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Chronic Graft Versus Host DiseasePhase 2NCT03007238

Extracorporeal Photopheresis and Low Dose Aldesleukin in Treating Patients With Steroid Refractory Chronic Graft-Versus-Host Disease

A Phase 2 study testing Aldesleukin, Extracorporeal Photopheresis and Laboratory Biomarker Analysis in people with Chronic Graft Versus Host Disease, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies efficacy of extracorporeal photopheresis and low dose aldesleukin (interleukin-2) in treating patients with chronic graft-versus-host disease (cGVHD) that does not respond to upfront treatment with steroids. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Graft Versus Host Disease
What is being tested?
Aldesleukin, Extracorporeal Photopheresis and Laboratory Biomarker Analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
18 Jan 2017to 26 Jun 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Recipients of allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens; alternative donor transplants (umbilical cord blood and haploidentical) are allowed
  • Patients with chronic GVHD requiring systemic therapy are eligible
  • Participants must have steroid-refractory cGVHD, which is defined as having persistent signs and symptoms of cGVHD despite the use of prednisone at 0.20 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks (or equivalent dosing of alternate corticosteroids) without complete resolution of signs and symptoms
  • Karnofsky performance status of 70-100 %
  • Estimated life expectancy greater than 3 months
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
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  • Stable dose of corticosteroids for 2 weeks prior to enrollment, i.e. the patient's steroid dose (mg/kg) will remain unchanged (eg 0.5 mg/kg) in the 2 weeks preceding enrollment; allowances will be made for up or down titrating the dose based on changes in body weight
  • Total bilirubin < 2.0 mg/dl-exception permitted in patients with Gilbert's syndrome
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 x upper limit of normal (ULN), unless hepatic dysfunction is a manifestation of presumed cGVHD
  • Abnormal liver function tests (LFTs) in the context of active cGVHD involving other organ systems may also be permitted if the treating physician documents the LFTs as being consistent with hepatic cGVHD and a liver biopsy will not be mandated in this situation
  • Serum creatinine within normal institutional limits or creatinine clearance > 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal
  • Absolute neutrophil count (ANC) > 1000/mm^3
  • Platelets > 50,000/mm^3
  • All subjects must have the ability to understand and the willingness to sign a written informed consent
  • Patients with steroid refractory cGVHD typically have received salvage with multiple lines of therapy; hence in this trial there will be no restriction in terms of prior lines of therapy received; prior ECP exposure is allowed, however prior IL-2 use is excluded

Who cannot join

  • Patients should not have any uncontrolled illness including ongoing or active infection; patients with an ongoing prednisone requirement of > 1 mg/kg/day (or equivalent) will be excluded
  • History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura
  • Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment
  • Donor lymphocyte infusion within 100 days prior to enrollment
  • Active malignant relapse
  • Uncontrolled cardiac angina or symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV)
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  • Human immunodeficiency virus (HIV)-positive individuals on combination antiretroviral therapy are ineligible
  • Patients may not be receiving any other investigational agents, or concurrent parenteral biological, chemotherapy, or radiation therapy. Oral chemotherapeutic agents or biologics-for example ruxolitinib therapy (either past or current exposure)-is allowed
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2
  • Patients must not have received prior chemotherapy (pentostatin) within 4 weeks before study enrollment, and those who have not recovered from the adverse events due to agents administered more than 4 weeks earlier are excluded
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with IL-2
  • Patients with other active malignancies are ineligible for this study, other than superficial localized skin cancer (basal or squamous cell carcinoma)
  • Subjects, who in the opinion of the investigator may not be able to comply with IL-2 or ECP treatment requirements or the safety monitoring requirements of the study, will be excluded from participation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Phase II Trial of Extracorporeal Photopheresis (ECP) Plus Low Dose IL-2 for Treatment of Steroid Refractory Chronic Graft-versus-Host Disease (cGVHD)

