Refractory B Acute Lymphoblastic Leukaemia Clinical Trial
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
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
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | March 18, 2024 |
| Est. primary completion date | March 18, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 13 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Malaysia | UKM Medical Centre | Bandar Tun Razak | Kuala Lumpur |
| Lead Sponsor | Collaborator |
|---|---|
| National University of Malaysia | GAIA Sdn Bhd |
Malaysia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall response rate (ORR) | Overall Response Rate (ORR) defined as Complete Response (CR) and CR with incomplete blood recovery (CRi) according to WHO criteria. | Participants will be followed for the duration of the treatment, with an expected average of 3 months. | |
| Primary | Complete response (CR) | Duration of response defined from the time when criteria for response (CR or CRi) are met to the first documentation of relapse or progression. | 12 Months | |
| Primary | CR with incomplete blood recovery (CRi). | Duration of response defined from the time when criteria for response (CR or CRi) are met to the first documentation of relapse or progression. | 12 Months | |
| Secondary | Overall survival (OS) | Overall Survival (OS) defined as the time from treatment to the date of death due to any cause. | 12 Months, 24 Months | |
| Secondary | Progression free survival (PFS) | Progression Free Survival (PFS) defined as the time from treatment to first documentation of objective leukemic progression (date of leukaemia assessment documenting progressive disease) or to death due to any cause. Progression is assessed by BM biopsy or CSF analysis according to NCCN criteria. It is assessed at Day 30 and monthly thereafter, or earlier if clinically indicated. | 12 Months, 24 Months | |
| Secondary | Time to next treatment (TTNT) | Time To Next Treatment (TTNT) defined as the end of study treatment until the institution of the next therapy. | 12 Months, 24 Months | |
| Secondary | Percentage of adverse events | Percentage of participants with adverse events | 30 days |