Graft Vs Host DiseaseNCT04337515
A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant
A study testing CliniMacs® in people with Graft Vs Host Disease and Graft-versus-host-disease, run by Christopher Dvorak at 1 site in United States.
Trial summary
Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Graft Vs Host Disease, Graft-versus-host-disease
- What is being tested?
- CliniMacs®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 1 Jan 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female 0-30 years of age at time of transplant admission
- Documentation of a disease requiring HCT
- A donor (mismatched related or unrelated) must be located who are healthy and willing, and whom are able to donate bone marrow (BM) or peripheral blood stem cells (PBSC). Matched related donors may be used for patients with Fanconi Anemia.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Who cannot join
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Presence of a healthy and willing HLA-identical related donor (except when the patient has Fanconi Anemia).
- Patient with an anticipated life expectancy of <1 month
- Patients with known hypersensitivity to murine (mouse) proteins or iron dextran
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Christopher C Dvorak, MD, 877-827-3222, cancertrials@ucsf.edu
Christopher C Dvorak, MD
About this study
Official title: A Feasibility Study of Using the CiniMacs® Device for Alpha/Best T-Cell Depletion in Stem Cell Transplant Recipients
Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the CliniMACS® Device is FDA-approved only for a narrow indication. All other uses of ex vivo processed cells must be done under a feasibility study protocol.
Read the detailed description
The original CliniMACS® device (CD34 Reagent System) employs a reagent consisting of an antibody that specifically binds to blood cells that express the CD34+ surface marker (hematopoietic stem cells or blood stem cells). The CD34 antibody is conjugated to an iron-containing particle that is only nanometers in size and safe for infusion. The enrichment of CD34+ cells is accomplished by passing the antibody/magnetically-labeled cell suspension through a magnetic separation column, which is provided as part of a single-use disposable tubing set. Magnetically-labeled CD34+ target cells are retained within the separation column, while the unlabeled cells flow through. Recovery of CD34+ cells is achieved by removing the magnetic field and eluting the targeted CD34+ stem cells into a collection bag.
On January 24, 2014, the FDA approved the CliniMACS CD34 Reagent System as a Humanitarian Use Device for the prevention of graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) in first complete remission undergoing allogeneic HCT from a matched related donor. Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. The CliniMACS® CD34 Reagent System is now indicated for processing hematopoietic progenitor cells collected by apheresis (PBSC) from an allogeneic, Human Leukocyte Antigen (HLA)-identical matched sibling donor (MSD) to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional GVHD prophylaxis in patients with AML in first morphologic complete remission (CR1). The approval as an HUD, however, asserts that there was sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury. Furthermore, the clinical data supported the premise of a "probable benefit"; in that the risk to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.19 The CliniMACS CD34 Reagent System was shown to meet these requirements.
Uses of the CliniMACS CD34 Reagent System beyond MSD PBSC HCT for AML in CR1 are currently not FDA approved and therefore considered research, even though CD34-selection is widely considered to be a standard-of-care option for haploidentical HCT. In Europe, the European Medicines Agency (EMA) has made the CliniMACs System components available as Conformité Européene (CE) marked medical devices, and "any clinical application of the target cells is exclusively within the responsibility of the user of a CliniMACS System."
The CD34-selection system has been widely used in haploidentical HCTs, with the first patient treated at University of California, San Francisco (UCSF) in 2002. Since then, CD34-selection has facilitated over 70 HCTs at UCSF on 2 successive protocols (#01151 and #10082). However, the removal of almost all cells beyond those which are CD34+ leads to minimal passive transfer of immunity. It is therefore complicated by a slow recovery of immunity, with high rates of life-threatening viral infections, and an appreciable degree of transplant-related mortality (TRM).
Beginning in 2014, a new approach to ex vivo processing of stem cells was developed with a goal of mainly replacing the older CD34-selection technology. This technique utilizes negative depletion of the cells thought to be most responsible for the development of aGVHD, the alpha-beta T-cell Receptor positive T-cells.
All trials of alpha-beta T-cell depleted have included simultaneous depletion of CD19+ B cells from the donor graft. All references to "alpha-beta T-cell depletion" herein implies simultaneous Cluster of Differentiation antigen (CD)19+ depletion as well.
