What side effects are associated with this type of intervention?

Common treatments for Acute Myeloid Leukemia, such as the CLAG-GO regimen (Cladribine, Cytarabine, G-CSF, and Gemtuzumab Ozogamicin), are associated with several side effects. These include severe myelosuppression leading to neutropenia, thrombocytopenia, and anemia, which increase the risk of infections and bleeding. Gastrointestinal symptoms like nausea, vomiting, and diarrhea are also frequent. Additionally, patients may experience fatigue, fever, and mucositis. Specific to Gemtuzumab Ozogamicin, liver toxicity and infusion-related reactions can occur. Monitoring and supportive care are essential to manage these adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Myeloid Leukemia (AML) that involve agents similar to those in the CLAG-GO trial. Gemtuzumab ozogamicin, an antibody-drug conjugate targeting CD33, has been approved for newly diagnosed and relapsed/refractory AML. Cytarabine, a chemotherapy agent, is a cornerstone of AML treatment and is often used in combination regimens. Cladribine, another chemotherapy agent, is primarily used for hairy cell leukemia but has been studied in AML. Granulocyte-colony stimulating factor (G-CSF) is used to support neutrophil recovery during chemotherapy. These agents, either alone or in combination, form part of the therapeutic arsenal against AML.

What other types of research exist?

Promising alternatives to CLAG-GO for AML patients include: 1) HMA (hypomethylating agents) plus venetoclax, which has shown improved outcomes in terms of overall survival and complete remission rates. 2) HMA plus ivosidenib, particularly for patients with IDH1 mutations. 3) Low-dose cytarabine (LoDAC) combined with venetoclax or glasdegib, both of which have demonstrated superior overall survival and complete remission rates compared to LoDAC monotherapy. These combinations offer novel mechanisms and improved efficacy for AML treatment.

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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.

Must not have

Any history of veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS).

Patients with acute promyelocytic leukemia (FAB-M3) or chronic myelogenous leukemia in blast phase.

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

No Placebo-Only Group

Summary

This trial uses a combination of four drugs, including Bisantrene, to treat adult patients with a specific type of leukemia that hasn't responded to standard treatments or has returned. Bisantrene, a new drug, has shown effectiveness in early tests with manageable side effects. The treatment works by killing cancer cells and boosting the body's ability to fight infections.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of VOD/SOS.

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I have acute promyelocytic leukemia or chronic myelogenous leukemia in blast phase.

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I do not have any severe illnesses that would stop me from following the study's requirements.

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My leukemia has spread to my brain or spinal cord.

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I have an active liver disease like hepatitis B or C.

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I have AML with bone marrow involvement.

Timeline

Screening ~ 3 weeks3 visits

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Response Rate (Efficacy)

Secondary study objectives

Presence of minimal residual disease

Time to relapse or death

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The CLAG-GO regimen for treating Acute Myeloid Leukemia (AML) combines Cladribine, which disrupts DNA synthesis, Cytarabine, which inhibits DNA replication, G-CSF, which boosts white blood cell production, and Gemtuzumab Ozogamicin, which targets and kills CD33-positive leukemia cells. These mechanisms collectively aim to eliminate leukemia cells, achieve remission, and enhance patient survival, addressing the aggressive nature of AML.