A Phase 2 interventional study of Dilanubicel and Cyclophosphamide in Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia and Chronic Myelogenous Leukemia, BCR-ABL1 Positive, sponsored by Fred Hutchinson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 10 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment
Among 32 studies in Leukemia, Biphenotypic, Acute by Fred Hutchinson Cancer Center — 10 open to participants now, 13 under way, none of them phase 3. Leukemia, Biphenotypic, Acute · Fred Hutchinson Cancer Center.
Among the 32 studies in Leukemia, Biphenotypic, Acute by Fred Hutchinson Cancer Center, this one is the 18th largest by enrollment of the 29 interventional ones, is the only one that started in 2022, is one of 17 in phase 2, reaches primary completion later than 0 of the 12 other live ones, and was the 21st registered.
246 studies on the registry are indexed under Leukemia, Biphenotypic, Acute; 56 are open to participants now.
This study's enrollment of 31 is below the median of 50 across 185 interventional studies indexed under Leukemia, Biphenotypic, Acute.
Browse Leukemia, Biphenotypic, Acute studies →10 of the 32 studies in Leukemia, Biphenotypic, Acute by Fred Hutchinson Cancer Center are open now, in 1 country. Each count lists the studies.
Of the 49 Leukemia, Biphenotypic, Acute studies recruiting now, 21 (43%) set no upper age limit and 22 (45%) stop at 75 or younger; 30 take children under 18; 3 take healthy volunteers.
This study: 10 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →32 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 1 started in 2022.
Median enrollment 46 across the 29 interventional studies. Of the 18 that completed or were terminated, 12 (67%) have results posted.
Fred Hutchinson Cancer Center is the lead sponsor of 547 studies on the registry; 80 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 46 (78%) have results posted.
6 of the studies in Leukemia, Biphenotypic, Acute by Fred Hutchinson Cancer Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04375631Fred Hutchinson Cancer CenterCLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia | 2027-02-28 |
| NCT04195633Fred Hutchinson Cancer CenterDonor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies | 2027-04-15 |
| NCT07046078Fred Hutchinson Cancer CenterCombination Chemotherapy (FLAG-Ida) Followed Immediately by Reduced-Intensity Total Body Radiation Therapy and Donor Hematopoietic Cell Transplant for the Treatment of Adults Age 60 and Older With Newly Diagnosed Adverse-Risk Acute Myeloid Leukemia or Other High-Grade Myeloid Cancer | 2027-06-30 |
| NCT03128034Fred Hutchinson Cancer Center211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia | 2027-06-30 |
| NCT03779854Fred Hutchinson Cancer CenterNaive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant | 2027-08-31 |
Among the 32 studies in Leukemia, Biphenotypic, Acute by Fred Hutchinson Cancer Center, from their registry updates:
This phase II trial studies how well donor umbilical cord blood transplant with ex-vivo expanded cord blood progenitor cells (dilanubicel) works in treating patients with blood cancer. Before the transplant, patients will receive chemotherapy (fludarabine, cyclophosphamide and in some cases thiotepa) and radiation therapy. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
OUTLINE:
Patients receive either regimen A or regimen B.
REGIMEN A: Patients (10 through 45 years old) receive fludarabine intravenously (IV) over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients undergo total body irradiation (TBI) twice daily (BID) on days -4 to -1. Patients receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
REGIMEN B: Patients (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Patients undergo TBI once daily (QD) on days -2 and -1. Patients receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0.
All patients undergo bone marrow aspirate and biopsy as clinically indicated during screening and on study. Patients undergo multigated acquisition scan (MUGA) or echocardiography (ECHO), and computed tomography (CT) during screening. Patients also undergo blood sample collection on study.
After completion of study treatment, patients are followed up at 180 days, 1 year, and 2 years.
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.
Malignancies included are:
DONOR: A backup unit must be identified and reserved prior to the start of the treatment plan for possible infusion in the unlikely event of poor post-thaw viability of the primary CB unit. A suitable back up unit will be considered, as follows:
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.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
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.
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.
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.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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.
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.
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.
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.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Patients receive either regimen A or regimen B. REGIMEN A: Patients (10 through 45 years old) receive fludarabine IV over 30 minutes on days -8 to -6 and cyclophosphamide IV on days -7 and -6. Patients undergo TBI BID on days -4 to -1. Patients receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0. REGIMEN B: Patients (10 through 65 years old) receive fludarabine IV over 30-60 minutes on days -6 to -3 and IV over 30 minutes on day -2, cyclophosphamide IV on day -6, and thiotepa IV over 2-4 hours on days -5 and -4. Patients undergo TBI QD on days -2 and -1. Patients receive unmanipulated cord blood unit IV followed by dilanubicel IV within the next 24 hours on day 0. All patients undergo bone marrow aspirate and biopsy as clinically indicated during screening and on study. Patients undergo MUGA or ECHO, and CT during screening. Patients also undergo blood sample collection on study.
Biological: Dilanubicel · Drug: Cyclophosphamide · Drug: Fludarabine · Drug: Thiotepa · Radiation: Total-Body Irradiation · Procedure: Umbilical Cord Blood Transplantation · Other: Laboratory Biomarker Analysis · Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspirate · Procedure: Bone Marrow Biopsy · Procedure: Multigated Acquisition Scan · Procedure: Electrocardiography · Procedure: Computed Tomography
Given IV
Also known as: Allogeneic UCB-derived Hematopoietic Stem and Progenitor Cells NLA101, NLA101, Allogeneic Umbilical Cord Blood-derived HSPCs NLA101
Given IV
Also known as: Carloxan, Cicloxal, Mitoxan, Neosar, Revimmune
Given IV
Also known as: fluoroadenine, Fluradosa
Given IV
Also known as: Oncotiotepa, STEPA, Tepadina, TESPA, Tespamine, Thiofosfamide, Thiofozil, Thiophosphoramide, Thiotef, Triethylene Thiophosphoramide
Undergo TBI
Also known as: SCT_TBI, Total Body Irradiation, Whole Body Irradiation, Whole-Body Irradiation
Given IV
Also known as: Cord Blood Transplantation, UCB transplantation
Correlative studies
Undergo blood sample collection
Also known as: Biological Sample Collection
Undergo bone marrow aspirate and biopsy
Also known as: Human Bone Marrow Aspirate
Undergo bone marrow aspirate and biopsy
Undergo MUGA
Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide ventriculography
Undergo ECHO
Also known as: ECG, EKG
Undergo CT
Also known as: CAT Scan
Number of Participants With Graft Failure
Primary graft failure/rejection as defined by no neutrophil recovery (regardless of donor chimerism) or autologous recovery (neutrophil recovery but \< 10% donor chimerism in blood and bone marrow \[BM\]).
Time frame: Up to day 45 post-transplant
Number of Participants Who Experienced Grade ≥3 Adverse Events Related to Study Product
Adverse events (AEs) were graded using the CTCAE v5.0. This outcome measured the number of participants who experienced at least one grade ≥ 3 adverse event considered related to the study product during the period of start of infusion of the study product (Day 0) until 100 days following transplant. An AE is considered related to the study product based on investigator assessment if it was assessed as definitely, probably, or possibly related; unrelated if it is assessed as unlikely related or unrelated. AE severity grade, seriousness, and relatedness were evaluated independently; therefore, grade ≥3 events were not necessarily serious adverse events (SAEs). Reporting of grade ≥3 AEs and all-grade SAEs is provided in the Adverse Events module. Dose-limiting toxicities (DLTs) were predefined.
Time frame: From study product infusion start through day 100 post-transplant
Time to Neutrophil Engraftment
The day of neutrophil recovery will be the 1st day of 2 consecutive days of absolute neutrophil count at or above 500 after the 1st post-cord blood transplant nadir.
Time frame: Up to day 45 post-transplant
Time to Platelet Engraftment
Measured by the number of participants with a platelet count \> 20,000/ul without subsequent transfusions for 7 days. Participants who did not reach platelet engraftment by day 100 post-transplant were censored at day 100.
