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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00323 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 9962 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| RG1001667 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized trial studies how well discontinuation or continuation of immunosuppressive therapy works in treating participants with chronic graft versus host disease. Continuation of immunosuppressive treatment may prevent graft-versus-host disease worsening.
PRIMARY OBJECTIVE:
I. Assess feasibility of enrolling and randomizing patients with chronic graft versus host disease (GVHD) to discontinuation (standard of care) versus continuation (investigation) of immunosuppressive therapy (IST).
SECONDARY OBJECTIVES:
I. Assess feasibility of enrolling and randomizing patients who are not local, and evaluate the quality of data received for those patients.
II. Assess whether prolonged IST decreases the need for pulses of high dose IST.
III. Evaluate the effect of prolonged IST on chronic GVHD manifestations and severity, risk of relapse, infection and organ toxicity.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants have their IST tapered and discontinued per the plan.
ARM II: Participants continue to receive a fixed dose IST for an additional 9 months with no taper.
After completion of study treatment, participants are followed up annually.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (discontinued IST) | Active Comparator | Participants have their IST tapered and discontinued per the plan. |
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| Arm II (continued IST) | Experimental | Participants continue to receive a fixed dose IST for an additional 9 months with no taper. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunosuppressive Therapy | Biological | Discontinued IST |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Enrolling Patients | Descriptive summary of number of patients enrolled on the study (signed consent) | 22.9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Randomizing Patients | Descriptive summary of percentage of patients randomized. | 22.9 months |
| Compliance With Treatment | Rate of patients following study immunosuppressive therapy management based on study arm (standard taper or continuation of low dose). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Lee | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
4 participants were not randomized. 1 could not be reached and 3 had a GVHD flare after enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Discontinued IST) | Participants have their IST tapered and discontinued per the plan. |
| FG001 | Arm II (Continued IST) | Participants continue to receive a fixed dose IST for an additional 9 months with no taper. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2020 |
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| Immunosuppressive Therapy | Biological | Continued IST |
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| Survey Administration | Other | Ancillary studies |
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| Up to 12 months after randomization |
| Compliance With Data Collection | Count of surveys completed by physicians and patients | Up to 12 months after randomization |
| Graft Versus Host Disease Manifestations | New chronic graft versus host disease (GVHD) manifestations and/or worsening of existing manifestations | Up to 12 months after randomization |
| Recurrent Malignancy | Incidence of relapse of primary disease | Up to 12 months after randomization |
| Incidence of Grade >= 3 Infections | Incidence of grade >= 3 infections | Up to 12 months after randomization |
| Incidence of Grade >= 3 Organ Toxicity | Incidence of grade >= 3 organ toxicity | Up to 12 months after randomization |
| Enrollment Rate of Participants Who Are Not Local | Enrollment rate of participants who are not local. Participants who are local defined as those who had all or some study visits completed at the cancer center. | Up to 12 months after randomization |
| Quality of Data of Participants Who Are Not Local | Participants who are local defined as those who had all or some study visits completed at the cancer center. | Up to 12 months after randomization |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Discontinued IST) | Participants have their IST tapered and discontinued per the plan. |
| BG001 | Arm II (Continued IST) | Participants continue to receive a fixed dose IST for an additional 9 months with no taper. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Enrolling Patients | Descriptive summary of number of patients enrolled on the study (signed consent) | Posted | Count of Participants | Participants | 22.9 months |
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| Secondary | Feasibility of Randomizing Patients | Descriptive summary of percentage of patients randomized. | Posted | Count of Participants | Participants | 22.9 months |
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| Secondary | Compliance With Treatment | Rate of patients following study immunosuppressive therapy management based on study arm (standard taper or continuation of low dose). | Posted | Count of Participants | Participants | Up to 12 months after randomization |
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| Secondary | Compliance With Data Collection | Count of surveys completed by physicians and patients | Posted | Number | surveys | Up to 12 months after randomization |
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| Secondary | Graft Versus Host Disease Manifestations | New chronic graft versus host disease (GVHD) manifestations and/or worsening of existing manifestations | Posted | Count of Participants | Participants | Up to 12 months after randomization |
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| Secondary | Recurrent Malignancy | Incidence of relapse of primary disease | Posted | Count of Participants | Participants | Up to 12 months after randomization |
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| Secondary | Incidence of Grade >= 3 Infections | Incidence of grade >= 3 infections | Posted | Count of Participants | Participants | Up to 12 months after randomization |
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| Secondary | Incidence of Grade >= 3 Organ Toxicity | Incidence of grade >= 3 organ toxicity | Posted | Count of Participants | Participants | Up to 12 months after randomization |
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| Secondary | Enrollment Rate of Participants Who Are Not Local | Enrollment rate of participants who are not local. Participants who are local defined as those who had all or some study visits completed at the cancer center. | All participants were local, no data were collected for this outcome measure. | Posted | Up to 12 months after randomization |
