Condition or disease | Intervention/treatment | Phase |
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Relapsed B Acute Lymphoblastic Leukaemia Refractory B Acute Lymphoblastic Leukaemia | Biological: CD19 CAR-T CELLS Drug: Cyclophosphamide Drug: Fludarabine | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | March 19, 2019 |
Estimated Primary Completion Date : | March 18, 2024 |
Estimated Study Completion Date : | March 18, 2024 |
Arm | Intervention/treatment |
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Experimental: 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.
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Biological: CD19 CAR-T CELLS
CD19 CAR-T cells will be administered after completion of the chemotherapy.
Drug: Cyclophosphamide Patients will receive lymphodepleting chemotherapies consisting Cyclophosphamide 250mg/m2/day IV(Day -5, Day -4, Day -3 ).
Drug: Fludarabine Patients will receive lymphodepleting chemotherapies consisting of Fludarabine 25mg/m2/day IV (Day -5, Day -4, Day -3 ).
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Ages Eligible for Study: | 13 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: S Fadilah Abdul Wahid, MD, DrIntMed, PhD | +60391456450 | sfadilah@ppukm.ukm.edu.my |
Malaysia | |
UKM Medical Centre | Recruiting |
Bandar Tun Razak, Kuala Lumpur, Malaysia, 56000 | |
Contact: S Fadilah Abdul Wahid, MD, DrIntMed, PhD +60391456450 sfadilah@ppukm.ukm.edu.my | |
Contact: Wan Fariza Wan Jamaludin, MD,DrIntMed +60391457709 wanfariza@ppukm.ukm.edu.my |
Tracking Information | |||||
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First Submitted Date ICMJE | April 22, 2019 | ||||
First Posted Date ICMJE | May 3, 2019 | ||||
Last Update Posted Date | May 6, 2019 | ||||
Actual Study Start Date ICMJE | March 19, 2019 | ||||
Estimated Primary Completion Date | March 18, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL | ||||
Official Title ICMJE | 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 | ||||
Brief 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 | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: 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.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
10 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | March 18, 2024 | ||||
Estimated Primary Completion Date | March 18, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 13 Years to 65 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Malaysia | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03937544 | ||||
Other Study ID Numbers ICMJE | JEP-2019-003 FF-2019-138 ( Other Identifier: UKM Medical Centre ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Prof. Dr S Fadilah Abdul Wahid, National University of Malaysia | ||||
Study Sponsor ICMJE | National University of Malaysia | ||||
Collaborators ICMJE | Gaia Science | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | National University of Malaysia | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |