Clinical Trials Logo

Clinical Trial Summary

This study evaluates the addition of BL-8040 to the standard consolidation therapy with cytarabine in the treatment of acute myeloid leukemia (AML) in adults. Half of participants will receive BL-8040 and cytarabine in combination, while the other half will receive placebo and cytarabine.


Clinical Trial Description

The majority of AML patients in first complete Remission (CR) do relapse despite the current consolidation therapy. Leukemic stem cells that are dormant in the bone marrow are presumed to be a major reason for AML relapse. Allogenic stem cell transplantation is an option only for a minority of AML patients in 1st CR. BL-8040 is a novel CXCR4 inhibitor that has a dual mechanism of action: inducing mobilization of leukemic blasts from the bone marrow which enhances cytotoxic effects of chemotherapy and has direct antileukemic, pro-apoptotic properties. The treatment with BL-8040 in combination with consolidation therapy (standard consolidation with high-dose cytarabine) should improve the efficacy of the consolidation therapy resulting in longer lasting remissions. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02502968
Study type Interventional
Source Martin-Luther-Universität Halle-Wittenberg
Contact Simone Kowoll, MSc
Phone +49-345-5574908
Email blast@kks-halle.de
Status Recruiting
Phase Phase 2
Start date September 2015

See also
  Status Clinical Trial Phase
Recruiting NCT03224819 - Study of AMG 673 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia Early Phase 1
Recruiting NCT03197714 - Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia Phase 1
Recruiting NCT03665480 - The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML Phase 2/Phase 3
Active, not recruiting NCT02485535 - Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant Phase 1
Not yet recruiting NCT03483948 - Phase I Study of HMPL-523+Azacitidine in Elderly Patients With Acute Myeloid Leukemia Phase 1
Recruiting NCT02882321 - Study of IACS-010759 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) Phase 1
Recruiting NCT03214562 - Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive Acute Myeloid Leukemia (AML) Induction/Consolidation Therapy With FLAG-IDA in Patients With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia (AML) Phase 1/Phase 2
Recruiting NCT03298984 - Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML). Phase 1
Not yet recruiting NCT03555955 - A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351 Phase 1
Not yet recruiting NCT03603795 - Study Impact on Outcome of Eltrombopag in Elderly Patients With Acute Myeloid Leukemia Receiving Induction Chemotherapy Phase 2
Not yet recruiting NCT03454984 - SGI-110 and Donor Lymphocyte Infusions (DLI) After Allogeneic Stem Cell Transplantation Phase 2
Not yet recruiting NCT03616470 - Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia Phase 3
Recruiting NCT03256071 - Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT Phase 2/Phase 3
Recruiting NCT02975869 - A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia N/A
Recruiting NCT02668653 - Quizartinib With Standard of Care Chemotherapy and as Maintenance Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) Phase 3
Recruiting NCT02909972 - Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome Phase 1
Active, not recruiting NCT02899286 - Efficacy and Safety Study of Recombinant Human Arginase 1 in Patients With Relapsed or Refractory Acute Myeloid Leukemia Phase 2
Not yet recruiting NCT02933333 - G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor Phase 4
Recruiting NCT02543879 - Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies Phase 1
Recruiting NCT02400255 - Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients Phase 2