Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02799550
Previous Study | Return to List | Next Study

Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02799550
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Brief Summary:
The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19) infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)

Condition or disease Intervention/treatment Phase
Leukemia Biological: allogeneic CART-19 Phase 1

Detailed Description:
The relapsed and/or refractory B-ALL patients will receive infusions of allogeneic CART-19 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily vindesine, mitoxantrone, cyclophosphamide, pegaspargase and dexamethasone, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19
Study Start Date : October 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Experimental: allogeneic CART-19
infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)
Biological: allogeneic CART-19
allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)




Primary Outcome Measures :
  1. Occurrence of study related adverse events [ Time Frame: 1 year ]
    defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria


Secondary Outcome Measures :
  1. Overall response rate of allogeneic CART-19 [ Time Frame: up to 24 weeks ]
    An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry or qPCR

  2. Disease-free survival [ Time Frame: up to 24 weeks ]
  3. Overall survival [ Time Frame: up to 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 60 years
  • Patient with relapsed and/or refractory CD19 positive B-cell acute lymphoblastic leukemia (B-ALL)
  • Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

  • Previous treatment with investigational gene or cell therapy medicine products
  • CD19 negative B-cell leukemia
  • Any uncontrolled active medical disorder that would preclude participation as outlined

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02799550


Contacts
Layout table for location contacts
Contact: Huisheng Ai, MD 861066947135 huishengai@163.com

Locations
Layout table for location information
China, Beijing
Affiliated Hospital of Academy of Military Medical Sciences , Recruiting
Beijing, Beijing, China, 100071
Contact: Huisheng Ai, MD    86-1066947126    huishengai@163.com   
Principal Investigator: Huisheng Ai, MD         
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Weidong Han, MD    86-13651392893    hanwdrsw@sina.com   
Principal Investigator: Weidong Han, MD         
Sponsors and Collaborators
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Chinese PLA General Hospital
Investigators
Layout table for investigator information
Study Chair: Huisheng Ai, MD Affiliated Hospital of Academy of Military Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02799550     History of Changes
Other Study ID Numbers: CART-ALL-2015
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences:
CART
ALL
Relapsed
Refractory
CD19+
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Neoplasms by Histologic Type
Neoplasms