This phase II trial studies efficacy of extracorporeal photopheresis and low dose aldesleukin (interleukin-2) in treating patients with chronic graft-versus-host disease (cGVHD) that does not respond to upfront treatment with steroids. In graft-vs-host disease, patients have a small quantity of a white blood cell called T regulatory cells or T-reg cells that helps to control the immune system. Extracorporeal photopheresis is a procedure where patient's blood is removed and treated with ultraviolet light and drugs that become active when exposed to light. The treated blood is then returned to the patient and may be effective in increasing T-reg cells in patients with cGVHD. Aldesleukin increases the activity and growth of white blood cells, and it has shown to enhance T-reg cells in patients with cGVHD and may be effective improving GVHD symptoms.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the anti-cGVHD activity of extracorporeal photopheresis (ECP) when combined with low dose IL-2 (interleukin 2) (aldesleukin), in patients with steroid refractory cGVHD, as assessed by overall cGVHD response rate (complete response [CR]+partial response [PR]+stable disease [SD]).

SECONDARY OBJECTIVES:

  1. Characterize and evaluate toxicities, including type, frequency, severity, attribution, time course and duration.

II. Estimate overall and failure-free survival, non-relapse mortality (NRM) and relapse, through 1 year after initiation of treatment.

III. Characterize chronic GVHD Symptom Scale scores -self-report (with assistance from register nurses [RNs] and medical doctors [MDs]).

IV. Assess the immunologic effects of low-dose daily subcutaneous (SC) IL-2 + ECP.

  1. Correlate clinical endpoints of response with ECP performance parameters.

OUTLINE:

Patients receive aldesleukin subcutaneously (SC) daily for 12 weeks. Patients also undergo ECP twice weekly on weeks 1-4 and then receive 2 ECP treatments every 2 weeks on weeks 5-12. Patients responding to upfront therapy with aldesleukin and ECP have the option to continue combination therapy per the discretion of the treating physician until clinical benefit is maintained or toxicities develop.

After completion of study treatment, patients are followed up periodically.

Being tested
Aldesleukin, Extracorporeal Photopheresis, Laboratory Biomarker Analysis, Quality-of-Life Assessment
Medical subject headings
Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AldesleukinBiological

    Also called 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2

    Given SC

  • Extracorporeal PhotopheresisProcedure or surgery

    Also called Extracorporeal Photophoresis, photopheresis, Photophoresis

    Undergo ECP

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT03007238
Study groupRoleWhat they receive
Supportive care (aldesleukin and ECP)ExperimentalPatients receive aldesleukin SC daily for 12 weeks. Patients also undergo ECP twice weekly on weeks 1-4 and then receive 2 ECP treatments every 2 weeks on weeks 5-12. Patients responding to upfront therapy with aldesleukin and ECP have the option to continue combination therapy per the discretion of the treating physician until clinical benefit is maintained or toxicities develop.
Receives: Biological: Aldesleukin; Procedure: Extracorporeal Photopheresis; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate at Week 16 (4 Weeks After the End of Treatment)

    Defined as the proportion of response-evaluable participates that achieve a CR/PR or SD at Week 16 (4 weeks after the end of treatment).

    Measured: At Week 16 (4 weeks after the end of treatment)

Secondary outcomes (2)

  1. Failure-free Survival

    Failure-free survival will be estimated using the product-limit method of Kaplan and Meier.

    Measured: From date of first dose of study drug to first documented cGVHD progression (necessitating change of treatment), malignancy relapse or progression or death from any cause, whichever occurs first, assessed up to 1 year

  2. Overall Survival

    Overall survival was estimated using the product-limit method of Kaplan and Meier.

    Measured: From date of first dose of study drug to date of death from any cause, assessed up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2017 (estimated)
  2. Study start18 Jan 2017
  3. Primary completion16 Oct 2018
  4. Study completion26 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03007238
Sponsor's protocol ID
15125
Other IDs
NCI-2015-01933, 15125
Status last verified
Apr 2024
First submitted
23 Nov 2015
Last updated
8 Apr 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aldesleukin, Extracorporeal Photopheresis and Laboratory Biomarker Analysis in people with Chronic Graft Versus Host Disease, run by City of Hope Medical Center 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 13 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 8 Apr 2024. 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Response Rate at Week 16 (4 Weeks After the End of Treatment) (time frame: At Week 16 (4 weeks after the end of treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03007238.

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 8 Apr 2024.

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