NCT02810223

Brief Summary

This is a single arm, open-label, multi-center study to determine the efficacy and safety of an experimental therapy called CART-19 in patients with chemo-refractory and relapsed B-cell ALL.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

October 14, 2016

Status Verified

June 1, 2016

Enrollment Period

1.6 years

First QC Date

June 16, 2016

Last Update Submit

October 13, 2016

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    2 years

Study Arms (1)

Single dose of CART-19

EXPERIMENTAL

2 to 5 x 10(6) autologous CART-19 transduced cells per kg body weight, with a maximum dose of 2.5 x 10(8) autologous CTL019 transduced cells via intravenous infusion.

Biological: CART-19

Interventions

CART-19BIOLOGICAL

2 to 5 x 10(6) autologous CART-19 transduced cells per kg body weight, with a maximum dose of 2.5 x 10(8) autologous CTL019 transduced cells via intravenous infusion.

Single dose of CART-19

Eligibility Criteria

Age1 Year - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male and female subjects with CD 19+ B cell acute lymphoblastic leukemia in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \<2 year survival) with currently available therapies will be enrolled
  • Age 1 to 60 years.
  • Expected survival \> 12 weeks
  • Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
  • ALT ≤ 5x normal
  • Bilirubin \<2.0 mg/dl
  • Any relapse after prior SCT will make patient eligible regardless of other prior therapy
  • ①. Have no active GVHD and require no immunosuppression
  • ②. Are more than 4 months from transplant
  • For those patients who require leukapheresis for T cell collection (i.e. no previously collected product exists), adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis
  • Voluntary informed consent is given
  • Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy (at infusion)

You may not qualify if:

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  • Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion
  • Uncontrolled active infection
  • Active hepatitis B or hepatitis C infection
  • Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of inhaled steroids, or hydrocortisone for physiological replacement in patients with adrenal insufficiency are permitted as well
  • Presence of grade 2-4 acute or extensive chronic GVHD
  • Under treatment for GVHD
  • Previous treatment with any gene therapy products
  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • HIV infection.
  • CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471000, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

CTL019 chimeric antigen receptor

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Peng Shicheng

CONTACT

86-10-82491911-6000jay.zhang@sanvalley.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 22, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2017

Last Updated

October 14, 2016

Record last verified: 2016-06

Locations

CN(1)