NCT02537977

Brief Summary

Relapsed/refractory leukemia and lymphoma lack effective treatment. The cancer immunotherapy with chimeric antigen receptor (CAR) T cells provides a potent new approach for them. In this clinical trial, the investigators aim to assess the safety and efficacy of administering T cell expressing an anti-CD19 CARs to patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.

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
60

participants targeted

Target at P75+ for phase_1 leukemia

Timeline
Completed

Started Jul 2015

Typical duration for phase_1 leukemia

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 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

4.9 years

First QC Date

August 26, 2015

Last Update Submit

November 29, 2018

Conditions

LeukemiaLymphoma

Outcome Measures

Primary Outcomes (1)

  • Occurrence of study related adverse events

    defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly，likely，or definitely related to the study.

    2 years

Secondary Outcomes (4)

  • Response rates to CAR-T cells

    2 years

  • Progression free survival(PFS)

    2 years

  • Duration of remission(DOR)

    2 years

  • Overall survival(OS) of patients treated with CAR-T cells

    2 years

Study Arms (1)

CAR-T cells

EXPERIMENTAL

Autologous 2nd generation CD19-directed CAR-T cells

Biological: CD19-directed CAR-T cells

Interventions

CD19-directed CAR-T cellsBIOLOGICAL

CD19-directed CAR-T cell infusion will be given by vein

CAR-T cells

Eligibility Criteria

Age6 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with CD19+ leukemia or lymphoma, meeting the following criteria:
  • At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy)
  • Less than 1 year between last chemotherapy and progression
  • Not eligible or appropriate for allo-HSCT
  • To be aged 6 to 85 years
  • Estimated survival of ≥ 6 months, but ≤ 2 years
  • ECOG score ≤2
  • Relapse after auto-HSCT
  • Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time
  • Voluntary participation in the clinical trials and sign the informed consent

You may not qualify if:

  • History of epilepsy or other CNS disease
  • Patients have GVHD, which needs treatment with immunosuppressive agents
  • Patients with prolonged QT interval or severe heart disease
  • Patients in pregnancy or breast-feeding period
  • Uncontrolled active infection
  • Active hepatitis B or hepatitis C infection
  • Previously treatment with any gene therapy products
  • Feasibility assessment during screening demonstrates \<20% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation
  • ALT /AST\>3 x normal value; Creatinine\> 2.5 mg/dl; Bilirubin \>2.0 mg/dl
  • Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
  • HIV infection
  • Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, 200065, China

RECRUITING

MeSH Terms

Conditions

LeukemiaLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Aibin Liang, MD,Ph.D.

    Shanghai Tongji Hospital, Tongji University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aibin Liang, MD,Ph.D.

CONTACT

0086-021-66111019lab7182@tongji.edu.cn

Ping Li, MD,Ph.D.

CONTACT

0086-021-66111015lilyforever76@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director，Department of Hematology

Study Record Dates

First Submitted

August 26, 2015

First Posted

September 2, 2015

Study Start

July 1, 2015

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

December 3, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)