Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
10 participants
INTERVENTIONAL
2019-03-19
2027-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CD19 CAR-T CELLS
A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.
CD19 CAR-T CELLS
CD19 CAR-T cells will be administered after completion of the lymphodepletion chemotherapy.
Cyclophosphamide
Patients will receive lymphodepleting chemotherapy consisting of Cyclophosphamide 250 - 300 mg/m2/day IV(Day -5, Day -4, Day -3 ).
Fludarabine
Patients will receive lymphodepleting chemotherapy consisting of Fludarabine 25-30 mg/m2/day IV (Day -5, Day -4, Day -3 ).
Interventions
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CD19 CAR-T CELLS
CD19 CAR-T cells will be administered after completion of the lymphodepletion chemotherapy.
Cyclophosphamide
Patients will receive lymphodepleting chemotherapy consisting of Cyclophosphamide 250 - 300 mg/m2/day IV(Day -5, Day -4, Day -3 ).
Fludarabine
Patients will receive lymphodepleting chemotherapy consisting of Fludarabine 25-30 mg/m2/day IV (Day -5, Day -4, Day -3 ).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
13 Years
65 Years
ALL
No
Sponsors
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Gaia Science
OTHER
National University of Malaysia
OTHER
Responsible Party
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Prof. Dr S Fadilah Abdul Wahid
Head of Pusat Terapi Sel / Principal Investigator
Locations
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UKM Medical Centre
Bandar Tun Razak, Kuala Lumpur, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FF-2019-138
Identifier Type: OTHER
Identifier Source: secondary_id
JEP-2019-003
Identifier Type: -
Identifier Source: org_study_id
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