[c09aa8]: / clusters / final9knumclusters / clust_1091.txt

Download this file

90 lines (89 with data), 18.9 kB

 1
 2
 3
 4
 5
 6
 7
 8
 9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
No intent to proceed with alloHCT using donor sources not specified in this protocol, including human leukocyte antigen (HLA)-mismatched related or unrelated donors (< 6/6 HLA related matched or < 8/8 HLA unrelated matched) or umbilical cord blood unit(s).
Recipient of 9/10 or 10/10 (human leukocyte antigen [HLA]-A, -B, -C, -DRB1, -DQB1) matched bone marrow allogeneic hematopoietic stem cell transplantation (HSCT) OR 4/6, 5/6, and 6/6 (HLA-A, -B, -DR) matched cord blood allogeneic HSCT
Availability of at least one 9-10/10 human leukocyte antigen (HLA)-matched related (excluding an identical twin) or unrelated donor, or an HLA-haploidentical related donor
The patient must have an available sibling or matched unrelated donor with at least a 7/8 human leukocyte antigen (HLA) match
TREATMENT WITH SJCAR19: CD19+ ALL with any of the following:\r\n* Primary refractory disease despite at least 2 cycles of an intensive chemotherapy regimen designed to induce remission\r\n* Refractory disease despite salvage therapy\r\n* 2nd or greater relapse\r\n* Any relapse after allogeneic hematopoietic cell transplantation \r\n* 1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and/or unsuitable for HCT for any of the following reasons:\r\n* Patients that do not have an available allogeneic donor (defined as at least a 7/8 human leukocyte antigen (HLA)-matched related/unrelated \r\ndonor, 5/6 HLA-matched umbilical cord donor, or 3/6 HLA-matched haploidentical donor)\r\n* Patients with refractory leukemia, for which allogeneic transplant is known to be less effective in the B-ALL population, and\r\n* Patients who are unable to receive myeloablative total body irradiation (TBI), which is included in standard transplant regimens for patients with B-ALL. \r\n**ALL must be confirmed to be CD19+ within 3 months prior to enrollment for treatment
DONOR: Must be a 10/10 human leukocyte antigen (HLA) genotypically match related or unrelated donor at all A, B, C, DRB1, and DQB1 loci, as tested by deoxyribonucleic acid (DNA) analysis.
DONOR: Human leukocyte antigen (HLA) haplo-identical matched related.
Lack of a human leukocyte antigen (HLA) matched donor or need to proceed fast to transplantation when a patient does not have an immediately available matched unrelated donor (typed by high-resolution in the registry);
Use of mobilized peripheral blood stem cells from fully human leukocyte antigen (HLA)-matched related or unrelated donor as a graft source
Relapsed AML after human leukocyte antigen (HLA)-matched related or unrelated allogeneic hematopoietic cell transplant (per IWG definition of relapse)
Availability of a CB unit matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens.
Lack of a human leukocyte antigen (HLA) matched related donor, lack of an immediately available 8/8 HLA matched unrelated donor
Matched related or unrelated (8/8 matched at human leukocyte antigen [HLA]-A, -B, -C, -DRB1) donor according to institutional standards
Availability of appropriate, willing, human leukocyte antigen (HLA)-matched related stem cell donor
No more than 1 antigen mismatch at human leukocyte antigen (HLA)-A, B, C, DRB1 and DQB1 locus for either related or unrelated donor
Patients must have a related donor who is human leukocyte antigen (HLA) mismatched at 2, 3, or 4 antigens at the HLA-A; B; C; DR loci in the graft-versus-host disease (GVHD) direction; (patients with related donors who are HLA identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but will have their outcomes will not be part of the statistical aims of the study); the HLA matched related category includes patients with a syngeneic donor
The recipient must have a related donor genotypically human leukocyte antigen (HLA)-A, B,C and DRB1 loci haploidentical to the recipient
Has a human leukocyte antigen (HLA)-matched or single allele-mismatched adult sibling serving as donor
No suitable human leukocyte antigen (HLA) matched sibling donor is available and the patient has one or more potentially suitable HLA matched unrelated donor(s) in the National Marrow Donor Registry or other available registry\r\n* The evaluation of donors shall be in accordance with existing National Marrow Donor Program (NMDP) Standard Policies and Procedures\r\n* HLA-matched donors are defined by allele matching at HLA-A, -B, -C, and DRB1 (8/8)
DONOR: Human leukocyte antigen (HLA)-matched or 1 antigen mismatched sibling donor
Human leukocyte antigen (HLA)-identical sibling or 8/8 matched unrelated donor transplant
Inadequate >= 7 out of 8 human leukocyte antigen (HLA) loci-matched related donor or HLA-matched unrelated donor
No available suitable human leukocyte antigen (HLA)-matched donor
Patients who do not have human leukocyte antigen (HLA)-matched (defined as matched in HLA A, B, C, and DRB1) related or unrelated donors
Must have a suitable donor defined as a sibling matched at 5/6 or 6/6 antigens (human leukocyte antigen [HLA]-A, B, and DRB1) or an unrelated volunteer matched at 7/8 or 8/8 HLA alleles (HLA-A, B, C, and DRB1)
6/6 human leukocyte antigen (HLA) matched family donor available
Presence of a willing adult human leukocyte antigen (HLA)-matched sibling (excluding identical twin) or HLA-matched unrelated donor meeting all the criteria for routine allo HSCT; all donors will be evaluated for eligibility and suitability per the standard of care according to the Foundation for the Accreditation of Cellular Therapy (FACT) and National Marrow Donor Program (NMDP) guidelines
RECIPIENT: 10/10 or 9/10 human leukocyte antigen (HLA)-matched related or unrelated donor or a haploidentical related donor
Patients who are deemed clinically fit for non-myeloablative transplantation and have a matched related or unrelated donor (9/10 human leukocyte antigen [HLA] allele matched or better using high resolution typing) eligible to provide a filgrastim (G-CSF) mobilized peripheral blood stem cell graft by institutional donor selection criteria; syngeneic donors are not permitted
Does not have a suitable human leukocyte antigen (HLA)-matched sibling donor (MSD) or volunteer HLA-matched unrelated donor (MUD) available in the necessary time for stem cell donation, or is not a candidate for MSD or MUD hematopoietic cell transplantation (HCT) due to refractory disease
Patients must have a related donor who is at least a 2-4/8 antigen mismatch at the human leukocyte antigen (HLA)-A; B; C; DR loci; patients with only a 1 out of 8 mismatch in the GVH direction will be classified in the matched related category
Patients must have a cord blood (CB) unit available which is matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens
Patients who have undergone an alemtuzumab or thymoglobulin-containing allogeneic transplant procedure from an human leukocyte antigen (HLA)-identical family donor, or an 8/8 HLA-matched unrelated donor
Patients must have a related donor who is human leukocyte antigen (HLA) mismatched at 2, 3, or 4 antigens at the HLA-A; B; C; DR loci in the GVHD direction; (patients with related donors who are HLA identical or are a 1-antigen mismatch may be treated on this therapeutic approach, but will have their outcomes will not be part of the statistical aims of the study)
Available 10/10 or 9/10 human leukocyte antigen (HLA)-matched related or unrelated donor or a haploidentical related donor
The UCB graft is matched at 4-6 human leukocyte antigen (HLA)-A, B, DRB1 antigens with the recipient; this may include 0-2 antigen mismatches at the A or B or DRB1 loci
Patients must have two CB units available which are matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens; each cord must contain at least 1.5 x 10^7 total nucleated cells/Kg recipient body weight (pre-thaw); cord blood units will be procured through the National Marrow Donor Program (NMDP)
Patient has at least one medically fit first- or second-degree family member expected to be human leukocyte antigen (HLA) mismatched at 2-9/10 loci; in addition, the prospective donor is willing to voluntarily donate hematopoietic stem cells and sign consent forms
Patients must have a cord blood unit available which is matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens
ENROLLMENT: Confirmation that a cord blood donor which is matched with the recipient at a 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and HLA class II (molecular) antigens.
Availability of a suitable human leukocyte antigen (HLA)-matched related donor
The unrelated UCB donors must be 4-6/6 human leukocyte antigen (HLA)-A, B, DRB1 matched with the recipient (HLA matching using molecular techniques: A and B at antigen level and DRB1 at allele level) and the UCB units must come from (a) qualified UCB bank(s) according to institutional standard operating procedures (SOPs); if the UCB unit is \unlicensed\ (most commonly on the basis of location [e.g., European countries], testing by non-Clinical Laboratory Improvements Amendment (CLIA) approved laboratories, or the UCB was collected before May 25, 2005), the Sponsor will make the final decision on patient eligibility based on the reason why the UCB is unlicensed\r\n* The patient must be free of HLA-specific antibodies for HLA antigens present on matched grafts\r\n* Suitable UCB units or haplo-identical donor available according to the UCB graft selection algorithm
Must have a 7/8 or 8/8 or haploidentical related donor matched at the human leukocyte antigen (HLA)-A, B, C, DRB1 who was evaluated and provided the donor transplant graft
Patients with a 5/6 or 6/6 related donor match are eligible or a 7-8/8 human leukocyte antigen (HLA)-A,B,C,DRB1 allele matched unrelated volunteer marrow and/or peripheral blood stem cell (PBSC) donor match
For patients in remission, there should be no readily available consenting human leukocyte antigen (HLA)-matched related donor who is either matched fully matched or mismatched at only one locus of HLA-A, -B, and DRB1; patients who have active leukemia (refractory or relapsed) may be transplanted on this protocol regardless of availability of a related donor since these patients would not typically be transplanted on standard of care treatment plans
Consenting first degree relative matched at 6/6 human leukocyte antigen (HLA) antigens (A, B, and DR)
Lack of a suitable human leukocyte antigen (HLA)-matched related donor
Lack of 6/6 or 5/6 human leukocyte antigen (HLA)-matched related, 8/8 HLA-matched unrelated donor, or unrelated donor not available within a time frame necessary to perform a potentially curative stem cell transplant
An human leukocyte antigen (HLA)-identical related or an HLA-matched unrelated donor (Fred Hutchinson Cancer Research Center [FHCRC] matching allowed will be Grade 1.0 to 2.1) is available
Patients must have a cord blood (CB) unit available which is matched with the patient at 3, 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens
Patients must have matched related or matched unrelated donor source OR CB unit(s) available for the primary transplant which is/are matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens; the cord(s) must contain at least 3 x 10^7 total nucleated cells/Kg recipient body weight (pre-thaw)
Recipient of 7-8/8 human leukocyte antigen (HLA)-matched (HLA-A, -B, -C, -DRB1) allogeneic hematopoietic stem cell transplantation or a 4-6/6 HLA-matched umbilical cord blood unit(s)
Patient with a human leukocyte antigen (HLA)-identical (HLA-A, B, C, and ribonucleic acid [RNA] binding motif protein 45 [DRB1] molecularly matched) unrelated donor or related donor capable of donating PBSC
DONORS: Matched related or unrelated donor stem cell transplant (SCT) matched at human leukocyte antigen (HLA) A- B, C, and DRB1 by molecular methods; 7 of 8 matched donor acceptable for related donors
Patients must NOT have a human leukocyte antigen (HLA)-matched sibling
DONOR: Human leukocyte antigen (HLA) compatible related or unrelated donor (i.e. a fully matched unmanipulated grafts or 1-2 HLA allele disparate donor for CD34 selected grafts)
Patients must have a histocompatible stem cell donor; a human leukocyte antigen (HLA)-identical related donor or a 8/8 matched unrelated donor
Patients must have undergone a human leukocyte antigen (HLA) matched (sibling) allogeneic HCT for a hematologic or lymphoid malignancy other than chronic myelogenous leukemia (CML) who have recurrent or persistent disease and are otherwise eligible for donor leukocyte infusions; CML patients with persistent disease after receiving donor lymphocyte infusion of at least 1 x 10^8 cells/kg will be eligible for CD8+ memory T cell infusion
A fully human leukocyte antigen (HLA) matched or single antigen/allele mismatched sibling or unrelated donor is available
MATCHED RELATED DONOR: Human leukocyte antigen (HLA)-matched related donor, excluding identical twins; donors must be matched at least 7 loci out of 8 at the allele or antigen level excluding antigen DRB1 mismatch
DONOR: Patients must have a healthy human leukocyte antigen (HLA) matched or mismatched related or unrelated donor who is willing to receive filgrastim (G-CSF) injections and undergo apheresis for peripheral blood stem cell (PBSC) collection, or undergo a marrow harvesting procedure
Patients must have two cord blood units available which are matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens; each cord must contain at least 10 million total nucleated cells/Kg recipient body weight (pre-thaw)
DONOR: Related or unrelated human leukocyte antigen (HLA) identical donors who are in good health and have no contra-indication to donation
Patients who have suitable human leukocyte antigen (HLA)-matched related or unrelated donors willing to receive filgrastim (G-CSF), undergo leukapheresis to collect peripheral blood mononuclear cell (PBMC), and to donate stem cells
Patients eligible for the study must have a human leukocyte antigen (HLA)-identical sibling or HLA-matched unrelated bone marrow donor available and willing to donate
Patient must have a partially (>= 3/6 class I antigen) human leukocyte antigen (HLA)-matched (by serology or low resolution deoxyribonucleic acid [DNA] testing) relative able to serve as a donor
Patients must have one of the following donor types identified who are willing to donate peripheral blood:\r\n* Related donor, 8/8 human leukocyte antigen (HLA)-matched for HLA-A, -B, C and DR matched or\r\n* Matched unrelated donor (MUD), 8/8 HLA-matched for HLA A, B, C and DRB1 using allele level typing
Patients must have two cord blood (CB) units available which are matched with the patient at 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and II (molecular) antigens; each cord must contain at least 1.5 x 10^7 total nucleated cells/kg recipient body weight (pre-thaw)
Patients must have an available 8/8 human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 matched-related or unrelated donor allogeneic hematopoietic peripheral blood stem cell graft
No more than 1 antigen mismatch at Human Leukocyte Antigen (HLA)-A, -B, -C, -DRB1 or -DQB1 locus for either related or unrelated donor; and
Must have consenting sibling matched at 6/6 human leukocyte antigen (HLA) antigens (A, B, DR)
Plan to receive an allogenic transplant from a 4-6/6 single or dual umbilical cord blood graft, or a 7-8/8 human leukocyte antigen (HLA)-matched sibling or unrelated donor (high resolution HLA-A, B, C, DRB1)
Patient’s donor must be a related or unrelated human leukocyte antigen (HLA) 8/8 allele-level match (HLA-A, B, C and DRB1)
DONOR: Human leukocyte antigen (HLA) >= 7/8 related or unrelated donors
Patients must be undergoing allogeneic hematopoietic stem cell transplantation (alloHCT) for hematologic malignancies from matched related or matched unrelated donors with 8/8 (A, B, C, DRB 1) high resolution human leukocyte antigen (HLA) donor allele matching
DONOR: Must be the same sibling donor from whom the recipient’s blood and marrow graft was collected for the original allogeneic transplant that is human leukocyte antigen (HLA) 7/8 or 8/8 matched at the HLA-A, B,C, DRB1
Recipient of 7-8/8 human leukocyte antigen (HLA)-matched (HLA-A, -B, -C, -DRB1) allogeneic hematopoietic stem cell transplantation
Patient must be the recipient of unrelated donor peripheral blood stem cell products; mismatches at both antigen and allele level will be eligible; match must be 6, 7, or 8 out of 8 loci (human leukocyte antigen [HLA] A, B, C and DRB1)
Patients transplanted from related or unrelated, human leukocyte antigen (HLA)-matched or mismatched donors
Each UCB unit must be matched at 4-6 human leukocyte antigen (HLA)-A, B, DRB1 antigens with the recipient; this may include 0-2 antigen mismatches at the A or B or DRB1 loci; each unit must be a 4-6 HLA-A, B, DRB1 antigen match to each other, not necessarily at the same loci they are matched to the recipient
Human leukocyte antigen (HLA) identical sibling donor, HLA matched unrelated donor, or donor mismatched at 1 HLA allele or antigen
No available human leukocyte antigen (HLA)-matched related donor
Availability of an human leukocyte antigen (HLA) matched related donor
Human leukocyte antigen (HLA) mismatched related or unrelated donor identified 8/10 or 9/10
Patients must have received transplantation from an human leukocyte antigen (HLA)-matched (6/6 loci at A, B, and DRB1) or mismatched (3-5/6) donor (related or unrelated); class I and II typing is to be performed by standard methods at our institution
Human leukocyte antigen (HLA) matched 8/8 (A, B, C, DRB1) related or unrelated donor
DONOR: Eligible donors will include siblings age >= 18 matched with the recipient at human leukocyte antigen (HLA)-A, B, C, and DRB1\r\n* Donor selection and stem cell product transplantation will be in compliance with 21 Code of Federal Regulation (CFR) 1271
Hematopoietic cell transplant (HCT)\r\n* No previous history of HCT or other cellular therapy (e.g., chimeric antigen receptor [CAR]-T cells, donor lymphocyte infusions)\r\n* Patient must be receiving cells from a first alternative donor defined as one of the following:\r\n** Unrelated donor with a complete human leukocyte antigen (HLA) match or a 1 or 2 HLA mismatch\r\n** Related donor with a 1 or 2 HLA mismatch
The patient has a human leukocyte antigen (HLA)-matched donor and is eligible for allogeneic transplantation for CML treatment.