New cocktail of old drugs shows promise for tough blood cancers
NCT ID NCT01515527
First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times
Summary
This Phase 2 trial tests whether combining cladribine, low-dose cytarabine, and decitabine can help control acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). About 160 older adults (60+) who haven't had prior intensive treatment will receive the drugs in cycles. The main goal is to see how long patients stay free of disease progression.
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, and decitabine
- What this could lead to
- If this works, it could offer a new combination therapy to help control acute myeloid leukemia or high-risk myelodysplastic syndrome, potentially improving disease-free survival.
- What could go wrong
- This is a Phase 2 study with only 160 participants, so results are preliminary. The drugs have known side effects, and the combination may not work better than existing treatments.
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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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2012
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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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.
Cohort 1 Inclusion Criteria: 1. Patients with previously untreated AML or high risk MDS (\>/= 10 % blasts or IPSS \>/= intermediate-2). Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, ATRA, or total dose of cytarabine up to 2g is allowed. Patients with history of MDS transformed to AML are eligible regardless of their prior therapy for MDS provided this will be their first induction therapy for AML. 2. Age \>/= 60 years. Patients aged \< 60 years who are unsuitable for standard induction therapy may be eligible after discussion with PI 3. Adequate organ function as defined below: * liver function (bilirubin \< 2mg/dL, AST and/or ALT \<3 x ULN) * kidney function (creatinine \< 1.5 x ULN ). 4. ECOG performance status of ≤ 2. 5. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. 6. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol. 7. Prior therapy with decitabine will be allowed unless the patient experienced progression to AML while being treated with decitabine. Exclusion Criteria: 1. Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided. 2. Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 3. Patient with documented hypersensitivity to any of the components of the chemotherapy program. 4. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. Cohort 2 Inclusion Criteria: 8\. Patients with previously untreated AML who are not currently eligible for other frontline clinical trials of AML therapy. Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, ATRA, or total dose of cytarabine up to 2g is allowed. Patients with history of MDS transformed to AML are eligible regardless of their prior therapy for MDS provided this will be their first induction therapy for AML. 9\. Age \>/= 18 years who are unsuitable for standard induction therapy are eligible after discussion with PI 10. Patients must have one of the following: * Creatinine \>/= 2 mg/dL * Total bilirubin \>/= 2 mg/dL * ECOG Performance Status equal to 3 or 4 * Is ineligible for participation in a protocol of higher priority 11. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. 12\. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol. 13\. Prior therapy with decitabine will be allowed unless the patient experienced progression to AML while being treated with decitabine. Exclusion Criteria: 5\. Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided. 6\. Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, unless these illnesses are judged to be related to the underlying leukemia. 7\. Patient with documented hypersensitivity to any of the components of the chemotherapy program. 8\. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. Cohort 3 Inclusion Criteria: 1. Patients with relapsed and or refractory AML who have received at least one prior therapy for their AML. 2. Age \>/= 18 years. 3. Adequate organ function as defined below: * liver function (bilirubin \< 2mg/dL, AST and/or ALT \<3 x ULN) * kidney function (creatinine \< 1.5 x ULN ). 4. ECOG performance status of ≤ 2. 5. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. 6. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol. 7. Prior therapy with venetoclax will be allowed. Exclusion Criteria 8. Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided. 9. Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 10. Patient with documented hypersensitivity to any of the components of the chemotherapy program. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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