Actively Recruiting
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
Led by University of Maryland, Baltimore · Updated on 2025-05-01
39
Participants Needed
1
Research Sites
378 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
H
Hematologics, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults age 18 years or older with confirmed AML excluding acute promyelocytic leukemia
- AML may be new or following prior blood disease or therapy
- Relapsed after or refractory to at least one intensive chemotherapy course
- Residual disease on day 13-22 of initial induction allowed if marrow cellularity 63 30% and blasts 63 20%
- ECOG performance status of 0-2
- Completed systemic chemotherapy or radiotherapy at least 7 days before study treatment (except certain drugs for cytoreduction)
- At least 20% CD33 expression by flow cytometry or immunohistochemistry
- Adequate kidney function (serum creatinine less than 1.8 mg/dL)
- Adequate liver function (direct bilirubin less than 2 times upper limit, AST, ALT, and alkaline phosphatase less than 3 times upper limit)
- Patients relapsing after allogeneic stem cell transplant eligible if at least 60 days post-transplant, no more than grade 1 graft-versus-host disease, and off immunosuppressive therapy for at least 2 weeks
- Females of childbearing potential must have negative pregnancy test and use contraception during treatment and for 6 months after last dose
- Males able to father children must use contraception during treatment and for 3 months after last dose and avoid sperm donation
- Able to provide written informed consent
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (FAB-M3) or chronic myelogenous leukemia in blast phase
- Isolated myeloid sarcoma without marrow involvement
- Known active AML involvement in central nervous system
- Prior treatment with gemtuzumab ozogamicin or cladribine for AML
- Symptomatic leukostasis at treatment start; asymptomatic hyperleukocytosis must be controlled and treatment stopped 24 hours before protocol therapy
- Active uncontrolled infection
- Known active hepatitis B or C or other active liver disorders
- Any history of veno-occlusive disease or sinusoidal obstruction syndrome
- Active other cancers unless disease-free for 3 years; exceptions for certain treated skin and cervical cancers and organ-confined prostate cancer
- Uncontrolled illnesses including severe heart conditions or psychiatric/social issues limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Maryland Greenebaumn Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
V
Veronica Kflu
CONTACT
O
Oyinkansola Arasanmi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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