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New treatment option for Relapsed B Acute Lymphoblastic Leukaemia
Official title Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL
ClinicalTrials.gov ID: NCT03937544
What this study is testing
What is CD19 CAR-T CELLS?
CD19 CAR-T CELLS is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed b acute lymphoblastic leukaemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 65
You may be able to join if
- Patients with relapsed/refractory B-ALL in accordance with World Health Organization (WHO) classification by virtue of BM morphology, flow cytometry...
- 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 \ 40%
You likely can't join if
- 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...
- Presence of active autoimmune disease or atopic allergy.
- HIV serology positivity.
- Active Hepatitis B or C infection as evidenced by quantitative viral PCR assay.
See the full eligibility 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 \ 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bandar Tun Razak, Kuala Lumpur, Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bandar Tun Razak, Kuala Lumpur, Malaysia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.