IFN-DLI for Relapsed Acute Leukemia After Allo-SCT

NCT02331706 | Completed Early Phase 1 DMC

• 1 other identifier: UPCC 09414
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  2 years

Secondary Outcomes (2)

• overall survival

  2 years

• disease-free survival

  2 years

Study Arms (2)

Subject Recipients

EXPERIMENTAL

Drug: Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily

Subject Donors

EXPERIMENTAL

Drug: Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily

Interventions

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

Subject Donors; Subject Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Leukemia

Interventions

Introns

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes

Study Officials

• David Porter, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: January 6, 2015
• Study Start: December 1, 2014
• Primary Completion: November 11, 2016
• Study Completion: November 11, 2017
• Last Updated: April 21, 2020

Record last verified: 2020-04

Locations

US (1)