CIBMTR Center Number: CIBMTR Recipient ID: RETIRED. Today s Date: Date of HSCT for which this form is being completed: &
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1 Systemic Lupus Erythematosus Pre-HSCT Data Sequence Number: Date Received: Registry Use Only Today s Date: Date of HSCT for which this form is being completed: & HSCT type: o autologous o allogeneic, o allogeneic, o syngeneic unrelated related (identical twin) Product type: o marrow o PBSC o cord blood o other product, specify: This form must be accompanied by Form 00 Recipient Baseline Data. All information in the box above, including the date, should be identical with the corresponding Form 00. Information should come from an actual examination by the Transplant Center physician, or the physician who is following the recipient pre-hsct, or abstraction of the recipient s medical records. Questions followed by the symbol & indicate additional information necessary to complete the question is referenced in the forms instruction manual. If this is a report of a second or subsequent transplant, check here o and continue with question 80. Disease Assessment at Diagnosis 1. What was the date of diagnosis of Systemic Lupus Erythematosus (SLE)? Specify if the the following American College of Rheumatology (ACR) criteria for SLE were present at diagnosis:. Serositis a) pleuritis convincing history of pleuritic pain or rub heard by a physician, or evidence of pleural effusion ~OR~ b) pericarditis documented by ECG, rub, or evidence of pericardial effusion 3. Oral ulcers oral or nasopharyngeal ulceration, usually painless, observed by a physician. Arthritis non-erosive arthritis involving two or more peripheral joints, characterized by tenderness, swelling, or effusion 5. Photosensitivity skin rash as a result of unusual reaction to sunlight, by patient history or physician observation 6. Hematologic disorder a) hemolytic anemia with reticulocytosis ~OR~ b) thrombocytopenia < 100,000/mm 3 platelets in the absence of offending drugs ~OR~ c) leukopenia < 000/mm 3 total on two or more occasions ~ OR ~ d) lymphopenia < 1500/ mm 3 on two or more occasions 7. Renal disorder a) persistent proteinuria > 0.5 grams per day or > 3+ on urine dipstick if quantitation not performed ~OR~ b) cellular casts may be red cell, hemoglobulin, granular, tubular, or mixed 8. Antinuclear antibody an abnormal titer of antinuclear antibody by immunofluorescence or an equivalent assay at any point in time and in the absence of drugs known to be associated with drug-induced lupus syndrome CIBMTR Form 5 revision (page 1 of 10) March 11 Mail this form to your designated campus (Milwaukee or Minneapolis). Retain the original at the transplant center.
2 9. Immunologic disorder a) anti-dna: antibody to native DNA in abnormal titer ~OR~ b) anti-sm: presence of antibody to Sm nuclear antigen ~OR~ c) positive antiphospholipid antibody ~OR~ d) false positive serologic test for syphilis known to be positive for at least 6 months and confirmed by Treponema pallidum immobilization or fluorescent treponemal antibody absorption test 10. Neurologic disorder a) seizures in the absence of offending drugs or known metabolic derangements; e.g., uremia, ketoacidosis, or electrolyte imbalance ~OR~ b) psychosis in the absence of offending drugs or known metabolic derangements, e.g., uremia, ketoacidosis, or electrolyte imbalance 11. Malar rash fixed erythema, flat or raised, over the malar eminences, tending to spare the nasolabial folds 1. Discoid rash erythematous raised patches with adherent keratotic scaling and follicular plugging; atrophic scarring may occur in older lesions 13. Were any of the recipient s family members also affected with SLE? Specify the recipient s familial relationships to blood relatives affected with SLE: 1. Monozygotic twin 15. Dizygotic twin 16. Other first-degree relative (parent, sibling, child) 17. Was lupus nephritis present prior to mobilization for stem cell collection (or high-dose therapy if mobilization was not done)? 18. Was a renal biopsy performed? 19. Date of most recent renal biopsy prior to mobilization for stem cell collection (or high-dose therapy if mobilization was not done):. Specify the degree of lupus nephritis (LN) according to the International Society of Nephrology / Renal Pathology Society (ISN / RPS) classification: Weening JJ, D Agati VD, Schwartz MM, et al. The Classification of Glomerulonephritis in Systemic Lupus Erythematosus Revisited. J Am Soc Nephrol 0; 15: o Class I minimal mesangial LN o Class II mesangial proliferative LN 3 o Class III focal LN o Class IV diffuse LN 5 o Class V membranous LN 6 o Class VI advanced sclerosis LN 1. Is a copy of the renal biopsy pathology report attached? Continue with table below Continue with question CIBMTR Form 5 revision (page of 10) March 11
