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This study will utilize Marqibo® as a replacement for standard vincristine in combination with UK ALL R3 induction 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.

Principal Investigator:
Huynh, Van

Research Coordinator:
Tina Templeman
(714) 509-8646

Visit clinicaltrials.gov for more information about this trial.


  • Clinical Trial Info
  • IRB Number: 161096
  • Sponsor: Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL)
  • Protocol Number: T2012-002
  • NCT Number: NCT02879643
  • Research Type: Adolescents and Young Adults, Leukemia/Lymphoma, Recurrent/Refractory Cancer
  • Phase: Pilot
  • Status: Active

Key Inclusion Criteria:

  • Age Patients must be ≥ 1 and ≤ 21 years of age at the time of enrollment.
  • Diagnosis Patients must have a diagnosis of acute lymphoblastic leukemia (ALL) with ≥ 5% blasts in the bone marrow (M2 or M3), with or without extramedullary disease (excluding active Central Nervous System 3 involvement).
  • Subjects with first relapse must have an M3 marrow to be eligible.

Key Exclusion Criteria:

  • Patients will be excluded if they have active Central Nervous System (CNS) 3 status.
  • Patients will be excluded if they have isolated testicular disease.
  • Patients with biphenotypic leukemia will be excluded.
  • Patients will be excluded if they have refractory disease or fourth relapse and beyond