Treatment of Patients With Donor Lymphocytes Sensitized b... | NCT00149032

Studies
Treatment of Patients With Donor Lymphocytes Sensitized by Antigens Expressed by the Host

NCT00149032

Sponsor

Hadassah Medical Organization

Status

Withdrawn

Last Update Posted

Apr 8, 2011Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Hematological Malignancy
Neoplasm Metastasis

Interventions

DLI sensitized against antigens expressed by the host.

Countries

Israel

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

Sep 2005

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2001

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 7, 2005

First Submission Date that Met QC Criteria

Sep 7, 2005

First Posted Date

Sep 8, 2005Estimated

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

Apr 7, 2011

Last Update Posted Date

Apr 8, 2011Estimated

Description Module

Brief Summary

Allogeneic stem cell transplantation is the only effective treatment to patients resistant to conventional chemotherapy. Donor lymphocytes infusion (DLI) serve as a routine treatment of choice for patients relapsing following allogeneic stem cell transplantation. The present proposal is presented for introducing the use of immune rather than naive donor lymphocytes for patients with resistant relapse and resistant to DLI. DLI primed in-vitro against tumor cells of host origin or against host alloantigens presented by parental alloantigens in one way mixed lymphocytes culture can induce much more than potent graft-vs-leukemia and graft-vs-tumor effects, while down-regulating graft-vs-host disease (GVHD).

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
DLI sensitized against antigens expressed by the host.	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Introducing more effective graft vs leukemia and graft vs tumor effects with immune donor lymphocytes in patients relapsing following allogeneic bone marrow or blood stem cell transplantation

Secondary Outcomes

Measure	Description	Time Frame
Upregulating of anti-tumor effects while minimizing anti-host responses

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with hematologic malignancy or metastatic solid tumor relapsing following allogeneic bone marrow or blood stem cell transplantation (alloBMT) or non-myeloablative stem cell transplantation resistant to DLI with no GVHD when taken off anti-GVHD prophylaxis.
Patients with documented chimerism to confirm induction of host-vs-graft transplantation tolerance.

Exclusion Criteria:

Patients not consenting to participate in the study, or minors without approved parental consent.
Patients with other diseases or complications that may limit their life span other than their basic disease.
Pregnant or lactating women.
Non-compliant patients or patients with poor performance status with life expectancy, e.g. 6 weeks.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shimon Slavin, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D019337	Hematologic Neoplasms
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided