LeukemiaAB-CliniMACsNCT02323867
Allogeneic Stem Cell Transplant With Alpha/Beta T AND B Cell Depletion for Hematologic Malignancies
A study testing CliniMACS α/β T-Cell and CD19+ B-Cell Depleted Peripheral Blood Stem Cell Transplant in people with Leukemia and Lymphoma, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This is a single-arm study evaluating allogeneic hematopoietic stem cell transplantation (HSCT) using mobilized peripheral blood stem cells from unrelated or partially matched related donors that are ex vivo depleted of α/β T cells and CD19+ B cells using the CliniMACS device. Read more about this study
- Who is it for?
- Ages Up to 23 years
- Conditions the study is for
- Leukemia, Lymphoma, Myelodysplasia
- What is being tested?
- CliniMACS α/β T-Cell and CD19+ B-Cell Depleted Peripheral Blood Stem Cell Transplant
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to May 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 23 or less years at time of enrollment
- Diagnosis of a hematologic malignancy, including:
- Acute myeloid leukemia (primary or secondary) in remission or <10% bone marrow blasts
- Acute lymphoblastic leukemia in hematologic remission
- Myelodysplastic syndrome
- Chronic myelogenous leukemia (chronic phase, accelerated phase, or blast crisis in second chronic phase)
Show all 18Show fewer
- Mixed lineage or biphenotypic acute leukemia
- Lymphoblastic lymphoma in remission
- Burkitt lymphoma/leukemia in remission
- Eligible for allogeneic hematopoietic stem cell transplantation (HSCT) per institutional criteria:
- Availability of an appropriate donor:
- Unrelated donor with up to one antigen mismatch or defined allele mismatch
- Partially matched related donor, including haploidentical donors
- Adequate organ function as per institutional bone marrow transplant (BMT) standards
- No active, uncontrolled infection
- Patients with prior fungal infection must have received ≥2 weeks of appropriate therapy and be clinically stable
- Negative pregnancy test for females of childbearing potential
- Ability to provide informed consent (≥18 years) or consent provided by parent/legal guardian
Who cannot join
- Does not meet disease eligibility criteria
- Inadequate organ function or uncontrolled infection
- No suitable donor available
- Prior allogeneic stem cell transplantation
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19103
About this study
Official title: Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha/Beta T-Cell and B-Cell Depletion for Patients With Hematologic Malignancies
This is a single-arm study evaluating allogeneic hematopoietic stem cell transplantation (HSCT) using mobilized peripheral blood stem cells from unrelated or partially matched related donors that are ex vivo depleted of α/β T cells and CD19+ B cells using the CliniMACS device. The study assesses engraftment, graft-versus-host disease (GVHD), treatment-related mortality, immune reconstitution, and one-year leukemia-free survival in patients with hematologic malignancies.
Read the detailed description
This is a single-arm, prospective study evaluating the safety and efficacy of allogeneic hematopoietic stem cell transplantation (HSCT) using ex vivo α/β T-cell-depleted and CD19+ B-cell-depleted peripheral blood stem cell grafts processed with the CliniMACS device in patients with hematologic malignancies who lack matched related donors.
Participants will receive mobilized peripheral blood stem cells from unrelated or partially matched related donors. The collected stem cell products will undergo ex vivo manipulation using the CliniMACS system to selectively deplete T-cell receptor (TCR) α/β-positive T lymphocytes and CD19+ B cells while preserving CD34+ hematopoietic stem cells, natural killer (NK) cells, and γ/δ T cells. This selective depletion strategy aims to reduce the risk of graft-versus-host disease (GVHD) while maintaining engraftment potential and immune function.
All patients will receive myeloablative conditioning with either total body irradiation-based or busulfan-based regimens, with anti-thymocyte globulin administered in selected patients based on donor type and clinical indication. Routine post-transplant pharmacologic GVHD prophylaxis is not planned but may be administered at the discretion of the treating physician if clinically indicated.
The primary objectives are to evaluate engraftment (including incidence of primary graft failure and time to neutrophil and platelet recovery), incidence and severity of acute and chronic GVHD, treatment-related mortality, and one-year leukemia-free survival. Secondary objectives include assessment of immune reconstitution, incidence of viral infections (including CMV, EBV, adenovirus, and HHV-6), and correlation of outcomes with donor and recipient killer immunoglobulin-like receptor (KIR) typing.
The study will enroll approximately 110 patients over a 10-year period, with outcomes analyzed descriptively using estimates of event rates and confidence intervals. The goal of this study is to determine whether selective α/β T-cell and CD19+ B-cell depletion using the CliniMACS system improves transplant outcomes by reducing GVHD while enabling durable engraftment and enhanced immune recovery in patients receiving alternative donor transplants.
- Conditions
- Leukemia, Lymphoma, Myelodysplasia
- Being tested
- CliniMACS α/β T-Cell and CD19+ B-Cell Depleted Peripheral Blood Stem Cell Transplant
- Keywords
- Transplant, Alternative Donor
- Medical subject headings
- Leukemia, Lymphoma, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CliniMACS α/β T-Cell and CD19+ B-Cell Depleted Peripheral Blood Stem Cell TransplantDevice
Allogeneic hematopoietic stem cell transplantation using mobilized peripheral blood stem cells from unrelated or partially matched related donors. The stem cell product is processed ex vivo using the CliniMACS device to selectively deplete TCR α/β T cells and CD19+ B cells prior to infusion. The final graft retains CD34+ stem cells, NK cells, and γ/δ T cells.
| Study group | Role | What they receive |
|---|---|---|
| CliniMACS αβ T-Cell/CD19+ B-Cell Depleted Peripheral Blood Stem Cell Transplant | Experimental | This is a single arm study for patients with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related mobilized peripheral stem cells (PSCs) using the CliniMACS system for αβ T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one year leukemia free survival. Receives: Device: CliniMACS α/β T-Cell and CD19+ B-Cell Depleted Peripheral Blood Stem Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engraftment Rate
Number of patients achieving neutrophil engraftment, defined as absolute neutrophil count (ANC) ≥ 500/µL for 3 consecutive days
Measured: 1-year post-transplant
Number of Participants With Grade IV Acute Graft-versus-Host Disease (GVHD)
Number of participants with of grade IV acute GVHD assessed using standard Glucksberg criteria
Measured: Up to 100 days post-transplant
Day 100 Treatment-Related Mortality (TRM)
Death due to causes other than relapse within 100 days after stem cell infusion
Measured: 100 days post-transplant
One-Year Leukemia-Free Survival (LFS)
Relapse or disease progression was assessed according to disease-specific standard criteria, including clinical evaluation, bone marrow examinations, peripheral blood testing, donor chimerism studies, imaging studies, and/or measurable disease assessments as appropriate for the participant's underlying malignancy. Relapse was defined as recurrence or progression of the primary disease after transplant, including reappearance of morphologic disease, increasing disease burden, loss of remission status, or other evidence of progression.
Measured: 1-year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionJul 2025
- Study completionMay 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Olson, Children's Hospital of Philadelphia
- Investigators
- Timothy Olson, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323867
- Sponsor's protocol ID
- 13-010495
- Other IDs
- 13BTθ51
- Acronym
- AB-CliniMACs
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2014
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Finke J, Bethge WA, Schmoor C, Ottinger HD, Stelljes M, Zander AR, Volin L, Ruutu T, Heim DA, Schwerdtfeger R, Kolbe K, Mayer J, Maertens JA, Linkesch W, Holler E, Koza V, Bornhauser M, Einsele H, Kolb HJ, Bertz H, Egger M, Grishina O, Socie G; ATG-Fresenius Trial Group. Standard graft-versus-host disease prophylaxis with or without anti-T-cell globulin in haematopoietic cell transplantation from matched unrelated donors: a randomised, open-label, multicentre phase 3 trial. Lancet Oncol. 2009 Sep;10(9):855-64. doi: 10.1016/S1470-2045(09)70225-6. Epub 2009 Aug 18.
PubMed 19695955Di Bartolomeo P, Santarone S, De Angelis G, Picardi A, Cudillo L, Cerretti R, Adorno G, Angelini S, Andreani M, De Felice L, Rapanotti MC, Sarmati L, Bavaro P, Papalinetti G, Di Nicola M, Papola F, Montanari M, Nagler A, Arcese W. Haploidentical, unmanipulated, G-CSF-primed bone marrow transplantation for patients with high-risk hematologic malignancies. Blood. 2013 Jan 31;121(5):849-57. doi: 10.1182/blood-2012-08-453399. Epub 2012 Nov 19.
PubMed 23165479Barge RM, Starrenburg CW, Falkenburg JH, Fibbe WE, Marijt EW, Willemze R. Long-term follow-up of myeloablative allogeneic stem cell transplantation using Campath "in the bag" as T-cell depletion: the Leiden experience. Bone Marrow Transplant. 2006 Jun;37(12):1129-34. doi: 10.1038/sj.bmt.1705385.
PubMed 16757974Fuchs EJ. Human leukocyte antigen-haploidentical stem cell transplantation using T-cell-replete bone marrow grafts. Curr Opin Hematol. 2012 Nov;19(6):440-7. doi: 10.1097/MOH.0b013e32835822dc.
PubMed 22954723Quinones RR, Gutierrez RH, Dinndorf PA, Gress RE, Ney AB, Taylor B, Karandish S, Carter CS, Luban NL, Reaman GH. Extended-cycle elutriation to adjust T-cell content in HLA-disparate bone marrow transplantation. Blood. 1993 Jul 1;82(1):307-17.
PubMed 8324231Schattenberg A, De Witte T, Preijers F, Raemaekers J, Muus P, Van der Lely N, Boezeman J, Wessels J, Van Dijk B, Hoogenhout J, et al. Allogeneic bone marrow transplantation for leukemia with marrow grafts depleted of lymphocytes by counterflow centrifugation. Blood. 1990 Mar 15;75(6):1356-63.
PubMed 2310832Soiffer RJ, Murray C, Cochran K, Cameron C, Wang E, Schow PW, Daley JF, Ritz J. Clinical and immunologic effects of prolonged infusion of low-dose recombinant interleukin-2 after autologous and T-cell-depleted allogeneic bone marrow transplantation. Blood. 1992 Jan 15;79(2):517-26.
PubMed 1730094Watts MJ, Somervaille TC, Ings SJ, Ahmed F, Khwaja A, Yong K, Linch DC. Variable product purity and functional capacity after CD34 selection: a direct comparison of the CliniMACS (v2.1) and Isolex 300i (v2.5) clinical scale devices. Br J Haematol. 2002 Jul;118(1):117-23. doi: 10.1046/j.1365-2141.2002.03561.x.
PubMed 12100134Champlin RE, Passweg JR, Zhang MJ, Rowlings PA, Pelz CJ, Atkinson KA, Barrett AJ, Cahn JY, Drobyski WR, Gale RP, Goldman JM, Gratwohl A, Gordon-Smith EC, Henslee-Downey PJ, Herzig RH, Klein JP, Marmont AM, O'Reilly RJ, Ringden O, Slavin S, Sobocinski KA, Speck B, Weiner RS, Horowitz MM. T-cell depletion of bone marrow transplants for leukemia from donors other than HLA-identical siblings: advantage of T-cell antibodies with narrow specificities. Blood. 2000 Jun 15;95(12):3996-4003.
PubMed 10845940Handgretinger R, Schumm M, Lang P, Greil J, Reiter A, Bader P, Niethammer D, Klingebiel T. Transplantation of megadoses of purified haploidentical stem cells. Ann N Y Acad Sci. 1999 Apr 30;872:351-61; discussion 361-2. doi: 10.1111/j.1749-6632.1999.tb08479.x.
PubMed 10372137Chen X, Hale GA, Barfield R, Benaim E, Leung WH, Knowles J, Horwitz EM, Woodard P, Kasow K, Yusuf U, Behm FG, Hayden RT, Shurtleff SA, Turner V, Srivastava DK, Handgretinger R. Rapid immune reconstitution after a reduced-intensity conditioning regimen and a CD3-depleted haploidentical stem cell graft for paediatric refractory haematological malignancies. Br J Haematol. 2006 Nov;135(4):524-32. doi: 10.1111/j.1365-2141.2006.06330.x. Epub 2006 Sep 28.
PubMed 17010105Ash RC, Horowitz MM, Gale RP, van Bekkum DW, Casper JT, Gordon-Smith EC, Henslee PJ, Kolb HJ, Lowenberg B, Masaoka T, et al. Bone marrow transplantation from related donors other than HLA-identical siblings: effect of T cell depletion. Bone Marrow Transplant. 1991 Jun;7(6):443-52.
