We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00149032
First Posted: September 8, 2005
Last Update Posted: April 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose
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).

Condition Intervention Phase
Hematological Malignancy Neoplasm Metastasis Procedure: DLI sensitized against antigens expressed by the host. Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Patients With Resistant Cancer/ Post Allogeneic Stem Cell Transplantation With Donor Lymphocytes Sensitized by Antigens Expressed by the Host

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Upregulating of anti-tumor effects while minimizing anti-host responses

Estimated Enrollment: 50
Study Start Date: August 2001
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149032


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00149032     History of Changes
Other Study ID Numbers: 240801-HMO-CTIL
First Submitted: September 7, 2005
First Posted: September 8, 2005
Last Update Posted: April 8, 2011
Last Verified: September 2005

Keywords provided by Hadassah Medical Organization:
Metastatic solid tumor

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes