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Antibody-Drug Conjugate
IMGN632 + Venetoclax/Azacitidine for Acute Myeloid Leukemia
Phase 1 & 2
Waitlist Available
Research Sponsored by ImmunoGen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have CD123-positive AML as confirmed by local flow cytometry (or immunohistochemistry [IHC]).
An estimated glomerular filtration rate (eGFR) of > 30 mL/min/1.73 m2 or creatinine clearance of > 30 mL/min.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 20 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug, IMGN632, to see if it is safe and effective when used alone or with other drugs to treat acute myeloid leukemia (AML).
Who is the study for?
Adults with CD123-positive Acute Myeloid Leukemia (AML) who have either relapsed or are treatment-naive can join this trial. They must be fit for experimental therapy, not have acute promyelocytic leukemia, and should not have had certain prior treatments. Participants need normal organ function and controlled previous cancers if any.Check my eligibility
What is being tested?
The safety and effectiveness of IMGN632 alone or combined with azacitidine and/or venetoclax in treating AML are being tested. This study is open-label, meaning everyone knows which treatment they're getting, and it's happening at multiple centers.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system due to monoclonal antibodies like IMGN632, liver issues from azacitidine or venetoclax, blood count changes, fatigue, digestive problems, and potential increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My AML is CD123-positive as confirmed by tests.
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My kidney function, measured by eGFR or creatinine clearance, is above 30 mL/min.
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I had a bone marrow transplant over 4 months ago, have no severe graft disease, and haven't been on immunosuppressants for 2 weeks.
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I have been diagnosed with AML, not including acute promyelocytic leukemia.
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I am a woman who can have children and agree to use birth control during and 7 months after the study.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 20 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 20 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Minimal Residual Disease Levels
Preliminary antileukemia activity
Safety and Tolerability
Secondary outcome measures
Anti-drug Antibody Concentration (Dose Escalation and Expansion)
Minimal Residual Disease Levels (Dose Escalation)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (Dose Expansion Phase)
+1 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Regimen D (Closed to Enrollment)Experimental Treatment1 Intervention
IMGN632, administered intravenously on Day 1 of a 21 day cycle at 0.045 mg/kg, as a monotherapy for Fit and Unfit MRD+ patients.
Group II: Regimen C - Frontline & Relapsed / Refractory (Closed to Enrollment)Experimental Treatment3 Interventions
IMGN632, administered intravenously on Day 7 of a 28 day cycle at 0.015 mg/kg or 0.045 mg/kg, in combination with azacitidine, administered subcutaneously or intravenously daily at 35-75 mg/m2 given for Days 1 to 7 of a 28 day cycle and venetoclax, administered orally daily at 100 mg on Day 1, 200mg on Day 2, and 400 mg on Day 3 up to Day 28 of a 28 day cycle. Alternate schedules with reduced venetoclax administration or reduced azacitidine dose or administration may be explored.
Group III: Regimen B (Closed to Enrollment)Experimental Treatment2 Interventions
IMGN632, administered intravenously on Day 7 of a 21 day cycle at 0.015 mg/kg, 0.045 mg/kg, or 0.09 mg/kg, in combination with venetoclax, administered orally daily at 100 mg on Day 1, 200mg on Day 2, and 400 mg on the day 3 up to Day 21 of a 21 day cycle. Alternate schedules with reduced venetoclax administration may be explored.
Group IV: Regimen A (Closed to Enrollment)Experimental Treatment2 Interventions
IMGN632, administered intravenously on Day 7 of a 28 day cycle at 0.015 mg/kg, 0.045 mg/kg, or 0.09 mg/kg, in combination with azacitidine, administered subcutaneously or intravenously daily at 75 mg/m2 on Days 1 to 7 of a 28 day cycle. Cycle 1 azacitidine dose in subsequent cohorts may be reduced.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
FDA approved
Venetoclax
FDA approved
Find a Location
Who is running the clinical trial?
ImmunoGen, Inc.Lead Sponsor
32 Previous Clinical Trials
3,613 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
248 Previous Clinical Trials
34,026 Total Patients Enrolled
Patrick Zweidler-McKay, MD, PhDStudy DirectorImmunoGen, Inc.
1 Previous Clinical Trials
264 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My AML is CD123-positive as confirmed by tests.My heart pumps well, with an ejection fraction of 45% or higher.I have had a liver condition called sinusoidal obstruction syndrome.I have had up to 2 previous cancer treatments.I do not have AML related to myeloproliferative neoplasm for the study's next phase.I have had a severe allergic reaction to monoclonal antibodies.I am in complete remission but still have minimal disease, with no more than 2 prior treatments.I received either intensive or non-intensive treatment for my condition.I do not have any active infections like hepatitis B or C, HIV, or cytomegalovirus.I had major surgery less than 4 weeks ago or haven't fully recovered yet.I agree to use contraception during and for 4 months after the study if I can father children.My white blood cell count is below 25,000 per microliter.My AML has returned or didn't respond to treatment and tests positive for CD123.I have not received any treatment for my condition, especially with hypomethylating agents.My previous cancer is under control, and I finished all treatments over 6 months ago.I have had treatments targeting CD123 before, but not IMGN632, and CD123 is still detectable in my tests.I am not allergic to IMGN632, azacitidine, or venetoclax.I haven't had a heart attack in the last 6 months and don't have severe heart issues.My side effects from previous treatments have mostly gone away.I am not pregnant or breastfeeding.I have been treated with IMGN632 before.My kidney function, measured by eGFR or creatinine clearance, is above 30 mL/min.I do not have active leukemia in my brain or spinal cord.I can carry out all my self-care but may not be able to do heavy physical work.I had a bone marrow transplant over 4 months ago, have no severe graft disease, and haven't been on immunosuppressants for 2 weeks.I haven't taken any cancer treatment or experimental drugs in the last 14 days, or 28 days for specific immune therapies.I have been diagnosed with AML, not including acute promyelocytic leukemia.I am a woman who can have children and agree to use birth control during and 7 months after the study.I am 18 years old or older.My doctor thinks this experimental therapy is right for me after considering all standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Regimen B (Closed to Enrollment)
- Group 2: Regimen C - Frontline & Relapsed / Refractory (Closed to Enrollment)
- Group 3: Regimen D (Closed to Enrollment)
- Group 4: Regimen A (Closed to Enrollment)
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
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