PubMed 1873591Casper J, Camitta B, Truitt R, Baxter-Lowe LA, Bunin N, Lawton C, Murray K, Hunter J, Pietryga D, Garbrecht F, et al. Unrelated bone marrow donor transplants for children with leukemia or myelodysplasia. Blood. 1995 May 1;85(9):2354-63.
PubMed 7727769Bunin N, Aplenc R, Grupp S, Pierson G, Monos D. Unrelated donor or partially matched related donor peripheral stem cell transplant with CD34+ selection and CD3+ addback for pediatric patients with leukemias. Bone Marrow Transplant. 2006 Jan;37(2):143-9. doi: 10.1038/sj.bmt.1705211.
PubMed 16284615Bunin NJ, Casper JT, Lawton C, Murray K, Camitta BM, Greenwood M, Geil J, Ash RC. Allogeneic marrow transplantation using T cell depletion for patients with juvenile chronic myelogenous leukemia without HLA-identical siblings. Bone Marrow Transplant. 1992 Feb;9(2):119-22.
PubMed 1571710
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unrelated and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha/Beta T-Cell and B-Cell Depletion for Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02323867
- Acronym / sponsor ID
- AB-CliniMACs / 13-010495
- Conditions
- Leukemia, Lymphoma, Myelodysplasia
- Keywords
- Transplant, Alternative Donor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Jul 2025 (actual)
- Study completion
- May 2026 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Posted 6 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm study evaluating allogeneic hematopoietic stem cell transplantation (HSCT) using mobilized peripheral blood stem cells from unrelated or partially matched related donors that are ex vivo depleted of α/β T cells and CD19+ B cells using the CliniMACS device. The study assesses engraftment, graft-versus-host disease (GVHD), treatment-related mortality, immune reconstitution, and one-year leukemia-free survival in patients with hematologic malignancies.
Detailed description
This is a single-arm, prospective study evaluating the safety and efficacy of allogeneic hematopoietic stem cell transplantation (HSCT) using ex vivo α/β T-cell-depleted and CD19+ B-cell-depleted peripheral blood stem cell grafts processed with the CliniMACS device in patients with hematologic malignancies who lack matched related donors.
Participants will receive mobilized peripheral blood stem cells from unrelated or partially matched related donors. The collected stem cell products will undergo ex vivo manipulation using the CliniMACS system to selectively deplete T-cell receptor (TCR) α/β-positive T lymphocytes and CD19+ B cells while preserving CD34+ hematopoietic stem cells, natural killer (NK) cells, and γ/δ T cells. This selective depletion strategy aims to reduce the risk of graft-versus-host disease (GVHD) while maintaining engraftment potential and immune function.
All patients will receive myeloablative conditioning with either total body irradiation-based or busulfan-based regimens, with anti-thymocyte globulin administered in selected patients based on donor type and clinical indication. Routine post-transplant pharmacologic GVHD prophylaxis is not planned but may be administered at the discretion of the treating physician if clinically indicated.
The primary objectives are to evaluate engraftment (including incidence of primary graft failure and time to neutrophil and platelet recovery), incidence and severity of acute and chronic GVHD, treatment-related mortality, and one-year leukemia-free survival. Secondary objectives include assessment of immune reconstitution, incidence of viral infections (including CMV, EBV, adenovirus, and HHV-6), and correlation of outcomes with donor and recipient killer immunoglobulin-like receptor (KIR) typing.
