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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 belowSelect...
I have never been treated with Gilteritinib.
Select...
My liver tests are within the normal range.
Select...
I am able to care for myself and perform daily activities.
Select...
I am 18 years old or older.
Select...
My cancer has a FLT3 mutation.
Select...
I am 18 or older with AML that hasn't responded to treatment.
Select...
My white blood cell count is below 25 x 10^9/L, or I'm taking medication to reach this.
Select...
My kidneys work well, with a creatinine clearance rate of 60 mL/min or more.
Select...
I am 75 or older with newly diagnosed AML and cannot undergo intensive chemotherapy.
Select...
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:Select...
I have ongoing or significant irregular heartbeats.
Select...
I haven't had a recent heart attack or unstable heart rhythm in the last 6 months.
Select...
I had a stem cell transplant from a donor within the last 6 months.
Select...
I have a condition that affects my body's calcium levels or prevents me from taking calcium supplements.
Select...
I do not have serious heart problems.
Select...
My heart condition limits my physical activity without discomfort.
Select...
I have a condition that affects my heart's rhythm.
Select...
I still have serious side effects from past treatments that haven't improved.
Select...
I have been diagnosed with acute promyelocytic leukemia.
Select...
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
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 moreAwards & 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
~2200
Azacitidine
2012
Completed Phase 3
~1440
Gilteritinib
2014
Completed Phase 2
~660
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.
Epigenetic deregulation in myeloid malignancies.Role of epigenetic in leukemia: From mechanism to therapy.Emerging Epigenetic Therapeutic Targets in Acute Myeloid Leukemia.
Find a Location
Who is running the clinical trial?
AbbVieIndustry Sponsor
1,019 Previous Clinical Trials
519,904 Total Patients Enrolled
CelgeneLead Sponsor
645 Previous Clinical Trials
130,418 Total Patients Enrolled
Michael Pourdehnad, M.D.Study DirectorCelgene
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have ongoing or significant irregular heartbeats.I haven't had a recent heart attack or unstable heart rhythm in the last 6 months.I had a stem cell transplant from a donor within the last 6 months.I had a mild or no symptom COVID-19 infection less than 10 days ago, or a severe one less than 20 days ago.I have never been treated with Gilteritinib.My liver tests are within the normal range.I have or might have leukemia affecting my brain or spinal cord.I have a condition that affects my body's calcium levels or prevents me from taking calcium supplements.I do not have serious heart problems.I am able to care for myself and perform daily activities.I am 18 years old or older.My cancer has a FLT3 mutation.I am 18 or older with AML that hasn't responded to treatment.My white blood cell count is below 25 x 10^9/L, or I'm taking medication to reach this.I am considering the venetoclax/azacitidine treatment combination.I haven't taken strong medication that affects liver enzymes in the last week.I am considering treatment with CC-90009 and gilteritinib.I am on immunosuppressive drugs after a stem cell transplant or have significant graft-versus-host disease.My heart condition limits my physical activity without discomfort.I have not eaten grapefruit, Seville oranges, or Star fruit in the last 3 days.I have a condition that affects my heart's rhythm.I had a stem cell transplant but haven't fully recovered from its effects.I still have serious side effects from past treatments that haven't improved.My kidneys work well, with a creatinine clearance rate of 60 mL/min or more.I have been diagnosed with acute promyelocytic leukemia.I haven't had a COVID-19 vaccine in the last 14 days.I understand and have signed the consent form for this study.I am eligible for treatment with CC-90009 combined with venetoclax/azacitidine.I haven't had cancer treatment or radiotherapy in the last 28 days or less than 5 half-lives of the treatment.I am 75 or older with newly diagnosed AML and cannot undergo intensive chemotherapy.I am 75 or older with newly diagnosed AML or cannot undergo intensive chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: CC-90009 in combination with venetoclax and azacitidine
- Group 2: CC-90009 in combination with gilteritinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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