Time frame: Up to day 100 post-transplant
Number of Participants With Acute Graft Versus Host Disease (aGVHD), by Grade
The presence of aGVHD was assessed using the Acute GVHD Grading Scale and represented as overall grade I-IV, with higher grade indicating worse outcomes. Grade I aGVHD is defined as skin stage 1-2 and stage 0 for both GI and liver. Grade II is stage 3 skin, stage 1 GI, or stage 1 liver. Grade III is stage 4 skin or stage 2-4 GI or stage 2-4 liver, without GVHD as a major contributing cause of death. Grade IV is stage 4 skin or stage 2-4 GI or stage 2-4 liver, with GVHD as a major contributing cause of death.
Time frame: At day 100 post-transplant
Number of Participants With Chronic Graft Versus Host Disease (cGVHD), by Severity
The presence of cGVHD was assessed using the Chronic GVHD Grading Scale, with higher severity indicating worse outcomes. Incidence of moderate or severe cGVHD were considered clinically significant. Mild cGVHD is defined as limited organ involvement with minimal functional impairment, typically affecting 1-2 organs/sites with no major impact on daily activities. Moderate cGVHD is indicated by more extensive organ involvement and/or clinically significant functional impairment, but without major disability. Severe cGVHD is defined as major organ involvement with substantial functional impairment or disability, often requiring intensive systemic therapy. Abnormalities that could indicate cGVHD are reviewed for the following organ systems: skin, nails, hair, mouth, eyes, vagina/vulva (for female patients), liver, lung, GI, fasciitis, serositis, muscle, skeletal.
Time frame: 1 year post-transplant
Number of Participants With Chronic Graft Versus Host Disease (cGVHD), by Severity
The presence of cGVHD was assessed using the Chronic GVHD Grading Scale, with higher severity indicating worse outcomes. Incidence of moderate or severe cGVHD were considered clinically significant. Mild cGVHD is defined as limited organ involvement with minimal functional impairment, typically affecting 1-2 organs/sites with no major impact on daily activities. Moderate cGVHD is indicated by more extensive organ involvement and/or clinically significant functional impairment, but without major disability. Severe cGVHD is defined as major organ involvement with substantial functional impairment or disability, often requiring intensive systemic therapy. Abnormalities that could indicate cGVHD are reviewed for the following organ systems: skin, nails, hair, mouth, eyes, vagina/vulva (for female patients), liver, lung, GI, fasciitis, serositis, muscle, skeletal.
Time frame: Up to 2 years post-transplant
Number of Participants Who Experienced Non-relapse Mortality
Non-relapse mortality (NRM) is defined as death without a prior relapse.
Time frame: At day 100 post-transplant
Number of Participants Who Experienced Non-relapse Mortality
Non-relapse mortality (NRM) is defined as death without a prior relapse.
Time frame: At day 180 post-transplant
Patients were recruited at the Fred Hutchinson Cancer Center (FHCC) Bone Marrow Transplant (BMT) during routine transplant evaluation. Patients eligible for umbilical cord blood transplant and meeting study criteria were invited to participate. Screening typically occurred within approximately 30 days. Eligible patients provided informed consent and were enrolled by FHCC BMT physicians.
| Milestone | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel |
|---|---|---|
| Started | 16 | 15 |
| Study treatment | 7 | 9 |
| Completed | 6 | 7 |
| Not completed | 10 | 8 |
| Withdrew: On study follow-up (<2 years post-transplant) | 7 | 5 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Relapse requiring alternative therapy | 1 | 1 |
| Withdrew: Physician decision | 2 | 1 |
Primary graft failure/rejection as defined by no neutrophil recovery (regardless of donor chimerism) or autologous recovery (neutrophil recovery but \< 10% donor chimerism in blood and bone marrow \[BM\]).
| Participants | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel |
|---|---|---|
| Graft failure | 0 | 0 |
| Engrafted | 14 | 14 |
Adverse events (AEs) were graded using the CTCAE v5.0. This outcome measured the number of participants who experienced at least one grade ≥ 3 adverse event considered related to the study product during the period of start of infusion of the study product (Day 0) until 100 days following transplant. An AE is considered related to the study product based on investigator assessment if it was assessed as definitely, probably, or possibly related; unrelated if it is assessed as unlikely related or unrelated. AE severity grade, seriousness, and relatedness were evaluated independently; therefore, grade ≥3 events were not necessarily serious adverse events (SAEs). Reporting of grade ≥3 AEs and all-grade SAEs is provided in the Adverse Events module. Dose-limiting toxicities (DLTs) were predefined.
| Participants | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel |
|---|---|---|
| Number of Participants Who Experienced Grade ≥3 Adverse Events Related to Study Product | 15 | 11 |
The day of neutrophil recovery will be the 1st day of 2 consecutive days of absolute neutrophil count at or above 500 after the 1st post-cord blood transplant nadir.
| days | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel |
|---|---|---|
| Time to Neutrophil Engraftment | 18 (15 to 30) | 18 (14 to 27) |
Measured by the number of participants with a platelet count \> 20,000/ul without subsequent transfusions for 7 days. Participants who did not reach platelet engraftment by day 100 post-transplant were censored at day 100.
| days | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel |
|---|---|---|
| Time to Platelet Engraftment | 30 (26 to 43) | 31 (23 to 42) |
The presence of aGVHD was assessed using the Acute GVHD Grading Scale and represented as overall grade I-IV, with higher grade indicating worse outcomes. Grade I aGVHD is defined as skin stage 1-2 and stage 0 for both GI and liver. Grade II is stage 3 skin, stage 1 GI, or stage 1 liver. Grade III is stage 4 skin or stage 2-4 GI or stage 2-4 liver, without GVHD as a major contributing cause of death. Grade IV is stage 4 skin or stage 2-4 GI or stage 2-4 liver, with GVHD as a major contributing cause of death.
| Participants | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel |
|---|---|---|
| Grade I | 0 | 2 |
| Grade II | 13 | 7 |
| Grade III | 0 | 0 |
| Grade IV | 0 | 0 |
| No aGVHD | 1 | 4 |
The presence of cGVHD was assessed using the Chronic GVHD Grading Scale, with higher severity indicating worse outcomes. Incidence of moderate or severe cGVHD were considered clinically significant. Mild cGVHD is defined as limited organ involvement with minimal functional impairment, typically affecting 1-2 organs/sites with no major impact on daily activities. Moderate cGVHD is indicated by more extensive organ involvement and/or clinically significant functional impairment, but without major disability. Severe cGVHD is defined as major organ involvement with substantial functional impairment or disability, often requiring intensive systemic therapy. Abnormalities that could indicate cGVHD are reviewed for the following organ systems: skin, nails, hair, mouth, eyes, vagina/vulva (for female patients), liver, lung, GI, fasciitis, serositis, muscle, skeletal.
| Participants | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel |
|---|---|---|
| Mild | 2 | 2 |
| Moderate | 0 | 0 |
| Severe | 0 | 0 |
| No cGVHD | 9 | 7 |
The presence of cGVHD was assessed using the Chronic GVHD Grading Scale, with higher severity indicating worse outcomes. Incidence of moderate or severe cGVHD were considered clinically significant. Mild cGVHD is defined as limited organ involvement with minimal functional impairment, typically affecting 1-2 organs/sites with no major impact on daily activities. Moderate cGVHD is indicated by more extensive organ involvement and/or clinically significant functional impairment, but without major disability. Severe cGVHD is defined as major organ involvement with substantial functional impairment or disability, often requiring intensive systemic therapy. Abnormalities that could indicate cGVHD are reviewed for the following organ systems: skin, nails, hair, mouth, eyes, vagina/vulva (for female patients), liver, lung, GI, fasciitis, serositis, muscle, skeletal.
Results for this outcome have not been posted.
Non-relapse mortality (NRM) is defined as death without a prior relapse.
| Participants | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel |
|---|---|---|
| Experienced non-relapse mortality | 0 | 1 |
| Did not experience non-relapse mortality | 14 | 13 |
Non-relapse mortality (NRM) is defined as death without a prior relapse.
| Participants | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel |
|---|---|---|
| Experienced non-relapse mortality | 0 | 1 |
| Did not experience non-relapse mortality | 14 | 13 |
Collected over AEs and SAEs were monitored and recorded from the start of study treatment (pre-transplant conditioning) until 100 days post-transplant. All-cause mortality was monitored from start of study treatment up to 2-years post-transplant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | 0/16 (0%) | 8/16 (50%) | 16/16 (100%) |
| Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel | 1/15 (6.7%) | 7/15 (46.7%) | 14/15 (93.3%) |
| Event | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel |
|---|---|---|
| FeverGeneral disorders | 3/16 | 1/15 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 2/16 | 0/15 |
| Abdominal painRenal and urinary disorders | 0/16 | 1/15 |
| Acute kidney injuryRenal and urinary disorders | 0/16 | 1/15 |
| Cardiac arrestCardiac disorders | 0/16 | 1/15 |
| ConjunctivitisInfections and infestations | 0/16 | 1/15 |
| DiarrheaGastrointestinal disorders | 1/16 | 1/15 |
| Disseminated adenovirus (ADV)Infections and infestations | 1/16 | 1/15 |
| Ejection fraction decreasedInvestigations | 0/16 | 1/15 |
| Encephalitis infectionInfections and infestations | 0/16 | 1/15 |
| Event | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 13/16 | 11/15 |
| AnorexiaMetabolism and nutrition disorders | 3/16 | 8/15 |
| Mucositis oralGastrointestinal disorders | 6/16 | 3/15 |
| Enterocolitis infectiousInfections and infestations | 3/16 | 5/15 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 5/16 | 4/15 |
| Acute kidney injuryRenal and urinary disorders | 0/16 | 3/15 |
| Urinary tract infectionInfections and infestations | 2/16 | 3/15 |
| Abdominal painGastrointestinal disorders | 3/16 | 2/15 |
| Cytomegalovirus (CMV) infection reactivationInfections and infestations | 3/16 | 1/15 |
| SepsisInfections and infestations | 3/16 | 2/15 |
| Age, Categorical(Participants) | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel | Total |
|---|---|---|---|
| <=18 years | 3 | 1 | 4 |
| Between 18 and 65 years | 13 | 14 | 27 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel | Total |
|---|---|---|---|
| Female | 7 | 8 | 15 |
| Male | 9 | 7 | 16 |
| Race (NIH/OMB)(Participants) | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 1 | 2 | 3 |
| White | 10 | 8 | 18 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 4 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 4 | 10 |
| Not Hispanic or Latino | 10 | 11 | 21 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Disease Diagnosis(Participants) | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel | Total |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | 7 | 9 | 16 |
| Biphenotypic Acute Leukemia (BAL) or Mixed-Lineage Leukemia (MPAL) | 1 | 0 | 1 |
| Acute Lymphoblastic Leukemia (ALL) | 7 | 5 | 12 |
| Myelodysplasia (MDS) | 0 | 1 | 1 |
| Chronic Myeloid Leukemia (CML) | 1 | 0 | 1 |
| Comorbidity Score(Participants) | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel | Total |
|---|---|---|---|
| 0 | 7 | 4 | 11 |
| 1 | 2 | 5 | 7 |
| 2 | 1 | 1 | 2 |
| 3 | 6 | 2 | 8 |
| 4 | 0 | 2 | 2 |
| 5 | 0 | 1 | 1 |
| Donor/graft characteristics(Participants) | Regimen A: High Dose Consisting of 1320 cGy TBI, Flu, Cy, Followed by UCB and Dilanubicel | Regimen B: Intermediate Dose Consisting of 400 cGy TBI, Flu, Cy, TT, Followed by UCB and Dilanubicel | Total |
|---|---|---|---|
| Fully matched, 6/6 | 0 | 0 | 0 |
| Single mismatch, 5/6 | 2 | 4 | 6 |
| Two mismatches, 4/6 | 14 | 11 | 25 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Dilanubicel
Leukemia, Biphenotypic, Acute →
Fred Hutchinson Cancer Center →