Relapsed B Acute Lymphoblastic LeukaemiaPhase 2/3NCT03937544
Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL
A Phase 2/3 study testing CD19 CAR-T CELLS, Cyclophosphamide and Fludarabine in people with Relapsed B Acute Lymphoblastic Leukaemia and Refractory B Acute Lymphoblastic Leukaemia, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Relapsed B Acute Lymphoblastic Leukaemia, Refractory B Acute Lymphoblastic Leukaemia
- What is being tested?
- CD19 CAR-T CELLS, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMalaysia
- Study dates
- 19 Mar 2019to 18 Mar 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
UKM Medical Centre
Bandar Tun Razak, Kuala Lumpur, 56000
S Fadilah Abdul Wahid, MD, DrIntMed, PhD, +60391456450, sfadilah@ppukm.ukm.edu.my
Wan Fariza Wan Jamaludin, MD,DrIntMed, +60391457709, wanfariza@ppukm.ukm.edu.my
About this study
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
- Being tested
- CD19 CAR-T CELLS, Cyclophosphamide, Fludarabine
- Medical subject headings
- Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CAR-T CELLSBiological
CD19 CAR-T cells will be administered after completion of the lymphodepletion chemotherapy.
CyclophosphamideDrug
Patients will receive lymphodepleting chemotherapy consisting of Cyclophosphamide 250 - 300 mg/m2/day IV(Day -5, Day -4, Day -3 ).
FludarabineDrug
Patients will receive lymphodepleting chemotherapy consisting of Fludarabine 25-30 mg/m2/day IV (Day -5, Day -4, Day -3 ).
| Study group | Role | What they receive |
|---|---|---|
| CD19 CAR-T CELLS | Experimental | A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously. Receives: Biological: CD19 CAR-T CELLS; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Overall Response Rate (ORR) defined as Complete Response (CR) and CR with incomplete blood recovery (CRi) according to WHO criteria.
Measured: Participants will be followed for the duration of the treatment, with an expected average of 3 months.
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.
Measured: 12 Months
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.
Measured: 12 Months
Secondary outcomes (4)
Overall survival (OS)
Overall Survival (OS) defined as the time from treatment to the date of death due to any cause.
Measured: 12 Months, 24 Months
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.
Measured: 12 Months, 24 Months
Time to next treatment (TTNT)
Time To Next Treatment (TTNT) defined as the end of study treatment until the institution of the next therapy.
Measured: 12 Months, 24 Months
Percentage of adverse events
Percentage of participants with adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start19 Mar 2019
- Primary completion18 Jan 2027 (estimated)
- Study completion18 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed B Acute Lymphoblastic LeukaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Gaia Science
- Responsible party
- Principal investigator, Prof. Dr S Fadilah Abdul Wahid, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937544
- Sponsor's protocol ID
- JEP-2019-003
- Other IDs
- FF-2019-138
- Status last verified
- May 2025
- First submitted
- 22 Apr 2019
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided