NCT02924753

Brief Summary

This is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

3 years

First QC Date

September 29, 2016

Last Update Submit

December 28, 2017

Conditions

B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • safety as assessed by the occurrence of study related adverse events.

    monitor the occurrence of study related adverse events.

    6 months

Secondary Outcomes (2)

  • efficacy

    2 years

  • duration of CART-19

    2 years

Study Arms (1)

CART-19

EXPERIMENTAL

patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.

Drug: CyclophosphamideDrug: FludarabineBiological: CART-19 cells

Interventions

CyclophosphamideDRUG

patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).

CART-19
FludarabineDRUG

Fludarabine 25mg/m2/day IV for 3 days (Day-5 to day-3).

CART-19
CART-19 cellsBIOLOGICAL

CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.

Also known as: CD19 specific Chimeric Antigen Receptor T-cells
CART-19

Eligibility Criteria

Age4 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years to 70 years, expected survival \> 3 months
  • CD19 positive B-cell acute lymphoblastic leukemia
  • Karnofsky Performance Status (KPS) \>70
  • Relapsed after allogeneic or autologous stem cell transplantation (SCT);
  • Cardiac function: 1-2 levels; Liver: TBIL≤3 Upper Limit of Normal (ULN)，aspartate aminotransferase (AST) ≤2.5 ULN，ALT ≤2.5 ULN; kidney: Cr≤1.25 ULN; bone marrow: White Blood Cell (WBC) ≥ 3.0×109/L, Hb ≥90 g/L, Platelet (PLT) ≥ 80×109/L）
  • No serious allergic constitution
  • No other serous diseases that conflicts with the clinical program
  • No other cancer history
  • No serious mental disorder
  • Informed consent is signed by a subject or his lineal relation.

You may not qualify if:

  • Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)
  • Uncontrolled active infection, HIV infection, syphilis serology reaction positive
  • Active hepatitis B or hepatitis C infection
  • Recent or current use of glucocorticoid or other immunosuppressor
  • With severe cardiac, liver, renal insufficiency, diabetes and other diseases
  • Transaminase \>2.5 ULN, Bilirubin \>3 ULN，Creatinine\>1.25 ULN
  • Participate in other clinical research in the past three months; previously treatment with any gene therapy products
  • Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

Cyclophosphamidefludarabine

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Yongping Song

    Henan Cancer Hospital

    STUDY DIRECTOR

Central Study Contacts

Yongping Song

CONTACT

ph200811@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

September 29, 2016

First Posted

October 5, 2016

Study Start

July 18, 2016

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

December 29, 2017

Record last verified: 2017-12

Locations

CN(1)