Description:

ENR Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF19AF22-C849-2763-E034-0003BA3F9857

Link:
https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=FF19AF22-C849-2763-E034-0003BA3F9857
Keywords:
  1. 9/19/12 9/19/12 -
  2. 1/9/15 1/9/15 - Martin Dugas
Uploaded on:

January 9, 2015

DOI:
To request one please log in.
License :
Creative Commons BY-NC 3.0 Legacy
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Leukemia, Myelocytic, Acute null Treatment - ENR - 2395563v3.0

No Instruction available.

Aml T Cell Depletion - Segment A
Patient Inclusion Criteria
Were Auer rods present
%
%
Record the patients Karnofsky performance status
Does the patient meet the World Health Organizations (WHO) criteria for do novo AML
Record the patients most recent complete remission stage
Was an adequate bone marrow aspirate performed within 4 weeks prior to the proposed conditioning date
If an adequate bone marrow aspirate was not perforned, was a bone marrow biopsy performed within 4 weeks prior to the proposed conditioning date
Is there any evidence of a persistently abnormal leaukemia population by flow cytometry
Is there any evidence of extramedullary leukemia
Does the patient have a history of CNS involvement
If yes, is there any evidence of leukemia blasts in the CSF
Indicate the number of cycles of infuction chemotherapy (or in0induction for patients in 2nd CR) the patient received to achieve first or second complete remission
Indicate the number of consolidation therapies the patient received prior to transplant (any consolidation regimen that does not require transplantation for hematopoetic recovery can be used)
Left Ventricular Ejection Fraction
%
Bilirubin
mg/dL
Alt
Ast
Serum Creatinine
mg/dL
mg/dL
Dlco (corrected For Hemoglobin)
%
Patient Exclusion Criteria
Is the patient HIV seropositive
Does the patient have uncontrolled diabetes mellitus
Is the patient diagnosed with an uncontrolled viral, bacterial, or fungal infection
Is the donor pregant (positive serum or unie B-HCG) or breastfeeding
Is the patient doagnosed with M3-AML (acute promyelocytic leukemia and in first complete remission)
Is the patient diagnosed with acute leukemia following blast transformation of prior chronic myelogenous leukemia (CML) or other myeloproliferative disease
Is the patient diagnosed with M4Eo-AML with inv 16 and in first complete remission
Is the patient diagnosed with AML with t(8;21) and in first complete remission
Is the patient participating in other clinical trails that involve investigational drugs or devices
Does the patient have a history of cytopenia consistent with diagnoses of myelodysplastic syndrome (MDS) for more then 3 months prior to the diagnosis of Aml or does the patient have reatments-related AML
Does the patients have evidence of active Hepatitis B or C infection or evidence of cirrhosis
Does the patient have a documented allergy to iron dextran or murine proteins and rabbit antithymocyte globulin
Has the patient had a prior allogeneic or autologous transplant
Donor Inclusion Criteria
Kg
Is the donor HIV seronegative within 30 days of apheresis collection
Is the donor seronegative for hepatitis B surface antigen within 30 days of apheresis collection
Is the donor seronegative for hepatitis C within 30 days of apheresis collection
Is the donor pregant (positive serum or unie B-HCG) or breastfeeding
Is the donor seronegative for syphilis within 30 days fo apheresis collection
Is the donor agreeable to second donation of PBSC in the event of graft failure of EBV-related lymphopropliferative diesase, if necessary
Is the donor agreeable to undergo general anesthesia and bone marrow donation, if necessary
Does the donor have adequate veins for leukapheresis or agress to placement fo a central catheter
Does the donor have evidence of active infection (including urinary tract infection or respiratory tract infection) or viral hepatitis exposure (on screeninig), unless only HBs, AB+ and HBV DNA negative
Does the donoe have any factors which place him-her at increase rick for complications from leukopharesis of G-CSF therapy (e.g., autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy)
Hla Typing
Type of HLA Match required by this protocol
Recipient Hla Typing
Hla-a
Typing method
Antigens/alleles provided
Hla-b
Typing method
Antigens/alleles provided
Hla-c
Hla-drb1
Typing method
Antigens/alleles provided
Donor Hla Typing
Hla-a
Typing method
Antigens/alleles provided
Hla-b
Typing method
Antigens/alleles provided
Hla-c
Hla-drb1
Typing method
Antigens/alleles provided
Do you agree with the calculated HLA Match score
Indicate your institution's HLA Match score for this participant

Similar models

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial