Gentler chemo approach shows promise for tough blood cancers in older patients
NCT ID NCT04668885
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether lower doses of the chemotherapy drug CPX-351 can help older patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) that have come back or not responded to other treatments. The goal is to control the disease while being gentler on the body. About 13 participants are involved, and the main focus is on how many patients see their cancer shrink or disappear.
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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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13 people
The number who actually took part.
- Started
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Jan 2021
- Expected to finish
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Jan 2027
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.
Inclusion Criteria: * Primary refractory or relapsed AML (defined by 2016 World Health Organization \[WHO\] criteria) patients who are not suitable for or not willing to receive intensive chemotherapy as evaluated by the treating physician. Primary refractory disease is defined as: * Failure to achieve a CR, CRi, or mLFS (defined as \<5% Bone Marrow (BM) blasts) after receiving 1 or 2 cycles of remission induction chemotherapy. * Failure to achieve a CR, CRi, or MLFS (defined as \<5% BM blasts) after receiving 4 cycles of non-intensive chemotherapy or whose disease progressed at any time point during the treatment. * Participants with MDS (according to 2016 WHO criteria) who did not respond to treatment with azacitidine, decitabine, or combination of HMA with another drug or lost their response to initial therapy with HMA. * Eastern Cooperative Oncology Group (ECOG) performance status \<=2 * Adequate hepatic (serum total bilirubin \< 1.5 x ULN, Serum glutamic pyruvic transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) \<2.5 x ULN) and renal function (creatinine \< 1.5mg/dL). * Participants must be willing and able to review, understand, and provide written consent before starting therapy. Exclusion Criteria: * Active signs or symptoms of central nervous system (CNS) involvement by malignancy (lumbar puncture \[LP\] not required). * Prior 7+3 remission induction chemotherapy for MDS or AML * More than 2 lines of prior non-intensive therapy. * New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia on rhythm control strategy or on pacemaker, uncontrolled hypertension (blood pressure \> 160 systolic and \> 110 diastolic not responsive to antihypertensive medication) * Acute myocardial infarction in the previous 12 weeks (from the start of treatment). * Any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent. * Any active malignancy (unrelated, non-hematological malignancy) diagnosed within the past 6 months of starting the study drug (other than curatively treated carcinoma-in-situ of the cervix or non-melanoma skin cancer). * History of allergic reactions attributed to compounds of similar chemical or biologic composition to CPX-351. * Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Known history of HIV or active hepatitis B or C. * No major surgery within 2 weeks prior to study enrollment. * Pregnant or breast feeding * Male and female participants who are fertile who do not agree to use an effective barrier methods of birth control (i.e. abstinence) to avoid pregnancy while receiving study treatment and for 30 days after last dose of study treatment. Non-childbearing is defined as \> 1 year postmenopausal or surgically sterilized. * Acute promyelocytic leukemia (APL)
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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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Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
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Other studies related to the condition(s) this trial covers.
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