Study of the Tocilizumab Optimization Timing for CART19 Associated Cytokine Release Syndrome

Completed · Phase 1

Conditions studied: Lymphoblastic Leukemia, Acute, Childhood

In brief

This is a two cohort, open-label, pilot study to describe the efficacy of administration timing of tocilizumab on CART19 (CTL019) associated cytokine release syndrome safety events in pediatric patients with CD19 expressing relapsed and refractory B-cell acute lymphoblastic leukemia with high versus low pre-infusion tumor burden following redirected autologous T cells transduced with the anti-CD19 lentiviral vector (CART19/CTL019).

Key facts

Study ID

NCT02906371

Run by

University of Pennsylvania

People needed

80

Starts

2016-08-01

Expected to finish

2021-06-30

Last updated by the study team

2021-07-02

Who can join

Age: 1 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent form must be obtained prior to any study procedure. Labs, marrows or other procedures obtained during routine clinical care may be used for eligibility if obtained within the protocol required windows.
• Relapsed or refractory B-cell ALL:
• 2nd or greater marrow relapse OR
• CNS relapse OR
• Any relapse after allogeneic hematopoietic stem cell (SCT) transplant and ≥ 4 months from SCT at enrollment OR
• Any relapse after CAR-modified T cell therapy OR
• Refractory disease defined as having not achieved an MRD-negative CR after ≥ 2 chemotherapy regimens/cycles (1 cycle for relapsed patients) OR
• Patients with Ph+ ALL are eligible if they are intolerant to or have failed tyrosine kinase inhibitor therapy OR
• Ineligible for allogeneic SCT because of:
• Comorbid disease
• Other contraindications to allogeneic SCT conditioning regimen
• Lack of suitable donor
• Prior SCT
• Declines allogeneic SCT as the therapeutic option after documented discussion, with expected outcomes, about the role of SCT with a bone marrow transplant (BMT) physician not part of the study team
• Patients with B lymphoblastic lymphoma will be eligible if they meet one of the above criteria OR:
• 2nd or greater relapse OR
• Refractory disease defined as having not achieved CR with frontline therapy or after 1 cycle of reinduction therapy for relapsed patients
• Patients with prior or current history of CNS3 disease will be eligible if CNS disease is responsive to therapy (at infusion, must meet criteria in Section 5.3)
• Documentation of CD19 tumor expression in bone marrow, peripheral blood, CSF, or tumor tissue by flow cytometry at relapse (or a recent sample in the case of refractory disease). If the patient has received CD19-directed therapy (i.e. blinatumomab), then the flow cytometry should be obtained after this therapy to show CD19 expression.
• Adequate organ function defined as:
• A serum creatinine based on age/gender as follows:
• Maximum Serum Creatinine (mg/dL)
• Age Male Female
• 1 to < 2 years 0.6 0.6
• 2 to < 6 years 0.8 0.8

You may not qualify if…

• Active hepatitis B or active hepatitis C.
• HIV Infection.
• Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy.
• CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.
• Pregnant or nursing (lactating) women. 8. Uncontrolled active infection.

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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