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CompletedNCT02491359Updated Feb 6, 2019Results posted

Carfilzomib in Treating Patients With Chronic Graft-Versus-Host Disease

A Phase 2 interventional study of Carfilzomib and Laboratory Biomarker Analysis in Chronic Graft Versus Host Disease, sponsored by Fred Hutchinson Cancer Center. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-06.

Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This pilot phase II trial studies how well carfilzomib works in treating patients with chronic graft-versus-host disease. Chronic graft-versus-host disease is a complication of a donor bone marrow or blood cell transplant, usually occurring more than three months after transplant, in which donor cells damage the host tissue. Carfilzomib may be an effective treatment for chronic graft-versus-host disease.

Read the detailed description

PRIMARY OBJECTIVE:

I. Determine proportion of subjects with treatment failure by 6 months of carfilzomib therapy for chronic graft-versus-host disease (GVHD).

SECONDARY OBJECTIVES:

I. Determine 3 month overall (complete + partial), and complete response rate.

II. Determine 6 month overall (complete + partial), and complete response rate.

III. Report overall survival, non-relapse mortality, primary malignancy relapse, failure-free survival, treatment success, and discontinuation of immune suppression at 6 months and 1 year.

IV. Examine functional outcome (2-minute walk test) and patient-reported outcomes (Lee Chronic GVHD Symptom Scale, quality of life [Short Form Health Survey (SF)-36, Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT) Questionnaire], Human Activity Profile [HAP]) at study enrollment, 6 months, and 1 year.

V. Study biologic effects of proteasome inhibition.

OUTLINE:

Patients receive carfilzomib intravenously (IV) over approximately 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 3, 6, and 12 months.

02

Conditions studied

  • Chronic Graft Versus Host Disease
03

In context

Bronchiolitis Obliterans Syndrome

376 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 104 are open to participants now.

This study's enrollment of 20 is below the median of 35 across 296 interventional studies indexed under Bronchiolitis Obliterans Syndrome.

Browse Bronchiolitis Obliterans Syndrome studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of chronic GVHD according to National Institutes of Health (NIH) Consensus Criteria

    • May have either classic chronic GVHD or overlap subtype of chronic GVHD
  • Failure of at least one prior line of systemic immune suppressive therapy for management of chronic GVHD
  • Subject underwent transplantation at least 3 months prior to enrollment
  • Anticipated life expectancy >= 6 months
  • Alanine aminotransferase (ALT) =\< 3.5 times the upper limit of normal, unless due to chronic GVHD
  • Bilirubin =\< 2 mg/dL, unless due to chronic GVHD
  • Absolute neutrophil count (ANC) >= 1.0 × 10\^9/L
  • Hemoglobin >= 8 g/dL
  • Platelet count >= 50 × 10\^9/L
  • Creatinine clearance (CrCl) >= 15 mL/minute, either measured or calculated
  • Signed informed consent in accordance with federal, local, and institutional guidelines
  • Females of childbearing potential (FCBP) must agree to a pregnancy test at study enrollment and to practice contraception during the study
  • Male subjects must agree to practice contraception during the study

Exclusion criteria

Exclusion Criteria:

  • Evidence of recurrent or progressive underlying malignant disease
  • Pregnant or lactating females

  • Surgery within 21 days prior to enrollment

    • Does not include placement of venous access device, bone marrow biopsy, GVHD diagnostic biopsy, or other routine procedures in chronic GVHD or post-transplantation care

  • Uncontrolled infection within 14 days prior to enrollment

    • Infection treated with appropriate antimicrobial therapy and without signs of progression/treatment failure does not constitute an exclusion criterion
  • Documented human immunodeficiency virus (HIV) infection
  • Active hepatitis B or C infection
  • Documented unstable angina or myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or grade 3 conduction system abnormalities (unless subject has a pacemaker), left ventricular ejection fraction (LVEF) \< 40%, history of torsade de pointe

  • Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment

    • Sustained systolic blood pressure > 160 or diastolic blood pressure > 100 despite medical therapy; sustained blood sugar > 300 despite medical therapy
    • Chronic hypertension or diabetes on appropriate medical therapy does not constitute an exclusion criterion