The study will enroll approximately 110 patients over a 10-year period, with outcomes analyzed descriptively using estimates of event rates and confidence intervals. The goal of this study is to determine whether selective α/β T-cell and CD19+ B-cell depletion using the CliniMACS system improves transplant outcomes by reducing GVHD while enabling durable engraftment and enhanced immune recovery in patients receiving alternative donor transplants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CliniMACS αβ T-Cell/CD19+ B-Cell Depleted Peripheral Blood Stem Cell Transplant | Experimental | Device: CliniMACS α/β T-Cell and CD19+ B-Cell Depleted Peripheral Blood Stem Cell TransplantThis is a single arm study for patients with hematologic malignancies with alternative donor sources receiving unrelated or partially matched related mobilized peripheral stem cells (PSCs) using the CliniMACS system for αβ T cell depletion plus CD19+ B cell depletion to determine efficacy as determined by engraftment and GVHD, and one year leukemia free survival. |
Who may qualify
- Ages
- Up to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- Age 23 or less years at time of enrollment
- Diagnosis of a hematologic malignancy, including:
- Eligible for allogeneic hematopoietic stem cell transplantation (HSCT) per institutional criteria:
- Adequate organ function as per institutional bone marrow transplant (BMT) standards
- No active, uncontrolled infection
Key exclusion criteria (4 listed)
- Does not meet disease eligibility criteria
- Inadequate organ function or uncontrolled infection
- No suitable donor available
- Prior allogeneic stem cell transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CliniMACS α/β T-Cell and CD19+ B-Cell Depleted Peripheral Blood Stem Cell TransplantAllogeneic hematopoietic stem cell transplantation using mobilized peripheral blood stem cells from unrelated or partially matched related donors. The stem cell product is processed ex vivo using the CliniMACS device to selectively deplete TCR α/β T cells and CD19+ B cells prior to infusion. The final graft retains CD34+ stem cells, NK cells, and γ/δ T cells. | Device | CliniMACS αβ T-Cell/CD19+ B-Cell Depleted Peripheral Blood Stem Cell Transplant |
Primary outcome
Engraftment Rate
Time frame: 1-year post-transplant
Number of patients achieving neutrophil engraftment, defined as absolute neutrophil count (ANC) ≥ 500/µL for 3 consecutive days
Number of Participants With Grade IV Acute Graft-versus-Host Disease (GVHD)
Time frame: Up to 100 days post-transplant
Number of participants with of grade IV acute GVHD assessed using standard Glucksberg criteria
Day 100 Treatment-Related Mortality (TRM)
Time frame: 100 days post-transplant
Death due to causes other than relapse within 100 days after stem cell infusion
One-Year Leukemia-Free Survival (LFS)
Time frame: 1-year post-transplant
Relapse or disease progression was assessed according to disease-specific standard criteria, including clinical evaluation, bone marrow examinations, peripheral blood testing, donor chimerism studies, imaging studies, and/or measurable disease assessments as appropriate for the participant's underlying malignancy. Relapse was defined as recurrence or progression of the primary disease after transplant, including reappearance of morphologic disease, increasing disease burden, loss of remission status, or other evidence of progression.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19695955Finke J, Bethge WA, Schmoor C, Ottinger HD, Stelljes M, Zander AR, Volin L, Ruutu T, Heim DA, Schwerdtfeger R, Kolbe K, Mayer J, Maertens JA, Linkesch W, Holler E, Koza V, Bornhauser M, Einsele H, Kolb HJ, Bertz H, Egger M, Grishina O, Socie G; ATG-Fresenius Trial Group. Standard graft-versus-host disease prophylaxis with or without anti-T-cell globulin in haematopoietic cell transplantation from matched unrelated donors: a randomised, open-label, multicentre phase 3 trial. Lancet Oncol. 2009 Sep;10(9):855-64. doi: 10.1016/S1470-2045(09)70225-6. Epub 2009 Aug 18.
- Background: PubMed 23165479Di Bartolomeo P, Santarone S, De Angelis G, Picardi A, Cudillo L, Cerretti R, Adorno G, Angelini S, Andreani M, De Felice L, Rapanotti MC, Sarmati L, Bavaro P, Papalinetti G, Di Nicola M, Papola F, Montanari M, Nagler A, Arcese W. Haploidentical, unmanipulated, G-CSF-primed bone marrow transplantation for patients with high-risk hematologic malignancies. Blood. 2013 Jan 31;121(5):849-57. doi: 10.1182/blood-2012-08-453399. Epub 2012 Nov 19.
- Background: PubMed 16757974Barge RM, Starrenburg CW, Falkenburg JH, Fibbe WE, Marijt EW, Willemze R. Long-term follow-up of myeloablative allogeneic stem cell transplantation using Campath "in the bag" as T-cell depletion: the Leiden experience. Bone Marrow Transplant. 2006 Jun;37(12):1129-34. doi: 10.1038/sj.bmt.1705385.