3 Pre-HSCT Treatment for Systemic Lupus Erythematosus. Did the recipient receive any disease-modifying treatments between the time of diagnosis and prior to mobilization for stem cell collection (or high-dose therapy if mobilization was not done)? Treatment Stopped Treatment Given? Stopped? Code 3. Androgens If code 3, specify other reason: 7. Antimalarial drugs If code 3, specify other reason: 31. Azathioprine (Azasan, Imuran) If code 3, specify other reason: 35. Corticosteroids & If code 3, specify other reason: 39. Was prednisone or other corticosteroid dosing changed between diagnosis and just prior to mobilization for stem cell collection? 1 o dose unchanged o dose increased 3 o dose decreased o unknown 0. Cyclophosphamide (CTX, Cytoxan, Neosar) If code 3, specify other reason:. Cyclosporine (CsA, Neoral, Sandimmune) If code 3, specify other reason: 8. Intravenous immune globulin (IVIG) If code 3, specify other reason: 5. Lymphocytopheresis Continue with table below Continue with question If code 3, specify other reason: Codes for Treatment Stopped 1 Failure Toxicity 3 Other reason Reason unknown CIBMTR Form 5 revision (page 3 of 10) March 11
4 Treatment Stopped Treatment Given? Stopped? Code 56. Methotrexate (MTX, Folex) If code 3, specify other reason: 60. Mycophenolate mofetil (MMF, CellCept) If code 3, specify other reason: 6. Plasmapheresis If code 3, specify other reason: 68. Rituximab (anti-cd, Rituxan) If code 3, specify other reason: 7. Other treatment If code 3, specify other reason: 76. Specify other treatment: 77. Was an MRI scan of the brain performed prior to mobilization? 78. Date of most recent MRI brain scan: 79. Specify results of most recent MRI brain scan: 1 o normal o abnormal, related to SLE 3 o abnormal, unrelated to SLE o unknown Codes for Treatment Stopped 1 Failure Toxicity 3 Other reason Reason unknown Laboratory Studies Prior to Mobilization Therapy for Stem Cell Collection 80. WBC: 81. Hemoglobin: 8. Platelets: 83. Serum creatinine: 1 o mg/dl o mmol/l 3 o µmol/l CIBMTR Form 5 revision (page of 10) March 11 Specify units: 1 o x 10 9 /L (x 10 3 /mm 3 ) o x 10 6 /L 1 o g/dl o g/l 3 o mmol/l 1 o x 10 9 /L (x 10 3 /mm 3 ) o x 10 6 /L
5 8. Creatinine clearance: 85. Urine protein (-hour): 86. Urine protein / creatinine ratio: 87. Were urine RBC / RBC casts detected? 88. Erythrocyte sedimentation rate: 89. Complement level of CH50: 90. Complement level of C3: 91. Complement level of C: 9. Antibody for anti-ana: 1 o positive o negative 93. Antibody level of anti-dsdna: 9. Antibody level of anti-sm: 95. Antibody level of anti-ss-a (anti-ro): 96. Antibody level of anti-ss-b (anti-la): mm / hour CIBMTR Form 5 revision (page 5 of 10) March 11 Specify units: 1 o ml/min o ml/sec 1 o mg / hours o g / day
6 97. Anti-cardiolipin IgG level: 98. Anti-cardiolipin IgM level: 99. Lupus-anticoagulant level: Specify the results of the following pulmonary function tests performed prior to mobilization therapy for stem cell collection: 100. Date pulmonary function tests were performed: 101. Vital capacity (VC): % (predicted value) 10. Was the actual VC value in the normal range ( 80% of predicted value)? 103. D L CO: % (predicted value) 10. Was the actual D L CO value in the normal range ( 80% of predicted value)? 105. D L CO corrected for hemoglobin: % (predicted value) 106. Was the D L CO value (corrected for hemoglobin) in the normal range ( 80% of predicted value)? 107. Was oxygen desaturation present on exercise testing? 108. Was an echocardiogram performed prior to mobilization therapy for stem cell collection? 109. Was pericardial effusion present? 110. Specify the size of the area of accumulated excess fluid: 1 o small o moderate 3 o large mm Hg 111. Left ventricular ejection fraction: % 11. Was pulmonary artery hypertension present? 113. Specify the estimated systolic pulmonary artery pressure: CIBMTR Form 5 revision (page 6 of 10) March 11
7 11. Was a multiple gate acquisition scan (MUGA test / nuclear ventriculography) performed prior to mobilization therapy for stem cell collection? 115. Specify the left ventricular ejection fraction: % Most Recent Disease Assessment Prior to the Start of the Preparative Regimen Information for this section should come from the most recent evaluation performed weeks prior to the preparative regimen. If the recipient was not evaluated prior to the preparative regimen, check here o and continue with the signature lines at question Date of evaluation prior to the preparative regimen: Specify if the following Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) criteria were present prior to the start of the preparative regimen and were attributable to Lupus: Score Criterion Arthritis More than joints with pain and signs of inflammation (i.e., tenderness, swelling, or effusion) Alopecia Ongoing abnormal, patchy, or diffuse loss of hair due to active lupus Cerebrovascular accident (CVA) New onset of cerebrovascular accident(s). Exclude 1. 