What side effects are associated with this type of intervention?

Common treatments for Acute Myeloid Leukemia, such as hypomethylating agents (azacitidine and decitabine), are associated with several side effects. These include cytopenias (reduction in the number of blood cells), febrile neutropenia (fever with low white blood cell count), and infections, which often necessitate hospitalization. Other side effects can include liver and kidney function abnormalities, requiring regular monitoring. Growth factor support and dose adjustments may be necessary to manage these toxicities. Overall, while these treatments can be effective, they come with a significant risk of severe adverse events.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Myeloid Leukemia (AML), including hypomethylating agents (HMAs) such as azacitidine and decitabine, which are commonly used for patients who are not candidates for intensive chemotherapy. Azacitidine has shown superior survival rates compared to best supportive care in clinical trials. Additionally, combination therapies like low-dose cytarabine (LoDAC) with venetoclax or glasdegib have been approved, offering superior outcomes compared to LoDAC monotherapy. Other notable FDA-approved treatments include IDH inhibitors for patients with specific genetic mutations and gemtuzumab ozogamicin for certain AML subtypes.

What other types of research exist?

Promising novel alternatives to CC-90009 for AML patients include: 1) Venetoclax combined with low-dose cytarabine (LoDAC), which has shown superior outcomes compared to LoDAC monotherapy. 2) IDH inhibitors such as ivosidenib (for mutant IDH1) and enasidenib (for mutant IDH2), which can be used for at least two years if the patient responds well. 3) Gemtuzumab ozogamicin (GO) as a single-agent maintenance therapy. 4) MEK inhibitor CI-1040, which induces apoptosis in AML cells. 5) Second-generation VCP inhibitor CB-5339, which impairs leukemic growth when combined with DNA-damaging agents. These alternatives offer various mechanisms of action and potential benefits for AML treatment.

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CAR T-cell Therapy

CC-90009 Combinations for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Gilteritinib treatment naïve

- Participant must have adequate liver function as demonstrated by: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) and bilirubin ≤ 1.5 x ULN

Must not have

- Persistent or clinically meaningful ventricular arrhythmias.

- Unstable angina pectoris or myocardial infarction ≤ 6 months prior to starting study treatments or unstable arrhythmia.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called CC-90009 combined with other leukemia drugs in patients with acute myeloid leukemia. It aims to find out if this combination is safe and effective, especially for those who are newly diagnosed or have not responded to previous treatments.

Who is the study for?

Adults with acute myeloid leukemia (AML) who understand the trial and can consent. They must be at least 18 years old, have certain types of AML or FLT3 mutation, and not fit for intensive chemotherapy if over 75. Participants need a performance status of 0-2, controlled white blood cell count, normal electrolytes, good liver function (AST/ALT ≤ 2.5x ULN; bilirubin ≤1.5x ULN), adequate kidney function (creatinine clearance ≥60 mL/min), and agree to pregnancy prevention measures.

What is being tested?

The trial is testing CC-90009 in combination with other anti-leukemia agents like Venetoclax/Azacitidine or Gilteritinib to assess safety and effectiveness against AML. It's an early-phase study where participants are openly assigned to different treatment combinations based on their specific condition.

What are the potential side effects?

Potential side effects may include changes in blood counts leading to increased infection risk or bleeding problems, fatigue, digestive issues such as nausea or constipation, liver enzyme alterations suggesting liver impact, potential heart rhythm abnormalities due to electrolyte imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never been treated with Gilteritinib.

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My liver tests are within the normal range.

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I am able to care for myself and perform daily activities.

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I am 18 years old or older.

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My cancer has a FLT3 mutation.

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I am 18 or older with AML that hasn't responded to treatment.

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My white blood cell count is below 25 x 10^9/L, or I'm taking medication to reach this.

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My kidneys work well, with a creatinine clearance rate of 60 mL/min or more.

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I am 75 or older with newly diagnosed AML and cannot undergo intensive chemotherapy.

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I am 75 or older with newly diagnosed AML or cannot undergo intensive chemotherapy.

Exclusion Criteria

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

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I have ongoing or significant irregular heartbeats.

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I haven't had a recent heart attack or unstable heart rhythm in the last 6 months.

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I had a stem cell transplant from a donor within the last 6 months.

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I have a condition that affects my body's calcium levels or prevents me from taking calcium supplements.

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I do not have serious heart problems.

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My heart condition limits my physical activity without discomfort.

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I have a condition that affects my heart's rhythm.

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I still have serious side effects from past treatments that haven't improved.

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I have been diagnosed with acute promyelocytic leukemia.

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I haven't had cancer treatment or radiotherapy in the last 28 days or less than 5 half-lives of the treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Adverse Events (AEs)

Dose Limiting Toxicity (DLT)

Secondary study objectives

Complete Remission Rate (CRR)

Duration of Remission

Objective Response Rate (ORR)

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: CC-90009 in combination with venetoclax and azacitidineExperimental Treatment3 Interventions

CC-90009 will be administered intravenously per dosing schedule in a 28-day cycle. Venetoclax will be administered orally QD. Azacitidine will be administered intravenously or subcutaneously on planned dosing days for each cycle.

Group II: CC-90009 in combination with gilteritinibExperimental Treatment1 Intervention

CC-90009 will be administered intravenously per dosing schedule in a 28-day cycle. Gilteritinib will be administered orally QD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CC-90009

2020

Completed Phase 1

~10

Venetoclax

2019

Completed Phase 3

~2240

Azacitidine

2012

Completed Phase 3

~1440

Gilteritinib

2014

Completed Phase 2

~660

0 / 20Eligibility 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

Common treatments for Acute Myeloid Leukemia (AML) include hypomethylating agents like azacitidine and decitabine, which work by inhibiting DNA methylation, leading to the reactivation of tumor suppressor genes and induction of cancer cell death. FLT3 inhibitors target mutations in the FLT3 gene, which are common in AML and drive the proliferation of leukemic cells. These treatments are crucial for AML patients as they offer targeted approaches to disrupt the growth and survival of cancer cells, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

Epigenetic deregulation in myeloid malignancies.Role of epigenetic in leukemia: From mechanism to therapy.Emerging Epigenetic Therapeutic Targets in Acute Myeloid Leukemia.