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| Secondary | Quality of Data of Participants Who Are Not Local | Participants who are local defined as those who had all or some study visits completed at the cancer center. | All participants were local, no data were collected for this outcome measure. | Posted | Up to 12 months after randomization |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Discontinued IST) | Participants have their IST tapered and discontinued per the plan. Immunosuppressive Therapy: Discontinued IST Survey Administration: Ancillary studies | 0 | 9 | 0 | 9 | 8 | 9 |
| EG001 | Arm II (Continued IST) | Participants continue to receive a fixed dose IST for an additional 9 months with no taper. Immunosuppressive Therapy: Continued IST Survey Administration: Ancillary studies | 0 | 8 | 2 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gangrene | Infections and infestations | Non-systematic Assessment |
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| heart failure | Cardiac disorders | Non-systematic Assessment | EF 30% |
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| myocardial infarction | Cardiac disorders | Non-systematic Assessment |
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| osteomyelitis | Infections and infestations | Non-systematic Assessment |
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| peripheral ischemia | Vascular disorders | Non-systematic Assessment |
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| retinal detachment | Eye disorders | Non-systematic Assessment |
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| stent placement | Cardiac disorders | Non-systematic Assessment |
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| wound complications | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
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| allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| anal fissures | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| corneal ulcer | Eye disorders | Non-systematic Assessment |
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| depression | Psychiatric disorders | Non-systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| dizziness | General disorders | Non-systematic Assessment |
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| dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
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| eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| elevated creatinine | Renal and urinary disorders | Non-systematic Assessment |
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| essential tremor | Nervous system disorders | Non-systematic Assessment |
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| fall | General disorders | Non-systematic Assessment |
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| fatigue | General disorders | Non-systematic Assessment |
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| fecal incontinence | Gastrointestinal disorders | Non-systematic Assessment |
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| fever | General disorders | Non-systematic Assessment |
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| flatulence | Gastrointestinal disorders | Non-systematic Assessment |
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| floaters, eye | Eye disorders | Non-systematic Assessment |
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| fracture, clavicle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
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| GI upset, drug induced | Gastrointestinal disorders | Non-systematic Assessment |
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| headache | General disorders | Non-systematic Assessment |
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| hernia, umbilical | Gastrointestinal disorders | Non-systematic Assessment |
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| hypertriglyceridemia | Gastrointestinal disorders | Non-systematic Assessment |
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| insomnia | General disorders | Non-systematic Assessment |
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| iron deficiency anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| IV contrast reaction | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| leukopenia | Immune system disorders | Non-systematic Assessment |
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| lightheadedness | General disorders | Non-systematic Assessment |
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| Mucous cyst (toe) | Infections and infestations | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| neuropathy | Nervous system disorders | Non-systematic Assessment |
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| prostatitis, presumed | Endocrine disorders | Non-systematic Assessment |
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| skin, ulcer or lesion | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| skin, erythematous bumps, macules | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| skin, dermatitis, pruritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| stiffness, muscular | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| urination, difficult | Renal and urinary disorders | Non-systematic Assessment |
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| weight gain or loss | General disorders | Non-systematic Assessment |
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| constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| lower respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| phimosis | Reproductive system and breast disorders | Non-systematic Assessment |
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| seizure | Nervous system disorders | Non-systematic Assessment |
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| thrombocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
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| thrush | Infections and infestations | Non-systematic Assessment |
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| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate Chilson | FHCRC | 206-667-6069 | kchilson@fredhutch.org |
| Apr 23, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 8, 2020 | Apr 23, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D007165 | Immunosuppression Therapy |
| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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