Clinical Trial DRUG CSLCT-AML-11-73
- A Phase 1 Study of CSL362 (Anti-IL3Ra / Anti-CD123 Monoclonal Antibody) in Patients with CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission with Incomplete Platelet Recovery at High Risk for Early Relapse
- Principal Investigator
- Jessica Altman
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CSLCT-AML-11-73
- The main purpose of the study is to find out the safety and effectiveness of repeat doses of CSL362 at increasing dose levels.
- Acute myeloid leukemia(AML) is often not cured because of rare cells called “leukemic stem cells” that are not killed by chemotherapy. It may take only few of these cells need to survive for the leukemia to grow back. It is believed that these leukemic stem cells' destruction is key cure AML. Lab studies show that CSL362 targets these rare cells, stops their growth,and kills them.CSL362 is an investigational (drug not approved by the U.S. Food & Drug Administration[FDA]). This study will determine how safe and well tolerated CSL362 is in participants who are at risk for an early relapse (cancer returns)of AML.
Some of the eligibility criteria include:
- Participants must be 18 years of age or older.
- Participants must have completed treatment for AML and achieved complete remission (the disappearance of all signs of cancer).
- Participants must have a life expectancy of 5 months or greater.
- Description of Treatment
- Participants will receive CSL362 intravenously (through a vein) once every 2 weeks for a period of 10 weeks. Participants will receive 6 doses unless their study doctor finds it in their best interest to stop.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by Jessica Altman
- 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, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects with Advanced Hematologic Malignancies with an IDH2 Mutation
- 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
- A Randomized Phase II Study of Oral Sapacitabine in Elderly Patients with Acute Myeloid Leukemia Previously Untreated or in First Relapse
- A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients with Newly Diagnosed Acute Myeloid Leukemia
- A Phase 1, Open-Label, Dose Escalation and Expanded Cohort, Continuous Intravenous Infusion, Multicenter Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EPZ-5676 in Treatment Relapsed/Refractory Patients with Leukemias Involving Translocations of the MLL Gene at 11q23 or Advanced Hematologic Malignancies
- Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin & Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age = 60 Years)
- A Phase I Study of Metformin and Cytarabine for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
- Phase II Study of Combined Tretinoin and Arsenic Trioxide for Patients with Newly Diagnosed Acute Promyelocytic Leukemia Followed by Risk-Adapted Postremission Therapy
- A Phase II Study of the BRAF Inhibitor, Vemurafenib, in Patients with Relapsed or Refractory Hairy Cell Leukemia
- A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
last updated: 29-Jan-15 04:20 PM
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