- Conditions
- Graft Vs Host Disease, Graft-versus-host-disease
- Being tested
- CliniMacs®
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CliniMacs®Device
Also called CliniMACS® CD34 Reagent System
CliniMACS® CD34 Reagent System is now indicated for processing hematopoietic progenitor cells collected by apheresis (PBSC) from an allogeneic, HLA-identical MSD to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional GVHD prophylaxis in patients with AML in first morphologic complete remission (CR1).
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving allogeneic hematopoietic cell transplant | Experimental | The test product is a stem cell product which has been alpha-beta T- cell depleted using the CliniMACS system. Alpha-beta T-cell depleted cells are given intravenously over a period of time as dictated by the final volume of the infused product (5 ml/kg/hour).
The target dose of CD34+ cells is ≥20x10^6/kg, but a minimum of
≥2.5x10^6/kg is required. The target dose of T-cell receptor (TCR) alpha-beta CD3+ cells is ≤1x10^5/kg. Receives: Device: CliniMacs® |
What is being measured
The primary outcome is the main question the study is designed to answer.
100-day incidence of Grade III-IV acute GVHD
The cumulative incidence of Grade III-IV acute GVHD at Day 100 will be summarized by incidence curves. GVHD evaluations will be performed using standard criteria.37 Patients with graft rejection will be censored.
Measured: 100 days
Secondary outcomes (5)
30-day incidence of engraftment
The cumulative incidence of donor cell engraftment at 30 days will be summarized by incidence curves. Engraftment will be defined as ANC recovery (>500 x 3 days) with evidence of donor myeloid cells on chimerism analysis, OR, for non-myeloablative HCTs, evidence of donor cells on chimerism analysis.
Measured: 30 days
1-year incidence of transplant-related mortality
The cumulative incidence of transplant-related mortality at 1-year will be summarized by incidence curves.
Measured: 12 months
1-year incidence of systemic steroid-requiring chronic GVHD
The cumulative incidence of systemic steroid-requiring chronic GVHD at 1-year will be summarized by incidence curves. GVHD evaluations will be performed using standard criteria.
Measured: 12 months
1-year incidence of autoimmunity requiring intervention with immunosuppressive agents as treatment.
The cumulative incidence of autoimmunity at 1-year will be summarized by incidence curves
Measured: 12 months
180-day incidence of T-cell reconstitution (CD4+ T-cell count >200 and proliferation to PHA >50% control).
The incidence of T-cell reconstitution at Day 180 will be summarized by numbers and percentages of subjects in corresponding categories. T cell reconstitution is defined as a CD4+ T-cell count >200 and Proliferation to PHA >50% control
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start19 Dec 2019
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Graft Vs Host DiseaseStudies of the same condition, open and under way.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher Dvorak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Dvorak, University of California, San Francisco
- Investigators
- Christopher C Dvorak, MD, Principal investigator, Professor of Clinical Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337515
- Sponsor's protocol ID
- 19-28063
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Leung W, Campana D, Yang J, Pei D, Coustan-Smith E, Gan K, Rubnitz JE, Sandlund JT, Ribeiro RC, Srinivasan A, Hartford C, Triplett BM, Dallas M, Pillai A, Handgretinger R, Laver JH, Pui CH. High success rate of hematopoietic cell transplantation regardless of donor source in children with very high-risk leukemia. Blood. 2011 Jul 14;118(2):223-30. doi: 10.1182/blood-2011-01-333070. Epub 2011 May 25.
PubMed 21613256Klein OR, Buddenbaum J, Tucker N, Chen AR, Gamper CJ, Loeb D, Zambidis E, Llosa NJ, Huo JS, Robey N, Holuba MJ, Kasamon YL, McCurdy SR, Ambinder R, Bolanos-Meade J, Luznik L, Fuchs EJ, Jones RJ, Cooke KR, Symons HJ. Nonmyeloablative Haploidentical Bone Marrow Transplantation with Post-Transplantation Cyclophosphamide for Pediatric and Young Adult Patients with High-Risk Hematologic Malignancies. Biol Blood Marrow Transplant. 2017 Feb;23(2):325-332. doi: 10.1016/j.bbmt.2016.11.016. Epub 2016 Nov 22.
