Non-Malignant NeoplasmPhase 1/2NCT04083183
Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases
A Phase 1/2 study testing Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10, Fludarabine and Cyclophosphamide in people with Non-Malignant Neoplasm, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This phase I/II trial studies the best dose of total body irradiation with astatine-211 BC8-B10 monoclonal antibody for the treatment of patients with nonmalignant diseases undergoing hematopoietic cell transplant. Radiation therapy uses high energy gamma rays to kill cancer cells and shrink tumors. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Non-Malignant Neoplasm
- What is being tested?
- Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2020to 9 Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age >= 18 years and < 50 years
- Nonmalignant disease treatable by allogeneic hematopoietic cell transplantation (HCT). Patients with a nonmalignant disease that is not clearly defined must be approved by the principal investigator (PI)
- Karnofsky score >= 70
- Patients must have normal elastography
- If ferritin is elevated, patient must have less than 7 mg/g liver iron concentration on liver T2 magnetic resonance imaging (MRI)
- Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation
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- DONOR INCLUSION
- HLA matched related donor that is genotypically or phenotypically identical for HLA-A, -B, -C, -DRB1, -DQB1. Phenotypic identity must be confirmed by high-resolution typing. Sibling donors are preferred over other relationships
- Unrelated donor.
- Matched for HLA-A, -B, -C, -DRB1, and DQB1 by high-resolution typing; OR
- Mismatched for a single HLA-class 1 allele or HLA-DQB1 antigen or allele by high-resolution typing.
- Note: A donor homozygous for one allele only at HLA-A, B, C, DRB1, or DQB1 is allowed (1 antigen mismatch for graft versus host disease [GVHD], 0 antigen mismatch for graft-rejection). In the case of a recipient who is homozygous at one locus, the mismatch is not allowed to be at that locus (0 antigen mismatch for GVHD, 1 antigen mismatch for graft-rejection)
- HLA haploidentical donor. There must be one shared HLA-haplotype based on inheritance. The noninherited haplotype is allowed to be mismatched at any or all of these loci: HLA-A, B, C, DRB1 or DQB1.
- Donor selection guideline recommendations: in the case where there are multiple donor options, donors should be selected based on the following priority numbered below:
- Related donor genotypically HLA-matched
- Related donor phenotypically HLA-matched
- Unrelated donor HLA-matched
- Unrelated donor with single allele level mismatch at class 1 (HLA-A, -B, or -C). For example, HLA-A02:01 versus HLA-A 02:02
- Unrelated donor with single allele level mismatch at DQB1
- HLA-haploidentical donor Note: We require that the donor testing be performed by a United States Clinical Laboratory Improvement Amendment (CLIA) approved laboratory. In the very rare case where the donor testing is not able to be performed in a CLIA approved laboratory, or there is confirmatory testing that needs to be performed, or for any donor identified from Europe and at risk for Creutzfeldt-Jakob Disease (CJD), we note this on the donor screening form and require that the unrelated donor medical director or the attending physician approves the use of the donor HPC-A product under urgent medical need
Who cannot join
- Patients with Fanconi Anemia
- Impaired cardiac function as evidenced by ejection fraction < 35% (or, if unable to obtain ejection fraction, shortening fraction of < 26%) or cardiac insufficiency requiring treatment or symptomatic coronary artery disease. Patients with a shortening fraction of < 26% may be enrolled if approved by a cardiologist. In addition, patients with poorly controlled hypertension on multiple anti-hypertensive medications, symptomatic coronary artery disease, or patients on cardiac medications for antiarrhythmic or inotropic effects are excluded
- Impaired pulmonary function as evidenced by carbon monoxide diffusing capability test (DLCO) < 35% of predicted or receiving supplemental continuous oxygen. In addition, if patients are unable to perform pulmonary function tests, then O2 saturation < 92% on room air
- Impaired renal function as evidenced by estimated creatinine clearance less than 50 ml/min or serum creatinine > 2 x upper normal limit or dialysis-dependent. Serum creatinine value must be within 28 days prior to start of conditioning
- The creatinine clearance may be estimated by the Cockcroft-Gault formula
