Actively Recruiting
ALaCART-B: Acute Leukemia and Chimeric Antigen Receptor-T Cell Therapy for B-lymphoblastic Leukemia.
Led by National University Hospital, Singapore · Updated on 2021-09-09
40
Participants Needed
1
Research Sites
274 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to assess the safety and efficacy of a immunophenotype-adapted approach using CAR T-cells in patients with high-risk, refractory or relapsed B-lineage acute lymphoblastic leukemia (B-ALL).
CONDITIONS
Official Title
ALaCART-B: Acute Leukemia and Chimeric Antigen Receptor-T Cell Therapy for B-lymphoblastic Leukemia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed B-cell acute lymphoblastic leukemia or lymphoma with bone marrow disease ≥ 0.01% by MRD or CNS disease or extramedullary relapse
- Induction failure defined by MRD ≥ 1% or >5% blasts after standard chemotherapy
- Refractory disease defined by MRD ≥ 0.01% at two or more timepoints after induction
- Presence of high-risk features like BCR-ABL1, MLL-r, hypodiploid ALL, or p53 mutation
- Inability to tolerate standard chemotherapy due to toxicity or other health issues
- Pulmonary reserve with grade ≤ 1 dyspnoea and oxygen saturation > 95% on room air
- Left ventricular systolic function ≥ 28% or ejection fraction ≥ 45% by echocardiogram within 3 months
- Performance status Karnofsky (age ≥ 16) or Lansky (age < 16) ≥ 50 at screening
- Normal age-adjusted creatinine clearance within 3 months
- Alanine aminotransferase ≤ 5 times upper limit of normal
- Patients with > 99.9% CD19 expression on blast cells eligible for anti-CD19 CAR T-cell infusion
- Patients with partial or absent CD19 expression (< 99.9%) eligible for other CAR T-cell combinations based on antigen profile
You will not qualify if you...
- Does not meet inclusion criteria
- Positive urine pregnancy test, pregnant, or lactating
- Genetic syndromes linked to bone marrow failure except Down syndrome
- Prior malignancy except treated carcinoma in situ of skin or cervix with no active disease
- Active or recent hepatitis B or C infection or uncontrolled infection
- Positive HIV test within 8 weeks
- Grade 2 to 4 acute or extensive chronic graft-versus-host disease
- Received investigational drug within 30 days
- Persistent disease or relapse after previous CAR T-cell therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Allen Yeoh Eng Juh
Singapore, Singapore, 119228
Actively Recruiting
Research Team
A
Allen Yeoh, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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