CMV pp65 Specific T Cell Adoptive Immunotherapy in Alloge... | NCT00611637

Studies
CMV pp65 Specific T Cell Adoptive Immunotherapy in Allogeneic Stem Cell Transplantation for Malignant Disease

NCT00611637

Sponsor

H. Kim Lyerly

Status

Terminated

Last Update Posted

Nov 12, 2012Estimated

Enrollment

2Actual

Phase

Phase 1

Conditions

Allogeneic Stem Cell Transplantation

Interventions

CMV pp65 Specific T Cells

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IND 11649

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low accrual

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Feb 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jan 29, 2008

First Submission Date that Met QC Criteria

Feb 8, 2008

First Posted Date

Feb 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2012

Last Update Posted Date

Nov 12, 2012Estimated

Name	Class
National Institutes of Health (NIH)	NIH
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Label	Type	Description	Intervention Names
1	Experimental		Biological: CMV pp65 Specific T Cells

Name	Type	Description	Arm Group Labels	Other Names
CMV pp65 Specific T Cells	Biological	Donor derived CMV pp65 specific T cells (1 x 105 CD3+ cells/kg (maximum 1 x 107 CD3+ cells) will be infused into recipient over 10 minutes.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of CMV pp65 specific CD8+ T cells produced.		Pre-infusion.
Development of grade III-IV GVHD or major organ toxicity.		Continuously for 100 days post-transplant.

Secondary Outcomes

Measure	Description	Time Frame
Presence of CMV in peripheral blood.		Tested before and following transplant and infusion.
Percentage of CD8+ T cells that are CMV pp65 specific.		Assessed weekly up to 6 months following T cell infusion.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stratum 1: Subjects must be undergoing a non-myeloablative stem cell transplant from a 6/6 matched, sibling donor for the treatment of a malignancy
Stratum 2: Subjects must be undergoing a non-myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
Stratum 3: Subjects must be undergoing a myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy.
Donor must be CMV sero-positive.
Karnofsky performance status ≥ 70%.
Subject and donor must be one of the following HLA types: HLA A*0201, HLA-A*0101, HLA-A*2402, HLA-B*0702, HLA-B*0801, HLA-B*35, HLA-DR*1, or HLA-DR*4.
Availability of the stem cell donor to provide multiple PBMC samples for T-cell culture if needed. These samples could be obtained via a 90cc peripheral blood draw or through leukapheresis. Stem cell donor must satisfy BMT Program criteria for undergoing leukapheresis to provide DLI and consent to provide repeat leukapheresis if this is necessary.
Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines.
Ability to return to Duke University Medical Center for adequate follow-up as required by this protocol.
In order to receive their T cell infusions, subjects should be:
At least 2 weeks from the time of their allogeneic stem cell transplant.
Without Grade 3 or 4, non-hematologic, major organ toxicity within the preceding 1 week; all non major organ toxicities must have resolved to grade-2 or less.

Exclusion Criteria:

Pregnant women and nursing mothers.
Current or prior history of brain metastases.
More than 12 months since their allogeneic stem cell re-infusion.
HIV+, Hepatitis BsAg+, Hepatitis C Ab+

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
H. Kim Lyerly, M.D.	Duke University	Principal Investigator
Michael A Morse, M.D.	Duke University	Principal Investigator