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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.
Must not have
Patients with a history of sinusoidal obstruction syndrome/venous occlusive disease of the liver.
Prior known hypersensitivity reactions to monoclonal antibodies (≥ Grade 3).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 20 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial tests a new drug, IMGN632, combined with other drugs to treat patients with a specific type of leukemia. It aims to see if this combination can effectively target and kill cancer cells while stopping them from growing.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a liver condition called sinusoidal obstruction syndrome.
Select...
I have had a severe allergic reaction to monoclonal antibodies.
Select...
I am not allergic to IMGN632, azacitidine, or venetoclax.
Select...
I haven't had a heart attack in the last 6 months and don't have severe heart issues.
Select...
I am not pregnant or breastfeeding.
Select...
I have been treated with IMGN632 before.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Minimal Residual Disease Levels
Preliminary antileukemia activity
Safety and Tolerability
Awards & Highlights
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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
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 chemotherapy, targeted therapies, and immunotherapies. Chemotherapy agents like cytarabine and daunorubicin work by interfering with DNA replication, leading to cell death.
Targeted therapies, such as FLT3 inhibitors, specifically inhibit mutant proteins that drive leukemia cell proliferation. Immunotherapies, including monoclonal antibodies like IMGN632, target specific antigens such as CD123 on leukemia cells, delivering cytotoxic agents directly to the cancer cells.
These mechanisms are crucial for AML patients as they offer more precise and effective treatment options, potentially reducing side effects and improving outcomes by directly targeting the malignant cells.
Emerging Epigenetic Therapeutic Targets in Acute Myeloid Leukemia.Molecular targeting in acute myeloid leukemia.Childhood acute myeloid leukaemia.
Emerging Epigenetic Therapeutic Targets in Acute Myeloid Leukemia.Molecular targeting in acute myeloid leukemia.Childhood acute myeloid leukaemia.
Find a Location
Who is running the clinical trial?
ImmunoGen, Inc.Lead Sponsor
32 Previous Clinical Trials
3,803 Total Patients Enrolled
Jazz PharmaceuticalsIndustry Sponsor
250 Previous Clinical Trials
34,756 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 D (Closed to Enrollment)
- Group 2: Regimen B (Closed to Enrollment)
- Group 3: Regimen C - Frontline & Relapsed / Refractory (Closed to Enrollment)
- Group 4: Regimen A (Closed to Enrollment)
Awards:
This trial has 3 awards, including:- 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.
- 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.