NCT01027702

Brief Summary

The purpose of this study is to determine the ability of a donor lymphocyte infusion (DLI) given with methotrexate to hasten immune recovery without causing severe graft-versus-host disease (GVHD) in recipients who have had a T-cell depleted transplant.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 8, 2017

Completed
Last Updated

April 22, 2022

Status Verified

October 1, 2017

Enrollment Period

7.3 years

First QC Date

December 7, 2009

Results QC Date

September 9, 2017

Last Update Submit

April 20, 2022

Conditions

Immunodeficiency

Keywords

Donor Lymphocyte InfusionImmune RecoveryT cell depleted transplantMismatched related donor transplantsUnrelated donor transplants

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Immune Recovery Following Transplantation

    Immune recovery was measured by CD4+ cells \> 100/μL by Day 120 following transplantation

    120 days after transplant

  • Incidence and Severity of GVHD

    Patients were evaluated for acute GVHD due to prophylactic DLI between the day of prophylactic DLI infusion and Day +180 after transplant. GVHD was graded using standard criteria.

    180 days after transplant

Secondary Outcomes (1)

  • Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)

    1 year

Study Arms (1)

Infusion of donor lymphocytes

EXPERIMENTAL

Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.

Biological: Infusion of donor lymphocytes

Interventions

Infusion of donor lymphocytesBIOLOGICAL

A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10\^4, 4 x 10\^4, 5 x 10\^4, 6 X 10\^4, 8 x 10\^4, and 10 X10\^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.

Infusion of donor lymphocytes

Eligibility Criteria

AgeUp to 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients must have been treated on the LCH BMT 09-01 protocol
  • Signed informed consent by patient or legal guardian

You may not qualify if:

  • Active GVHD at the time when DLI are due
  • History of acute GVHD \> grade I prior to DLI
  • Disease due to viral infection (eg. CMV) when DLI are due (asymptomatic viral replication or viral shedding is not a contraindication)
  • Uncontrolled bacterial or fungal infection
  • O2 saturation by pulse oximetry \< 95%
  • Bilirubin \> 3mg/dL or ALT \> 5 x upper limit of normal
  • Creatinine \> 3x baseline (at transplant)
  • ANC (WBC x % neutrophils + bands) \< 500/ul
  • Significant effusions (eg. pleural or pericardial) or ascites
  • EBV-related PTLD
  • Persistent or increasing mixed chimerism requiring therapeutic DLI as defined on the LCH BMT 09-01 protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Levine Children's Hospital, Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Related Publications (1)

  • Gilman AL, Leung W, Cowan MJ, Cannon M, Epstein S, Barnhart C, Shah K, Hyland M, Fukes T, Ivanova A. Donor lymphocyte infusion and methotrexate for immune recovery after T-cell depleted haploidentical transplantation. Am J Hematol. 2018 Feb;93(2):169-178. doi: 10.1002/ajh.24949. Epub 2017 Nov 17.

    PMID: 29047161DERIVED

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

Title
Dr. Andrew Gilman
Organization
PRA Health Sciences
gilmanandy@prahs.com
704-615-2744

Study Officials

  • Andrew Gilman, MD

    Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

December 7, 2009

First Posted

December 9, 2009

Study Start

August 1, 2009

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 22, 2022

Results First Posted

November 8, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)