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CLAG-GO for Relapsed or Refractory AML

This study is testing a combination of chemotherapy drugs called CLAG-GO (cladribine, cytarabine, granulocyte-colony stimulating factor, and gemtuzumab ozogamicin) for adults with acute myeloid leukemia (AML) that has come back (relapsed) or hasn't responded well to previous treatments (refractory). The goal is to see how many patients respond to the treatment and to monitor any side effects. You would need to be 18 or older with a confirmed AML diagnosis (excluding acute promyelocytic leukemia) and have already received at least one intensive chemotherapy treatment. The study aims to enroll 39 patients. The current status of the study is unclear.

Study design
This is a single-arm, two-stage Phase II study, meaning all participants receive the same treatment. It plans to enroll up to 39 adult patients.
What's involved
If eligible, you would be hospitalized for 4-5 weeks to receive the study treatment, called induction chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be checked after induction chemotherapy. Side effects will be monitored from enrollment until death or up to one year, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04050280

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Maryland, Baltimore
~39 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response Rate (Efficacy)
Measured over Responses will be assessed following induction chemotherapy, within 14 days of documented full blood count recovery.
+1 more outcome measured

Conditions

Acute Myeloid Leukemia, Adult
Acute Myeloid Leukemia Recurrent
Acute Myeloid Leukemia, Relapsed, Adult

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Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Vu H. Duong, MD, MS · PRINCIPAL_INVESTIGATOR · University of Maryland Greenebaumn Comprehensive Cancer Center

Who to contact

Veronica Kflu
[email protected]
410-328-9416
Email the study team

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What this trial measures

  • Response Rate (Efficacy)Responses will be assessed following induction chemotherapy, within 14 days of documented full blood count recovery.

    Responses will be judged according to modified European LeukemiaNet recommendations published in 2017. Patients who achieve either 1) complete remission without minimal residual disease, 2) complete remission, or 3) complete remission with incomplete hematologic recovery will be considered responders

  • Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)From date of enrollment until death from any cause, whichever comes first, assessed up to 1 year.

    All adverse events will be graded according to CTCAE version 5.