LeukemiaEarly Phase 1NCT02331706
IFN-DLI for Relapsed Acute Leukemia After Allo-SCT
A Early Phase 1 study testing Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily in people with Leukemia, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 11 Nov 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
- Conditions
- Leukemia
- Being tested
- Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous dailyDrug
| Study group | Role | What they receive |
|---|---|---|
| Subject Recipients | Experimental | Not described Receives: Drug: Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily |
| Subject Donors | Experimental | Not described Receives: Drug: Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 2 years
Secondary outcomes (2)
overall survival
Measured: 2 years
disease-free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startDec 2014
- Primary completion11 Nov 2016
- Study completion11 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Porter, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331706
- Sponsor's protocol ID
- UPCC 09414
- Status last verified
- Apr 2020
- First submitted
- 22 Dec 2014
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02331706
- Acronym / sponsor ID
- UPCC 09414
- Conditions
- Leukemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- 11 Nov 2016 (actual)
- Study completion
- 11 Nov 2017 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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%.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily | Drug | Subject Donors, Subject Recipients |
Primary outcome
Number of Adverse Events
Time frame: 2 years
2 secondary outcomes
overall survival
Time frame: 2 years
disease-free survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Porter, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily in people with Leukemia, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.