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Monoclonal Antibodies
Flotetuzumab for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Jonathan Webster, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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 2 years
Awards & highlights
Study Summary
This trial is testing if a new drug is safe and effective for people with a certain type of leukemia.
Who is the study for?
Adults over 18 with AML that's come back after a transplant can join this trial. They need to have had the transplant at least 30 days ago, not be on certain GVHD treatments, and show signs of AML in their bone marrow but not in the CNS or testes. Their organ functions must meet specific criteria, they shouldn't have uncontrolled infections like HIV or hepatitis, and they agree to use birth control during the study.Check my eligibility
What is being tested?
The trial is testing Flotetuzumab for safety and tolerability in patients whose AML has returned post-transplant. It checks if this drug can help when given under these conditions.See study design
What are the potential side effects?
Possible side effects aren't listed here, but since Flotetuzumab is an immunotherapy drug similar to others used for leukemia treatment, it may cause immune-related reactions, infusion responses, fatigue, blood count changes and increase infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 flotetuzumab in patients with relapsed/refractory AML following alloHSCT
Secondary outcome measures
Acute graft-versus-host disease (GVHD) incidence
Chronic GVHD incidence
Leukemia, Myelocytic, Acute
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Flotetuzumab Following Allogeneic TransplantExperimental Treatment1 Intervention
All participants will receive one cycle (28 days) of flotetuzumab. After one cycle, all participants will undergo a bone marrow biopsy to assess response and based on the response, may receive additional cycles up to a total cycle of six cycles.
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Who is running the clinical trial?
MacroGenicsIndustry Sponsor
48 Previous Clinical Trials
5,360 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,904 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,889 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bone marrow transplant from a donor did not work.My liver, kidneys, heart, lungs, or adrenal glands are not working well.I have been treated for GVHD within the last 30 days.I do not have any untreated, uncontrolled infections.I do not have an uncontrolled HIV or chronic hepatitis B or C.I had a stem cell transplant for my AML while in complete remission.I am currently pregnant or breastfeeding.I haven't taken any immune system boosting drugs in the last 2 weeks.I have an active autoimmune disorder that hasn't been treated.I have had radiotherapy or immunotherapy within the specified timeframe.I am taking more than 10 mg/day of oral prednisone or its equivalent.I am 18 years old or older.My thyroid function is normal, with or without medication.My leukemia cells test positive for CD123.I can take care of myself and am up and about more than half of the day.My AML has spread to my brain/spinal cord or testes.It's been over a month since my transplant, and my disease has worsened.I haven't needed treatment for GVHD in the last 30 days.I've had CD123-targeted therapy without severe side effects.I had to stop a CD123 therapy because of a bad reaction.
Research Study Groups:
This trial has the following groups:- Group 1: Flotetuzumab Following Allogeneic Transplant
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.
Are there any safety risks associated with Flotetuzumab usage?
"Limited clinical data exists in support of flotetuzumab's safety and efficacy, so it achieved a score of 1."
Answered by AI
How many individuals are being administered the treatment in this trial?
"Yes, the listed information on clinicaltrials.gov verifies that this research is actively recruiting participants. Initially posted on October 20th 2022 and recently updated on November 2nd 2022, 16 patients are needed from 1 trial site."
Answered by AI
Are there available slots for participants in this trial?
"Affirmative, the information posted to clinicaltrials.gov implies that this medical trial is currently enrolling participants. The research was first published on October 20th 2022 and last modified November 2nd of that same year. This study seeks a total of 16 individuals across 1 site for participation."
Answered by AI
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