PubMed 27888014Berger M, Lanino E, Cesaro S, Zecca M, Vassallo E, Faraci M, De Bortoli M, Barat V, Prete A, Fagioli F. Feasibility and Outcome of Haploidentical Hematopoietic Stem Cell Transplantation with Post-Transplant High-Dose Cyclophosphamide for Children and Adolescents with Hematologic Malignancies: An AIEOP-GITMO Retrospective Multicenter Study. Biol Blood Marrow Transplant. 2016 May;22(5):902-9. doi: 10.1016/j.bbmt.2016.02.002. Epub 2016 Feb 6.
PubMed 26860636Abboud R, Keller J, Slade M, DiPersio JF, Westervelt P, Rettig MP, Meier S, Fehniger TA, Abboud CN, Uy GL, Vij R, Trinkaus KM, Schroeder MA, Romee R. Severe Cytokine-Release Syndrome after T Cell-Replete Peripheral Blood Haploidentical Donor Transplantation Is Associated with Poor Survival and Anti-IL-6 Therapy Is Safe and Well Tolerated. Biol Blood Marrow Transplant. 2016 Oct;22(10):1851-1860. doi: 10.1016/j.bbmt.2016.06.010. Epub 2016 Jun 16.
PubMed 27318038Handgretinger 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.
PubMed 11477433Mancusi A, Ruggeri L, Velardi A. Haploidentical hematopoietic transplantation for the cure of leukemia: from its biology to clinical translation. Blood. 2016 Dec 8;128(23):2616-2623. doi: 10.1182/blood-2016-07-730564. Epub 2016 Oct 3.
PubMed 27697774Ortin M, Raj R, Kinning E, Williams M, Darbyshire PJ. Partially matched related donor peripheral blood progenitor cell transplantation in paediatric patients adding fludarabine and anti-lymphocyte gamma-globulin. Bone Marrow Transplant. 2002 Sep;30(6):359-66. doi: 10.1038/sj.bmt.1703667.
PubMed 12235520Dvorak CC, Long-Boyle JR, Holbrook-Brown L, Abdel-Azim H, Bertaina A, Vatsayan A, Talano JA, Bunin N, Anderson E, Flower A, Lalefar N, Higham CS, Kapoor N, Klein O, Odinakachukwu MC, Cho S, Jacobsohn DA, Collier W, Pulsipher MA. Effect of rabbit ATG PK on outcomes after TCR-alphabeta/CD19-depleted pediatric haploidentical HCT for hematologic malignancy. Blood Adv. 2024 Dec 10;8(23):6003-6014. doi: 10.1182/bloodadvances.2024012670.
PubMed 39042892
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Using the CiniMacs® Device for Alpha/Best T-Cell Depletion in Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT04337515
- Acronym / sponsor ID
- 19-28063
- Conditions
- Graft Vs Host Disease, Graft-versus-host-disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Christopher DvorakUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients in need of an allogeneic hematopoietic cell transplant (HCT) are at risk of developing graft-versus-host-disease (GVHD). In certain clinical situations, the optimal approach to minimize the risk of GVHD is to perform ex vivo alpha-beta T-cell depletion of the donor cells. However, the CliniMACS® Device is FDA-approved only for a narrow indication. All other uses of ex vivo processed cells must be done under a feasibility study protocol.
Detailed description
The original CliniMACS® device (CD34 Reagent System) employs a reagent consisting of an antibody that specifically binds to blood cells that express the CD34+ surface marker (hematopoietic stem cells or blood stem cells). The CD34 antibody is conjugated to an iron-containing particle that is only nanometers in size and safe for infusion. The enrichment of CD34+ cells is accomplished by passing the antibody/magnetically-labeled cell suspension through a magnetic separation column, which is provided as part of a single-use disposable tubing set. Magnetically-labeled CD34+ target cells are retained within the separation column, while the unlabeled cells flow through. Recovery of CD34+ cells is achieved by removing the magnetic field and eluting the targeted CD34+ stem cells into a collection bag.
On January 24, 2014, the FDA approved the CliniMACS CD34 Reagent System as a Humanitarian Use Device for the prevention of graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) in first complete remission undergoing allogeneic HCT from a matched related donor. Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. The CliniMACS® CD34 Reagent System is now indicated for processing hematopoietic progenitor cells collected by apheresis (PBSC) from an allogeneic, Human Leukocyte Antigen (HLA)-identical matched sibling donor (MSD) to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional GVHD prophylaxis in patients with AML in first morphologic complete remission (CR1). The approval as an HUD, however, asserts that there was sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury. Furthermore, the clinical data supported the premise of a "probable benefit"; in that the risk to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.19 The CliniMACS CD34 Reagent System was shown to meet these requirements.
Uses of the CliniMACS CD34 Reagent System beyond MSD PBSC HCT for AML in CR1 are currently not FDA approved and therefore considered research, even though CD34-selection is widely considered to be a standard-of-care option for haploidentical HCT. In Europe, the European Medicines Agency (EMA) has made the CliniMACs System components available as Conformité Européene (CE) marked medical devices, and "any clinical application of the target cells is exclusively within the responsibility of the user of a CliniMACS System."
The CD34-selection system has been widely used in haploidentical HCTs, with the first patient treated at University of California, San Francisco (UCSF) in 2002. Since then, CD34-selection has facilitated over 70 HCTs at UCSF on 2 successive protocols (#01151 and #10082). However, the removal of almost all cells beyond those which are CD34+ leads to minimal passive transfer of immunity. It is therefore complicated by a slow recovery of immunity, with high rates of life-threatening viral infections, and an appreciable degree of transplant-related mortality (TRM).
Beginning in 2014, a new approach to ex vivo processing of stem cells was developed with a goal of mainly replacing the older CD34-selection technology. This technique utilizes negative depletion of the cells thought to be most responsible for the development of aGVHD, the alpha-beta T-cell Receptor positive T-cells.
All trials of alpha-beta T-cell depleted have included simultaneous depletion of CD19+ B cells from the donor graft. All references to "alpha-beta T-cell depletion" herein implies simultaneous Cluster of Differentiation antigen (CD)19+ depletion as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving allogeneic hematopoietic cell transplant | Experimental | Device: CliniMacs®The test product is a stem cell product which has been alpha-beta T- cell depleted using the CliniMACS system. Alpha-beta T-cell depleted cells are given intravenously over a period of time as dictated by the final volume of the infused product (5 ml/kg/hour). The target dose of CD34+ cells is ≥20x10^6/kg, but a minimum of ≥2.5x10^6/kg is required. The target dose of T-cell receptor (TCR) alpha-beta CD3+ cells is ≤1x10^5/kg. |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Male or female 0-30 years of age at time of transplant admission
- Documentation of a disease requiring HCT
- A donor (mismatched related or unrelated) must be located who are healthy and willing, and whom are able to donate bone marrow (BM) or peripheral blood stem cells (PBSC). Matched related donors may be used for patients with Fanconi Anemia.
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Key exclusion criteria (5 listed)
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Presence of a healthy and willing HLA-identical related donor (except when the patient has Fanconi Anemia).
- Patient with an anticipated life expectancy of <1 month
- Patients with known hypersensitivity to murine (mouse) proteins or iron dextran
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®Also: CliniMACS® CD34 Reagent SystemCliniMACS® CD34 Reagent System is now indicated for processing hematopoietic progenitor cells collected by apheresis (PBSC) from an allogeneic, HLA-identical MSD to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional GVHD prophylaxis in patients with AML in first morphologic complete remission (CR1). | Device | Patients receiving allogeneic hematopoietic cell transplant |
Primary outcome
100-day incidence of Grade III-IV acute GVHD
Time frame: 100 days
The cumulative incidence of Grade III-IV acute GVHD at Day 100 will be summarized by incidence curves. GVHD evaluations will be performed using standard criteria.37 Patients with graft rejection will be censored.
5 secondary outcomes
30-day incidence of engraftment
Time frame: 30 days
1-year incidence of transplant-related mortality
Time frame: 12 months
1-year incidence of systemic steroid-requiring chronic GVHD
Time frame: 12 months
1-year incidence of autoimmunity requiring intervention with immunosuppressive agents as treatment.
Time frame: 12 months
180-day incidence of T-cell reconstitution (CD4+ T-cell count >200 and proliferation to PHA >50% control).
