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| ID | Type | Description | Link |
|---|---|---|---|
| 96950 | Other Identifier | Stanford University alternate IRB Number | |
| BMT177 | Other Identifier | OnCore | |
| NCI-2011-00450 | Other Identifier | National Cancer Institute (NCI) |
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The addition of rituximab to prednisone for the initial treatment of chronic GVHD will increase the overall response rate, enable a more rapid and effective steroid taper.
To determine the efficacy of Rituximab as first line of treatment of chronic GVHD. Efficacy will be defined as he ability to taper prednisone to a dose of 0.25 mg/kg per day by 6 months without clinical or GVHD relapse/ recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rituximab + prednisone arm | Experimental | Rituximab will be given as an IV fusion as initial treatment, followed by predisone (given during registration) which will be continued through-out trial and tapered off by physician. Cyclosporine A and tacrolimus will be used if chances of new diagnosis of chronic GVHD occur. Both drugs have no interaction with Rituxan, but will be tapered off after predisone is completely tapered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | 375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose. | Participants that have successfully tapered prednisone to a dose of 0.25 mg/kg/Day by 6 Months without clinical relapse. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete and/or Partial GVHD Response | To have physician documentation of clinical GVHD response using organ staging and scoring scale- NIH clinical GVHD consensus response criteria applied 6 months after rituximab infusion began | 6 months |
| Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Miklos | Stanford University | Principal Investigator |
| Sally Arai | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
IPD will be available in the publication which is forthcoming.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab + Prednisone Arm | To determine the efficacy of Rituximab as first line of treatment of chronic GVHD. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab + Prednisone Arm | To determine the efficacy of Rituximab as first line of treatment of chronic GVHD. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With the Ability to Successfully Taper Prednisone to a Dose Lower Dose. | Participants that have successfully tapered prednisone to a dose of 0.25 mg/kg/Day by 6 Months without clinical relapse. | Participants who have complete or partial clinical response to therapy as well as a steroid dose, tapered to <0.25 mg/kg/day within 6 months after initiation of rituximab | Posted | Count of Participants | Participants | 6 months |
|
|
4 years
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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 | Rituximab + Prednisone Arm | Rituximab will be given as an IV fusion as initial treatment, followed by predisone (given during registration) which will be continued through-out trial and tapered off by physician. Cyclosporine A and tacrolimus will be used if chances of new diagnosis of chronic GVHD occur. Both drugs have no interaction with Rituxan, but will be tapered off after predisone is completely tapered. Rituximab: 375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9 Prednisone: 1 mg/kg; po per day with taper Cyclosporine A: trough 200-300 or lower; po tacrolimus: trough 5-10 or lower; po |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David B. Miklos | Stanford University | 650 725-4959 | 650 | dmiklos@stanford.edu |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D011241 | Prednisone |
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Prednisone | Drug | 1 mg/kg; po per day with taper |
|
|
| Cyclosporine A | Drug | trough 200-300 or lower; po |
|
|
| tacrolimus | Drug | trough 5-10 or lower; po |
|
|
Participants that decreased total daily corticosteroids ≤ 0.25mg/kg one year after rituximab infusion began |
| 1 year |
| Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation | Failure-free survival (FFS) was defined as participants who are surviving with no relapse and second line of cGVHD treatment. | 6 and 12 Months |
| Overall Survival | Overall survival at 6 and 12 months | 6 and 12 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Number of Participants With Complete and/or Partial GVHD Response | To have physician documentation of clinical GVHD response using organ staging and scoring scale- NIH clinical GVHD consensus response criteria applied 6 months after rituximab infusion began | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Participants Who Reduced Steroid Use at One Year After Enrollment on the Trial | Participants that decreased total daily corticosteroids ≤ 0.25mg/kg one year after rituximab infusion began | Posted | Count of Participants | Participants | 1 year |
|
|
|
| Secondary | Failure-free Survival at 6 and 12 Months Post-Rituximab Initiation | Failure-free survival (FFS) was defined as participants who are surviving with no relapse and second line of cGVHD treatment. | At initiation of therapy, all patients were on high dose of steroids (1mg/kg/day). Failure-free survival (FFS) rate for the 31 patients at 6 and 12 months post-rituximab initiation. | Posted | Count of Participants | Participants | 6 and 12 Months |
|
|
|
| Secondary | Overall Survival | Overall survival at 6 and 12 months | Posted | Count of Participants | Participants | 6 and 12 months |
|
|
|
| 35 |
| 35 |
| 26 |
| 35 |
| Nocardia infection | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | on leg, fore-arm and lower extremities. Includes superficial |
|
| Abscess | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | Including: Incision, drainage, right paraspinous muscle |
|
| Low absolute neutrophil count | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | Including: fungal |
|
| bilirubin levels increasing | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Blood | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | Large amounts of blood seen in ET tube and trachea |
|
| Cardiac arrest | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment | Inlcudes pulseless electrical activity |
|
| Chest pain | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Graft versus host disease | General disorders | CTCAE (4.0) | Non-systematic Assessment | Including: of the- mouth, liver, skin lung and chronic |
|
| Confusion | General disorders | CTCAE (4.0) | Non-systematic Assessment | (worsening) |
|
| Conjunctivitis | Eye disorders | CTCAE (4.0) | Non-systematic Assessment | ( viral ) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Includes: severe and prodcutive |
|
| Death | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment | (bloody) |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Includes: worsening |
|
| Erythematous rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Includes: Dry and flaky |
|
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| H1N1 | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Veno-occlusive disease | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Osteomyelitis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Tbili | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Syncope | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Stroke | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sespis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Respiratory syncytial virus | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Multi-organ system failure | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Ischemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Disseminated aspergillus | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment | inlcudes Isolated events |
|
| Sinus bradycardia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Includes: Superficial |
|
| Cold symptoms | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Decrease in diffusing capacity of the lungs for carbon monoxide | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Includes: pain in abdomin, on forearm, |
|
| Infections | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | Includes: E.Coli |
|
| Erythematous | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypertensive | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| influenza A | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Orthostatic hypotension | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Paranasal sinus disease | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| slight decrease in her forced expiratory volume in 1 second | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D010455 | Peptides |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |