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

NCT03575325 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MCC-19482
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoid Leukemia; Acute Lymphoblastic Leukemia; Refractory Acute Lymphoblastic Leukemia; Relapsed Acute Lymphoblastic Leukemia

Keywords

T-cell acute lymphoblastic leukemia; B-cell acute lymphoblastic leukemia

Outcome Measures

Primary Outcomes (1)

• Complete Remission Rate (CR) + CR With Incomplete Recovery (CRi)

  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).

  At day 28

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  12 months

• Overall Survival (OS)

  12 months

• Minimal Residual Disease (MRD)

  At day 28

Study Arms (1)

CPX-351 Treatment

EXPERIMENTAL

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

Interventions

CPX-351 DRUG

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.

Also known as: Vyxeos, cytarabine:daunorubicin

CPX-351 Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or mixed phenotype acute 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 suspected 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

You may not qualify if:

• 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, active/prior veno-occlusive disease of the liver 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).

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Jazz Pharmaceuticals: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma

Interventions

CPX-351

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma

Results Point of Contact

• Title: Bijal D. Shah, MD, MS
• Organization: Moffitt Cancer Center

Bijal.Shah@moffitt.org

813-745-4294

Study Officials

• Bijal Shah, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 2, 2018
• Study Start: October 11, 2018
• Primary Completion: June 7, 2021
• Study Completion: September 14, 2023
• Last Updated: December 12, 2024
• Results First Posted: July 14, 2022

Record last verified: 2024-12

Locations

US (1)