Lymphoid Leukemia, AcutePhase 1NCT05350163

T-cell Receptor α/β Depleted Donor Lymphocyte Infusion

A Phase 1 study testing T-cell Receptor α/β Depleted Donor Lymphocyte Infusions in people with Lymphoid Leukemia, Acute and Myeloid Malignancy, run by Guenther Koehne at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

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). Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Lymphoid Leukemia, Acute, Myeloid Malignancy, Plasma Cell Tumor
What is being tested?: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 5 Apr 2022to 18 Sep 2023
Phase: Phase 1
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 18 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
Cardiac: asymptomatic or if symptomatic then left ventricular ejection fraction (LVEF) at rest must be 50% and must improve with exercise.
Hepatic: < 3x upper limit of normal (ULN) AST and < 1.5 mg/dL total serum bilirubin, unless there is congenital benign hyperbilirubinemia. Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval (e.g., patients with PNH, Gilbert's disease or other hemolytic disorders).
Renal: serum creatinine: ≤ 1.2 mg/dL or if serum creatinine is outside the normal range, then creatinine clearance (CrCl) > 40 mL/min (measured or calculated/estimated).
Pulmonary: asymptomatic or if symptomatic, diffusing capacity of the lungs for carbon monoxide (DLCO) 50% of predicted (corrected for hemoglobin).
Each patient must be willing to participate as a research subject and must sign an informed consent form.

Who cannot join

Patients with active acute GvHD.

Trial locations and contacts

1 site in 1 country.

United States1 site

Miami Cancer Institute at Baptist Health, Inc
Miami, Florida, 33176

Other trials in United States

About this study

Official title: Phase I Dose Escalation of T-cell Receptor α/β Depleted Donor Lymphocyte Infusions Following CD34+- Selected Allogeneic Stem Cell Transplantation From Related & Unrelated Donors in Patients With Lymphoid, Myeloid or Plasma Cell Malignancies

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.

Conditions: Lymphoid Leukemia, Acute, Myeloid Malignancy, Plasma Cell Tumor
Being tested: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma, Plasmacytoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T-cell Receptor α/β Depleted Donor Lymphocyte InfusionsBiological
T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients

Study groups in NCT05350163
Study group	Role	What they receive
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) Receives: Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
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 Receives: Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
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 Receives: Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
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) Receives: Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
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 Receives: Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
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 Receives: Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 days post-infusion

Secondary outcomes (4)

Number of Participants in Remission
Remission - measured by absence of signs and symptoms
Measured: 2 years
Number of Participants With Transplant-associated Viral Complications
Transplant-associated viral complications - measured by viral infections associated with transplant
Measured: 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.
Measured: 2 years
Overall Survival
Overall survival - measured by death
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Apr 202218 Sep 2023

First posted28 Apr 2022
Study start5 Apr 2022
Primary completion18 Sep 2023
Study completion18 Sep 2023

Why it stopped: The study met criteria for stopping due to lack of efficacy per protocol specifications.

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 (32)Papers the sponsor has linked to this study.
Other trials for Lymphoid Leukemia, AcuteStudies 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05350163
Sponsor's protocol ID: 2019-KOE-004
Status last verified: Dec 2024
First submitted: 22 Apr 2022
Last updated: 10 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 20215642
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.
PubMed 18978746
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.
PubMed 21921045
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.
PubMed 22010102
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.
PubMed 21493797
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.
PubMed 8413388
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.
PubMed 10979948
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.
PubMed 9746768
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.
PubMed 12433695
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.
PubMed 2207321
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.
PubMed 6115110
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.
PubMed 11477433
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.
PubMed 17717135
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.
PubMed 12091376
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.
PubMed 15753458

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 1
CART22 Alone or in Combination With huCART19 for ALL
Chemotherapy Resistant Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia
RecruitingObservational study
Establishment of a Novel Flow Cytometric Diagnostic Assay to Effectively Evaluate Immune Reconstitution After Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia
Acute Lymphobkastic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingObservational study
A Multi-site Study to Evaluate the Persistence of Protective Immunity to Routine Childhood Vaccinations in Participants With B-ALL/Ly Who Have Received Blinatumomab
B-Cell ALL, B-Cell Acute Lymphoblastic Leukaemia

All Lymphoid Leukemia, Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Dose Escalation of T-cell Receptor α/β Depleted Donor Lymphocyte Infusions Following CD34+- Selected Allogeneic Stem Cell Transplantation From Related & Unrelated Donors in Patients With Lymphoid, Myeloid or Plasma Cell Malignancies
ClinicalTrials.gov ID: NCT05350163
Acronym / sponsor ID: 2019-KOE-004
Conditions: Lymphoid Leukemia, Acute, Myeloid Malignancy, Plasma Cell Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study met criteria for stopping due to lack of efficacy per protocol specifications.
Enrolment: 11 participants (actual)
Lead sponsor: Guenther KoehneUniversity, hospital or other
Study start: 5 Apr 2022 (actual)
Primary completion: 18 Sep 2023 (actual)
Study completion: 18 Sep 2023 (actual)
First posted: 28 Apr 2022 (actual)
Results: Posted 10 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6
Model description: 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.

