34 Participants Needed

Talazoparib + Chemotherapy for Acute Myeloid Leukemia

(PARPAML Trial)

Recruiting at 9 trial locations
SC
MM
SB
SC
Overseen ByStefania Chirita
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing the safety of using talazoparib with standard chemotherapy in cancer patients. Talazoparib works by stopping cancer cells from repairing themselves, which could make chemotherapy more effective. The study aims to find the safest dose combination and see if this approach helps patients. Talazoparib is FDA approved for certain types of breast cancer that have spread and were previously treated with chemotherapy.

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.

What safety data exists for topotecan in combination with other drugs?

Topotecan, when used in combination with other chemotherapy drugs, has been studied for safety in various cancers. The main safety concern is myelosuppression (a decrease in bone marrow activity), particularly neutropenia (low levels of a type of white blood cell), which limits the dose that can be safely given.12345

What makes the drug combination of Talazoparib, Gemcitabine, and Topotecan unique for treating acute myeloid leukemia?

This drug combination is unique because it includes Talazoparib, a PARP inhibitor that may enhance the effects of chemotherapy by preventing cancer cells from repairing their DNA, combined with Gemcitabine and Topotecan, which have shown antitumor activity in various cancers. This approach explores a novel mechanism of action compared to traditional treatments for acute myeloid leukemia.26789

What data supports the effectiveness of the drug combination Talazoparib + Chemotherapy for Acute Myeloid Leukemia?

Research shows that topotecan, one of the drugs in the combination, has been effective in treating acute myeloid leukemia (AML) when used with other chemotherapy drugs, achieving complete remission in some patients. However, the effectiveness of the specific combination of Talazoparib with these drugs for AML is not directly supported by the provided studies.26789

Who Is on the Research Team?

NL

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

My leukemia has the same genetic features as when first diagnosed.
It's been over 24 hours since my last mild cancer treatment.
It's been over 2 weeks since my last intense cancer treatment, and I feel mostly recovered.
See 16 more

Exclusion Criteria

I am currently undergoing or planning to start any cancer treatment soon.
Pregnant subjects or those unwilling to use an effective method of birth control.
People with Down syndrome cannot participate in the study.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

4-8 weeks
Multiple visits (in-person)

Dose Expansion

Preliminary estimates of efficacy are obtained through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase.

28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Gemcitabine
  • Talazoparib
  • Topotecan
Trial Overview The study tests the safety and effectiveness of Talazoparib combined with chemotherapy drugs Gemcitabine and Topotecan in pediatric AML patients. It's a Phase 1 trial that will first find the highest dose patients can tolerate without severe side effects before assessing how well it works.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Talazoparib with topotecan and gemcitabineExperimental Treatment3 Interventions

Gemcitabine is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Gemzar for:
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Approved in United States as Gemzar for:
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Approved in Canada as Gemzar for:
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Approved in Japan as Gemzar for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Jennifer Lauren Kamens

Lead Sponsor

Trials
1
Recruited
30+

Norman J. Lacayo

Lead Sponsor

Trials
1
Recruited
30+

Gateway for Cancer Research

Collaborator

Trials
47
Recruited
2,500+

Published Research Related to This Trial

In a clinical trial involving 21 patients with relapsed acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), the combination of topotecan and cytarabine showed promising efficacy, achieving complete remission in 33% of patients and partial remission in 38%.
The treatment was generally safe for older patients (60 years and older), with no treatment-related deaths, although hematologic toxicity led to dose adjustments in some cases, and fever was a common side effect.
Phase I/II clinical study of topotecan and cytarabine in patients with myelodysplastic syndrome, chronic myelomonocytic leukemia and acute myeloid leukemia.Weihrauch, MR., Staib, P., Seiberlich, B., et al.[2019]
Topotecan, a drug that targets topoisomerase I, has shown significant antitumor activity when combined with various chemotherapy agents like cisplatin and doxorubicin in both adult and pediatric patients with solid tumors.
The main side effect of these combination therapies is myelosuppression, particularly neutropenia, which limits the dosage; however, many early studies have reported major responses, indicating the potential effectiveness of these regimens.
Topotecan in combination chemotherapy.Rowinsky, EK., Kaufmann, SH.[2017]
Irinotecan can be safely administered in combination with cytarabine (Ara-C) to patients with acute myeloid leukemia (AML) who are refractory to or have relapsed after previous treatments, showing promising results in terms of safety and efficacy.
The treatment led to rapid cytoreduction in all courses, with two patients achieving complete remission, indicating that this combination therapy warrants further investigation for its effectiveness in AML.
Sequential administration of irinotecan and cytarabine in the treatment of relapsed and refractory acute myeloid leukemia.Minderman, H., O'Loughlin, KL., Smith, PF., et al.[2018]

Citations

Phase I/II clinical study of topotecan and cytarabine in patients with myelodysplastic syndrome, chronic myelomonocytic leukemia and acute myeloid leukemia. [2019]
Topotecan in combination chemotherapy. [2017]
Sequential administration of irinotecan and cytarabine in the treatment of relapsed and refractory acute myeloid leukemia. [2018]
New chemotherapeutic agents in acute myeloid leukemia. [2013]
The association of topotecan and cytarabine in the treatment of secondary or relapsed acute myeloid leukemia. [2013]
Phase II study of weekly topotecan in patients with recurrent or persistent epithelial ovarian cancer. [2013]
Long-term topotecan therapy in recurrent or persistent ovarian cancer. [2020]
Efficacy and toxicity of weekly topotecan in recurrent epithelial ovarian and primary peritoneal cancer. [2013]
Phase I study of topotecan in combination with temozolomide (TOTEM) in relapsed or refractory paediatric solid tumours. [2023]
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