Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

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 will be administered after completion of the chemotherapy.

CD19 CAR-T CELLS

Patients will receive lymphodepleting chemotherapies consisting Cyclophosphamide 250mg/m2/day IV(Day -5, Day -4, Day -3 ).

Patients will receive lymphodepleting chemotherapies consisting of Fludarabine 25mg/m2/day IV (Day -5, Day -4, Day -3 ).

S Fadilah Abdul Wahid, MD, DrIntMed, PhD

Wan Fariza Wan Jamaludin, MD,DrIntMed

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

Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL

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

Overall Response Rate (ORR) defined as Complete Response (CR) and CR with incomplete blood recovery (CRi) according to WHO criteria.

Duration of response defined from the time when criteria for response (CR or CRi) are met to the first documentation of relapse or progression.

Overall Survival (OS) defined as the time from treatment to the date of death due to any cause.

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.

Time To Next Treatment (TTNT) defined as the end of study treatment until the institution of the next therapy.

Percentage of participants with adverse events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL	NCT03937544	Relapsed B Acut... Refractory B Ac...	CD19 CAR-T CELL... Cyclophosphamid... Fludarabine	13 Years - 65 Years	National University of Malaysia
Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL	NCT03937544	Relapsed B Acut... Refractory B Ac...	CD19 CAR-T CELL... Cyclophosphamid... Fludarabine	13 Years - 65 Years	National University of Malaysia

Spots Global Cancer Trial Database for refractory b acute lymphoblastic leukaemia