Arm	Type	Receives
HLA Matched Cohort I	Experimental	Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions5 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	Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions5 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	Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions5 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	Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions1 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	Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions1 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
HLA Mismatched Cohort III	Experimental	Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions1 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

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (1 listed)

Patients with active acute GvHD.

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
T-cell Receptor α/β Depleted Donor Lymphocyte InfusionsT-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients	Biological	HLA Matched Cohort I, HLA Matched Cohort II, HLA Matched Cohort III, HLA Mismatched Cohort I, HLA Mismatched Cohort II, HLA Mismatched Cohort III

Primary outcome

Incidence of Treatment-emergent Serious Adverse Events (TE-SAEs)
Time frame: 30 days post-infusion
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.

4 secondary outcomes

Number of Participants in Remission
Time frame: 2 years
Number of Participants With Transplant-associated Viral Complications
Time frame: 2 years
Disease Free Survival- Measured by Absence of Relapse/Recurrence or Death.
Time frame: 2 years
Overall Survival
Time frame: 2 years

Results and safety

Results posted to the registry on 10 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HLA Matched Cohort I	10	0
HLA Matched Cohort II	0	0
HLA Matched Cohort III	0	0
HLA Mismatched Cohort I	1	0
HLA Mismatched Cohort II	0	0
HLA Mismatched Cohort III	0	0

Primary outcome: Incidence of Treatment-emergent Serious Adverse Events (TE-SAEs)

Time frame: 30 days post-infusion. Count of participants. Unit: Participants

Measure	HLA Matched Cohort I n = 10	HLA Matched Cohort II n = 0	HLA Matched Cohort III n = 0	HLA Mismatched Cohort I n = 1	HLA Mismatched Cohort II n = 0	HLA Mismatched Cohort III n = 0
Value	1	0	0	0	0	0

Population analysed: The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: The longest any participant was on study was approximately 14 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HLA Matched Cohort I	6 of 10 (60%)	10 of 10 (100%)	5 of 10
HLA Matched Cohort II	0 of 0	0 of 0	0
HLA Matched Cohort III	0 of 0	0 of 0	0
HLA Mismatched Cohort I	1 of 1 (100%)	1 of 1 (100%)	1 of 1
HLA Mismatched Cohort II	0 of 0	0 of 0	0
HLA Mismatched Cohort III	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20215642Seggewiss 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.
Background: PubMed 18978746Lang 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.
Background: PubMed 21921045Reisner 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.
Background: PubMed 22010102Jagasia 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.
Background: PubMed 21493797Arora 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.
Background: PubMed 8413388Chao 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.
Background: PubMed 10979948Nash 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.
Background: PubMed 9746768Ratanatharathorn 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.
Background: PubMed 12433695Gratwohl 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.
Background: PubMed 2207321Martin 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.
Background: PubMed 6115110Reisner 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.
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.
Miami Cancer Institute WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Lymphoid Leukemia, Acute

RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 1
CART22 Alone or in Combination With huCART19 for ALL
Chemotherapy Resistant Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia
RecruitingObservational study
Establishment of a Novel Flow Cytometric Diagnostic Assay to Effectively Evaluate Immune Reconstitution After Hematopoietic Stem Cell Transplantation for Acute Lymphoblastic Leukemia
Acute Lymphobkastic Leukemia
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
RecruitingObservational study
A Multi-site Study to Evaluate the Persistence of Protective Immunity to Routine Childhood Vaccinations in Participants With B-ALL/Ly Who Have Received Blinatumomab
B-Cell ALL, B-Cell Acute Lymphoblastic Leukaemia

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.

Guenther Koehne, MD, PhD principal investigator

Miami Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing T-cell Receptor α/β Depleted Donor Lymphocyte Infusions in people with Lymphoid Leukemia, Acute and Myeloid Malignancy, run by Guenther Koehne 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 8 inclusion and 1 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: stopped early, as of the sponsor's last update on 10 Dec 2024. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2024). 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?

Incidence of Treatment-emergent Serious Adverse Events (TE-SAEs) (time frame: 30 days post-infusion). 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 NCT05350163, which also lists 32 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 10 Dec 2024.