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

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ClinicalTrials.gov Identifier: NCT03575325
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lymphoid Leukemia Acute Lymphoblastic Leukemia Refractory Acute Lymphoblastic Leukemia Relapsed Acute Lymphoblastic Leukemia Drug: CPX-351 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is an open label, single arm, single center, phase 2 pilot study of Vyxeos induction & consolidation in relapsed and refractory ALL.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Open-Label Phase 2 Pilot Study of Vyxeos (CPX-351) in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CPX-351 Treatment

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).

 Drug: 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.
Other Names:
  • Vyxeos
  • cytarabine:daunorubicin


Outcome Measures
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Primary Outcome Measures :
  1. Complete Remission Rate (CR) + CR with Incomplete Recovery (CRi) [ Time Frame: At day 28 ]
    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). 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).


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 12 months ]
    Progression Free Survival as defined by Cheson 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.

  2. Overall Survival (OS) [ Time Frame: 12 months ]
    Overall Survival as defined by Cheson 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.

  3. Minimal Residual Disease (MRD) [ Time Frame: At day 28 ]
    MRD will be studied as a dichotomous endpoint using a cutoff of 1x10^4 cells/transcripts as the lower limit for residual leukemia, and presented as the percentage of participants reaching this landmark as their best response. MRD assessment will be obtained with each bone marrow biopsy assessment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent/assent for the trial.
  • Be ≥ 18 years of age on day of signing informed consent.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Pathologically confirmed B- or T-cell acute lymphoblastic leukemia, with >5% peripheral blood or bone marrow lymphoblasts and/or extramedullary disease >1x1cm.
  • Relapsed or refractory acute lymphoblastic leukemia after at least 1 prior cycle of therapy. Patients with Philadelphia chromosome positive disease must have failed at least two prior tyrosine kinase inhibitors.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Cardiac ejection fraction ≥ 50% by echocardiography or multigated acquisition scan (MUGA).
  • Must be at least 2 weeks out from any prior systemic chemotherapy, blinatumumab, radiation, and/or other investigational agents, and have recovered to grade 1 from any toxicity related to prior therapy. Glucocorticoids are permitted up to 1 day prior to the first dose.
  • Serum bilirubin and creatinine less than 1.5x upper limit of normal (ULN). AST and ALT must be less than 3x ULN, unless there is liver involvement.
  • Females of childbearing potential (FCBP) must have a negative serum pregnancy test at screening. A FCBP is considered when a sexually mature female: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months.
  • A FCBP must agree to use of two methods of highly effective contraception, be surgically sterile, or abstain from heterosexual activity for the course of the study through 30 days after the last dose of study treatment.
  • Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 30 days after the last dose of study therapy. Men must agree to not donate sperm during and after the study

Exclusion Criteria:

  • Clinical evidence of active central nervous system (CNS) leukemia.
  • Any major surgery or radiation therapy within four weeks.
  • Any active infection requiring systemic therapy, including HIV, Hepatitis B, and/or Hepatitis C.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator (including but not limited to severe graft-versus-host disease, unstable angina, pulmonary hypertension, or severe CHF (NYHA III-IV).
  • Patients with active (uncontrolled, metastatic) second malignancies.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 30 after the last dose of trial treatment.
  • Hypersensitivity to cytarabine, daunorubicin, or liposomal products.
  • History of Wilson's disease or other copper-metabolism disorder.
  • Patients with prior cumulative anthracycline exposure of greater than 368 mg/m^2 daunorubicin or equivalent).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575325


Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Elyce Turba    813-745-1706    elyce.turba@moffitt.org   
Contact: Anthony McLaughlin    813-745-5941    anthony.mclaughlin@moffitt.org   
Principal Investigator: Bijal Shah, M.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Jazz Pharmaceuticals
Investigators
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Principal Investigator: Bijal Shah, M.D. H. Lee Moffitt Cancer Center and Research Institute
More Information
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Additional Information:
Moffitt Cancer Center Clinical Trials website  This link exits the ClinicalTrials.gov site

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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03575325     History of Changes
Other Study ID Numbers: MCC-19482
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
T-cell acute lymphoblastic leukemia
B-cell acute lymphoblastic leukemia

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Daunorubicin
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors