Clinical Trial IDNCT04050280
Lead SponsorUniversity of Maryland, Baltimore
Principal Investigator
Start Date2020-01-01
Completion Date2023-02-01
Study TypeInterventional
PhasePhase 2
StatusNot yet recruiting

Purpose

This study involves evaluating a combination of chemotherapy drugs known as "CLAG-GO" [cladribine, cytarabine, granulocyte-colony stimulating factor (G-CSF) and gemtuzumab ozogamicin (GO)] in the treatment of acute myeloid leukemia (AML) that has not responded well to standard therapy or has returned after an initial remission (relapsed). The trial will be conducted at the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC). Potential participants will go through a screening period to see if they are eligible to join the study. If eligible, participants will be hospitalized for 4-5 weeks to receive study treatment with CLAG-GO, called induction chemotherapy. If tests show that the cancer is in remission after induction chemotherapy, participants may undergo further chemotherapy (known as consolidation) or may proceed with bone marrow/stem cell transplantation. Patients who receive consolidation chemotherapy and remain in remission may have up to 8 cycles of outpatient maintenance therapy. A cycle lasts about 28 days. All participants will be monitored carefully for both side effects and to see if the study treatment is working. Lab tests and exams will be conducted throughout the entire study. In addition, special studies will be done at various time points to try to understand better how the drugs work and which patients are likely to respond best.

Conditions

ConditionInterventionPhase
Acute Myeloid Leukemia, Adult, Acute Myeloid Leukemia Recurrent, Acute Myeloid Leukemia, Relapsed, AdultDrug: Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO)Phase 2

Eligibility

AgeGenderAccepts Healthy Volunteers
18 Years and older.AllNo