Your session is about to expire
← Back to Search
Monoclonal Antibodies
Tagraxofusp + Gemtuzumab for Acute Myeloid Leukemia (GO-TAG Trial)
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights
GO-TAG Trial Summary
This trial is testing a new drug to treat relapsed/refractory acute myeloid leukemia. It will measure safety and efficacy of the drug in combination with another drug.
Who is the study for?
This trial is for patients aged 12 or older with relapsed/refractory AML, confirmed by WHO criteria. Participants must have a good heart function (LVEF ≥ 50%), no significant ECG abnormalities, adequate kidney function (CrCl ≥ 60mL/min), and acceptable liver function tests. They should not have received certain treatments recently and must be able to consent and follow the study schedule. Women of childbearing potential need a negative pregnancy test.Check my eligibility
What is being tested?
The trial is testing tagraxofusp-erzs combined with gemtuzumab ozogamicin in patients with AML that has come back or didn't respond to treatment. It's an open-label Phase Ia/Ib study aiming to find the safest dose for phase 2 trials while checking how well patients tolerate this drug combination.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system, such as inflammation in various organs due to the body's response to these drugs; blood disorders; fatigue; digestive issues like nausea or diarrhea; and increased risk of infections.
GO-TAG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determination of the recommended phase 2 dose (RP2D) of tagraxofusp-erzs in combination with gemtuzumab ozogamicin in patient with relapsed or refractory acute myeloid leukemia (AML)
Determination of the safety and tolerability of combination gemtuzumab and tagraxofusp-erzs when administered at the RP2D.
Secondary outcome measures
Duration of response
Overall Survival
Overall response rate
+2 moreGO-TAG Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase 1b recommended Phase 2 dose (RP2D) of tagraxofusp- erzs in r/r AMLExperimental Treatment1 Intervention
This is dose expansion at the RP2D of tagraxofusp. Participants with relapsed or refractory acute myeloid leukemia (r/r AML) will receive the RP2D of tagraxofusp-erzs, as determined in Phase 1a, and gemtuzumab at a dose of 3mg/m2 (max absolute dose of 4.5mg) on days 1,4, and 7 of cycle 1 and day 1 of subsequent cycles.
Group II: Phase 1a Dose Escalation of tagraxofusp-erzs in r/r AMLExperimental Treatment1 Intervention
Tagraxofusp-erzs and gemtuzumab ozogamicin (GO) will be administered every 4 weeks with 28 days defined as a treatment cycle. Tagraxofusp-erzs dose escalation for cycles 1-4 in combination with fixed dose GO.
This is a dose escalation design . The dose-limiting toxicity (DLT) period will be the 28 days following the first dose of GO. The initial dose level 1 (DL1) cohort will receive GO 3mg/m2 (capped at a maximum dose of 4.5mg) intravenously (IV) on cycle 1 days 1, 4, and 7 and tagraxofusp-erzs at an initial dose of 7μg/kg/day on days 10, 11, 12. For subsequent cycles of DL1, GO will continue to be administered at a dose of 3mg/m2 IV on day 1 and tagraxofusp-erzs will be administered IV at a dose of 7μg/kg/day on days 4,5,and 6. Subsequent escalation dose levels will receive tagraxofusp-erzs doses of 7mcg/kg/day, 9mcg/kg/day or 12mcg/kg/day. Initial cycle doses of tagraxofusp at these levels will be given on Days 5,6 and 7, then in subsequent cycles on days 1,2 and 3.
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,884 Total Patients Enrolled
StemlineTherapeutics, Inc.UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious heart problems or uncontrolled high blood pressure.I have not had a blood or bone marrow transplant in the last 60 days and do not have active graft versus host disease.I have not had chemotherapy, radiation, or biologic therapy in the last 14 days.I have a history of cancer that might affect this study's results, but it's not one of the less serious types listed.I had brain involvement from cancer but it's now clear after treatment.I do not have any uncontrolled illnesses that would stop me from following the study rules.My condition worsened or didn't respond to gemtuzumab treatment.I have been treated with tagraxofusp-erzs before.I have a history of HIV, Hepatitis B, or Hepatitis C.I am not on strong immunosuppressants, except possibly low-dose prednisone, and have no severe GVHD.My condition worsened or didn't improve after one treatment cycle, excluding certain drugs.I have a serious lung condition that could worsen with this study.I have lasting side effects from past cancer treatments that are not easily managed.My leukemia cells show CD33 and CD123 markers.I am 12 years old or older.I am able to care for myself and perform daily activities.I have been diagnosed with acute myeloid leukemia according to WHO criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1a Dose Escalation of tagraxofusp-erzs in r/r AML
- Group 2: Phase 1b recommended Phase 2 dose (RP2D) of tagraxofusp- erzs in r/r AML
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.
Has the FDA authenticated Phase 1a Dose Escalation of tagraxofusp-erzs in relapsed or refractory Acute Myeloid Leukemia?
"Based on our internal assessment, the safety of phase 1a dose escalation of tagraxofusp-erzs in r/r AML was rated a 1 as this is still an early stage trial and there is minimal data to support its efficacy or safety."
Answered by AI
Does this research endeavor currently have any openings for participants?
"This study, which was first published on February 25th 2023 and last edited on January 27th 2023, is not presently enrolling patients. Nonetheless, there are 512 other clinical trials that require participants at this time."
Answered by AI
What objectives does this research endeavor seek to realize?
"This clinical trial seeks to evaluate the safety and tolerability of a combination therapy comprised of gemtuzumab and tagraxofusp-erzs. The primary outcome will be assessed over 2.5 years, with secondary outcomes such as overall survival rate (calculated via Kaplan and Meier), response rate according to 2022 international consensus classification (ICC) standards, and time taken for patients to respond to treatment being monitored too."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger