A Phase 1 interventional study of indium In 111 anti-CD45 monoclonal antibody BC8 and yttrium Y 90 anti-CD45 monoclonal antibody BC8 in Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma and Angioimmunoblastic T-cell Lymphoma, sponsored by Fred Hutchinson Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-02.
Sponsored by Fred Hutchinson Cancer Center · Phase 1, Interventional, and Treatment
Among 15 studies in Lymphoma, Extranodal NK-T-Cell by Fred Hutchinson Cancer Center — none open to participants now, none under way, none of them phase 3. Lymphoma, Extranodal NK-T-Cell · Fred Hutchinson Cancer Center.
Among the 15 studies in Lymphoma, Extranodal NK-T-Cell by Fred Hutchinson Cancer Center, this one is the 14th largest by enrollment, is one of 2 that started in 1999, is one of 2 in phase 1, and was the 14th registered.
270 studies on the registry are indexed under Lymphoma, Extranodal NK-T-Cell; 36 are open to participants now.
Browse Lymphoma, Extranodal NK-T-Cell studies →None of the 15 studies in Lymphoma, Extranodal NK-T-Cell by Fred Hutchinson Cancer Center is open now. The open studies under Lymphoma, Extranodal NK-T-Cell, anywhere →
Of the 20 Lymphoma, Extranodal NK-T-Cell studies recruiting now, 11 (55%) set no upper age limit and 8 (40%) stop at 75 or younger; 4 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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15 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 9
First in 1997; this study’s year is marked. 2 started in 1999.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2 is below the median of 33 across 225 interventional studies indexed under Lymphoma, Extranodal NK-T-Cell.
Median enrollment 37 across the 15 interventional studies. Of the 14 that completed or were terminated, 9 (64%) have results posted.
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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.
None of the studies under way reaches primary completion within a year.
Among the 15 studies in Lymphoma, Extranodal NK-T-Cell by Fred Hutchinson Cancer Center, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This phase I trial studies the side effects and best dose of monoclonal antibody therapy before stem cell transplant in treating patients with relapsed or refractory lymphoid malignancies. Radiolabeled monoclonal antibodies, such as yttrium-90 anti-CD45 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal 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. Giving radiolabeled monoclonal antibody before a stem cell transplant may be an effective treatment for relapsed or refractory lymphoid malignancies.
PRIMARY OBJECTIVES:
I. To estimate the maximally tolerated dose (MTD) of 90Y-BC8-DOTA (anti-cluster of differentiation [CD]45) (yttrium-90 anti-CD45 monoclonal antibody BC8) that can be delivered prior to autologous stem cell transplantation for patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL), T-cell NHL (T-NHL), and Hodgkin lymphoma (HL).
SECONDARY OBJECTIVES:
I. To optimize the protein dose (antibody [Ab]) to deliver a favorable biodistribution in the majority of patients.
II. To describe the impact of rituximab concentrations, B-cell depletion, and disease burden on CD20 and CD45 targeting.
III. To describe response rates and remission durations in relapsed B-NHL, T-NHL, and HL following administration of myeloablative doses of 90Y-BC8-DOTA prior to autologous stem cell transplant (ASCT).
IV. To assess the correlation of lymphoma biomarkers with outcomes.
OUTLINE: This is a dose-escalation study of yttrium-90 anti-CD45 monoclonal antibody BC8.
Patients receive indium-111 anti-CD45 monoclonal antibody BC8 intravenously (IV) on day -28 and (if necessary) day -21 to evaluate the antibody's biodistribution. Patients then receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -14. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.
After completion of study treatment, patients are followed up at 3, 6, and 12 months and then annually thereafter.
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.
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
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.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
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 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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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.
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.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
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.
Patients receive indium-111 anti-CD45 monoclonal antibody BC8 IV on day -28 and (if necessary) day -21. Patients receive yttrium-90 anti-CD45 monoclonal antibody BC8 IV on day -28, -14, and -13. Patients then undergo autologous peripheral blood stem cell transplantation on day 0.
Biological: indium In 111 anti-CD45 monoclonal antibody BC8 · Radiation: yttrium Y 90 anti-CD45 monoclonal antibody BC8 · Procedure: peripheral blood stem cell transplantation
Given IV
Also known as: In 111 MOAB BC8, In 111 monoclonal antibody BC8, In111 MOAB BC8, indium In 111 MOAB BC8
Given IV
Also known as: 90Y anti-CD45 MAb BC8, 90Y anti-CD45 MoAb BC8
Undergo autologous peripheral blood stem cell transplant
Also known as: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell
Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45
A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.
Time frame: Up to 30 days after receiving study drug
Overall Response Rate
Time frame: Up to 6 years
Overall Survival
Time frame: Up to 6 years
Progression-free Survival
Time frame: Up to 6 years
Tumor to Normal Organ Ratios
Derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of 90Y.
Time frame: Up to 6 years
| Milestone | Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) |
|---|---|
| Started | 2 |
| Completed | 2 |
| Not completed | 0 |
A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.
| Participants | Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) |
|---|---|
| Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45 | 0 |
| Participants | Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) |
|---|---|
| Overall Response Rate | 0 |
| days | Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) |
|---|---|
| Overall Survival | 750.5 (243 to 1258) |
| Participants | Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) |
|---|---|
| Progression-free Survival | 0 |
Derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of 90Y.
No measurements were reported for this outcome.
Collected over AEs will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to the investigational product in this study (i.e., the start of the first dosimetry infusion) through day +30 post transplant or through discharge prior to that date from the SCCA system to care of the patient's primary physician. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) | — | 0/2 (0%) | 2/2 (100%) |
| Event | Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) |
|---|---|
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/2 |
| HyperglycemiaMetabolism and nutrition disorders | 1/2 |
| Age, Continuous(years) | Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) |
|---|---|
| Mean | 52 ± 0 |
| Sex: Female, Male(Participants) | Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) |
|---|---|
| Female | 1 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8) |
|---|---|
| United States | 2 |
Ran from Sep 1999 to primary completion in Sep 2013, 168 months.
Results were first posted in Nov 2017, 4 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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