- Background: PubMed 22954723Fuchs EJ. Human leukocyte antigen-haploidentical stem cell transplantation using T-cell-replete bone marrow grafts. Curr Opin Hematol. 2012 Nov;19(6):440-7. doi: 10.1097/MOH.0b013e32835822dc.
- Background: PubMed 8324231Quinones RR, Gutierrez RH, Dinndorf PA, Gress RE, Ney AB, Taylor B, Karandish S, Carter CS, Luban NL, Reaman GH. Extended-cycle elutriation to adjust T-cell content in HLA-disparate bone marrow transplantation. Blood. 1993 Jul 1;82(1):307-17.
- Background: PubMed 2310832Schattenberg A, De Witte T, Preijers F, Raemaekers J, Muus P, Van der Lely N, Boezeman J, Wessels J, Van Dijk B, Hoogenhout J, et al. Allogeneic bone marrow transplantation for leukemia with marrow grafts depleted of lymphocytes by counterflow centrifugation. Blood. 1990 Mar 15;75(6):1356-63.
- Background: PubMed 1730094Soiffer RJ, Murray C, Cochran K, Cameron C, Wang E, Schow PW, Daley JF, Ritz J. Clinical and immunologic effects of prolonged infusion of low-dose recombinant interleukin-2 after autologous and T-cell-depleted allogeneic bone marrow transplantation. Blood. 1992 Jan 15;79(2):517-26.
- Background: PubMed 12100134Watts MJ, Somervaille TC, Ings SJ, Ahmed F, Khwaja A, Yong K, Linch DC. Variable product purity and functional capacity after CD34 selection: a direct comparison of the CliniMACS (v2.1) and Isolex 300i (v2.5) clinical scale devices. Br J Haematol. 2002 Jul;118(1):117-23. doi: 10.1046/j.1365-2141.2002.03561.x.
- Background: PubMed 10845940Champlin RE, Passweg JR, Zhang MJ, Rowlings PA, Pelz CJ, Atkinson KA, Barrett AJ, Cahn JY, Drobyski WR, Gale RP, Goldman JM, Gratwohl A, Gordon-Smith EC, Henslee-Downey PJ, Herzig RH, Klein JP, Marmont AM, O'Reilly RJ, Ringden O, Slavin S, Sobocinski KA, Speck B, Weiner RS, Horowitz MM. T-cell depletion of bone marrow transplants for leukemia from donors other than HLA-identical siblings: advantage of T-cell antibodies with narrow specificities. Blood. 2000 Jun 15;95(12):3996-4003.
- Background: PubMed 10372137Handgretinger R, Schumm M, Lang P, Greil J, Reiter A, Bader P, Niethammer D, Klingebiel T. Transplantation of megadoses of purified haploidentical stem cells. Ann N Y Acad Sci. 1999 Apr 30;872:351-61; discussion 361-2. doi: 10.1111/j.1749-6632.1999.tb08479.x.
- Background: PubMed 17010105Chen X, Hale GA, Barfield R, Benaim E, Leung WH, Knowles J, Horwitz EM, Woodard P, Kasow K, Yusuf U, Behm FG, Hayden RT, Shurtleff SA, Turner V, Srivastava DK, Handgretinger R. Rapid immune reconstitution after a reduced-intensity conditioning regimen and a CD3-depleted haploidentical stem cell graft for paediatric refractory haematological malignancies. Br J Haematol. 2006 Nov;135(4):524-32. doi: 10.1111/j.1365-2141.2006.06330.x. Epub 2006 Sep 28.
- Background: PubMed 1873591Ash RC, Horowitz MM, Gale RP, van Bekkum DW, Casper JT, Gordon-Smith EC, Henslee PJ, Kolb HJ, Lowenberg B, Masaoka T, et al. Bone marrow transplantation from related donors other than HLA-identical siblings: effect of T cell depletion. Bone Marrow Transplant. 1991 Jun;7(6):443-52.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Olson, MD, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CliniMACS α/β T-Cell and CD19+ B-Cell Depleted Peripheral Blood Stem Cell Transplant in people with Leukemia and Lymphoma, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engraftment Rate (time frame: 1-year post-transplant). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323867, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.