IFN-DLI for Relapsed Acute Leukemia After Allo-SCT
Study Details
Study Description
Brief Summary
This trial is designed to determine the feasibility of conventional induction chemotherapy, IFNand G-CSF mobilized DLI (IFN-DLI) in subjects with relapsed AML and ALL after allo-SCT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Subject Recipients
|
Drug: Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily
|
| Experimental: Subject Donors
|
Drug: Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily
|
Outcome Measures
Primary Outcome Measures
- Number of Adverse Events [2 years]
Secondary Outcome Measures
- overall survival [2 years]
- disease-free survival [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
DLI Recipient
-
Relapsed AML or ALL ≥ 60 days after allogeneic SCT.
-
Evidence of residual donor chimerism on most recent analysis (within 4 weeks of enrollment).
-
Age ≥ 18 years of age,
-
Karnofsky performance status ≥ 60%.
-
Absence of active GVHD and off immunosuppression. Subjects on tapering prednisone will be eligible if their dose is 0.25 mg/kg or less and being actively tapered. We suggest a 28 day waiting period off of immunosuppression but some subjects with rapidly progressive disease may need to be treated before 30 days and will still be eligible.
-
Adequate organ function: Cr ≤ 2 mg/dL; ALT/AST < 3x ULN, direct bili <3x ULN.
-
Matched sibling or un-related donor (A, B, C, and DR) available to undergo leukopheresis.
-
Subjects must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
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Willing to provide blood samples for research purposes.
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Willing to adhere to medically accepted form of birth control to prevent pregnancy (includes: complete abstention from intercourse, condoms, diaphragms, cervical cap, intra-uterine device, history of surgical sterility - tubal ligation or vasectomy in patient or partner, or oral contraceptive).
DLI Donor
-
HLA identical to recipient subject.
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Considered medically eligible for leukopheresis procedure by independent donor physician (University of Pennsylvania physician who is not the recipient's primary transplant physician for related donors; physician designated by National Marrow Donor Program for unrelated donors).
-
Considered medically eligible to receive G-CSF (filgrastim) by independent donor physician.
Exclusion Criteria
Recipient
-
Prior cell therapy for relapse within the past 90 days.
-
Requirement for active immunosuppression to treat GVHD.
-
Pregnant or lactating women. The safety of this therapy on unborn children and effects on breast milk are not known.
-
Uncontrolled active infection
-
Any uncontrolled active medical disorder that would preclude participation as outlined.
Donor
- Unable to participate in a leukopheresis procedure or receive G-CSF (filgrastim).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
Investigators
- Principal Investigator: David Porter, MD, Abramson Cancer Center of the University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UPCC 09414