53 Participants Needed

Cladribine Chemotherapy for Acute Myeloid Leukemia

MC
Overseen ByMedical College of Wisconsin Clinical Cancer Center
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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, MD | Froedtert & the ...

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

I can care for myself but may not be able to do heavy physical work.
I am using or willing to use effective birth control during the study.
Ability to understand a written informed consent document and the willingness to sign it
See 4 more

Exclusion Criteria

I have an infection that isn't responding well to treatment.
Pregnant or breast feeding women
I have been diagnosed with Acute Promyelocytic Leukemia.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a cladribine-based salvage chemotherapy regimen, with each cycle lasting 30 days. A second cycle may be administered if necessary.

4-10 weeks
Outpatient visits as needed

Follow-up

Participants are monitored for safety, MRD negativity, and overall survival after treatment

4 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cladribine
  • Mitoxantrone
Trial Overview The trial is testing two chemotherapy regimens for AML/MDS: CLAG-M (Cladribine, Cytarabine, Mitoxantrone, G-CSF) and CLLDAC (Cladribine and Cytarabine). It's a phase II study to see how well these treatments work and to understand the genetic factors that affect response to therapy.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: CLLDAC regimenExperimental Treatment1 Intervention
Group II: CLAG-M regimenExperimental Treatment1 Intervention

Cladribine is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Leustatin for:
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Approved in European Union as Litak for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

Published Research Related to This Trial

Cladribine (CdA) has shown significant efficacy in treating acute myeloid leukemia (AML), with complete response rates of up to 70% in newly diagnosed adults and around 50% in relapsed/refractory cases, based on various studies.
Despite its effectiveness and similar toxicity profiles to existing treatments, many medical centers have not yet adopted CdA combination regimens for managing these challenging AML populations.
Revisiting the role of cladribine in acute myeloid leukemia: an improvement on past accomplishments or more old news?Freyer, CW., Gupta, N., Wetzler, M., et al.[2014]
In a phase II trial involving 20 patients with relapsed acute myeloid leukemia (AML), the combination of cladribine, cytarabine, and idarubicin achieved a complete remission rate of 60%, demonstrating its efficacy in this challenging condition.
The treatment was associated with significant toxicity, primarily infections, but when combined with allogeneic stem cell transplantation, it led to a 5-year survival rate of 55% among those who underwent the transplant, indicating potential for long-term survival.
Long-term follow-up of Cladribine, high-dose Cytarabine, and Idarubicin as salvage treatment for relapsed acute myeloid leukemia and literature review.Mayer, K., Hahn-Ast, C., Schwab, K., et al.[2021]
In a study involving 96 children with acute myeloid leukemia (AML), the combination of cladribine and continuous-infusion cytarabine showed promising efficacy, with 5-year event-free survival and overall survival rates of 44.1% and 50.0%, respectively.
While both treatment arms (daily vs. continuous infusion) did not show significant differences in blast percentages or Ara-CTP levels, the continuous infusion (arm B) suggested trends toward better complete remission rates and overall survival, indicating it may be a more effective approach for therapy.
Combination of cladribine and cytarabine is effective for childhood acute myeloid leukemia: results of the St Jude AML97 trial.Rubnitz, JE., Crews, KR., Pounds, S., et al.[2021]

Citations

Revisiting the role of cladribine in acute myeloid leukemia: an improvement on past accomplishments or more old news? [2014]
Long-term follow-up of Cladribine, high-dose Cytarabine, and Idarubicin as salvage treatment for relapsed acute myeloid leukemia and literature review. [2021]
Combination of cladribine and cytarabine is effective for childhood acute myeloid leukemia: results of the St Jude AML97 trial. [2021]
Efficacy and safety of cladribine addition to induction treatment of newly diagnosed acute myeloid leukemia: a systematic review and meta-analysis. [2022]
Effect of Dose Ratio on Mitoxantrone and Daunorubicin in Acute Myeloid Leukemia: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2021]
Mitoxantrone in the treatment of relapsed and refractory acute leukemia. [2019]
Vosaroxin in relapsed/refractory acute myeloid leukemia: efficacy and safety in the context of the current treatment landscape. [2020]
Cladribine combined with mitoxantrone in the treatment of blastic phase of chronic myeloid leukemia. [2013]
Cladribine and mitoxantrone dose escalation in indolent non-Hodgkin's lymphoma. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Therapeutic potential of a reduced-intensity preparative regimen for allogeneic transplantation with cladribine, busulfan, and antithymocyte globulin against advanced/refractory acute leukemia/lymphoma. [2013]
[Cladribine]. [2013]
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