IFN-DLI for Relapsed Acute Leukemia After Allo-SCT

Completed · Early Phase 1

Conditions studied: Leukemia

In brief

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.

Key facts

Study ID

NCT02331706

Run by

Abramson Cancer Center at Penn Medicine

People needed

16

Starts

2014-12-01

Expected to finish

2017-11-11

Last updated by the study team

2020-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Willing to provide blood samples for research purposes.
• 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.
• 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.

You may not qualify if…

• 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).

Where it is running

• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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