Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes | NCT00048100

Studies
Anti-Leukemic Dendritic Cell Activated Donor Lymphocytes

NCT00048100

Sponsor

M.D. Anderson Cancer Center

Status

Terminated

Last Update Posted

Oct 31, 2018Actual

Enrollment

2Actual

Phase

Phase 1

Conditions

Leukemia, Myelocytic, Acute

Interventions

Apheresis
Stem Cell Transplant

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

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow accrual.

Expanded Access Info

Start Date

Feb 2001

Primary Completion Date

May 2005Actual

Completion Date

May 2005Actual

First Submitted Date

Oct 24, 2002

First Submission Date that Met QC Criteria

Oct 24, 2002

First Posted Date

Oct 25, 2002Estimated

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

Oct 30, 2018

Last Update Posted Date

Oct 31, 2018Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Description Module

Brief Summary

Objectives:

Determine the toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.
Quantitate the alloreactivity of DC/ADL and circulating immune effector cells in patients after infusion.
Assess efficacy of acute myelogenous leukemia (AML) or Chronic Myelogenous Leukemia in Blastic Crisis (CML-BC) derived dendritic cells and activated lymphocytes in promoting and sustaining remission in patients with relapse after allo-BMT or stem cell transplant.

Detailed Description

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Apheresis + Transplant	Experimental	Skin biopsy & either a leukodepletion apheresis or an additional marrow aspiration prior to marrow or stem cell transplantation.	Procedure: Apheresis Biological: Stem Cell Transplant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Apheresis	Procedure	Apheresis for T-Cell collection	Apheresis + Transplant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participant Toxicity Levels	Participant toxicity of infusions of allogeneic donor lymphocytes activated by acute leukemia derived dendritic cells (DC/ADL) in relapsed patients after allo-stem cell transplants.	From stem cell transplant baseline to 30 plus days post transplant.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AML (any type except M3) or CIVIL in blast crisis with greater than or equal to 20% bone marrow blasts at the time of related donor marrow or stem cell transplantation or at relapse post transplant.
Willing to undergo a skin biopsy and either a leukodepletion apheresis or an additional marrow aspiration.
Stem cell or marrow donor willing to have apheresis for T-Cell collection.
Written voluntary informed consent must be obtained from patient and donor.

Exclusion Criteria:

Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
AML French-American-British (FAB) subtype M3.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elizabeth J. Shpall, MD	UT MD Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M.D. Anderson Cancer Center		Houston	Texas	77030-4009	United States

Label	URL
UT MD Anderson Cancer Center website	View source

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001781	Blood Component Removal
D033581	Stem Cell Transplantation

Ancestor Terms

ID	Term
D013812	Therapeutics
D017690	Cell Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy

Browse Leaves

Not provided

Browse Branches

Not provided