Status:
TERMINATED
Trial of Donor Lymphocyte Infusion (DLI) and Activated DLI Following Relapse After Allogeneic Stem Cell Transplant
Lead Sponsor:
University of Pennsylvania
Conditions:
Chronic Myelogenous Leukemia
Acute Myelogenous Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is for patients with relapsed of disease after allogeneic bone marrow The donor's T cells are activated by exposure to 2 compounds or antibodies that bind (or stick to) two compounds on T ...
Detailed Description
You are being asked to participate in this research study because your disease has relapsed after allogeneic bone marrow transplantation (putting normal bone marrow from one person into another that w...
Eligibility Criteria
Inclusion
- Prior allogeneic stem cell transplant.
- Expected survival \> 4 weeks
- Original bone marrow donor available for leukocyte donation.
- Absence of active acute GVHD \> grade I, or chronic GVHD.
- Off all immune suppression for GVHD for 28 days (an exception may be made for patients with acute leukemia whose disease is progressing rapidly and a 28 day waiting period after discontinuation of immune suppression is not practical or appropriate).
- Creatinine \< 2.5 mg/dl.
- Relapsed or persistent advanced malignancy with less than a 50% chance of responding to unstimulated DLI:
- a. CML: Relapse with accelerated phase, or blast phase disease b. AML, ALL i. Cytogenetic relapse (less than 5% blasts).
- The patient's leukemia-specific chromosome abnormality is detectable by standard cytogenetics in more than 25% of cells at any time greater than day 50 post-transplant.
- ii. Hematologic relapse: More than 5% blasts in the marrow or peripheral blood.
- c. MDS d. Non-Hodgkin's Lymphoma or Hodgkin's Disease i. Relapse: Recurrent disease by serial physical exam, radiographic studies, or molecular studies. If possible, tumor should be re-biopsied to determine histology and rule out possibility of EBV-related lymphoproliferative disease e. CLL f. Myeloma
Exclusion
- Active chronic or acute GVHD \> grade I.
- Requirement for active immunosuppression to treat GVHD.
- Pregnant or lactating women. The safety of this therapy on unborn children or effects on breast milk are not known.
- Uncontrolled active infection
- Any uncontrolled active medical disorder that would preclude participation as outlined.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00674427
Start Date
January 1 2008
End Date
January 1 2012
Last Update
August 17 2020
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104