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 21613256Leung W, Campana D, Yang J, Pei D, Coustan-Smith E, Gan K, Rubnitz JE, Sandlund JT, Ribeiro RC, Srinivasan A, Hartford C, Triplett BM, Dallas M, Pillai A, Handgretinger R, Laver JH, Pui CH. High success rate of hematopoietic cell transplantation regardless of donor source in children with very high-risk leukemia. Blood. 2011 Jul 14;118(2):223-30. doi: 10.1182/blood-2011-01-333070. Epub 2011 May 25.
- Background: PubMed 27888014Klein OR, Buddenbaum J, Tucker N, Chen AR, Gamper CJ, Loeb D, Zambidis E, Llosa NJ, Huo JS, Robey N, Holuba MJ, Kasamon YL, McCurdy SR, Ambinder R, Bolanos-Meade J, Luznik L, Fuchs EJ, Jones RJ, Cooke KR, Symons HJ. Nonmyeloablative Haploidentical Bone Marrow Transplantation with Post-Transplantation Cyclophosphamide for Pediatric and Young Adult Patients with High-Risk Hematologic Malignancies. Biol Blood Marrow Transplant. 2017 Feb;23(2):325-332. doi: 10.1016/j.bbmt.2016.11.016. Epub 2016 Nov 22.
- Background: PubMed 26860636Berger M, Lanino E, Cesaro S, Zecca M, Vassallo E, Faraci M, De Bortoli M, Barat V, Prete A, Fagioli F. Feasibility and Outcome of Haploidentical Hematopoietic Stem Cell Transplantation with Post-Transplant High-Dose Cyclophosphamide for Children and Adolescents with Hematologic Malignancies: An AIEOP-GITMO Retrospective Multicenter Study. Biol Blood Marrow Transplant. 2016 May;22(5):902-9. doi: 10.1016/j.bbmt.2016.02.002. Epub 2016 Feb 6.
- Background: PubMed 27318038Abboud R, Keller J, Slade M, DiPersio JF, Westervelt P, Rettig MP, Meier S, Fehniger TA, Abboud CN, Uy GL, Vij R, Trinkaus KM, Schroeder MA, Romee R. Severe Cytokine-Release Syndrome after T Cell-Replete Peripheral Blood Haploidentical Donor Transplantation Is Associated with Poor Survival and Anti-IL-6 Therapy Is Safe and Well Tolerated. Biol Blood Marrow Transplant. 2016 Oct;22(10):1851-1860. doi: 10.1016/j.bbmt.2016.06.010. Epub 2016 Jun 16.
- Background: PubMed 11477433Handgretinger 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.
- Background: PubMed 27697774Mancusi A, Ruggeri L, Velardi A. Haploidentical hematopoietic transplantation for the cure of leukemia: from its biology to clinical translation. Blood. 2016 Dec 8;128(23):2616-2623. doi: 10.1182/blood-2016-07-730564. Epub 2016 Oct 3.
- Background: PubMed 12235520Ortin M, Raj R, Kinning E, Williams M, Darbyshire PJ. Partially matched related donor peripheral blood progenitor cell transplantation in paediatric patients adding fludarabine and anti-lymphocyte gamma-globulin. Bone Marrow Transplant. 2002 Sep;30(6):359-66. doi: 10.1038/sj.bmt.1703667.
- Derived from this study: PubMed 39042892Dvorak CC, Long-Boyle JR, Holbrook-Brown L, Abdel-Azim H, Bertaina A, Vatsayan A, Talano JA, Bunin N, Anderson E, Flower A, Lalefar N, Higham CS, Kapoor N, Klein O, Odinakachukwu MC, Cho S, Jacobsohn DA, Collier W, Pulsipher MA. Effect of rabbit ATG PK on outcomes after TCR-alphabeta/CD19-depleted pediatric haploidentical HCT for hematologic malignancy. Blood Adv. 2024 Dec 10;8(23):6003-6014. doi: 10.1182/bloodadvances.2024012670.
- 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.
Christopher C Dvorak, MD principal investigator
Professor of Clinical Pediatrics
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® in people with Graft Vs Host Disease and Graft-versus-host-disease, run by Christopher Dvorak 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher C. Dvorak, MD (415-476-0554, christopher.dvorak@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100-day incidence of Grade III-IV acute GVHD (time frame: 100 days). 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 NCT04337515, which also lists 8 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 13 Apr 2026.