A Study to Accelerate Immune System Recovery Following Stem Cell Transplantation

NCT00429039 | Terminated Phase 2 DMC

• 2 other identifiers: 01.00822000-66
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if pre-treating donor lymphocytes with an investigational drug known as L-leucyl-L-leucine methyl ester (LLME, prior to donor lymphocyte infusion (DLI) will improve the recovery of the immune system following stem cell transplant.

Conditions

ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION

Interventions

L-leucyl-L-leucine methyl ester (LLME) DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• To be treated on this study, patients must have recently undergone a T-cell depleted allogeneic bone marrow or peripheral blood stem cell transplant from an HLA-matched sibling donor, an HLA matched unrelated donor, or an HLA partially matched (single antigen mismatched, two antigen mismatched, or haplodisparate) donor. Patients will be counseled and will sign informed consent for this study prior to their transplant. Our intention is to analyze the effectiveness of LLME treated DLI (Donor Lymphocyte Infusion) on an intent to treat basis. To proceed with this therapy after HSCT, patients must meet the other selection criteria below at the time of first DLI. Additionally, discussion prior to transplant helps present the patient (and donor) a picture of the proposed therapy in its entirety, rather than in piecemeal fashion. A patient or donor's unwillingness to participate in this study will in no way affect their eligibility for transplant therapy at our center.
• At the time of initial DLI therapy, patients must be between 28 and 42 days post allogeneic HSCT or between 28 and 42 days after the last dose of ATG if that agent was used after the transplant as part of their graft rejection prophylaxis. They must also meet the following criteria during the week prior to first infusion:
• Patients must have achieved primary engraftment with an absolute neutrophil count of at least 1000 per l for 3 consecutive days.
• Patients must have a CD4+ lymphocyte count of less than 200 per l. An absolute lymphocyte count of less than 200 per l will be taken as prime facie evidence that the CD4+ lymphocyte count meets this criteria.
• Patients must be 16 years of age or older. There is no upper age limit for this study.
• Patients must not be pregnant.
• Patients must not have any documented graft-versus-host disease.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Kimmel Cancer Center at Thomas Jefferson University

Study Officials

• Neal Flomenberg, M.D.

  Thomas Jefferson University, Department of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 31, 2007
• Study Start: September 1, 2000
• Primary Completion: October 1, 2007
• Study Completion: August 1, 2009
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

US (1)