IFN-DLI for Relapsed Acute Leukemia After Allo-SCT

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.

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.

Study Overview

• Status: Completed
• Conditions: Leukemia
• Intervention / Treatment: Drug: Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• 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

1. HLA identical to recipient subject.
2. 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).
3. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Adverse Events	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	2 years
disease-free survival	2 years

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania
• Investigators: Principal Investigator: David Porter, MD, Abramson Cancer Center of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): November 11, 2016
• Study Completion (Actual): November 11, 2017

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Physiological Effects of Drugs; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Interferon alpha-2
• Other Study ID Numbers: UPCC 09414