OncoMatch/Clinical Trials/NCT04050280
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
Is NCT04050280 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO) for acute myeloid leukemia, adult.
Treatment: Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CD33 expression >= 20% (>= 20%)
At least 20% expression of CD33 as determined by flow cytometry or immunohistochemical staining.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: intensive chemotherapy (anthracycline, cytarabine)
relapsed after or be refractory to at least one course of an intensive chemotherapy regimen, for example anthracycline/cytarabine ("7+3" or daunorubicin and cytarabine liposome)
Cannot have received: gemtuzumab ozogamicin (gemtuzumab ozogamicin)
Prior treatment with gemtuzumab ozogamicin or cladribine for AML
Cannot have received: cladribine (cladribine)
Prior treatment with gemtuzumab ozogamicin or cladribine for AML
Lab requirements
Kidney function
serum creatinine < 1.8 mg/dL
Liver function
direct bilirubin < 2x ULN; AST, ALT, Alk Phos < 3x ULN
Adequate renal function, defined as a serum creatinine less than 1.8 mg/dL. Adequate hepatic function, defined as a direct bilirubin less than 2 times the institutional upper limit of normal (ULN) and AST, ALT and Alkaline Phosphatase less than 3 times the ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Maryland Greenebaumn Comprehensive Cancer Center · Baltimore, Maryland
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