1 |
1 |
|
8 |
allele level phenotypic match is to obtain a panel reactive antibody pra screens to class i and class ii antigens for all patients before hct if the pra shows > = 10 activity then flow cytometric or b and t cell cytotoxic cross matches shomcLd be obtained the donor shomcLd be excluded if any of the cytotoxic cross match assays are |
4 |
|
8 |
2 |
10 |
subject is |
6 |
a 0201 |
4 |
. |
6 |
3 |
13 |
patients must be |
4 |
a2 |
4 |
for those patients with an hla class i allele mismatch flow cytometric or b and t cell cytotoxic cross matches shomcLd be obtained regardless of the pra resmcLts a positive anti donor cytotoxic crossmatch is an absolute donor exclusion |
4 |
4 |
7 |
donor donors are excluded when preexisting immunoreactivity is identified that womcLd jeopardize donor hematopoietic cell engraftment this determination is based on the standard practice of the individual institution the recommended procedure for patients with 10 of 10 |
2 |
a 02 01 hla a 02 05 and / or hla a 02 06 |
3 |
for those patients with an hla class i allele mismatch flow cytometric or b and t cell cytotoxic cross matches shomcLd be obtained regardless of the pra resmcLts |
2 |
5 |
17 |
must be |
2 |
phenotype |
2 |
for those patients with an hla class i allele mismatch flow cytometric or b and t cell cytotoxic cross matches shomcLd be obtained regardless of the pra resmcLts a positive anti donor cytotoxic crossmatch is an absolute donor exclusion r n patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two allele mismatch i . e . the patient is a 0101 and the donor is a 0102 and this type of mismatch is not allowed |
1 |
6 |
22 |
subjects must be |
2 |
matched unrelated donor donors are excluded when preexisting immunoreactivity is identified that womcLd jeopardize donor hematopoietic cell engraftment this determination is based on the standard practice of the individual institution the recommended procedure for patients with 10 of 10 hla allele level phenotypic match is to obtain a panel reactive antibody pra screens to class i and class ii antigens for all patients before hct if the pra shows > = 10 activity then flow cytometric or b and t cell cytotoxic cross matches shomcLd be obtained the donor shomcLd be excluded if any of the cytotoxic cross match assays are |
1 |
for those patients with an hla class i allele mismatch |
1 |
7 |
28 |
subject must be |
2 |
matched related donor or an hla matched unrelated donor who meets standard seattle cancer care alliance scca and / or national marrow donor program nmdp or other donor center criteria for peripheral blood stem cell pbsc or bone marrow donation as follows r n related donor related to the patient and genotypically or phenotypically identical for hla a b c drb1 and dqb1 phenotypic identity must be confirmed by high resolution typing r n unrelated donor r n matched for hla a b c drb1 and dqb1 by high resolution typing or r n mismatched for a single allele without antigen mismatching at hla a b or c as defined by high resolution typing but otherwise matched for hla a b c drb1 and dqb1 by high resolution typing r n donors are excluded when preexisting immunoreactivity is identified that womcLd jeopardize donor hematopoietic cell engraftment the recommended procedure for patients with 10 of 10 hla allele level phenotypic match is to obtain panel reactive antibody pra screens to class i and class ii antigens for all patients before hematopoietic cell transplant hct if the pra shows > = 10 activity then flow cytometric or b and t cell cytotoxic cross matches shomcLd be obtained the donor shomcLd be excluded if any of the cytotoxic cross match assays are |
1 |
for those patients with and hla class i allele mismatch flow cytometric or b and t cell cytotoxic cross matches shomcLd be obtained regardless of the pra resmcLts a positive anti donor cytotoxic crossmatch is an absolute donor exclusion r n patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two allele mismatch i . e . the patient is a 0101 and the donor is a 0102 and this type of mismatch is not allowed |
1 |
8 |
2 |
patients must have an |
1 |
matched related donor or an unrelated donor who meets standard seattle cancer care alliance scca and or national marrow donor program nmdp or other donor center criteria for peripheral blood stem cell pbsc donation or bone marrow donation as follows r n related donor related to the patient and genotypically or phenotypically identical for hla a b c drb1 and dqb1 phenotypic identity must be confirmed by high resolution typing r n unrelated donor r n matched for hla a b c drb1 dqb1 by high resolution typing or r n mismatched for a single allele without antigen mismatching at hla a b or c as defined by high resolution typing but otherwise matched for hla a b c drb1 and dqb1 by high resolution typing r n patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two allele mismatch i . e . the patient is a 0101 and the donor is a 0102 and this type of mismatch is not allowed r n donors are excluded when preexisting immunoreactivity is identified that womcLd jeopardize donor hematopoietic cell engraftment this determination is based on the standard practice of the individual institution the recommended procedure for patients with 10 of 10 hla allele level phenotypic match is to obtain panel reactive antibody pra screens to class i and class ii antigens for all patients before hct if the pra shows > = 10 activity then flow cytometric or b and t cell cytotoxic cross matches shomcLd be obtained the donor shomcLd be excluded if any of the cytotoxic cross match assays are |
1 |
as determined by a central laboratory . this determination will be made under a pre enrollment screening informed consent form icf . there are no restrictions on the timing of hla typing for screening and data can be taken from subjects records . |
1 |
9 |
3 |
unrelated donor a positive anti donor cytotoxic crossmatch is an absolute donor exclusion donors are excluded when preexisting immunoreactivity is identified that womcLd jeopardize donor hematopoietic cell engraftment this determination is based on the standard practice of the individual institution the recommended procedure for patients with 10 of 10 |
1 |
identical sibling donor or an hla matched unrelated donor who meets standard seattle cancer care alliance scca and / or national marrow donor program nmdp or other donor center criteria for pbsc or bone marrow donation as follows r n related donor related to the patient and genotypically or phenotypically identical for hla a b c drb1 and dqb1 phenotypic identity must be confirmed by high resolution typing r n unrelated donor r n matched for hla a b c drb1 and dqb1 by high resolution typing or mismatched for a single allele without antigen mismatching at hla a b or c as defined by high resolution typing but otherwise matched for hla a b c drb1 and dqb1 by high resolution typing r n doors are excluded when preexisting immunoreactivity is identified that womcLd jeopardize donor hematopoietic cell engraftment this determination is based on the standard practice of the individual institution the recommended procedure for patients with 10 of 10 hla allele level phenotypic match is to obtain panel reactive antibody pra screens to class i and class ii antigens for all patients before hematopoietic cell transplant hct if the pra shows > = 10 activity then flow cytometric or b and t cell cytotoxic cross matches shomcLd be obtained the donor shomcLd be excluded if any of the cytotoxic cross match assays are |
1 |
. subject has any a 02 nmcLl allele designated with an n e . g . a 02 32n as the sole hla a 02 allele . |
1 |
10 |
4 |
donor a positive anti donor cytotoxic crossmatch is an absolute donor exclusion donors are excluded when preexisting immunoreactivity is identified that womcLd jeopardize donor hematopoietic cell engraftment this determination is based on the standard practice of the individual institution the recommended procedure for patients with 10 of 10 |
1 |
allele level phenotypic match is to obtain a panel reactive antibody screens to class i and ii antigens for all patients before hct if the pra shows > = 10 activity then flow cytometric or b and t cell cytotoxic cross matches shomcLd be obtained the donor shomcLd be excluded if any of the cytotoxic cross match assays are |
1 |
in either allele subject has hla a 02 07 as the sole hla a 02 allele e . g . a subject with hla alleles a 02 04 and a 02 07 is eligible or subject has any a 02 nmcLl allele designated with an n e . g . a 02 32n as the sole hla a 02 allele |
1 |
11 |
5 |
patients must have a human leukocyte antigen |
1 |
a 02 01 and / or hla a 02 06 |
1 |
retesting is not required for patients who have previous documented hla a 02 01 positivity |
1 |
12 |
6 |
patients must have an human leukocyte antigen |
1 |
a 02 05 in either allele hla b 15 01 and / or hla b 46 01 |
1 |
by central assay |
1 |
13 |
8 |
unrelated donors donors are excluded when preexisting immunoreactivity is identified that womcLd jeopardize donor hematopoietic cell engraftment this determination is based on the standard practice of the individual institution recommended procedure for patients with 10 of 10 |
1 |
a 1101 |
1 |
. note patients who were previously hla typed for participation in other immatics sponsored clinical trials and were hla phenotype positive may enter ima202 101 main screening |
1 |
14 |
24 |
be |
1 |
a 02 05 |
1 |
by central lab |
1 |
15 |
29 |
human leukocyte antigen |
1 |
a 02 01 or hla a 02 06 |
1 |
as determined by deoxyribonucleic acid dna allele specific polymerase chain reaction pcr assay hla restriction is not required for cohorts 4 and 5 |
1 |
16 |
9 |
|
NA |
a 02 05 hla b 15 01 and / or hla b 46 01 |
1 |
as determined by deoxyribonucleic acid dna allele specific polymerase chain reaction pcr assay r n for cohort 5 after amendment 9 and cohort 6 there is no hla restriction |
1 |
17 |
11 |
|
NA |
a 02 01 |
1 |
patients |
1 |
18 |
12 |
|
NA |
a 01 |
1 |
by high resolution testing . |
1 |
19 |
14 |
|
NA |
a 02 hla a 03 hla a 11 or hla a 24 |
1 |
|
NA |
20 |
15 |
|
NA |
a 0201 hla a 0205 and / or hla a 0206 |
1 |
|
NA |
21 |
16 |
|
NA |
a02 01 |
1 |
|
NA |
22 |
18 |
|
NA |
dpb1 04 01 |
1 |
|
NA |