A Pilot Study to Determine the Feasibility of Conventional Induction Chemotherapy Followed by G-CSF Mobilized Donor Leukocyte Infusion (DLI) and IFN-α (IFN-DLI) for Relapsed Acute Leukemia After Allogeneic Stem Cell Transplantation.

Abramson Cancer Center at Penn Medicine1 site in 1 country16 target enrollmentDecember 2014

ConditionsLeukemia

InterventionsInterferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily

DrugsInterferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily

Overview

Phase: Early Phase 1
Intervention: Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily
Conditions: Leukemia
Sponsor: Abramson Cancer Center at Penn Medicine
Enrollment: 16
Locations: 1
Primary Endpoint: Number of Adverse Events
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

November 11, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abramson Cancer Center at Penn Medicine

Responsible Party

Sponsor

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