A Phase 1 interventional study of T-cell Receptor α/β Depleted Donor Lymphocyte Infusions in Lymphoid Leukemia, Acute, Myeloid Malignancy and Plasma Cell Tumor, sponsored by Guenther Koehne. Terminated at 1 site in United States. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Guenther Koehne · Phase 1, Interventional, and Treatment
This pilot study is being conducted to treat patients who have a certain type of malignancy (lymphoid or myeloid) with immune effector cells after a T-cell depleted allogeneic hematopoietic cell transplantation (TCD HSCT).
This study is designed to see whether an investigational cellular product of immune cells obtained from a donor's cells that have been treated so that the type of cells that can lead to graft vs host disease have been removed can be safely administered. These cell products are administered following the initial stem cell transplant to assess the effect and improvement on minimal residual disease status, infectious complication, progression-free and overall survival.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
This study's enrollment of 11 is below the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →Guenther Koehne is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must have adequate organ function measured by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
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
Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
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
Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
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)
Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
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
Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
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
Biological: T-cell Receptor α/β Depleted Donor Lymphocyte Infusions
T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
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.
Time frame: 30 days post-infusion
Number of Participants in Remission
Remission - measured by absence of signs and symptoms
Time frame: 2 years
Number of Participants With Transplant-associated Viral Complications
Transplant-associated viral complications - measured by viral infections associated with transplant
Time frame: 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.
Time frame: 2 years
Overall Survival
Overall survival - measured by death
Time frame: 2 years
| Milestone | HLA Matched Cohort I | HLA Matched Cohort II | HLA Matched Cohort III | HLA Mismatched Cohort I | HLA Mismatched Cohort II | HLA Mismatched Cohort III |
|---|---|---|---|---|---|---|
| Started | 10 | 0 | 0 | 1 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 10 | 0 | 0 | 1 | 0 | 0 |
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.
| Participants | HLA Matched Cohort I | HLA Matched Cohort II | HLA Matched Cohort III | HLA Mismatched Cohort I | HLA Mismatched Cohort II | HLA Mismatched Cohort III |
|---|---|---|---|---|---|---|
| Incidence of Treatment-emergent Serious Adverse Events (TE-SAEs) | 1 | 0 | 0 | 0 | 0 | 0 |
Remission - measured by absence of signs and symptoms
No measurements were reported for this outcome.
Transplant-associated viral complications - measured by viral infections associated with transplant
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Overall survival - measured by death
No measurements were reported for this outcome.
Collected over The longest any participant was on study was approximately 14 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HLA Matched Cohort I | 5/10 (50%) | 6/10 (60%) | 10/10 (100%) |
| HLA Matched Cohort II | — | — | — |
| HLA Matched Cohort III | — | — | — |
| HLA Mismatched Cohort I | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| HLA Mismatched Cohort II | — | — | — |
| HLA Mismatched Cohort III | — | — | — |
| Event | HLA Matched Cohort I | HLA Matched Cohort II | HLA Matched Cohort III | HLA Mismatched Cohort I | HLA Mismatched Cohort II | HLA Mismatched Cohort III |
|---|---|---|---|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 2/10 | — | — | 1/1 | — | — |
| ColitisGastrointestinal disorders | 0/10 | — | — | 1/1 | — | — |
| Lung infectionInfections and infestations | 2/10 | — | — | 0/1 | — | — |
| Upper respiratory infectionInfections and infestations | 1/10 | — | — | 0/1 | — | — |
| Chest painCardiac disorders | 1/10 | — | — | 0/1 | — | — |
| Cognitive disturbanceNervous system disorders | 1/10 | — | — | 0/1 | — | — |
| Decreased platelet countInvestigations | 1/10 | — | — | 0/1 | — | — |
| Generalized muscle weaknessMusculoskeletal and connective tissue disorders | 1/10 | — | — | 0/1 | — | — |
| Pleuritic painRespiratory, thoracic and mediastinal disorders | 1/10 | — | — | 0/1 | — | — |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 1/10 | — | — | 0/1 | — | — |
| Event | HLA Matched Cohort I | HLA Matched Cohort II | HLA Matched Cohort III | HLA Mismatched Cohort I | HLA Mismatched Cohort II | HLA Mismatched Cohort III |
|---|---|---|---|---|---|---|
| Epstein-Barr virus infection reactivationInfections and infestations | 3/10 | — | — | 1/1 | — | — |
| ViremiaInfections and infestations | 1/10 | — | — | 1/1 | — | — |
| AppendicitisInfections and infestations | 0/10 | — | — | 1/1 | — | — |
| BacteremiaInfections and infestations | 0/10 | — | — | 1/1 | — | — |
| DiarrheaGastrointestinal disorders | 5/10 | — | — | 0/1 | — | — |
| FatigueGeneral disorders | 2/10 | — | — | 0/1 | — | — |
| Febrile neutropeniaBlood and lymphatic system disorders | 2/10 | — | — | 0/1 | — | — |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/10 | — | — | 0/1 | — | — |
| Back painMusculoskeletal and connective tissue disorders | 1/10 | — | — | 0/1 | — | — |
| ConjunctivitisInfections and infestations | 1/10 | — | — | 0/1 | — | — |
The study was terminated so we did not yet accrue to some cohorts, as the cohorts were filled sequentially within HLA Matched and Mismatched groupings.
| Age, Categorical(Participants) | HLA Matched Cohort I | HLA Matched Cohort II | HLA Matched Cohort III | HLA Mismatched Cohort I | HLA Mismatched Cohort II | HLA Mismatched Cohort III | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 0 | 0 | 1 | 0 | 0 | 6 |
| >=65 years | 5 | 0 | 0 | 0 | 0 | 0 | 5 |
| Age, Continuous(years) | HLA Matched Cohort I | HLA Matched Cohort II | HLA Matched Cohort III | HLA Mismatched Cohort I | HLA Mismatched Cohort II | HLA Mismatched Cohort III | Total |
|---|---|---|---|---|---|---|---|
| Mean | 60.4 ± 14.3 | — | — | 57 ± 0 | — | — | 60.1 ± 13.6 |
| Sex: Female, Male(Participants) | HLA Matched Cohort I | HLA Matched Cohort II | HLA Matched Cohort III | HLA Mismatched Cohort I | HLA Mismatched Cohort II | HLA Mismatched Cohort III | Total |
|---|---|---|---|---|---|---|---|
| Female | 4 | — | — | 0 | — | — | 4 |
| Male | 6 | — | — | 1 | — | — | 7 |
| Ethnicity (NIH/OMB)(Participants) | HLA Matched Cohort I | HLA Matched Cohort II | HLA Matched Cohort III | HLA Mismatched Cohort I | HLA Mismatched Cohort II | HLA Mismatched Cohort III | Total |
|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 5 | — | — | 0 | — | — | 5 |
| Not Hispanic or Latino | 5 | — | — | 1 | — | — | 6 |
| Unknown or Not Reported | 0 | — | — | 0 | — | — | 0 |
| Race (NIH/OMB)(Participants) | HLA Matched Cohort I | HLA Matched Cohort II | HLA Matched Cohort III | HLA Mismatched Cohort I | HLA Mismatched Cohort II | HLA Mismatched Cohort III | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | — | — | 0 | — | — | 0 |
| Asian | 0 | — | — | 1 | — | — | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | — | — | 0 | — | — | 0 |
| Black or African American | 0 | — | — | 0 | — | — | 0 |
| White | 10 | — | — | 0 | — | — | 10 |
| More than one race | 0 | — | — | 0 | — | — | 0 |
| Unknown or Not Reported | 0 | — | — | 0 | — | — | 0 |
| Region of Enrollment(participants) | HLA Matched Cohort I | HLA Matched Cohort II | HLA Matched Cohort III | HLA Mismatched Cohort I | HLA Mismatched Cohort II | HLA Mismatched Cohort III | Total |
|---|---|---|---|---|---|---|---|
| United States | 10 | — | — | 1 | — | — | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Precursor Cell Lymphoblastic Leukemia-Lymphoma →
Guenther Koehne