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Experimental chemo cocktail targets resistant leukemia
NCT ID NCT03150004
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of chemotherapy drugs (cladribine, cytarabine, mitoxantrone, and G-CSF) in 53 adults with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that had come back or not responded to prior treatment. The goal was to see how many patients achieved complete remission with no detectable cancer cells. However, the trial was terminated early, so the full results are not available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cladribine, cytarabine, mitoxantrone, and G-CSF (CLAG-M regimen)
- What this could lead to
- If successful, this could offer a treatment option for people with hard-to-treat leukemia or MDS who have not responded to other therapies.
- What could go wrong
- The trial was terminated early, so results are limited. It is a small, single-center study, and the chemotherapy has significant side effects like infection and organ damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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53 people
The number who actually took part.
- Started
-
Jun 2017
- Finished
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Mar 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years at the time of informed consent. 2. Morphologically documented: * Primary Acute Myeloid Leukemia (AML) or * AML secondary to Myelodysplastic Syndrome (MDS) or myeloproliferative neoplasm (MPN), or * Therapy related AML (t-AML), as defined by World Health Organization (WHO) criteria. * Subjects with high risk MDS after failure of hypomethylating agents are also eligible. 3. Subjects must meet one of the following criteria: * In first or subsequent relapse or refractory status, with or without prior hematopoietic stem cell transplant (HSCT) OR * Subjects with MDS or MPN transformed to AML will be eligible even if they had not received prior therapy for AML. * Subjects with high risk MDS after failure of hypomethylating agents. 4. Eastern Cooperative Oncology Group (ECOG) performance score 0-3. 5. It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, female subjects participating in this study should avoid becoming pregnant, and male subjects should avoid impregnating a female partner. Non- sterilized female subjects of reproductive age and male subjects should use effective methods of contraception through defined periods during and after study treatment as specified below. Female subjects must meet one of the following: * Postmenopausal for at least one year before the screening visit, or * Surgically sterile, or if they are of childbearing potential, agree to practice two effective methods of contraception from the time of signing of the informed consent form through 90 days after the last dose of study drug, AND * Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, or * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable contraception methods.) Male subjects, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following: * Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, OR * Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable methods of contraception.) 6. Ability to understand a written informed consent document and the willingness to sign it. 7. Subjects must meet the following clinical laboratory criteria: CLAG-M Arm Only: For abnormalities in liver function tests, elevation thought to be due to hepatic infiltration by AML, Gilbert's syndrome or hemolysis would not be treated as exclusion criteria. * Absolute neutrophil count ≥1,000/mm\^3 Unless related to AML * Platelets ≥75,000/mm\^3 Unless related to AML * Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN) (if elevated, then complete direct bilirubin). * AST(SGOT)/ALT Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN * Creatinine clearance ≥ 30 mL/min * Resting left ventricular ejection fraction ≥ 45% CLLDAC ARM ONLY: * Absolute neutrophil count ≥ 1,000/mm\^3 unless related to AML * Platelets ≥ 75,000/mm\^3 unless related to AML Exclusion Criteria: 1. Acute Promyelocytic Leukemia. 2. Active infection not well controlled by antibacterial or antiviral therapy. 3. Pregnant or breast feeding women. 4. Participation in clinical trials with other investigational agents not included in this trial, throughout the duration of this trial. Participation of follow-up portion of another clinical trial will not exclude patient from participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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