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Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy

A Pilot Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy for Children, Adolescents, and Young Adults With Relapse of Acute Lymphoblastic Leukemia

NCT02879643•Therapeutic Advances in Childhood Leukemia Consortium

View on ClinicalTrials.gov

Summary

This is a pilot study utilizing Marqibo® (vincristine sulfate liposome injection) combined with dexamethasone, mitoxantrone and asparaginase (UK ALL R3) for relapsed acute lymphoblastic leukemia (ALL).

Detailed Description

This study will utilize Marqibo® as a replacement for standard vincristine in combination with chemotherapy for children with relapsed ALL. The hypothesis is that the incorporation of Marqibo® with combination chemotherapy will be safe and feasible. In the context of this pilot study, overall outcomes and efficacy will be a secondary objective. It is hypothesized that data from this combination may show improved efficacy including, complete remission (CR), minimal residual disease (MRD) negativity, and progression free survival (PFS) rates and safety (i.e., neurotoxicity) in comparison to outcomes in historical regimens, including the UK ALL R3 with standard vincristine.

Eligibility

Age

1 - 21 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age
•Patients must be ≥ 1 and ≤ 21 years of age at the time of enrollment.
•Diagnosis
•Cohort A: Patients must have a diagnosis of acute lymphoblastic leukemia (ALL) or mixed phenotypic acute leukemia with ≥ 5% blasts in the bone marrow (M2 or M3), with or without extramedullary disease) or a diagnosis of lymphoblastic lymphoma.
•Cohorts B \& C: Patients must have a diagnosis of acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma, or mixed phenotypic acute leukemia with any level of detectable disease (minimal residual disease level acceptable) with or without extramedullary disease
•Performance Level -Karnofsky \> 50% for patients \> 16 years of age and Lansky \> 50% for patients ≤ 16 years of age.
•Prior Therapy
•Patients must have recovered from the acute toxic effects (≤ Grade 2 or baseline) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, unless otherwise specified. Subjects with disease related cytopenias will be eligible.
•Patients must have relapsed or refractory disease after attaining at least a first remission. They may be in first to third relapse..
•Patients with Philadelphia chromosome t(9;22) positive disease must have received at least two prior tyrosine kinase inhibitors.
+22 more criteria

Exclusion Criteria

•Patients will be excluded if they have isolated testicular disease.
•Patients will be excluded if they have previously received Marqibo®.
•Patients will be excluded if they have a known allergy to any of the drugs used in the study, with the exception that patients with an allergy to PEG-asparaginase who can receive Erwinia asparaginase are eligible. Patients unable to receive any formulation of asparaginase may only enroll on cohort C
•Patients will be excluded if they have active, uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment.
•Patients who require azole antifungal agents will be excluded. Azoles must be discontinued at least one week prior to the start of Marqibo®.
•Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, another investigational agent or immunotherapy during the study period.
•Patients with pre-existing, persistent grade 2 or greater sensory or motor neuropathy from any cause will be excluded.
•Patients will be excluded if they have, significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or adherence with the protocol treatment or procedures or interfere with consent, study participation, follow up, or interpretation of study results.Patients with Down syndrome will not be eligible for enrollment on Cohort A
•Patients with a known history of human immunodeficiency virus (HIV) will will be excluded due to the increased risk of complications such as severe infection and unknown interaction of Marqibo® with antiretroviral drugs.
•Active hepatitis B or C infection as defined by seropositive for hepatitis B (hepatitis B surface antigen (HBsAg)) or hepatitis C and elevated liver transaminases (defined as above the ULN per the institution normal ranges).

Locations (35)

Childrens Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital Orange County

Orange, California, United States

UCSF School of Medicine

San Francisco, California, United States

The Children's Hospital, University of Colorado

Aurora, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

University of Miami

Miami, Florida, United States

All Children's Hospital

St. Petersburg, Florida, United States

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, United States

Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Sidney Kimmel Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Key Dates

Start Date

January 31, 2017

Primary Completion Date

July 29, 2022

Completion Date

December 31, 2024

Last Updated

October 22, 2025

Enrollment

ACTUAL participants

Conditions

ALL, ChildhoodLymphoblastic Leukemia, Acute, ChildhoodLymphoblastic Leukemia, Acute

Interventions

Marqibo

DRUG

Childhood Cancer Survivors' Affective Response to Exercise

NCT05763290

ALL, ChildhoodAcute Lymphoblastic Leukemia

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RECRUITINGPHASE2

BCL-2 Inhibitors Combined with the HyperCVAD Regimen for Newly Diagnosed T-lymphoblastic Leukemia/lymphoma.

NCT06598722

Lymphoblastic Lymphoma, AdultLymphoblastic Leukemia, Acute T-cell

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With UK ALL R3 Induction Chemotherapy

Inclusion Criteria

Exclusion Criteria

Childhood Cancer Survivors' Affective Response to Exercise

BCL-2 Inhibitors Combined with the HyperCVAD Regimen for Newly Diagnosed T-lymphoblastic Leukemia/lymphoma.

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