Talazoparib + Chemotherapy for Acute Myeloid Leukemia
(PARPAML Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of combining the drug talazoparib (Talzenna) with standard chemotherapy to determine the optimal dose for treating acute myeloid leukemia (AML). It evaluates the effectiveness of these treatments, particularly for those whose leukemia has returned or hasn't responded to previous treatments. Candidates may qualify if their AML persisted after at least two rounds of chemotherapy or if it recurred, provided they have no active infections or specific conditions like Down syndrome. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants an opportunity to contribute to groundbreaking research.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you are not receiving any other cancer therapies. You should discuss your current medications with the trial team to see if they are compatible with the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining talazoparib with chemotherapy might be safe and manageable for treating certain cancers. In earlier studies, patients received talazoparib alongside chemotherapy drugs such as topotecan and gemcitabine. Initial results suggested that most participants tolerated this combination well. However, as this is an early study phase, the primary goal is to determine safe doses. While side effects may occur, the aim is to achieve a balance where benefits outweigh risks. The research appears promising, but further information is needed to confirm safety.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about the combination of talazoparib with topotecan and gemcitabine for treating acute myeloid leukemia because it offers a novel approach. Unlike traditional chemotherapy options like cytarabine and daunorubicin, talazoparib is a PARP inhibitor, which means it targets cancer cells by interfering with their DNA repair mechanism, potentially leading to more effective cancer cell death. The combination of these drugs might enhance the overall treatment effectiveness, offering a new ray of hope for patients with this aggressive type of leukemia. This multi-drug regimen is administered in a specific cycle that might optimize the interaction between the drugs, potentially providing better outcomes than existing treatments.
What evidence suggests that this trial's treatments could be effective for acute myeloid leukemia?
This trial will evaluate the combination of talazoparib with the chemotherapy drugs gemcitabine and topotecan for treating acute myeloid leukemia (AML). Research has shown that while talazoparib alone is not very effective, combining it with chemotherapy creates a strong anti-cancer effect. Talazoparib prevents cancer cells from repairing themselves, enhancing the chemotherapy's ability to destroy the cancer. Early results from similar studies have shown promise in shrinking tumors and slowing cancer spread. These findings offer hope for its potential success in treating AML.12356
Who Is on the Research Team?
Norman Lacayo, MD
Principal Investigator
Stanford Universiy
Are You a Good Fit for This Trial?
This trial is for children and young adults up to 21 years old with relapsed or refractory Acute Myeloid Leukemia (AML) or similar conditions. They should have had a stem cell transplant at least 60 days ago, be recovered from previous treatments, and not have uncontrolled infections or other cancer therapies ongoing. Pregnant individuals or those with certain leukemia subtypes are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Talazoparib is administered orally on Days 1 to 5 concurrently with topotecan and a single dose of gemcitabine on Day 1 of a 28-day cycle for 1 or 2 cycles. Subjects on dose level 5 receive an additional 5-day treatment course of talazoparib on days 15-19.
Dose Expansion
Preliminary estimates of efficacy are obtained through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gemcitabine
- Talazoparib
- Topotecan
Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
- Pancreatic cancer
- Breast cancer
- Ovarian cancer
- Non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Jennifer Lauren Kamens
Lead Sponsor
Norman J. Lacayo
Lead Sponsor
Gateway for Cancer Research
Collaborator