Neoplasms

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Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

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Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

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Anti-Infective Agents

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Cytarabine

Daunorubicin

Antimetabolites

Antiviral Agents

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Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Participants will receive induction with CPX-351 at a dose of 100 u/m\^2 administered intravenously over 90 minutes on days 1, 3 and 5 of a 28 day cycle.

This may be followed by consolidation with CPX-351 at a dose of 65 u/m\^2 administered intravenously over 90 minutes on days 1 and 3 of a 28 day cycle (up to 3 cycles).

The infusion of CPX-351 (cytarabine:daunorubicin) Liposome Injection will be performed through a central venous catheter, using an infusion pump to ensure that the drug is infused over the specified time period.

CPX-351

Bijal Shah, M.D.

This study involves Vyxeos (CPX-351), a formulation of a fixed combination of the two anti-tumor drugs, cytarabine and daunorubicin that will be given as an infusion over 90 minutes. This study will use what is called a "liposome" injection. This is a special fat capsule (called a liposome) that surrounds the cytarabine and daunorubicin and protects the drugs from being eliminated/destroyed by the body.

This is an open label, single arm, single center, phase 2 pilot study of Vyxeos induction \& consolidation in relapsed and refractory ALL.

Vyxeos(CPX-351) in Adults w R/R Acute Lymphoblastic Leukemia

A Single-Arm, Open-Label Phase 2 Pilot Study of Vyxeos (CPX-351) in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia

Expansion from phase II pilot to a phase II trial will depend on demonstration of CR/CRi amongst 4 of the initial 10 treated patients. Investigators will measure remission rate at day 28 to address the primary endpoint of complete remission (with or without complete hematologic recovery), as defined by Cheson Criteria (ref 27). For those with extramedullary disease, Lugano criteria will be used to assess response. This is a standard assessment of drug efficacy for phase 2 clinical trial design in acute leukemias, as response correlates closely with progression free- and overall survival (PFS and OS).

Progression Free Survival as defined by Cheson and Lugano Criteria, namely progression, failure to respond, or death, as assessed from time of first treatment. Progression Free Survival will be reported as per Cheson Criteria, and analyzed using a standard Kaplan-Meier approach. Patients will undergo bone marrow biopsy evaluation after each cycle of therapy per standard of care to facilitated assessment.

Overall Survival as defined by Cheson and Lygano Criteria, namely death due to any cause as assessed from time of first treatment. Overall Survival will be reported as per Cheson Criteria, and analyzed using a standard Kaplan-Meier approach. Patients will undergo bone marrow biopsy evaluation after each cycle of therapy per standard of care to facilitated assessment.

MRD assessment will be provided using ClonoSeq test result. ClonoSEQ® is an FDA-cleared test used to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL).

Jazz Pharmaceuticals

H. Lee Moffitt Cancer Center and Research Institute

Participants who received induction with CPX-351 at a dose of 100 u/m\^2 administered intravenously over 90 minutes on days 1, 3 and 5 of a 28 day cycle.

CPX-351 Treatment Induction Dose

Participants who received induction with CPX-351 at a dose of 100 u/m\^2 administered intravenously over 90 minutes on days 1, 3 and 5 of a 28 day cycle. Participants then received one consolidation dose of CPX-351 at a dose of 65 u/m\^2 administered intravenously over 90 minutes on days 1 and 3 of a 28 day cycle

CPX-351 Treatment Induction Dose + 1 Consolidation Dose

Participants who received induction with CPX-351 at a dose of 100 u/m\^2 administered intravenously over 90 minutes on days 1, 3 and 5 of a 28 day cycle. Participants then received two consolidation doses of CPX-351 at a dose of 65 u/m\^2 administered intravenously over 90 minutes on days 1 and 3 of a 28 day cycle

CPX-351 Treatment +2 Consolidation Doses

Participants will receive induction with CPX-351 at a dose of 100 u/m\^2 administered intravenously over 90 minutes on days 1, 3 and 5 of a 28 day cycle.

This may be followed by consolidation with CPX-351 at a dose of 65 u/m\^2 administered intravenously over 90 minutes on days 1 and 3 of a 28 day cycle (up to 3 cycles).

CPX-351: The infusion of CPX-351 (cytarabine:daunorubicin) Liposome Injection will be performed through a central venous catheter, using an infusion pump to ensure that the drug is infused over the specified time period.

Spots Global Cancer Trial Database for Vyxeos(CPX-351) in Adults w R/R Acute Lymphoblastic Leukemia

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