CLAG-GO for Patients With Persistent, Relapsed or Refractory AML

PHASE2RecruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

November 1, 2019

Primary Completion Date

June 30, 2026

Study Completion Date

February 28, 2027

Conditions
Acute Myeloid Leukemia, AdultAcute Myeloid Leukemia RecurrentAcute Myeloid Leukemia, Relapsed, Adult
Interventions
DRUG

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."

Trial Locations (1)

21201

RECRUITING

University of Maryland Greenebaumn Comprehensive Cancer Center, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Hematologics, Inc

UNKNOWN

lead

University of Maryland, Baltimore

OTHER