  • Non-hematologic malignancy within the past 3 years with the exception of:

    • Adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer
    • Carcinoma in situ of the cervix or breast
    • Prostate cancer of Gleason grade 6 or less with stable prostate-specific antigen levels
    • Cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study
  • Significant neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) version (ver.) 4.03 or current version (grade 3 and above, or grade 2 with pain) within 14 days prior to enrollment
  • History of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)
  • Contraindication to all available herpes simplex virus (HSV)/varicella prophylactic antiviral drugs
  • Pleural effusions requiring thoracentesis, or ascites requiring paracentesis, within 14 days prior to enrollment
  • Any other clinically significant medical or psychological disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
  • New systemic immune suppressive agent added for the treatment of chronic GVHD within 2 weeks prior to enrollment
  • Treatment with a non-Food and Drug Administration (FDA) approved drug in the previous 4 weeks
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Treatment (carfilzomib)

    Patients receive carfilzomib IV over approximately 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

    Drug: Carfilzomib · Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment · Other: Questionnaire Administration

Interventions

  • DrugCarfilzomib

    Given IV

    Also known as: Kyprolis, PR-171

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • OtherQuality-of-Life Assessment

    Ancillary studies

    Also known as: Quality of Life Assessment

  • OtherQuestionnaire Administration

    Ancillary studies

06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Events

    according to National Cancer Institute CTCAE, version 4.03

    Time frame: Up to 30 days following completion of study treatment

  2. Probability of Treatment Failure at 6mo

    Kaplan-Meier estimate assessed at 6 months for treatment failure, defined as requirement of an additional line of systemic immune-suppressive therapy, recurrent malignancy, or death.

    Time frame: 6 months

Secondary outcomes

  1. Complete Response Rate

    Complete response (CR) at 6 months will be determined by both clinician-defined CR, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference.

    Time frame: Up to 6 months

  2. Cumulative Incidence of Non-relapse Mortality and Primary Malignancy Relapse

    The cumulative incidence of non-relapse mortality (defined as death in the absence of primary malignancy relapse after transplant) and relapse (defined as hematologic relapse or any unplanned intervention to prevent progression of disease in patients with evidence (molecular, cytogenetic, flow cytometric, radiographic) of malignant disease after transplantation) will be estimated from time of study therapy initiation. These will be treated as competing-risk events, and estimated at 1 year.

    Time frame: 1 year

  3. Probability of Failure-free Survival at 1 Year

    Kaplain-Meier estimate assessed at 1 year for failure-free survival, defined as absence of death from any cause, relapse, or addition of secondary immune-suppressive agents.

    Time frame: 1 year

  4. Impact of Proteasome Inhibition

    The biologic impact of proteasome inhibition in the treatment of chronic GVHD will be assessed at baseline, 3 and 6 months. The association between biologic outcome measures and clinical parameters (response, treatment failure, mortality) will be studied.

    Time frame: Up to 6 months

  5. Incidence of Discontinuation of All Systemic Immune-suppressive Therapies

    The incidence of complete discontinuation of all systemic immune-suppressive therapies will be determined at 1 year.

    Time frame: 1 year

  6. Overall Response Rate

    Overall response rate (ORR) (complete response + partial response) at 6 months will be determined by both clinician-defined categories of complete response and partial response, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference.

    Time frame: 6 months

  7. Probability of Overall Survival at 1 Year

    Kaplan-Meier estimate assessed at 1 year for overall survival, defined as absence of death from any cause.

    Time frame: 1 year

  8. Treatment Success

    Treatment success will be estimated at 1 year with a composite outcome of complete resolution of all reversible chronic GVHD manifestations, discontinuation of all systemic immune suppressive agents, and freedom from death or primary malignancy relapse after transplant.

    Time frame: 1 year

  9. Use of Additional Systemic Immune-suppressive Therapies

    Addition of therapy after carfilzomib constitutes failure, could occur at any time from baseline to 12mo.

    Time frame: 1 year

  10. Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)

    SF-36 subscales have min=0 and max=100; results given are actual scores at 12mo, with higher scores indicating higher quality of life.

    Time frame: baseline

  11. Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)

    FACT-BMT subscales have various min/max, see below; results given are actual 12mo scores, with higher scores indicating better functioning. FACT physical well-being (0-28) FACT social/family well-being (0-28) FACT emotional well-being (0-24) FACT functional well-being (0-28) FACT Bone Marrow Transplant (BMT) subscale (0-40) FACT trial outcome index (0-96) FACT-General (G) (0-108) FACT-BMT total (0-148)

    Time frame: baseline

  12. Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)

    HAP subscales have min=0 and max=94; results given are actual 12mo scores, with higher scores indicating better functioning. Maximum Activity Score (MAS) is highest item number answered still doing. Represents highest oxygen demanding activity that respondent still performs. Adjusted Activity Score (AAS) is MAS minus total number of stopped doing responses below MAS. A measure of usual daily activities. Modified AAS is MAS minus total number of stopped doing responses below MAS but not penalized for not doing activities not permitted post transplant. The following items are not counted against the score:11,15,19,20,22,25,34,41,42,47,49,50,52,53,54,57,72,73,77,78.

    Time frame: baseline

  13. Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale

    Lee symptom scale (LSS) has subscales with min=0, max=100; results given are 12mo scores, with higher numbers indicating higher symptom burden.

    Time frame: baseline

07

Results

Posted Feb 6, 2019

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Carfilzomib)
Started20
Completed4
Not completed16

Outcome measures

PrimaryIncidence of Adverse Events

according to National Cancer Institute CTCAE, version 4.03

Time frame:
Up to 30 days following completion of study treatment
Reported as:
Number · participants
Incidence of Adverse Events
participantsTreatment (Carfilzomib)
Serious Adverse Events8
Non-Serious Adverse Events7
PrimaryProbability of Treatment Failure at 6mo

Kaplan-Meier estimate assessed at 6 months for treatment failure, defined as requirement of an additional line of systemic immune-suppressive therapy, recurrent malignancy, or death.

Time frame:
6 months
Reported as:
Number · probability of treatment failure
Probability of Treatment Failure at 6mo
probability of treatment failureTreatment (Carfilzomib)
Probability of Treatment Failure at 6mo0.4
SecondaryComplete Response Rate

Complete response (CR) at 6 months will be determined by both clinician-defined CR, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference.

Time frame:
Up to 6 months
Reported as:
Number · participants
Complete Response Rate
participantsResponse Evaluated by MDResponse Evaluated by NIH
partial response54
mixed response04
unchanged21
progressive20
failed77
SecondaryCumulative Incidence of Non-relapse Mortality and Primary Malignancy Relapse

The cumulative incidence of non-relapse mortality (defined as death in the absence of primary malignancy relapse after transplant) and relapse (defined as hematologic relapse or any unplanned intervention to prevent progression of disease in patients with evidence (molecular, cytogenetic, flow cytometric, radiographic) of malignant disease after transplantation) will be estimated from time of study therapy initiation. These will be treated as competing-risk events, and estimated at 1 year.

Time frame:
1 year
Reported as:
Count of participants · Participants
Cumulative Incidence of Non-relapse Mortality and Primary Malignancy Relapse
ParticipantsTreatment (Carfilzomib)
Cumulative Incidence of Non-relapse Mortality and Primary Malignancy Relapse7
SecondaryProbability of Failure-free Survival at 1 Year

Kaplain-Meier estimate assessed at 1 year for failure-free survival, defined as absence of death from any cause, relapse, or addition of secondary immune-suppressive agents.

Time frame:
1 year
Reported as:
Number · probability of failure-free survival
Probability of Failure-free Survival at 1 Year
probability of failure-free survivalTreatment (Carfilzomib)
Probability of Failure-free Survival at 1 Year.32
SecondaryImpact of Proteasome Inhibition

The biologic impact of proteasome inhibition in the treatment of chronic GVHD will be assessed at baseline, 3 and 6 months. The association between biologic outcome measures and clinical parameters (response, treatment failure, mortality) will be studied.

