NCT00675831

Brief Summary

The purpose of this research study is to evaluate the safety and efficacy of cell depletion in a donor lymphocyte infusion (DLI) product with the use of the CliniMACS machine. Previously, patients with hematologic malignancies who have relapsed after transplant have been given infusions of donor white blood cells calsed donor lymphocyte infusion (DLI) as a way to boost their immune function and fight cancer. Information from other research studies suggests that lowering the number of a certain type of white blood cell called CD25+ Tregs in the DLI may allow for a greater effect. In this research study, we are looking for the appropriate dose of DLI depleted of the CD25+ Treg white blood cells that can be given safely.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

September 29, 2016

Status Verified

September 1, 2016

Enrollment Period

5.1 years

First QC Date

May 8, 2008

Last Update Submit

September 28, 2016

Conditions

Hematologic Malignancies

Keywords

CD25+TregsDLIDonor lymphocyte infusion

Outcome Measures

Primary Outcomes (2)

  • To determine the feasibility of using the ClinMACS CD25 Reagent device to engineer a DLI product outlined in the protocol

    3 years

  • To determine the safety of CD25+ Treg depleted DLI in this patient population.

    3 years

Secondary Outcomes (2)

  • To assess clinical response after infusions of CD25+ Treg depleted donor lymphocytes

    3 years

  • To assess the immunologic impact of infusions of CD25+ Treg depleted donor lymphocytes

    3 years

Study Arms (1)

CD25+ Treg depleted DLI dose schema

EXPERIMENTAL

Patients will receive a defined dose of CD25+ Treg depleted DLI. 5 patients will be enrolled, initially at dose level B, and subsequent cohorts will be dose adjusted per the CD3+ dose escalation/de-escalation schema: * Dose level -C: 3x10\^7 (CD3+Dose (#cells/kg\*)) * Dose level -B: 1x10\^7 (CD3+Dose (#cells/kg\*)) * Dose level -A: 1x10\^6 (CD3+Dose (#cells/kg\*)) \*Recipient's body weight in Kg

Device: CliniMACS CD25 Reagent Device

Interventions

CliniMACS CD25 Reagent DeviceDEVICE

Used to engineer CD25+ depleted donor lymphocytes which will be infused intravenously over 5-10 minutes

CD25+ Treg depleted DLI dose schema

Eligibility Criteria

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

You may qualify if:

  • Patients with hematologic malignancies that have relapsed after HLA-A, -B, -C, and-DRBI matched allogeneic hematopoietic stem cell transplantation
  • At least 2 months following hematopoietic stem cell transplantation
  • Off any systemic immunosuppressive medication for treatment or prevention of GVHD, for a minimum of 2 weeks prior to study entry
  • Recipient with donor chimerism of 20% or greater within 6 weeks prior to DLI
  • Patient with less than 50% bone marrow involvement (% cellularity) and less than 5cm lymph nodes, in the 6 weeks prior to DLI
  • years of age or older
  • ECOG Performance Status score 0-2
  • Prior stem cell donor is medically fit to undergo leukapheresis procedure

You may not qualify if:

  • Relapsed CML in chronic phase
  • Prior donor lymphocyte infusion or other immunotherapy treatment within 8 weeks prior to enrollment
  • Chemotherapy within 4 weeks prior to enrollment
  • Clinically significant and active autoimmune disease in donor or patient. This is defined as autoimmune disease resulting in organ dysfunction and/or requiring systemic therapy
  • Evidence of active acute or chronic GVHD
  • Uncontrolled infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Nikiforow S, Kim HT, Daley H, Reynolds C, Jones KT, Armand P, Ho VT, Alyea EP 3rd, Cutler CS, Ritz J, Antin JH, Soiffer RJ, Koreth J. A phase I study of CD25/regulatory T-cell-depleted donor lymphocyte infusion for relapse after allogeneic stem cell transplantation. Haematologica. 2016 Oct;101(10):1251-1259. doi: 10.3324/haematol.2015.141176. Epub 2016 Jun 27.

    PMID: 27354021DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • John Koreth, MBBS, DPhil

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MBBS, DPhil

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 12, 2008

Study Start

December 1, 2007

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

September 29, 2016

Record last verified: 2016-09

Locations

US(1)