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New treatment option for Leukemia
Official title Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
ClinicalTrials.gov ID: NCT03826992
What this study is testing
What is Vyxeos?
Vyxeos is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for leukemia.
Also referred to as cytarabine and daunorubicin liposome, CPX-351.
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 study evaluates the safety and tolerability of combining venetoclax with Vyxeos (CPX-351) in pediatric and young adult patients with acute leukemia that has come back or not responded to treatment.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 39
You may be able to join if
- Ages 1 Year to 39 Years
- Diagnosis of one of the following:
- Acute myeloid leukemia (AML), any subtype except
- Patients with acute promyelocytic leukemia (APML) are NOT eligible
- Patients with ML-DS are NOT eligible
You likely can't join if
- Diagnosis of one of the following:
- Myeloid Leukemia associated with Down Syndrome (ML-DS)
- Acute Promyelocytic Leukemia (APML)
- Acute leukemia with CNS status 3 involvement
- Philadelphia chromosome t(9;22) positive leukemia (Ph+ ALL, AML, MPAL, or AUL)
- Fanconi Anemia, Shwachman-Diamond syndrome, or any other bone marrow failure syndrome or DNA repair disorder
See the full eligibility criteria
- Ages 1 Year to 39 Years
- Diagnosis of one of the following:
- Acute myeloid leukemia (AML), any subtype except
- Patients with acute promyelocytic leukemia (APML) are NOT eligible
- Patients with ML-DS are NOT eligible
- Myeloid sarcoma
- Acute leukemia of ambiguous lineage (ALAL)
- Acute undifferentiated leukemia (AUL)
- T/myeloid mixed phenotype acute leukemia (MPAL)
- B/myeloid MPAL
- MPAL with KMT2A-rearrangement MPAL with t (9;22) are NOT eligible
- T-cell acute lymphoblastic leukemia (T ALL)
- Early thymocyte precursor (ETP) ALL
- KMT2A-rearranged ALL
- Disease Status
- Relapsed/Refractory AML, MPA, and AUL
- Untreated therapy related AML
- Relapsed/Refractory KMT2A-rearranged ALL, T-cell ALL, ETEP ALL
- Karnofsky/Lanksy performance level score of greater than or equal to 50 percent.
- Prior therapy requirements
- Fully recovered from acute toxicities of Hematopoietic Stem Cell Transplant (HSCT) or Anthracycline Exposure
- 14 days must have elapsed since the completion of systemic cytotoxic therapy other than hydroxyurea, decitabine or azacitidine
- 2 weeks must have elapsed for local palliative radiotherapy (RT); 6 months must have elapsed if prior craniospinal RT or if 50% radiation of pelvis, and at least 6 weeks must have elapsed if other substantial bone...
- Adequate renal, liver, cardiac, and central nervous system (CNS) function
- Diagnosis of one of the following:
- Myeloid Leukemia associated with Down Syndrome (ML-DS)
- Acute Promyelocytic Leukemia (APML)
- Acute leukemia with CNS status 3 involvement
- Philadelphia chromosome t(9;22) positive leukemia (Ph+ ALL, AML, MPAL, or AUL)
- Fanconi Anemia, Shwachman-Diamond syndrome, or any other bone marrow failure syndrome or DNA repair disorder
- Wilson's Disease or other copper-metabolism disorder
- Pregnant or breastfeeding
- Uncontrolled infection
- Received greater than 13.6 Gray (Gy) prior radiation to the mediastinum
- Receipt of growth factors within 7 days prior to enrollment
- Currently receiving another investigational drug
- Currently receiving anti-cancer agents (with the exception of intrathecal (IT) agents or hydroxyurea)
- Unable to comply with the safety monitoring requirements of the study
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, 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, 1 year to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, 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.