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Ixazomib Citrate in Treating Patients With Chronic Graft-versus-Host Disease
Phase 2 trial testing Ixazomib Citrate in Chronic Graft Versus Host Disease in 50 participants. Completed in 27 June 2018.
| Lead sponsor | Fred Hutchinson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 8 December 2015 |
| Primary completion | 5 January 2018 |
| Estimated completion | 27 June 2018 |
| Sites | 6 locations across United States |
Fred Hutchinson Cancer Center — full company profile →
18 and older, any sex, with Chronic Graft Versus Host Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ixazomib Citrate) | 19 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ixazomib Citrate) | 18 |
Kaplan-Meier estimate assessed at 6 months for probability of treatment failure, defined as addition of a line of systemic immune-suppressive therapy, recurrent malignancy, or death.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ixazomib Citrate) | .28 |
The biologic impact of proteasome inhibition in the treatment of chronic GVHD will be assessed.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ixazomib Citrate) | 0 |
Response will be determined by both clinician-defined, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference.
| Group | Value | 95% CI |
|---|---|---|
| Response Evaluated by MD | 16 | |
| Response Evaluated by NIH | 17 | |
| Response Evaluated by MD | 4 | |
| Response Evaluated by NIH | 10 | |
| Response Evaluated by MD | 9 | |
| Response Evaluated by NIH | 4 | |
| Response Evaluated by MD | 3 | |
| Response Evaluated by NIH | 2 |
Kaplan-Meier estimate assessed at 1 year for probability of non-relapse mortality, defined as death in the absence of primary malignancy relapse after transplant.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ixazomib Citrate) | 0.1 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ixazomib Citrate) | 1 |
Kaplan-Meier estimate assessed at 1 year for failure-free survival, defined as the absence of death from any cause, relapse or addition of secondary immune suppressive agents.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ixazomib Citrate) | 0.57 |
The incidence of complete discontinuation of all systemic immune-suppressive therapies will be determined at 1 year.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ixazomib Citrate) | 0 |
ORR 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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ixazomib Citrate) | 16 |
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ixazomib Citrate) | 17 |
Kaplan-Meier estimate assessed at 1 year for overall survival, defined as absence of death from any cause.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ixazomib Citrate) | .9 |
Treatment success will be estimated at 1 year with a composite outcome of complete resolution of all reversible chronic graft-versus-host disease (GVHD) manifestations, discontinuation of all systemic immune suppressive agents, and freedom from death or primary malignancy relapse after transplant.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ixazomib Citrate) | 0 |
Addition of therapy after ixazomib constitutes failure, could occur at any time from baseline to 12mo.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Ixazomib Citrate) | 21 |
Time frame: 30 days after stopping study drug. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Ixazomib Citrate) |
|---|---|---|
| fever | General disorders | — |
| pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Death | General disorders | — |
| Calcaneal fracture | Musculoskeletal and connective tissue disorders | — |
| Pancreatitis | Gastrointestinal disorders | — |
| atrial fibrillation | Cardiac disorders | — |
| respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| vomiting, nausea, diarrhea | Gastrointestinal disorders | — |
| chills/weakness | General disorders | — |
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | — |
| right bundle branch block | Cardiac disorders | — |
| flu-like symptoms | General disorders | — |
| pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| skin infection | Infections and infestations | — |
| avascular necrosis of hip | Musculoskeletal and connective tissue disorders | — |
| perforated colon | Gastrointestinal disorders | — |
| periorbital cellulitis | Eye disorders | — |
| dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| osteonecrosis | Musculoskeletal and connective tissue disorders | — |
| Progressive multifocal leukoencephalopathy | Nervous system disorders | — |
| leg ulcers/cellulitis | Skin and subcutaneous tissue disorders | — |
| pericardial effusion | Cardiac disorders | — |
| acute bronchitis | Respiratory, thoracic and mediastinal disorders | — |
| nausea | Gastrointestinal disorders | — |
| pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Treatment (Ixazomib Citrate) |
|---|---|---|
| thrombocytopenia | Blood and lymphatic system disorders | — |
| hypertriglyceridemia | Metabolism and nutrition disorders | — |
| peripheral neuropathy | Nervous system disorders | — |
| amylase increased | Investigations | — |
| constipation | Gastrointestinal disorders | — |
| diarrhea | Gastrointestinal disorders | — |
| fatigue | General disorders | — |
| headache | Nervous system disorders | — |
| hyperglycemia | Metabolism and nutrition disorders | — |
| hyponatremia | Metabolism and nutrition disorders | — |
| hypophosphatemia | Metabolism and nutrition disorders | — |
| influenza a | Infections and infestations | — |
| leg pain | Musculoskeletal and connective tissue disorders | — |
| lipase increased | Investigations | — |
| lymphopenia | Blood and lymphatic system disorders | — |
| muscle weakness | Musculoskeletal and connective tissue disorders | — |
| otomastoiditis | Ear and labyrinth disorders | — |
| pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| restlessness | Nervous system disorders | — |
| skin infection | Infections and infestations | — |
| worsening pain | Musculoskeletal and connective tissue disorders | — |
| wound infection | Infections and infestations | — |
Most-reported serious reactions: fever, pleural effusion, Death, Calcaneal fracture, Pancreatitis, atrial fibrillation, respiratory failure, vomiting, nausea, diarrhea.
Data from ClinicalTrials.gov NCT02513498 adverse events section.
This phase II trial studies how well ixazomib citrate 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. Ixazomib citrate may be an effective treatment for chronic graft-versus-host disease.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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