DF/PCC CHART REVIEW FORM

Transcription

1 DF/PCC CHART REVIEW FORM Date of audit June 19-21, 2002 Protocol number Patient s initials Patient s DOB Patient s case ID number Patient s institutional MR number Patient s DFCI number Disease (ALL) Acute Lymphoblastic Leukemia Affiliate institution A. PATIENT ENTRY: Date Consent form signed Date Registered Date Randomized Date Treatment began Date Treatment ended Date Taken Off Study Date of Death Pt status active tx, F/U, off-study, expired IRB, CONSENT, REGISTRATION: YES NO N/A Was the protocol approved by the IRB and were continuing reviews done annually? Was a complete consent form available, signed, and dated appropriately? Were age, literacy, language and mental competency requirements legitimate for signing the consent form? Was a copy of the consent given to the pt/ parents/guardians? Were parents wishes regarding randomization documented? Was the patient registered with the QACT before beginning treatment? Was the patient randomized within 2 weeks after registration? Consent for CVL? Consent for RT? DOB, sex, and race documented? QACT Elig. checklist matches protocol? Randomization is not blinded. DFCI protocol initial approval date: 08/15/00 and activation: 09/22/00 (*photocopy protocol pages and ) 1

2 Randomization: B. ELIGIBILITY: (section 3.0) YES NO N/A 1. Acute lymphoblastic leukemia, excluding known mature B-cell ALL by presence of any of the following: surface immunoglobulins L3 morphology t(8;14)(q24;q32) t(8;22) t(2;8) Patients with mature B-cell ALL will be removed from the protocol as soon as that diagnosis is made and should be treated on a B-cell leukemia (Burkitt s) protocol. Note: Patients with T-cell surface markers and t(8;14)(q24;q11) are eligible for protocol No prior therapy except 1 week of steroids, or emergent radiation therapy to the mediastinum. Note: Due to time constraints, if full consent form is not obtained prior to the initiation of diagnostic lumbar puncture, then patients may have an individual consent form signed for intrathecal cytarabine prior to enrollment on the protocol. 4. Age 12 months years 5. If patient is known to be HIV positive, they will be removed from the protocol. HIV testing is not mandatory prior to protocol enrollment RISK GROUP CLASSIFICATION INFO (section 3.1): Age (in decimals) yrs Highest pre-treatment WBC: K/mm3, date Day 0 Diagnostic spinal tap? yes, no ; Day 0 CNS-1, CNS-2, CNS-3, traumatic tap Cranial nerve palsy?: present, absent Anterior mediastinal mass? present, absent T-cell markers on lymphoblasts? present, absent Induction Day 14 and/or 28 CNS-1, CNS-2, CNS-3 t(9;22) from cytogenetic and/or FISH sample: present, absent Any histologically-measurable extra-medullary ds? yes, no Peripheral blood without lymphoblasts, and <5% lymphoblasts in a normocellular BM with recovery of peripheral counts (APC > 1,000/mm3, plts > 100,000/mm3)? yes, no Standard Risk High Risk 2

3 C. PRE-THERAPY REQUIREMENTS: YES NO N/A 1. *Bone Marrow Biopsy (back-up) 2. *Bone Marrow Aspirate 3. *Imunophenotype/Immune Markers 4. *Cytogenetics/FISH 5. **Signed informed consent 6. ***Diagnostic LP (with IT medications) 7. CBC/diff and platelets 8. Histochemistry 9. Initial CNS disease status 10. Mediastinal mass status (radiologic) 11. Chest x-ray 12. Echocardiogram and ECG 13. Direct bilirubin 14. Asparaginase enzyme level measurement 15. Risk Group Stratification Information: Stratum 1: Standard Risk Patients with age 2 years to age 8.99 years and highest pre-therapy WBC <20,000/mm 3 Stratum 2: All other Standard Risk pts Stratum 3: High Risk Patients Patients with t(9;22) are not eligible for randomization and will be directly assigned to each arm: a. Asparaginase-arm A (fixed dosing; e.coli L-asparaginase 25,000 IU/m 2 /week x 30 weeks) b. Corticosteriod-arm C (Prednisone) Randomization assignment? Fixed Asparaginase Dose-adjusted Asparaginase Direct-assigned/ Fixed Comments: (*) = in this order 3

4 INDUCTION Patient initials: Year: SR or HR # D 0 Date Wt or BSA P (mg/day) V (mg/day) D +/- Dox M (gm IV) L A (IU) MAH IT IT Ara-C *asp *LP bx 1 2 start time : 3 Leucovorin start date: Leucov. start time: : Serum MTX < 0.1 on (date) at : M A H * second echo prior to day 28 for HR kids 28 M A *, + 4

5 H CNS THERAPY Pt initials: Year: SR or HR # D Date wt or BSA NED APC PLT Bili. SGOT V 6-MP IT MAH (total: 4 doses) RT HR (8 days) (cgy) D/D HR pre CSF periph bl BM extramed CR established before CNS therapy started? CNS therapy phase is 3 weeks It is theoretically possible that the pt has no tx during the third week. 5

6 INTENSIFICATION ** STANDARD RISK ** Pt initials: Year: m A # date wt V P/Dex 6-MP 1x/wk 1x/wk D or (5 d/wk) (d after A) (30 doses) BSA (IU) pre APC PLT Mucositis SGOT Bili. IT MAH (q 9-18 wks after CNS start) 1 Wk Wk Wk (May need multiple copies of this page, ~ 10.) 6

7 INTENSIFICATION *** HIGH RISK *** Pt initials: Year: # D pre date kg or BSA APC PLT Mucositis SGOT Bili. V P/Dex (5 d/wk) 6-MP m (** p D/D) 1x/wk (d after A) A 1x/wk (30 doses) (IU) IT MA (q 18 wk p start CNS; HOLD m) D/D ** total 300mg/ m2 or 9 mos p CR 1 Wk Wk Wk (May need multiple copies of this page, ~ 10.) 7

8 D. ON-STUDY EVALUATIONS: YES NO N/A 1. Height/Weight/BSA Per GD, there is no required schedule for obtaining BSAs. If weight is measured, dose must not be off by > 5%. It is preferable that weights be done weekly. 2. Immunophenotype 3. Chest x-ray for all patients on Day 0 (on or prior to Day 28 if positive on Day 0) 4. Physical exam 5. APC, WBC, RBC, PLT, CNS Blasts in cytospin 6. LFTs: SGOT (AST), Bilirubin, 7. Mucositis check 8. Echocardiogram and ECG: Day 0 for all patients Prior to Day 28 (HR patients only) After achieving cumul. dose of 300 mg/m 2 9. DNA analysis 10. Urine test 11. Quality of Life assessment: Day 21 of Induction CNS Rx: 2 nd week Intensification: approx. 4 mos from dx Continuation: approx. 18 mos from dx 12. Bone marrow aspirate/biopsy 13. At time suspected relapsed: Bone marrow aspirate for morphology, Cytogenetics/ FISH Peripheral blood for research studies CSF for cell count/cytospin, research studies QOL study (after relapse confirmed) 14. Successful Remission Induction? Red Flags for dose-modification: (protocol pages 24, 27, 31, 37, 41 44) Hyperbilirubinemia (rough guide: direct bili > 1.4 mg/dl; total bili > 3.0 mg/dl) Amylase > 3 x normal; elevated lipase glucose Mucositis Significant edema/ascites/effusions Elevated creatinine APC < 500 PLT < 75 K SGOT > 8 x ULN Asparaginase level less than 0.1 or greater than 0.13 IU/mL Allergic reaction Cardiac dysfunction (CHF; abn. Echo or EKG) DVT or CVA (CNS bleed, thrombus, infarct) Steroids, watch for: myalgias and arthralgias; aseptic necrosis; fractures; mood * Watch for +blood cultures, seizures, fractures, serious neuro. tox (stroke), PCP. 8

9 E. FOLLOW-UP (off-treatment): YES NO N/A 1. Physical exam 2. CBC with differential every month x 6 months, Then every 2 months x 6 months Then every 4 months x 1 year Then every year 3. Echocardiograms: For high risk patients only: ECHO at completion of therapy Suggested follow-up every 1-2 years 4. Ophthalmologic Evaluation: to be performed annually to rule out cataracts 5. Quality of Life assessment: Every 2 years from end of therapy At time of relapse Comments: F. TREATMENT OVERVIEW: YES NO N/A 1. Were correct drugs used? 2. Were any additional drugs/rx w/in protocol limitations used appropriately? 3. Were treatment doses correctly calculated? 4. Were treatment dates accurately recorded in chart? 5. If dose reductions occurred were they justified? 6. If dose modifications occurred, were they modified according to protocol? 7. If delays in therapy occurred, were they justified? 8. Are PO medications documented? Comments: Refer to the treatment audit sheet to complete this section. Pill diaries have not been used per GD. Pharmacy audits have not been done in the past per GD. 9

10 G. TOXICITY: YES NO N/A 1. Are grades, types, and dates of toxicities accurately recorded on data forms? 2. Can all claimed toxicities on data forms be substantiated by the medical record? 3. If serious toxicity was noted, was the ADR properly reported? Comments: H. RESPONSE: YES NO N/A 1. Was the frequency and type of measurements correct? 3. Are protocol-directed response criteria being followed? 4. Is the claimed response correct? Comments: (Refer to Sect 6.0 of the protocol for the clinical definitions) I. GENERAL FOLLOW-UP: YES NO N/A 2. If the patient is off study, can survival data be obtained? 3. If the patient is lost to follow-up, is the reason legitimate? Comments: J. DATA COLLECTION: YES NO N/A 1. Are CRFs up to date? 2. Are CRFs accurate? Comments: 10

11 K. THE AUDITOR MAY MAKE ANY ADDITIONAL COMMENTS: AUDITOR S SIGNATURE: DATE: 11

12 Patient initials: ALL Worksheet Bone marrow specimen collection: Date Bx or asp Results CSF specimen collection: Date Result Blasts? Abnormal labs Date APC <500 PLT < 75 K SGOT > 8 x ULN d. Bili > 1.4 Amylase > 3 x ULN Creatinine > ULN 12

13 Presence of mucositis: Date Description: Adverse Events notes (date/description/result): Myalgias: Arthralgias: Fractures: Signif. mood changes: CNS bleed (stroke, infarct): DVT: Seizure: Significant edema, ascites, and/or effusions: Positive blood cultures: 13

14 BSA Worksheet Height: 1 inch = 2.54 cm feet x 12 inches = inches + inches = total inches total inches x 2.54 cm/in = cm Weight: 1 pound = kg pounds x kg/lb = kg BSA m2 = cm x kg = cm x kg Date Ht (cm) Wt (kg) BSA (m2) Date Ht Wt BSA 14