Actively Recruiting
A Phase II Study of Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor With Fractionated Gemtuzumab Ozogamicin (CLAG-GO) for Treatment of Persistent, Relapsed or Refractory Acute Myeloid Leukemia
Led by University of Maryland, Baltimore · Updated on 2025-05-01
39
Participants Needed
1
Research Sites
30 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
Researchers are evaluating a combination chemotherapy regimen called CLAG-GO, which includes cladribine, cytarabine, granulocyte-colony stimulating factor (G-CSF), and gemtuzumab ozogamicin (GO), in adults with acute myeloid leukemia (AML) that has not responded to standard treatments or has relapsed. This phase II trial aims to assess how well this combination works and to monitor its safety in patients with persistent or relapsed AML. The study is conducted at the University of Maryland Greenebaum Comprehensive Cancer Center and includes careful monitoring for side effects and treatment responses.
CONDITIONS
Brief Title
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients age 18 years or older with confirmed diagnosis of AML excluding acute promyelocytic leukemia (APL)
- AML may be de novo or following prior hematologic disease or therapy-related
- Relapsed after or refractory to at least one course of intensive chemotherapy such as anthracycline/cytarabine
- Residual disease on day 13-22 of initial induction chemotherapy with bone marrow cellularity ≥ 30% and blasts ≥ 20%
- Eastern Cooperative Oncology Group performance status of 0-2
- Completed any systemic chemotherapy or radiotherapy at least 7 days before starting study treatment, except hydroxyurea or 6-mercaptopurine
- At least 20% expression of CD33 on leukemia cells
- Adequate kidney function with serum creatinine less than 1.8 mg/dL
- Adequate liver function with direct bilirubin less than 2 times normal and AST, ALT, Alkaline Phosphatase less than 3 times normal
- Patients relapsing after allogeneic stem cell transplant eligible if at least 60 days post-transplant, no > grade 1 graft versus host disease, off immunosuppressive therapy for at least 2 weeks
- Female patients of childbearing potential must have negative pregnancy test and agree to contraception through treatment and 6 months after last dose
- Male patients must agree to contraception through treatment and 3 months after last dose and avoid sperm donation
- Ability 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 of the central nervous system
- Prior treatment with gemtuzumab ozogamicin or cladribine for AML
- Symptomatic leukostasis at presentation
- Active uncontrolled infection
- Known active hepatitis B or C or other active liver disorder
- History of veno-occlusive disease or sinusoidal obstruction syndrome
- Active other cancer unless disease-free for at least 3 years except treated skin or cervical conditions
- Uncontrolled illness such as symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Induction: 5 days; Consolidation: 5 days (optional); Maintenance: up to 8 cycles approximately every 28 days
Participants receive induction chemotherapy with CLAG-GO including G-CSF, cladribine, cytarabine, and gemtuzumab ozogamicin. Responders may also receive one cycle of consolidation chemotherapy with the same regimen and up to eight maintenance infusions of gemtuzumab ozogamicin.
Multiple visits during induction, consolidation, and maintenance phases as per treatment schedule
Duration - At least 30 days post-transplant and up to 2 years post enrollment
Participants who proceed to allogeneic hematopoietic stem cell transplantation are monitored for at least 30 days post-transplant for complications such as veno-occlusive disease. Safety and survival outcomes are assessed up to 2 years after enrollment.
Approximately 6 post-treatment visits during long-term monitoring
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
O
Oyinkansola Arasanmi
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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