Your session is about to expire
← Back to Search
CAR T-cell Therapy
JNJ-75276617 Combination Therapy for Acute Myeloid Leukemia
Phase 1
Recruiting
Research Sponsored by Janssen Research & Development, LLC
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 3 years 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests JNJ-75276617, an oral drug that blocks a key protein interaction in leukemia cells. It targets adults with AML who have specific genetic changes making their disease hard to treat. The drug aims to stop cancer cells from growing and spreading.
Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) as per WHO criteria, including those with de novo or secondary AML and relapsed/refractory cases. Participants must be in relatively good health (ECOG grade 0-2), have adequate organ function, not require supplemental oxygen, and women of childbearing potential must test negative for pregnancy.
What is being tested?
The study tests JNJ-75276617 combined with other AML therapies like Venetoclax, Azacitidine, Cytarabine, Daunorubicin or Idarubicin to find the safest and most effective dose. It aims to establish a recommended Phase 2 dose and assess safety at that level.
What are the potential side effects?
Potential side effects may include typical reactions associated with chemotherapy such as nausea, fatigue, increased risk of infection due to low blood cell counts; liver or kidney issues; bleeding problems; heart complications; allergic reactions to the drugs used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Adverse Events (AEs)
Number of Participants with Adverse Events (AEs) by Severity
Number of Participants with Dose-limiting Toxicity (DLT)
Secondary study objectives
Number of Participants with Depletion of Leukemic Blasts
Percentage of Participants who Achieve Complete Remission (CR)
Percentage of Participants who Achieve Complete Remission with Incomplete Hematologic Recovery (CRi)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm C: Newly Diagnosed Chemotherapy Eligible SettingExperimental Treatment3 Interventions
Participants will receive combination of bleximenib with cytarabine+daunorubicin or idarubicin chemotherapy as frontline treatment regimen for participants \>=18 to \<75 years of age with AML harboring either NPM1 or KMT2A alterations and eligible for intensive chemotherapy.
Group II: Arm B: Newly Diagnosed Chemotherapy Ineligible SettingExperimental Treatment3 Interventions
Participants will receive bleximenib in combination with VEN+AZA as frontline chemo therapy for newly diagnosed AML participants harboring either KMT2A or NPM1 alterations who are greater than or equal to (\>=)75 years of age or \>= 18 years of age to less than (\<) 75 years of age with comorbidities that preclude the use of intensive induction chemotherapy.
Group III: Arm A: Relapsed/Refractory SettingExperimental Treatment3 Interventions
Participants with relapsed/refractory AML harboring either NPM1 or KMT2A alterations will receive bleximenib in combination with either venetoclax (VEN) (Cohort A1: bleximenib+VEN) or azacitidine (AZA) (Cohort A2: bleximenib +AZA) or VEN+AZA (Cohort A3: bleximenib+VEN+AZA) to select the recommended phase 2 dose (RP2D) of bleximenib in combination with VEN, AZA or VEN+AZA (dose selection). In dose expansion portion of the study, participants will receive bleximenib in combination with AML directed therapies at the RP2D(s).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine (AZA)
2012
Completed Phase 1
~10
Cytarabine
2016
Completed Phase 3
~3330
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 most common treatments for Acute Myeloid Leukemia (AML) include targeted therapies and small molecule inhibitors, which work by specifically targeting and inhibiting the molecular abnormalities driving the cancer. For example, FLT3 inhibitors target mutations in the FLT3 gene, IDH inhibitors target mutations in the IDH1 or IDH2 genes, and hypomethylating agents like azacitidine and decitabine inhibit DNA methylation, leading to reactivation of tumor suppressor genes.
These targeted approaches are crucial for AML patients as they offer more precise treatment options with potentially fewer side effects compared to traditional chemotherapy, and they can be particularly effective in patients with specific genetic mutations.
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?
Janssen Research & Development, LLCLead Sponsor
1,003 Previous Clinical Trials
6,397,796 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
769 Previous Clinical Trials
3,973,536 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received a solid organ transplant.I need extra oxygen to help me breathe properly.I can take care of myself and am up and about more than half of my waking hours.My AML diagnosis fits WHO criteria, including specific genetic changes.My blood, liver, and kidney tests are within normal ranges.I have been diagnosed with a specific type of leukemia.All my side effects from cancer treatment, except hair loss and some stable conditions, are mild or gone.My leukemia has spread to my brain or spinal cord.I do not have serious heart or blood vessel problems.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Newly Diagnosed Chemotherapy Ineligible Setting
- Group 2: Arm A: Relapsed/Refractory Setting
- Group 3: Arm C: Newly Diagnosed Chemotherapy Eligible Setting
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.
Share this study with friends
Copy Link
Messenger