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CAR T-cell Therapy
GDX012 for Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 months
Awards & highlights
Study Summary
This trial is testing a new therapy to treat certain types of cancer, to see if it's safe & effective.
Who is the study for?
Adults with a body weight of at least 40 kg who have relapsed or refractory Acute Myeloid Leukemia (AML) and are not eligible for stem cell transplantation can join. They should be in relatively good health otherwise, with an expected lifespan over 3 months and able to perform daily activities with little or no assistance.Check my eligibility
What is being tested?
The trial is testing GDX012, a new cell therapy for AML. It aims to find out how safe the treatment is, how well patients tolerate it, and determine the best dose when combined with chemotherapy agents.See study design
What are the potential side effects?
While specific side effects of GDX012 aren't listed here, common side effects from similar treatments include immune system reactions, fatigue, fever, digestive issues and potential risks associated with chemotherapy such as hair loss and increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of GDX012
Number of Participants With Adverse Events (AEs)
Number of Participants With Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Duration of Response (DOR)
Event-free Survival (EFS)
Number of Participants With Disease Response
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase 2a: GDX012Experimental Treatment2 Interventions
Participants will receive GDX012 (weight-based) IV infusion at pre-selected one or two dose levels from Phase 1, on Day 1 after lymphodepleting chemotherapy. Some participants may be eligible for a second dose.
Group II: Phase 1: Dose Escalation of GDX012Experimental Treatment2 Interventions
Participants will receive GDX012 weight-based dose as intravenous (IV) infusion on Day 1 of Phase 1 after lymphodepleting chemotherapy. Three dose levels of GDX012 will be tested in Phase 1. Some participants may be eligible for a second dose.
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Who is running the clinical trial?
TakedaLead Sponsor
1,203 Previous Clinical Trials
4,177,891 Total Patients Enrolled
16 Trials studying Leukemia
3,374 Patients Enrolled for Leukemia
Study DirectorStudy DirectorTakeda
1,211 Previous Clinical Trials
489,219 Total Patients Enrolled
17 Trials studying Leukemia
4,391 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with acute promyelocytic leukemia.I have not received, nor plan to receive, any excluded treatments before my specific chemotherapy.I had a bone marrow transplant less than 3 months ago or still need treatment for graft-versus-host disease.I weigh at least 40 kg.I have been cancer-free for 2+ years, except for certain low-risk types or skin cancer.My cancer has spread to my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1: Dose Escalation of GDX012
- Group 2: Phase 2a: GDX012
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical experiment still in the recruitment phase?
"The clinicaltrials.gov website shows us that this particular study is no longer actively recruiting; the trial was first posted on July 7th 2023 and last edited May 24th 2023. Despite not currently needing participants, 1494 other trials are searching for patients now."
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