NCT03564977

Brief Summary

The main purpose of this study is to explore the efficacy of CD19-targeted CAR-T cell therapy for minimal residual disease (MRD) in B-cell Malignancies after autologous stem cell transplantation.

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 below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

June 11, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

July 15, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

1.9 years

First QC Date

June 11, 2018

Last Update Submit

June 28, 2018

Conditions

Lymphoma, B-CellLeukemia, B-CellMinimal Disease, Residual

Keywords

CAR-Tminimal residual diseaseB cell maliganacy

Outcome Measures

Primary Outcomes (4)

  • Objective response rate

    2 years

  • Disease control rate

    2 years

  • Overall survival

    2 years

  • Progress-free survival

    2 years

Study Arms (1)

CD19-targeted CAR-T cells

EXPERIMENTAL
Biological: CD19-targeted CAR-T cells

Interventions

CD19-targeted CAR-T cellsBIOLOGICAL

MDR+ patients after autologous stem cell transplantation were treated with CD19-targeted CAR-T cells.

CD19-targeted CAR-T cells

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed by pathological biopsy in patients with B-cell malignancies and treated by autologous stem cell transplantation.
  • Age 18 to 75 years old, both male and female;
  • Is expected to survive more than 3 months;
  • Physical condition is good: ECOG score≤2;
  • In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination.
  • General requirements autologous as basic, normal blood T lymphocytes in autologous count must \>= 0.2 x10\^9 / L;
  • No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
  • Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.

You may not qualify if:

  • Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
  • Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
  • Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
  • Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution;
  • Coagulation abnormalities and severe thrombosis;
  • Pregnancy and lactation women;
  • Any other chronic disease patients who have been treated with immune agents or hormone therapy;
  • Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
  • The Investigator believe the patients should not participate in this experiment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-CellLeukemia, B-CellNeoplasm, Residual

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLeukemiaHematologic DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Peng Zhao, doctor

CONTACT

8653284961737zp8102@126.com

Ketao Lana

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2018

First Posted

June 21, 2018

Study Start

July 15, 2018

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

CN(1)