Cladribine Chemotherapy for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a prospective phase II clinical study planned to be conducted at the Medical College of Wisconsin (MCW). After meeting the study criteria and enrollment, patients will be treated with a cladribine based salvage regimen and followed at periodic intervals to determine the primary and secondary objectives.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is Cladribine safe for use in humans?
Cladribine has been studied for its safety in treating acute myeloid leukemia (AML) and other conditions. It has shown similar side effects to other chemotherapy regimens, including bone marrow suppression, mucositis (inflammation of the mouth and gut lining), and hair loss, but no heart-related toxicity was observed. Overall, it has a safety profile comparable to other treatments used for AML.12345
What makes the drug cladribine unique for treating acute myeloid leukemia?
Cladribine is unique because it is a purine analogue that can induce cell death in myeloid cells, showing promising complete response rates in both relapsed and newly diagnosed acute myeloid leukemia patients. It is often used in combination with other drugs like mitoxantrone to enhance its effectiveness, offering a novel approach compared to traditional treatments.16789
What data supports the effectiveness of the drug Cladribine for treating acute myeloid leukemia?
Research shows that Cladribine, when used alone or in combination with other drugs, has been effective in treating acute myeloid leukemia (AML), with complete remission rates of about 70% in newly diagnosed adults and 50% in relapsed cases. Additionally, a combination of Cladribine and Cytarabine was effective in childhood AML, with a 5-year survival rate of around 50%.1291011
Who Is on the Research Team?
Ehab L. Atallah
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
Adults (18+) with high-risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML), including those who've failed hypomethylating agents, can join. They must have an ECOG score of 0-3 and meet specific health criteria like organ function tests. Pregnant women, breastfeeding mothers, and those with uncontrolled infections or Acute Promyelocytic Leukemia are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a cladribine-based salvage chemotherapy regimen, with each cycle lasting 30 days. A second cycle may be administered if necessary.
Follow-up
Participants are monitored for safety, MRD negativity, and overall survival after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cladribine
- Mitoxantrone
Cladribine is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor