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The study met criteria for stopping due to lack of efficacy per protocol specifications.
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This pilot study is being conducted to treat patients who have a certain type of malignancy (lymphoid or myeloid) with immune effector cells after a T-cell depleted allogeneic hematopoietic cell transplantation (TCD HSCT).
This study is designed to see whether an investigational cellular product of immune cells obtained from a donor's cells that have been treated so that the type of cells that can lead to graft vs host disease have been removed can be safely administered. These cell products are administered following the initial stem cell transplant to assess the effect and improvement on minimal residual disease status, infectious complication, progression-free and overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLA Matched Cohort I | Experimental | 5 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) |
|
| HLA Matched Cohort II | Experimental | 5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose |
|
| HLA Matched Cohort III | Experimental | 5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 2 x 10^6/kg 3-4 weeks after second dose |
|
| HLA Mismatched Cohort I | Experimental | 1 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) |
|
| HLA Mismatched Cohort II | Experimental | 1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 5 x 10^5/kg 3-4 weeks after second dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-cell Receptor α/β Depleted Donor Lymphocyte Infusions | Biological | T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Serious Adverse Events (TE-SAEs) | TE-SAEs are defined as the composite of death, non-fatal pulmonary embolism, stroke, acute graft versus host disease (GvHD), and clinically significant laboratory test abnormalities. | 30 days post-infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Remission | Remission - measured by absence of signs and symptoms | 2 years |
| Number of Participants With Transplant-associated Viral Complications | Transplant-associated viral complications - measured by viral infections associated with transplant |
Not provided
Inclusion Criteria:
Patients with hematologic malignancies that are candidates CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation.
Patients must have a Karnofsky (adult) Performance Status of at least 70%.
Patients must have adequate organ function measured by:
Each patient must be willing to participate as a research subject and must sign an informed consent form.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guenther Koehne, MD, PhD | Miami Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Cancer Institute at Baptist Health, Inc | Miami | Florida | 33176 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20215642 | Background | Seggewiss R, Einsele H. Immune reconstitution after allogeneic transplantation and expanding options for immunomodulation: an update. Blood. 2010 May 13;115(19):3861-8. doi: 10.1182/blood-2009-12-234096. Epub 2010 Mar 9. | |
| 18978746 | Background | Lang P, Handgretinger R. Haploidentical SCT in children: an update and future perspectives. Bone Marrow Transplant. 2008 Oct;42 Suppl 2:S54-9. doi: 10.1038/bmt.2008.285. |
| Label | URL |
|---|---|
| Miami Cancer Institute Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | HLA Matched Cohort I | 5 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| FG001 | HLA Matched Cohort II | 5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| FG002 | HLA Matched Cohort III | 5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 2 x 10^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| FG003 | HLA Mismatched Cohort I | 1 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| FG004 | HLA Mismatched Cohort II | 1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 5 x 10^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| FG005 | HLA Mismatched Cohort III | 1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | HLA Matched Cohort I | 5 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Treatment-emergent Serious Adverse Events (TE-SAEs) | TE-SAEs are defined as the composite of death, non-fatal pulmonary embolism, stroke, acute graft versus host disease (GvHD), and clinically significant laboratory test abnormalities. | The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially. | Posted | Count of Participants | Participants | 30 days post-infusion |
|
The longest any participant was on study was approximately 14 months.
The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings. Therefore the number of participants at risk for some groups was 0.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HLA Matched Cohort I | 5 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
Several of the participants had been on study for more than a year by the time the study was terminated. However, because the study was terminated early, the study did not accrue to the target, some cohorts had zero participants accrued, and no participants completed the study. Therefore, no conclusions can be drawn at this time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Research Concept & Protocol Development | Miami Cancer Institute at Baptist Health, Inc. | (786) 527-9546 | MCIResearchConceptAndProtocolDev@baptisthealth.net |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2022 | Aug 29, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D010954 | Plasmacytoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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The model is both parallel and sequential, in that Matched and Mismatched strata run in parallel and independently. Within each stratum, Cohorts I-III are filled sequentially. In addition, Cohort I of each stratum has three groups (A-C) that are filled sequentially.
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|
| HLA Mismatched Cohort III | Experimental | 1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose |
|
| 2 years |
| Disease Free Survival- Measured by Absence of Relapse/Recurrence or Death. | Disease free survival - measured by (absence of ) relapse/recurrence or death. Relapse and recurrence, both will be measured by greater than 5% circulating leukemic blasts in the marrow or peripheral blood and/or the presence of blasts in any extra medullary site and/or disease determined by clinical assessment. | 2 years |
| Overall Survival | Overall survival - measured by death | 2 years |
| 21921045 | Background | Reisner Y, Hagin D, Martelli MF. Haploidentical hematopoietic transplantation: current status and future perspectives. Blood. 2011 Dec 1;118(23):6006-17. doi: 10.1182/blood-2011-07-338822. Epub 2011 Sep 14. |
| 22010102 | Background | Jagasia M, Arora M, Flowers ME, Chao NJ, McCarthy PL, Cutler CS, Urbano-Ispizua A, Pavletic SZ, Haagenson MD, Zhang MJ, Antin JH, Bolwell BJ, Bredeson C, Cahn JY, Cairo M, Gale RP, Gupta V, Lee SJ, Litzow M, Weisdorf DJ, Horowitz MM, Hahn T. Risk factors for acute GVHD and survival after hematopoietic cell transplantation. Blood. 2012 Jan 5;119(1):296-307. doi: 10.1182/blood-2011-06-364265. Epub 2011 Oct 18. |
| 21493797 | Background | Arora M, Klein JP, Weisdorf DJ, Hassebroek A, Flowers ME, Cutler CS, Urbano-Ispizua A, Antin JH, Bolwell BJ, Boyiadzis M, Cahn JY, Cairo MS, Isola L, Jacobsohn DA, Jagasia M, Klumpp TR, Lee SJ, Petersdorf EW, Santarone S, Gale RP, Schouten HC, Spellman S, Wingard JR, Horowitz MM, Pavletic SZ. Chronic GVHD risk score: a Center for International Blood and Marrow Transplant Research analysis. Blood. 2011 Jun 16;117(24):6714-20. doi: 10.1182/blood-2010-12-323824. Epub 2011 Apr 14. |
| 8413388 | Background | Chao NJ, Schmidt GM, Niland JC, Amylon MD, Dagis AC, Long GD, Nademanee AP, Negrin RS, O'Donnell MR, Parker PM, et al. Cyclosporine, methotrexate, and prednisone compared with cyclosporine and prednisone for prophylaxis of acute graft-versus-host disease. N Engl J Med. 1993 Oct 21;329(17):1225-30. doi: 10.1056/NEJM199310213291703. |
| 10979948 | Background | Nash RA, Antin JH, Karanes C, Fay JW, Avalos BR, Yeager AM, Przepiorka D, Davies S, Petersen FB, Bartels P, Buell D, Fitzsimmons W, Anasetti C, Storb R, Ratanatharathorn V. Phase 3 study comparing methotrexate and tacrolimus with methotrexate and cyclosporine for prophylaxis of acute graft-versus-host disease after marrow transplantation from unrelated donors. Blood. 2000 Sep 15;96(6):2062-8. |
| 9746768 | Background | Ratanatharathorn V, Nash RA, Przepiorka D, Devine SM, Klein JL, Weisdorf D, Fay JW, Nademanee A, Antin JH, Christiansen NP, van der Jagt R, Herzig RH, Litzow MR, Wolff SN, Longo WL, Petersen FB, Karanes C, Avalos B, Storb R, Buell DN, Maher RM, Fitzsimmons WE, Wingard JR. Phase III study comparing methotrexate and tacrolimus (prograf, FK506) with methotrexate and cyclosporine for graft-versus-host disease prophylaxis after HLA-identical sibling bone marrow transplantation. Blood. 1998 Oct 1;92(7):2303-14. |
| 12433695 | Background | Gratwohl A, Brand R, Apperley J, Biezen Av Av, Bandini G, Devergie A, Schattenberg A, Frassoni F, Guglielmi C, Iacobelli S, Michallet M, Kolb HJ, Ruutu T, Niederwieser D; Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation (CLWP-EBMT). Graft-versus-host disease and outcome in HLA-identical sibling transplantations for chronic myeloid leukemia. Blood. 2002 Dec 1;100(12):3877-86. doi: 10.1182/blood.V100.12.3877. |
| 2207321 | Background | Martin PJ, Schoch G, Fisher L, Byers V, Anasetti C, Appelbaum FR, Beatty PG, Doney K, McDonald GB, Sanders JE, et al. A retrospective analysis of therapy for acute graft-versus-host disease: initial treatment. Blood. 1990 Oct 15;76(8):1464-72. |
| 6115110 | Background | Reisner Y, Kapoor N, Kirkpatrick D, Pollack MS, Dupont B, Good RA, O'Reilly RJ. Transplantation for acute leukaemia with HLA-A and B nonidentical parental marrow cells fractionated with soybean agglutinin and sheep red blood cells. Lancet. 1981 Aug 15;2(8242):327-31. doi: 10.1016/s0140-6736(81)90647-4. |
| 11477433 | Background | Handgretinger R, Klingebiel T, Lang P, Schumm M, Neu S, Geiselhart A, Bader P, Schlegel PG, Greil J, Stachel D, Herzog RJ, Niethammer D. Megadose transplantation of purified peripheral blood CD34(+) progenitor cells from HLA-mismatched parental donors in children. Bone Marrow Transplant. 2001 Apr;27(8):777-83. doi: 10.1038/sj.bmt.1702996. |
| 17717135 | Background | Jakubowski AA, Small TN, Young JW, Kernan NA, Castro-Malaspina H, Hsu KC, Perales MA, Collins N, Cisek C, Chiu M, van den Brink MR, O'Reilly RJ, Papadopoulos EB. T cell depleted stem-cell transplantation for adults with hematologic malignancies: sustained engraftment of HLA-matched related donor grafts without the use of antithymocyte globulin. Blood. 2007 Dec 15;110(13):4552-9. doi: 10.1182/blood-2007-06-093880. Epub 2007 Aug 23. |
| 12091376 | Background | Urbano-Ispizua A, Rozman C, Pimentel P, Solano C, de la Rubia J, Brunet S, Perez-Oteyza J, Ferra C, Zuazu J, Caballero D, Bargay J, Carvalhais A, Diez JL, Espigado I, Alegre A, Rovira M, Campilho F, Odriozola J, Sanz MA, Sierra J, Garcia-Conde J, Montserrat E; Spanish Group for Allogeneic Peripheral Blood Transplantation (Grupo Espanol de Trasplante Hemopoyetico) and Instituto Portugues de Oncologia-Porto. Risk factors for acute graft-versus-host disease in patients undergoing transplantation with CD34+ selected blood cells from HLA-identical siblings. Blood. 2002 Jul 15;100(2):724-7. doi: 10.1182/blood-2001-11-0057. |
| 15753458 | Background | Aversa F, Terenzi A, Tabilio A, Falzetti F, Carotti A, Ballanti S, Felicini R, Falcinelli F, Velardi A, Ruggeri L, Aloisi T, Saab JP, Santucci A, Perruccio K, Martelli MP, Mecucci C, Reisner Y, Martelli MF. Full haplotype-mismatched hematopoietic stem-cell transplantation: a phase II study in patients with acute leukemia at high risk of relapse. J Clin Oncol. 2005 May 20;23(15):3447-54. doi: 10.1200/JCO.2005.09.117. Epub 2005 Mar 7. |
| Background | Devine S, Soiffer R, Pasq uini M, Carter S, Hari P, DeVore S, Stein A, Lazarus H, Linker C, Stadtrnauer E, Keever-Taylor C, O'Reil ly RJ . HLA-identical sibling matched, CD34+ selected, T cell depleted peripheral blood stem cells following rnyeloablative conditioning for first or second remission acute rnyeloid leukemia (AM L): Results of blood and marrow trans plant clinical trials network (BMT CTN) Protocol 0303. Blood, 1 14 (22), 273. |
| 14525766 | Background | Bethge WA, Hegenbart U, Stuart MJ, Storer BE, Maris MB, Flowers ME, Maloney DG, Chauncey T, Bruno B, Agura E, Forman SJ, Blume KG, Niederwieser D, Storb R, Sandmaier BM. Adoptive immunotherapy with donor lymphocyte infusions after allogeneic hematopoietic cell transplantation following nonmyeloablative conditioning. Blood. 2004 Feb 1;103(3):790-5. doi: 10.1182/blood-2003-07-2344. Epub 2003 Oct 2. |
| 14576063 | Background | Peggs KS, Thomson K, Hart DP, Geary J, Morris EC, Yong K, Goldstone AH, Linch DC, Mackinnon S. Dose-escalated donor lymphocyte infusions following reduced intensity transplantation: toxicity, chimerism, and disease responses. Blood. 2004 Feb 15;103(4):1548-56. doi: 10.1182/blood-2003-05-1513. Epub 2003 Oct 23. |