Time frame:
Up to 6 months

No measurements were reported for this outcome.

SecondaryIncidence of Discontinuation of All Systemic Immune-suppressive Therapies

The incidence of complete discontinuation of all systemic immune-suppressive therapies will be determined at 1 year.

Time frame:
1 year
Reported as:
Count of participants · Participants
Incidence of Discontinuation of All Systemic Immune-suppressive Therapies
ParticipantsTreatment (Carfilzomib)
Incidence of Discontinuation of All Systemic Immune-suppressive Therapies2
SecondaryOverall Response Rate

Overall response rate (ORR) (complete response + partial response) at 6 months will be determined by both clinician-defined categories of complete response and partial response, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference.

Time frame:
6 months
Reported as:
Number · participants
Overall Response Rate
participantsTreatment (Carfilzomib)
Physician impression ORR4
NIH ORR3
SecondaryProbability of Overall Survival at 1 Year

Kaplan-Meier estimate assessed at 1 year for overall survival, defined as absence of death from any cause.

Time frame:
1 year
Reported as:
Number · probability of overall survival
Probability of Overall Survival at 1 Year
probability of overall survivalTreatment (Carfilzomib)
Probability of Overall Survival at 1 Year.65
SecondaryTreatment Success

Treatment success will be estimated at 1 year with a composite outcome of complete resolution of all reversible chronic GVHD manifestations, discontinuation of all systemic immune suppressive agents, and freedom from death or primary malignancy relapse after transplant.

Time frame:
1 year
Reported as:
Number · participants
Treatment Success
participantsTreatment (Carfilzomib)
Treatment Success0
SecondaryUse of Additional Systemic Immune-suppressive Therapies

Addition of therapy after carfilzomib constitutes failure, could occur at any time from baseline to 12mo.

Time frame:
1 year
Reported as:
Number · participants
Use of Additional Systemic Immune-suppressive Therapies
participantsTreatment (Carfilzomib)
Use of Additional Systemic Immune-suppressive Therapies13
SecondarySymptoms as Measured by Patient Self-report--Short Form-36 (SF-36)

SF-36 subscales have min=0 and max=100; results given are actual scores at 12mo, with higher scores indicating higher quality of life.

Time frame:
baseline
Reported as:
Median · units on a scale
Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)
units on a scaleTreatment (Carfilzomib)
Norm-based physical functioning36 (14.9 to 52.8)
norm-based role-physical score33.6 (17.7 to 54.4)
norm-based bodily pain score41.4 (19.9 to 62.1)
norm-based general health score32.9 (23.4 to 48.2)
norm-based vitality score42.7 (30.2 to 64.6)
norm-based social functioning40.5 (13.2 to 56.8)
norm-based role-emotional score40.3 (17 to 55.9)
norm-based mental health score50 (33.1 to 61.3)
standardized physical component score37 (15.9 to 52.2)
standardized mental component score49 (28.6 to 64.1)
SecondarySymptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)

FACT-BMT subscales have various min/max, see below; results given are actual 12mo scores, with higher scores indicating better functioning. FACT physical well-being (0-28) FACT social/family well-being (0-28) FACT emotional well-being (0-24) FACT functional well-being (0-28) FACT Bone Marrow Transplant (BMT) subscale (0-40) FACT trial outcome index (0-96) FACT-General (G) (0-108) FACT-BMT total (0-148)

Time frame:
baseline
Reported as:
Median · units on a scale
Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)
units on a scaleTreatment (Carfilzomib)
physical well-being21.5 (7 to 26)
social/family well-being21.5 (15 to 28)
emotional well-being18.5 (8 to 24)
functional well-being16.5 (5 to 23)
BMT subscale28 (21 to 33.3)
FACT-G72.8 (53 to 98)
trial outcome index65 (39 to 81)
FACT-BMT total101.3 (75 to 131.3)
SecondarySymptoms as Measured by Patient Self-report--Human Activities Profile (HAP)

HAP subscales have min=0 and max=94; results given are actual 12mo scores, with higher scores indicating better functioning. Maximum Activity Score (MAS) is highest item number answered still doing. Represents highest oxygen demanding activity that respondent still performs. Adjusted Activity Score (AAS) is MAS minus total number of stopped doing responses below MAS. A measure of usual daily activities. Modified AAS is MAS minus total number of stopped doing responses below MAS but not penalized for not doing activities not permitted post transplant. The following items are not counted against the score:11,15,19,20,22,25,34,41,42,47,49,50,52,53,54,57,72,73,77,78.

Time frame:
baseline
Reported as:
Median · units on a scale
Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)
units on a scaleTreatment (Carfilzomib)
maximum activity score66 (6 to 87)
adjusted activity score57 (2 to 82)
modified adjusted activity score60 (2 to 82)
SecondarySymptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale

Lee symptom scale (LSS) has subscales with min=0, max=100; results given are 12mo scores, with higher numbers indicating higher symptom burden.

Time frame:
baseline
Reported as:
Median · units on a scale
Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale
units on a scaleTreatment (Carfilzomib)
skin scale32.5 (0 to 100)
energy scale42.9 (7.1 to 96.4)
lung scale5 (0 to 30)
eye scale62.5 (0 to 100)
nutrition scale5 (0 to 20)
psychological scale25 (0 to 66.7)
mouth scale0 (0 to 75)
overall summary score21.6 (8.2 to 49.3)

Adverse events

Collected over 30 days after stopping study drug. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Carfilzomib)2/20 (10%)8/20 (40%)7/20 (35%)
Most frequent serious events
Most frequent serious events
EventTreatment (Carfilzomib)
sepsisInfections and infestations2/20
pneumothoraxRespiratory, thoracic and mediastinal disorders1/20
hypoxiaRespiratory, thoracic and mediastinal disorders1/20
fever/infusion reactionGeneral disorders1/20
leg ulcersSkin and subcutaneous tissue disorders1/20
pneumoniaRespiratory, thoracic and mediastinal disorders1/20
acute renal failure/sepsisRenal and urinary disorders1/20
respiratory failureRespiratory, thoracic and mediastinal disorders1/20
nausea/vomitting/diarrheaGastrointestinal disorders1/20
fallInjury, poisoning and procedural complications1/20
Most frequent other events
Showing 10 of 11
Most frequent other events
EventTreatment (Carfilzomib)
decreased lymphocyte countBlood and lymphatic system disorders2/20
bullous dermatitisSkin and subcutaneous tissue disorders1/20
fungal lung infectionInfections and infestations1/20
diarrheaGastrointestinal disorders1/20
esophageal varicesGastrointestinal disorders1/20
hypokalemiaMetabolism and nutrition disorders1/20
increased ALTHepatobiliary disorders1/20
intermittent hyperglycemiaMetabolism and nutrition disorders1/20
Left hip hemiarthroplastyMusculoskeletal and connective tissue disorders1/20
myositisMusculoskeletal and connective tissue disorders1/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment (Carfilzomib)
Median53 (46 to 64)
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Carfilzomib)
Female7
Male13
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Carfilzomib)
Hispanic or Latino3
Not Hispanic or Latino17
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Carfilzomib)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander1
Black or African American3
White16
More than one race0
Unknown or Not Reported0
Primary Disease
Primary Disease(Participants)Treatment (Carfilzomib)
Acute leukemia (ALL/AML)12
Chronic leukemia (CML/CLL)4
Lymphoma (NHL/HD)2
Myeloma1
Myeloproliferative neoplasm1
08

Study locations

5 sites
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • Ohio State University Comprehensive Cancer Center
    Columbus, Ohio 43210, United States
  • University of Pittsburgh Cancer Institute (UPCI)
    Pittsburgh, Pennsylvania 15232, United States
  • Fred Hutch/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 9, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02491359
Lead sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 8, 2015
Start date
Nov 12, 2015
Primary completion
Feb 19, 2018
Completion
Sep 12, 2018
Results posted
Feb 6, 2019
Last update
Feb 6, 2019

Study contacts

Stephanie Lee
principal investigator · Fred Hutch/University of Washington Cancer Consortium

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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