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

Leukemia Clinical Trial

Official title:

Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02799550
• Other study ID #: CART-ALL-2015
• Status: Recruiting
• Phase: Phase 1
• Start date: October 2015
• Est. completion date: May 2020

Study information

• Verified date: June 2018
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: Huisheng Ai, MD
• Phone: 861066947135
• Email: huishengai[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia

Intervention

Biological:
• allogeneic CART-19
allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)

Locations

Country	Name	City	State
China	Affiliated Hospital of Academy of Military Medical Sciences ,	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences	Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria	1 year
Secondary	Overall response rate of allogeneic CART-19	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	up to 24 weeks
Secondary	Disease-free survival		up to 24 weeks
Secondary	Overall survival		up to 24 weeks