39
Participants
Start Date
November 1, 2019
Primary Completion Date
June 30, 2026
Study Completion Date
February 28, 2027
Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO)
"Induction:~G-CSF 300 mcg subcutaneously daily on days 0-5.~Cladribine 5 mg/m2 in normal saline given intravenously over 2 hours daily on days 1-5.~Cytarabine 2000 mg/m2 in normal saline given intravenously over 4 hours daily on days 1-5.~Gemtuzumab ozogamicin 3 mg/m2 intravenously over 2 hours on days 1 and 4, prior to cladribine and cytarabine.~Consolidation:~If CRMRD-, CR or CRi is confirmed by bone marrow biopsy and aspirate after induction chemotherapy, patients may receive one cycle of consolidation chemotherapy (at the discretion of the investigator) with the same CLAG-GO regimen at the same doses given for induction. In addition, the investigator has the option of giving CLAG alone without GO if there is concern for increased risk of sinusoidal obstruction syndrome.~Patients who remain in CRMRD-, CR or CRi after consolidation chemotherapy may receive up to eight infusions of GO 2 mg/m2 approximately every 28 days."
RECRUITING
University of Maryland Greenebaumn Comprehensive Cancer Center, Baltimore
Collaborators (1)
Hematologics, Inc
UNKNOWN
University of Maryland, Baltimore
OTHER