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A Phase I/II Study of Llme Treated Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies

Phase 1/Phase 2
18 Years
Not Enrolling
Hematologic Malignancies

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Trial Information

A Phase I/II Study of Llme Treated Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies

We believe that the risks of allogeneic transplant can be drastically reduced if the
following criteria can be met: (1) consistent engraftment, (2) little or no GVHD with the
ability to rapidly withdraw immune suppression, (3) rapid recovery of CD4 counts to levels
greater than 200 cells/micro liter. Our prior (ongoing) trial attempts to address how LLME
treated T cells given as DLI can address points 2 and 3 above. The current study addresses
how treatment of the CD34- fraction of the graft attempts to address points 1 and 2 (and to
a lesser extent point 3) above. We believe that if these points can be consistently
achieved that the mortality of allogeneic HSCT may be reduced to levels more akin to those
of autologous HSCT. We propose to test the hypothesis that LLME-treated T cells will be
safe with regard to reducing GVHD or other infusion related toxicities and that their
administration as part of the transplant will facilitate engraftment. We believe that this
approach will ultimately be an important step in a variety of transplant settings ranging
from matched siblings to haplodisparate donors.

Inclusion Criteria:

- Patients must be > 18 years of age, with no upper age limit.

- Patients must have an ECOG performance status of 0 or 1.

- Any patient with a hematologic malignancy which is unlikely to be cured by
conventional treatment is eligible for this study.

- Patients for whom a disease specific protocol exists will be transplanted on those
protocols as discussed in the introduction.

- Patients who have had prior autografts may be treated on this protocol.

- Patients must have adequate physical function as measured by the following criteria:

- Cardiac: Asymptomatic or, if symptomatic, then left ventricular ejection fraction at
rest must be >40%.

- Hepatic: AST micro 3x the upper limits of normal and total serum bilirubin < 2.5
mg/dL. Patients with a higher bilirubin from "benign conditions" such as Gilbert's
disease may still be eligible for the study.

- Renal: Serum creatinine within the normal range or if creatinine outside normal range
then creatinine clearance > 60 ml/min/1.73m2. Serum creatinine must be less than or
equal to 2.0 mg/dl.

- Pulmonary: Asymptomatic or, if symptomatic, DLCO (diffusion capacity) > 45% of
predicted (corrected for hemoglobin)

- The patient or guardian(s) must be able to give informed consent to the study.

- Patient must have a suitable donor who is identical for HLA-A, -B, -C, - DR. Single
antigen mismatches for HLA-A, -B, -C, -DR are also permitted. Donors obtained through
the NMDP will follow NMDP guidelines.

Exclusion Criteria:

- Patients who are eligible for a standard myeloablative transplant and for whom a
standard myeloablative transplant is preferable will not be treated on this protocol.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of CD34+ Stem Cell Infusions followed by LLME

Outcome Description:

Determine the safety of CD34+ stem cell infusions followed by the LLME treated CD34- fraction. This includes monitoring the patients for any side effects associated with the LLME treated cell infusion or any other unexpected adverse events. This regimen will be gauged as to its safety using 100 day mortality as the measured endpoint. Deaths from all causes will be included.

Outcome Time Frame:

Through 100 days post-transplant or death

Safety Issue:


Principal Investigator

John Wagner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Thomas Jefferson University


United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

May 2009

Related Keywords:

  • Hematologic Malignancies
  • Hematologic Malignancies
  • GVHD
  • Graft-Versus-Host-Disease
  • LLME
  • CD34+ stem cell infusions
  • CD34- fraction
  • Cyclosporine
  • Mycophenolate Mofetil
  • HSCT
  • Hematopoietic stem cell transplantation
  • Neoplasms
  • Graft vs Host Disease
  • Hematologic Neoplasms



Thomas Jefferson University` Philadelphia, Pennsylvania  19107