effectiveness of an investigational new drug called BL-8040. BL-8040 is not approved by the Food and Drug Administration (FDA) for patients with AML, but may potentially be of benefit as it promotes movement of abnormal blood cells from the bone marrow to the circulation, where they are exposed to chemotherapy. Animal studies have also shown that BL-8040 selectively kills leukemia cells. In addition, BL-8040 has been studied previously in 18 subjects with multiple myeloma (another form of blood cancer) in which single doses were safe and well tolerated. It is therefore hoped that BL-8040 will provide therapeutic advantage in the treatment of AML.
Some of the eligibility criteria include:
- Participants must have AML that did not respond to therapy or returned after previous therapy.
- Participants must be 18-75 years of age.
- Description of Treatment
- Study participants will receive treatment as follows: On Days 1 and 2, they will just receive BL-8040. It will be administered by subcutaneous (under the skin) injection, once daily in the morning. On Days 3-7, participants will be treated once daily in the morning with BL-8040 (by subcutaneous injection) followed by chemotherapy 4 hours later. The chemotherapy will consist of Ara-C, which is an accepted and approved treatment in such clinical condition, administered intravenously (directly into a vein) over 3 hours. During the second phase of the study, participants who are found to have high white cell counts following the first or second dose of BL-8040 may have the BL-8040 administration on Day 2 and/or Day 3 omitted.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase I, Open, Cohort Dose Escalation Trial with BI 836858 in Patients with Refractory or Relapsed Acute Myeloid Leukemia
- A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Hematologic Malignancies with an IDH1 Mutation
- A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients with Advanced Hematologic Malignancies with an IDH1 and/or IDH2 Mutation
last updated: 21-Oct-16 06:09 AM
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