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

Patients enrolled will receive infusion of CD19-targeting CAR T-cells

Patients enrolled will receive infusion of CD19-targeting CAR T-cells with a target dose of 5\~10×10E6/kg of recipient weight, after the preparative regimen consisted of fludarabin (30mg/m2, day -5 to -3) and cyclophosphamide (300mg/m2, day -5 to -3).

CAR T-cell therapy

Jia Chen, M.D., Ph.D.

Xiang Zhang, M.D.

Depei Wu, M.D., Ph.D.

Jia Chen, M.D.

Aining Sun, M.D., Ph.D.

Huiying Qiu, M.D., Ph.D.

Xiaowen Tang, M.D., Ph.D.

Yue Han, M.D., Ph.D.

Zhengming Jin, M.D.

Chengcheng Fu, M.D., Ph.D.

Feng Chen, M.D., Ph.D.

Xiao Ma, M.D., Ph.D.

Suning Chen, M.D., Ph.D.

Refractory and relapsed (R/R) acute lymphoblastic leukemia (ALL) patients with active disease always have a dismal outcome. Chimeric antigen receptor (CAR) T-cell therapy targeting to Cluster of Differentiation Antigen 19 (CD19) has been proved as a potent approach to attain remission in B-cell R/R patients. Therefore, the investigators conduct a trial to evaluate the the efficacy and safety of locally producing CAR T cells targeting CD19, and to analyze the outcome of enrolled B-cell ALL patients with active disease or persistent residual disease.

CAR-T Cell Therapy Targeting to CD19 for R/R ALL

CD19-targeting Chimeric Antigen Receptor T-cell Therapy for Patients With Refractory and Relapsed B-cell Acute Lymphoblastic Leukemia

defined as less than 5% blasts in the bone marrow without myelosuppression, no circulating blasts in peripheral blood, and the absence of extramedullary disease, regardless of cell count recovery

defined as less than 0.01% bone marrow blasts assessed by multiparameter flow cytometry, and absence of genetic aberrants assessed by karyotype analysis or molecular detection

grading according to the criteria proposed by Lee, et al (Blood, 2014, 124: 188-195). This grading system ranges from grade 1 (best) to grade 5 (worst), by measuring related symptoms (such as fever, nausea, fatigue, headache, etc.), oxygen requirement, blood pressure and organ toxicity (referred to CTCAE v4.0 grading)

calculating from the day of CAR T-cell infusion to death or the end of follow-up

calculating from the day of CAR T-cell infusion to death, disease progression or the end of follow-up

calculating from the day of CAR T-cell infusion to disease progression or the end of follow-up

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

The First Affiliated Hospital of Soochow University

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Lenalidomide

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

CC-5013 (lenalidomide) plus oral high-dose dexamethasone

Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone

Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle.

CC-5013

Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.

Robert Knight, MD

Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.

This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle; Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.

CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

A Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.

Overall survival was calculated as the time from randomization to death from any cause.

The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.

The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.

Celgene

Analyses of safety (Serious Adverse Events and Other Adverse Events) were based upon the Safety Population (all subjects who were administered at least one dose of study medication) and include all data available.

CC-5013/Dex

Placebo/Dex

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Canada

Region of Enrollment

Analyses for efficacy had data cutoff dates of 07 Jun 2005 and a data cutoff date of 23 Jul 2008 for overall survival. Only safety data were collected for 6 subjects ongoing beyond the 23 Jul 2008 data cutoff date.

Robert Knight, M.D.

Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.

Time to Tumor Progression (TTP)

Overall Survival

Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized. Results reported (Response) are numbers of subjects.

Myeloma Response

Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CAR-T Cell Therapy Targeting to CD19 for R/R ALL	NCT03919240	Acute Lymphobla...	CAR T-cell ther...	-	The First Affiliated Hospital of Soochow University
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma	NCT00056160	Multiple Myelom...	CC-5013 Dexamethasone	18 Years -	Celgene
CAR-T Cell Therapy Targeting to CD19 for R/R ALL	NCT03919240	Acute Lymphobla...	CAR T-cell ther...	-	The First Affiliated Hospital of Soochow University

Spots Global Cancer Trial Database for refractory and relapsed