8 arteriosclerosis or hypertensive causes. Cranial nerve disorder New onset of sensory or motor neuropathy involving cranial nerves. Include vertigo due to lupus. 11. Fever > 38 C. Exclude infectious cause Hematuria > 5 red blood cells/high power field. Exclude stone, infection, or other cause. 13. Increased DNA binding > 5% binding by Farr assay, or above normal range for testing laboratory. 1. Leukopenia < 3,000 white blood cells/mm 3 (x 10 9 /L). Exclude drug causes Low complement Decrease in CH50, C3, or C below the lower limit of normal for testing laboratory Lupus headache Severe, persistent headache: may be migrainous, but must be nonresponsive to narcotic analgesia. 17. Mucosal ulcers Ongoing oral or nasal ulcerations due to active lupus Myositis Proximal muscle aching/weakness associated with elevated creatine phosphokinase/aldolase or electromyogram changes, or a biopsy showing myositis. 19. New rash Ongoing inflammatory lupus rash Organic brain syndrome Altered mental function with impaired orientation, memory, or other intellectual function, with rapid onset and fluctuating clinical features. Include clouding of consciousness with reduced capacity to focus and inability to sustain attention to environment, plus at least of the following: perceptual disturbance, incoherent speech, insomnia or daytime drowsiness or increased or decreased psychomotor activity. Exclude metabolic, infectious, or drug causes. CIBMTR Form 5 revision (page 7 of 10) March 11
8 Score Criterion 131. Pericarditis Classic and severe pericardial pain, rub, effusion, or electrocardiogram confirmation. 13. Pleurisy Classic and severe pleuritic chest pain, pleural rub, effusion, or new pleural thickening due to lupus Proteinuria > 0.5 gm/ hours. New onset or recent increase of > 0.5 gm/ hours. 13. Psychosis Altered ability to function in normal activity due to severe disturbance in the perception of reality. Include hallucinations, incoherence, marked loose associations, impoverished thought content, marked illogical thinking, bizarre, disorganized or catatonic behavior. Exclude uremia and drug causes Pyuria > 5 white blood cells/high power field. Exclude infection Seizures Recent onset (last 10 days). Exclude metabolic, infectious, or drug cause, or seizure due to past irreversible CNS damage Thrombocytopenia < 100,000 platelets/mm 3 (x 10 9 /L) Urinary casts Heme-granular or red blood cell casts Vasculitis Ulceration, gangrene, tender finger nodules, periungual infarction, splinter hemorrhages or biopsy or angiogram proof of vasculitis Visual disturbance Retinal and eye changes of SLE. Include cytoid bodies, retinal hemorrhages, serous exudate or hemorrhages in the choroid, optic neuritis, scleritis, or episcleritis. Exclude hypertension, infection, or drug causes. 11. Total SLEDAI score: 1. Was an MRI scan of the brain performed prior to the start of the preparative regimen? Date of most recent MRI brain scan: 1. Specify results of most recent MRI brain scan: 1 o normal o abnormal, related to SLE 3 o abnormal, unrelated to SLE o unknown Laboratory Studies Prior to the Start of the Preparative Regimen 15. Creatinine clearance: Specify units: 1 o ml/min o ml/sec 16. Cerebral spinal fluid (CSF) protein: 17. Cerebral spinal fluid (CSF) IgG: 1 o mg/dl o g/l 1 o mg/dl o g/l CIBMTR Form 5 revision (page 8 of 10) March 11
9 18. Cerebral spinal fluid (CSF) cell count: 19. Urine protein (-hour): 150. Urine protein / creatinine ratio: 151. Were urine RBC / RBC casts detected? 15. Erythrocyte sedimentation rate: 153. Complement level of CH50: 15. Complement level of C3: 155. Complement level of C: 156. Antibody for anti-ana: 1 o positive o negative 157. Antibody level of anti-dsdna: 158. Antibody level of anti-sm: 159. Antibody level of anti-ss-a (anti-ro): mm / hour Specify units: 1 o mg / hours o g / day CIBMTR Form 5 revision (page 9 of 10) March 11
10 160. Antibody level of anti-ss-b (anti-la): 161. Anti-cardiolipin IgG level: 16. Anti-cardiolipin IgM level: 163. Lupus-anticoagulant level: Specify the results of the following pulmonary function tests performed prior to the start of the preparative regimen: 16. Date pulmonary function tests were performed: 165. Vital capacity (VC): % (predicted value) 166. Was the actual VC value in the normal range ( 80% of predicted value)? 167. D L CO: o no % (predicted value) 168. Was the actual D L CO value in the normal range ( 80% of predicted value)? 169. D L CO corrected for hemoglobin: o no % (predicted value) 170. Was the D L CO value (corrected for hemoglobin) in the normal range ( 80% of predicted value)? 171. Was oxygen desaturation present on exercise testing? 17. Signed: Person completing form Please print name: Phone: ( ) Fax: ( ) address: CIBMTR Form 5 revision (page 10 of 10) March 11
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