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Recruiting NCT03937544

Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL

Phase II / Phase III Interventional Relapsed B Acute Lymphoblastic Leukaemia Refractory B Acute Lymphoblastic Leukaemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CD19 CAR-T CELLS, Cyclophosphamide, Fludarabine.
Who it may be relevant to
Registry conditions: Relapsed B Acute Lymphoblastic Leukaemia, Refractory B Acute Lymphoblastic Leukaemia. Basic parameters: 13 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Malaysia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II/III Prospective, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed/ Refractory B-Acute Lymphoblastic Leukaemia

Overview

This is Phase II / III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed / Refractory B-Acute Lymphoblastic Leukaemia

Interventions

  • Biological CD19 CAR-T CELLS
    CD19 CAR-T cells will be administered after completion of the lymphodepletion chemotherapy.
  • Drug Cyclophosphamide
    Patients will receive lymphodepleting chemotherapy consisting of Cyclophosphamide 250 - 300 mg/m2/day IV(Day -5, Day -4, Day -3 ).
  • Drug Fludarabine
    Patients will receive lymphodepleting chemotherapy consisting of Fludarabine 25-30 mg/m2/day IV (Day -5, Day -4, Day -3 ).

Primary outcome measures

  • Overall response rate (ORR) [Time frame: Participants will be followed for the duration of the treatment, with an expected average of 3 months.]
  • Complete response (CR) [Time frame: 12 Months]
  • CR with incomplete blood recovery (CRi). [Time frame: 12 Months]
Secondary outcome measures (4)
  • Overall survival (OS) [Time frame: 12 Months, 24 Months]
  • Progression free survival (PFS) [Time frame: 12 Months, 24 Months]
  • Time to next treatment (TTNT) [Time frame: 12 Months, 24 Months]
  • Percentage of adverse events [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • Patients with relapsed/refractory B-ALL in accordance with World Health Organization (WHO) classification by virtue of BM morphology, flow cytometry, cytogenetics and molecular genetics
  • Age between ≥13 to ≤ 65 years
  • No detectable leukaemia in the CSF (CNS-1)
  • CNS leukaemia without clinically evident neurological symptoms (CNS-2; with <5 WBC per μL and cytology positive for blasts)
  • Adequate organ function as defined by a creatinine clearance > 50 ml/min, serum total bilirubin < 5 times the normal value, left ventricular ejection fraction > 40%
  • ECOG performance status ≤ 2
  • Life expectancy > 3 months
  • Post allogeneic HSCT must be ≥ Day +100 with no evidence of active GVHD and not receiving immunosuppression
  • Female patients of child bearing age must have negative pregnancy test and is on highly effective contraception methods
  • Male patients must use highly effective contraception methods

Exclusion criteria

  • Patients with CNS-3 leukaemia.
  • Active cancer (other than B-ALL).
  • Evidence of severe lung, heart (NYHA class III/IV, arrhythmia, AV block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder.
  • Presence of active autoimmune disease or atopic allergy.
  • HIV serology positivity.
  • Active Hepatitis B or C infection as evidenced by quantitative viral PCR assay.
  • Uncontrolled sepsis
  • Pregnant / nursing female.
  • Ongoing prednisolone > 1mg/kg daily or equivalent.
  • Chemotherapy immunotherapy in the recent 4 weeks such as allogeneic cellular therapy weeks, anti-GVHD therapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Malaysia · 1 center
  • UKM Medical Centre — Bandar Tun Razak

Identifiers

NCT: NCT03937544 · JEP-2019-003 · FF-2019-138

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