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Talazoparib + Gemtuzumab for Acute Myeloid Leukemia
Study Summary
This trial is testing talazoparib + gemtuzumab ozogamicin to treat patients with relapsed/refractory AML that is CD33+. Talazoparib may work by blocking some enzymes needed for cell growth. Gemtuzumab ozogamicin is an antibody that targets AML cells expressing CD33. Adding talazoparib to gemtuzumab ozogamicin therapy may lead to increased effectiveness in treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777Trial Design
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Who is running the clinical trial?
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- I am experiencing moderate to severe graft-versus-host disease.I have an ongoing infection that hasn't improved with treatment.My kidney function, measured by creatinine levels, is within the normal range.You have any mental health condition or personal circumstances that might make it difficult for you to follow the study rules.My white blood cell count is below 25,000/mcL.My AML returned after it was previously in remission following chemotherapy.I had skin cancer or early cervical cancer, but it was completely removed and is not active.I am fully active or can carry out light work.My condition has returned or didn't respond to treatment.My AML hasn't responded to at least 1 cycle of initial chemotherapy.My leukemia is a specific type known as APL with a certain genetic feature.I haven't had chemotherapy, radiotherapy, or new drug trials in the last 2 weeks.If you have had other types of cancer in the past or at the same time as the current one, the decision to include you in the study will be made after talking to the main researcher.I had a brain condition treated successfully with no signs of it in my last test.My daily activity is limited due to my health condition.I had a bone marrow transplant over a month ago, am not on strong immunosuppressants, and don't have GVHD.I have a cancer that is not currently being treated because it's not active.My stage I breast cancer was treated successfully, and I'm either not on any treatment or just on anti-hormonal therapy.I do not have active hepatitis B, C, or HIV requiring treatment.I have AML with more than 5% myeloblasts and CD33+.My prostate cancer is early stage, low grade, and has low PSA levels.My colorectal cancer was fully removed over 2 years ago and I've been cancer-free since.My leukemia has progressed from a chronic phase to a blast phase.I do not have a severe heart condition.My liver function is moderately impaired.I do not have any uncontrolled illnesses.I do not have a severe lung condition.My heart pumps well, with an ejection fraction of 40% or higher.I have had a stroke or a mini-stroke.
- Group 1: Treatment (talazoparib, gemtuzumab ozogamicin)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does Talazoparib have a history of being studied in clinical trials?
"86 clinical trials involving Talazoparib are underway, with 6 of them in Phase 3. The most studies for Talazoparib are based Boston, Massachusetts, but there are 2893 total locations running trials for this medication."
What are the primary objectives of this experiment?
"The goal of this 28-day clinical trial is to assess the overall response rate (ORR). Additionally, the study will evaluate best response rate (defined as CRi and partial remission [PR]), overall survival (OS; estimated using standard Kaplan-Meier methods), and incidence of adverse events (AEs; summarized by dose level and grade using frequencies and relative frequencies)."
How many people are eligible to enroll in this test phase of the research?
"That is correct, the clinical trial is recruiting patients as indicated by the information on clinicaltrials.gov. The study was first posted on 10/23/2020 and has been updated as recently as 6/15/2022. They are enrolling a total of 20 participants at 2 sites."
Are there any openings for patients who want to participate in this clinical trial?
"That is correct, the clinical trial listed on clinicaltrials.gov is currently looking for 20 volunteers at 2 sites. The study was first posted on 10/23/2020 and was most recently edited on 6/15/2022."
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