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Anti-tumor antibiotic

CLAG-GO for Acute Myeloid Leukemia

Phase 2
Recruiting
Led By Vu H. Duong, MD, MS
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate renal function, defined as a serum creatinine less than 1.8 mg/dL.
Patients must have 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). Patients with residual disease on day 13-22 of initial induction chemotherapy are eligible, provided the bone marrow cellularity is ≥ 30% AND bone marrow blasts are ≥ 20%. Hypomethylating agents such as azacitidine or decitabine are allowed as a prior therapy, but are not considered an intensive chemotherapy regimen.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured from the date of confirmed remission until the date of confirmed relapse, assessed up to 2 years. time to death (survival) is measured from the date of enrollment until the date of death, assessed up to 2 years.
Awards & highlights

Study Summary

This trial is studying a combination of chemotherapy drugs in the treatment of acute myeloid leukemia that has not responded well to standard therapy or has returned after an initial remission.

Who is the study for?
This trial is for adults with AML that hasn't improved after standard chemo or has come back. They must have had at least one intensive chemo treatment, be in good physical shape, and not pregnant or fathering children during the study. People can't join if they have certain types of leukemia, active infections, other cancers unless cured over 3 years ago, severe heart problems, mental health issues affecting compliance, or previous specific treatments for AML.Check my eligibility
What is being tested?
The CLAG-GO trial tests a combo of chemotherapy drugs (cladribine, cytarabine, G-CSF and gemtuzumab ozogamicin) on patients with tough cases of AML. Participants will receive induction therapy in hospital followed by possible consolidation therapy or bone marrow transplant if remission occurs. Maintenance therapy may follow for those remaining in remission.See study design
What are the potential side effects?
Possible side effects include reactions to drug infusion like fever and nausea; blood disorders such as low counts leading to bleeding risks or infection; liver problems; kidney damage; fatigue; and potential harm to unborn babies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is good, with creatinine below 1.8 mg/dL.
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My cancer did not respond or came back after strong chemotherapy.
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My liver tests are within the required range.
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I am 18 or older with a confirmed diagnosis of AML, not including APL.
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I am able to get out of my bed or chair and move around.
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My cancer cells show a high level of CD33.
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I am not pregnant and agree to use birth control during and 6 months after treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured from the date of confirmed remission until the date of confirmed relapse, assessed up to 2 years. time to death (survival) is measured from the date of enrollment until the date of death, assessed up to 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured from the date of confirmed remission until the date of confirmed relapse, assessed up to 2 years. time to death (survival) is measured from the date of enrollment until the date of death, assessed up to 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Response Rate (Efficacy)
Secondary outcome measures
Presence of minimal residual disease
Time to relapse or death

Trial Design

1Treatment groups
Experimental Treatment
Group I: CLAG-GOExperimental Treatment1 Intervention
Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO)

Find a Location

Who is running the clinical trial?

Hematologics, IncUNKNOWN
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,617 Total Patients Enrolled
Vu H. Duong, MD, MSPrincipal InvestigatorUniversity of Maryland Greenebaumn Comprehensive Cancer Center

Media Library

Cladribine (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04050280 — Phase 2
Acute Myeloid Leukemia Research Study Groups: CLAG-GO
Acute Myeloid Leukemia Clinical Trial 2023: Cladribine Highlights & Side Effects. Trial Name: NCT04050280 — Phase 2
Cladribine (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04050280 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any records of past studies in which Cladribine, Cytarabine and Granulocyte-Colony Stimulating Factor have been combined with Fractionated Gemtuzumab Ozogamicin (CLAG-GO)?

"Currently, 383 ongoing medical studies are investigating the effects of Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO) with 91 trials in Phase 3. Of these investigations, a number are happening in Saint Louis, Missouri while all together there is representation from 12385 locations across the world."

Answered by AI

What hazards has the combination of Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO) posed to patients?

"Our team at Power gave CLAG-GO a score of 2, indicating that while there is some data pointing to its safety and none detailing efficacy, it has yet to pass the clinical trial phase 3."

Answered by AI

What illnesses typically respond to the combination of Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO)?

"Commonly used to address multiple sclerosis, Cladribine, Cytarabine and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO) has also demonstrated effectiveness in treating bone marrow transplantation, diagnostic imaging and febrile neutropenia."

Answered by AI

Does this research endeavor currently accept participants?

"According to publicly-available information on clinicaltrials.gov, this trial is actively recruiting participants with the most recent edits made on March 2nd 2022. The investigation was initially posted in November 1st 2019."

Answered by AI

How many subjects are participants in this experiment?

"Affirmative. Details on clinicaltrials.gov indicate that this trial, initially posted on November 1st 2019, is currently seeking volunteers. A total of 39 people have to be recruited from one medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
Vu Duong 2019. "CLAG-GO for Patients With Persistent, Relapsed or Refractory AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04050280.
~13 spots leftby Jun 2026
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