| 18503987 | Background | Frey NV, Porter DL. Graft-versus-host disease after donor leukocyte infusions: presentation and management. Best Pract Res Clin Haematol. 2008 Jun;21(2):205-22. doi: 10.1016/j.beha.2008.02.007. |
| 16940425 | Background | Meyer RG, Britten CM, Wehler D, Bender K, Hess G, Konur A, Hartwig UF, Wehler TC, Ullmann AJ, Gentilini C, Uharek L, Huber C, Kolbe K, Herr W. Prophylactic transfer of CD8-depleted donor lymphocytes after T-cell-depleted reduced-intensity transplantation. Blood. 2007 Jan 1;109(1):374-82. doi: 10.1182/blood-2006-03-005769. Epub 2006 Aug 29. |
| 22329587 | Background | Farhan S, Lee DA, Champlin RE, Ciurea SO. NK cell therapy: targeting disease relapse after hematopoietic stem cell transplantation. Immunotherapy. 2012 Mar;4(3):305-13. doi: 10.2217/imt.11.174. Epub 2012 Feb 13. |
| 22914586 | Background | Handgretinger R. Negative depletion of CD3(+) and TcRalphabeta(+) T cells. Curr Opin Hematol. 2012 Nov;19(6):434-9. doi: 10.1097/MOH.0b013e3283582340. |
| 23160468 | Background | Tyler EM, Jungbluth AA, O'Reilly RJ, Koehne G. WT1-specific T-cell responses in high-risk multiple myeloma patients undergoing allogeneic T cell-depleted hematopoietic stem cell transplantation and donor lymphocyte infusions. Blood. 2013 Jan 10;121(2):308-17. doi: 10.1182/blood-2012-06-435040. Epub 2012 Nov 16. |
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| 23993299 | Background | Schumm M, Lang P, Bethge W, Faul C, Feuchtinger T, Pfeiffer M, Vogel W, Huppert V, Handgretinger R. Depletion of T-cell receptor alpha/beta and CD19 positive cells from apheresis products with the CliniMACS device. Cytotherapy. 2013 Oct;15(10):1253-8. doi: 10.1016/j.jcyt.2013.05.014. |
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| 8639809 | Background | Blazar BR, Taylor PA, Bluestone JA, Vallera DA. Murine gamma/delta-expressing T cells affect alloengraftment via the recognition of nonclassical major histocompatibility complex class Ib antigens. Blood. 1996 May 15;87(10):4463-72. |
| 16870417 | Background | Bonneville M, Scotet E. Human Vgamma9Vdelta2 T cells: promising new leads for immunotherapy of infections and tumors. Curr Opin Immunol. 2006 Oct;18(5):539-46. doi: 10.1016/j.coi.2006.07.002. Epub 2006 Jul 25. |
| 15504550 | Background | Grimes HL, Schanie CL, Huang Y, Cramer D, Rezzoug F, Fugier-Vivier I, Ildstad ST. Graft facilitating cells are derived from hematopoietic stem cells and functionally require CD3, but are distinct from T lymphocytes. Exp Hematol. 2004 Oct;32(10):946-54. doi: 10.1016/j.exphem.2004.07.011. |
| 21812770 | Background | Leung W. Use of NK cell activity in cure by transplant. Br J Haematol. 2011 Oct;155(1):14-29. doi: 10.1111/j.1365-2141.2011.08823.x. Epub 2011 Aug 4. |
| BG001 | HLA Matched Cohort II | 5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| BG002 | HLA Matched Cohort III | 5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 2 x 10^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| BG003 | HLA Mismatched Cohort I | 1 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| BG004 | HLA Mismatched Cohort II | 1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 5 x 10^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| BG005 | HLA Mismatched Cohort III | 1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| HLA Matched Cohort II |
5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| OG002 | HLA Matched Cohort III | 5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 2 x 10^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| OG003 | HLA Mismatched Cohort I | 1 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| OG004 | HLA Mismatched Cohort II | 1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 5 x 10^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
| OG005 | HLA Mismatched Cohort III | 1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients |
|
|
| Secondary | Number of Participants in Remission | Remission - measured by absence of signs and symptoms | Because the study was terminated early, no participants completed 2 years. | Posted | 2 years |
|
|
| Secondary | Number of Participants With Transplant-associated Viral Complications | Transplant-associated viral complications - measured by viral infections associated with transplant | Because the study was terminated early, no participants completed 2 years | Posted | 2 years |
|
|
| Secondary | Disease Free Survival- Measured by Absence of Relapse/Recurrence or Death. | Disease free survival - measured by (absence of ) relapse/recurrence or death. Relapse and recurrence, both will be measured by greater than 5% circulating leukemic blasts in the marrow or peripheral blood and/or the presence of blasts in any extra medullary site and/or disease determined by clinical assessment. | Because the study was terminated early, no participants completed 2 years. | Posted | 2 years |
|
|
| Secondary | Overall Survival | Overall survival - measured by death | Because the study was terminated early, no participants completed 2 years. | Posted | 2 years |
|
|
| 5 |
| 10 |
| 6 |
| 10 |
| 10 |
| 10 |
| EG001 | HLA Matched Cohort II | 5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | HLA Matched Cohort III | 5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 2 x 10^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | HLA Mismatched Cohort I | 1 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C) T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients | 1 | 1 | 1 | 1 | 1 | 1 |
| EG004 | HLA Mismatched Cohort II | 1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 5 x 10^5/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients | 0 | 0 | 0 | 0 | 0 | 0 |
| EG005 | HLA Mismatched Cohort III | 1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose T-cell Receptor α/β Depleted Donor Lymphocyte Infusions: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients | 0 | 0 | 0 | 0 | 0 | 0 |
| Lung infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Chest pain | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Decreased platelet count | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Epstein-Barr virus infection reactivation | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Viremia | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bacteremia | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Other, Large B cell lymphoma | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Decreased platelet count | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Dry eye | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Generalized edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Elevated ALT | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Elevated AST | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Encephalitis infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Other, Hepatotoxicity | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypercalcemia | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Other, COVID-19 | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Other, Sapovirus | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Other, Strongloidiasis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Hematoma | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |