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New treatment option for Recurrent Acute Myeloid Leukemia
Official title Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT03629171
What this study is testing
What is Liposome-encapsulated Daunorubicin-Cytarabine?
Liposome-encapsulated Daunorubicin-Cytarabine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for recurrent acute myeloid leukemia.
Also referred to as CPX-351, Cytarabine-Daunorubicin Liposome for Injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine and venetoclax work in treating participants with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or has not been treated (untreated). Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For the lead in phase: Patients \>= 18 years of age with a diagnosis of relapsed and/or refractory AML will be eligible. Patients who have had prior...
- For the dose expansion cohort A (relapsed/refractory [R/R] AML): Patients \>= 18 years of age with a diagnosis of relapsed and/or refractory AML will...
- For the dose expansion cohort B (de novo AML): Patients \>= 18 years to 69 years of age; patients in this cohort must have received no prior therapy...
- Prior therapy with hydroxyurea, hematopoietic growth factors, or tretinoin (ATRA) (for emergency use for stabilization) is allowed with no washout. A...
- Bilirubin =\< 2 mg/dL
You likely can't join if
- Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects...
- Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (New York Heart...
- Patient with documented hypersensitivity to any of the components of the chemotherapy program
- Patients with acute promyelocytic leukemia (M3) or core-binding factor AML
- Patients with active central nervous system (CNS) leukemia are excluded since the antileukemia activity of the treatment components against CNS...
- Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception...
See the full eligibility criteria
- For the lead in phase: Patients \>= 18 years of age with a diagnosis of relapsed and/or refractory AML will be eligible. Patients who have had prior treatment with venetoclax will be allowed to participate in the lead...
- For the dose expansion cohort A (relapsed/refractory [R/R] AML): Patients \>= 18 years of age with a diagnosis of relapsed and/or refractory AML will be eligible
- For the dose expansion cohort B (de novo AML): Patients \>= 18 years to 69 years of age; patients in this cohort must have received no prior therapy for AML
- Prior therapy with hydroxyurea, hematopoietic growth factors, or tretinoin (ATRA) (for emergency use for stabilization) is allowed with no washout. A cumulative dose of ara-C of up to 3 g for emergency stabilization in...
- Bilirubin =\< 2 mg/dL
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN) or \< 5 x ULN if related to leukemic involvement
- Creatinine =\< 1.5 x ULN
- Known cardiac ejection fraction of \> or = 45% within the past 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
- A negative urine or serum pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. A woman of childbearing potential is defined as a woman who has not been...
- Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their...
- 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...
- Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris...
- Patient with documented hypersensitivity to any of the components of the chemotherapy program
- Patients with acute promyelocytic leukemia (M3) or core-binding factor AML
- Patients with active central nervous system (CNS) leukemia are excluded since the antileukemia activity of the treatment components against CNS leukemia are not known
- 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
- Prior treatment with CPX-351 or venetoclax. Patients with prior treatment with venetoclax will be allowed in patients with relapsed/refractory (R/R) disease including those in the lead-in phase as well as those in...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.