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Monoclonal Antibodies

Venetoclax + Inotuzumab for Acute Lymphoblastic Leukemia

Phase 1
Recruiting
Led By Marlise R Luskin, MD, MSCE
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have ECOG performance status of 0-3
Participants with a known history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to end of treatment up to 9 months
Awards & highlights

Study Summary

This trial is studying how well venetoclax and inotuzumab ozogamicin work in combination in treating patients with acute lymphoblastic leukemia.

Who is the study for?
Adults with confirmed CD22+ B-ALL or B-LBL, including those with chronic myeloid leukemia in lymphoid blast crisis refractory to treatments. Must have adequate organ function, no severe liver disease, and agree to contraception. Excludes pregnant women, those on certain drugs affecting venetoclax metabolism, and individuals with uncontrolled illnesses.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of combining venetoclax with inotuzumab ozogamicin for treating acute lymphoblastic leukemia (ALL). Dexamethasone is also part of the treatment regimen. The goal is to see how well these drugs work together against ALL.See study design
What are the potential side effects?
Potential side effects include nausea, fatigue, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems. Liver issues could occur due to drug interactions or underlying conditions; close monitoring will be necessary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can care for myself but may not be able to do active work.
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I have had hepatitis C but my current viral load is undetectable.
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I am 18 years old or older.
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I am HIV-positive, on treatment, and my viral load has been undetectable for 6 months.
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I can understand and sign the consent form.
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My cancer has returned or didn't respond after at least one chemotherapy treatment.
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My leukemia is confirmed to be CD22 positive.
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I have chronic hepatitis B but my viral load is undetectable.
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My liver and kidney functions are within the required range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to end of treatment up to 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to end of treatment up to 9 months for reporting.

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 of venetoclax in combination with inotuzumab ozogamicin
Secondary outcome measures
Disease-free survival (DFS)
Event-free survival (EFS)
Measurable residual disease (MRD)-response
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Venetoclax + Inotuzumab Ozogamicin with DexamethasoneExperimental Treatment3 Interventions
Phased 28 day treatment cycles with lead in: Lead In Cycle: Dose escalated venetoclax 1x daily for days 1-3 with and Dexamethasone daily for days 1-3 lead in, 7 days total. Induction Cycle 1: Dose escalated venetoclax 1x daily for days 1-21, Dexamethasone daily for days 1-4, Inotuzumab ozogamicin on days 1, 8, and 15 Induction Cycle 2: Dose escalated venetoclax 1x daily for days and Inotuzumab ozogamicin on days 1, 8, and 15 Consolidation Cycles: Up to 5 cycles of dose escalated Venetoclax 1x daily for days and Inotuzumab ozogamicin on days 1, 8, and 15
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Venetoclax
FDA approved
Inotuzumab ozogamicin
FDA approved

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,077 Previous Clinical Trials
340,717 Total Patients Enrolled
AbbVieIndustry Sponsor
950 Previous Clinical Trials
496,902 Total Patients Enrolled
Marlise R Luskin, MD, MSCEPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Inotuzumab Ozogamicin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05016947 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Venetoclax + Inotuzumab Ozogamicin with Dexamethasone
Acute Lymphoblastic Leukemia Clinical Trial 2023: Inotuzumab Ozogamicin Highlights & Side Effects. Trial Name: NCT05016947 — Phase 1
Inotuzumab Ozogamicin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05016947 — Phase 1

Frequently Asked Questions

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

Could you detail any other research conducted on Venetoclax?

"Currently, there are 770 Venetoclax studies in progress with 170 of them being Phase 3 trials. While the majority are situated in Edmonton, Alberta, a total of 25 871 locations spanning the globe are taking part in these investigations."

Answered by AI

Are there any vacancies within this clinical trial?

"Affirmative. Clinicaltrials.gov substantiates that this clinical investigation is currently recruiting, first posted on September 24th 2021 and most recently updated October 31st 2022. The trial aims to enlist 26 participants from 2 medical sites."

Answered by AI

Has Venetoclax received official sanction by the Food and Drug Administration?

"The safety of venetoclax was assessed as a 1 on our Power team's scale, due to the limited evidence available during this early-stage trial."

Answered by AI

What maladies is Venetoclax therapeutically employed to address?

"Venetoclax is traditionally prescribed for ophthalmic and sympathetic diseases, but it can also be used to treat branch retinal vein occlusion, macular edema, and communicable maladies."

Answered by AI

What is the current enrollment size of this clinical experiment?

"Affirmative. As indicated on clinicaltrials.gov, this medical trial is still enrolling candidates with its initial posting being made on September 24th 2021 and the last update happening at the end of October in 2022. The recruitment quota set by researchers includes 26 patients from two distinct sites."

Answered by AI
~2 spots leftby Jul 2024