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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing a new drug, CC-90009, to see if it is safe and effective when used with other drugs to treat acute myeloid leukemia.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events (AEs)

Dose Limiting Toxicity (DLT)

Secondary outcome measures

Complete Remission Rate (CRR)

Duration of Remission

Objective Response Rate (ORR)

+6 more

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

~1990

Azacitidine

2012

Completed Phase 3

~1440

Gilteritinib

2014

Completed Phase 2

~560

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor

954 Previous Clinical Trials

501,083 Total Patients Enrolled

CelgeneLead Sponsor

636 Previous Clinical Trials

128,949 Total Patients Enrolled

Michael Pourdehnad, M.D.Study DirectorCelgene

Media Library

CC-90009 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04336982 — Phase 1

Acute Myeloid Leukemia Research Study Groups: CC-90009 in combination with venetoclax and azacitidine, CC-90009 in combination with gilteritinib

Acute Myeloid Leukemia Clinical Trial 2023: CC-90009 Highlights & Side Effects. Trial Name: NCT04336982 — Phase 1

CC-90009 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04336982 — Phase 1

Frequently Asked Questions

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

How many healthcare facilities are conducting this clinical trial?

"The medical research is accepting participants from 13 different sites, including Montreal, San Francisco and Saint Louis. To reduce the need to travel far distances, it would be beneficial to choose a trial location in close proximity."

Answered by AI

How many participants have been recruited for this medical experiment?

"AbbVie, the trial's sponsor, needs to enlist 43 eligible patients in order to conduct this study. They will be recruiting from two medical centres: Hopital Maisonneuve-Rosemont located in Montreal and University Of California, San Francisco situated in San Francisco."

Answered by AI

Are there any precedential reports of CC-90009 being tested in the laboratory?

"CC-90009 was researched for the first time in 2006 at Chinese University of Hong Kong-Prince of Wales Hospital. Presently, there are 218 finalized clinical trials and 348 ongoing ones around the world; Montreal Quebec is a major hub for these studies."

Answered by AI

What illness is CC-90009 most commonly administered for?

"CC-90009 is frequently used to address complete blood count, as well as induction chemotherapy, refractory anemias, and acute myelocytic leukemia."

Answered by AI

What are the aspirations of this research endeavor?

"This experiment will be surveying for Adverse Events (AEs) over a 28-day period, with secondary objectives being the Duration of Remission, Pharmacokinetics - t1/2 and Complete Remission Rate (CRR)."

Answered by AI

Is this research currently open for participants?

"Affirmative. Clinicaltrials.gov's data reveals that this research venture is still recruiting participants, with the initial posting being made on August 5th 2020 and last updated November 16th 2022. The study seeks to enrol 43 patients at thirteen different medical centres."

Answered by AI

Recent research and studies

BloodJournal

CC-90009, a Novel Cereblon E3 Ligase Modulator, Targets Acute Myeloid Leukemia Blasts and Leukemia Stem Cells

Surka, Christine, Liqing Jin, Nathan Mbong, Chin-Chun Lu, In Sock Jang, Emily Rychak, Derek Mendy, et al.. 2021. “CC-90009, a Novel Cereblon E3 Ligase Modulator, Targets Acute Myeloid Leukemia Blasts and Leukemia Stem Cells”. Blood. American Society of Hematology. doi:10.1182/blood.2020008676.

clinicaltrials.govStudy

A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia

2020. "A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04336982.

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