- Impaired liver function as evidenced by abnormal hepatic function within 2 months prior to the astatine-211 infusion date defined as a total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) > 2 times the upper limit of normal (with the exception of elevated total bilirubin level, predominantly indirect bilirubin, in patients with hemoglobinopathy due to acute and/or chronic hemolysis). In addition, patients with the following liver abnormalities are excluded: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease
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- An uncontrolled infection requiring deferral of conditioning as recommended by an infectious disease specialist. A viral upper respiratory tract infection does not constitute an uncontrolled infection in this context
- Patients who are known to be positive for HIV (human immunodeficiency virus)
- Women of childbearing potential who are pregnant or breast-feeding
- Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
- Allergy to murine-based monoclonal antibodies
- Known contraindication to radiotherapy
- DONOR EXCLUSION
- Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before hematopoietic cell transplantation (HCT). If the PRA shows > 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. For those patients with an HLA class I allele or class II allele or antigen mismatch or haploidentical donors, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Phuong Vo, 206-667-2749, ptvo@fredhutch.org
Phuong Vo
About this study
Official title: Targeted Astatine-211-Labeled BC8-B10 Monoclonal Antibody as Reduced Intensity Conditioning for Nonmalignant Diseases
This phase I/II trial studies the best dose of total body irradiation with astatine-211 BC8-B10 monoclonal antibody for the treatment of patients with nonmalignant diseases undergoing hematopoietic cell transplant. Radiation therapy uses high energy gamma rays to kill cancer cells and shrink tumors. Astatine-211-labeled BC8-B10 monoclonal antibody is a monoclonal antibody, called anti-CD45 monoclonal antibody BC8-B10, linked to a radioactive/toxic agent called astatine 211. Anti-CD45 monoclonal antibody BC8-B10 is attached to CD45 antigen positive cancer cells in a targeted way and delivers astatine 211 to kill them. Giving astatine-211 BC8-B10 monoclonal antibody and total-body irradiation before a donor stem cell transplant may help 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.
Read the detailed description
OUTLINE:
Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 intravenously (IV) on any day between days -10 and -7, fludarabine IV on days -6 to -2, cyclophosphamide IV over 1 hour on days -6 to -5 and 3 to 4, and thymoglobulin IV over 4-6 hours on days -4 to -2. Patients undergo TBI on day -1 and hematopoietic cell transplant on day 0. Beginning day 5, patients also receive mycophenolate mofetil orally (PO) or IV thrice daily every 8 hours up to day 35 if no GVHD present and sirolimus PO daily until day 365. Patients undergo blood sample collection and may undergo bone marrow aspiration throughout the study.
After completion of study treatment, patients are followed up at 1 and 2 years and then periodically for up to 5 years.
Note: National Heart, Lung, and Blood Institute (NHLBI) funding for this study ended in 2022.
- Conditions
- Non-Malignant Neoplasm
- Being tested
- Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10, Fludarabine, Cyclophosphamide, Lapine T-Lymphocyte Immune Globulin, Total-Body Irradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10Biological
Also called Astatine 211-Labeled Anti-CD45 Monoclonal Antibody BC8-B10, Astatine At 211 MAb BC8-B10, At 211 Anti-CD45 Monoclonal Antibody BC8-B10, At 211 MAb BC8-B10
Given IV
FludarabineDrug
Also called 2-Fluorovidarabine, 21679-14-1, 9-Beta-D-arabinofuranosyl-2-fluoro-9H-purin-6-amine, 9-Beta-D-arabinofuranosyl-2-fluoroadenine
Given IV
CyclophosphamideDrug
Also called Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal
Given IV
Lapine T-Lymphocyte Immune GlobulinBiological
Also called Anti-thymocyte Globulin Rabbit, Grafalon, Rabbit Anti-Human Thymocyte Globulin (RATG), Rabbit Anti-Thymocyte Globulin
Given IV
Total-Body IrradiationRadiation
Also called TBI, TOTAL BODY IRRADIATION, Whole Body Irradiation, Whole-Body Irradiation
Undergo TBI
Hematopoietic Cell TransplantationProcedure or surgery
Also called HCT, Hematopoietic Stem Cell Transplantation, HSCT, Stem Cell Transplant
Undergo hematopoietic cell transplantation
Also called Cellcept, MMF, 115007-34-6
Given PO or IV
SirolimusDrug
Also called RAPA, Rapamune, Rapamycin, SILA 9268A
Given PO
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration
Biospecimen CollectionProcedure or surgery
Undergo blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT) | Experimental | Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 IV on any day between days -10 and -7, fludarabine IV on days -6 to -2, cyclophosphamide IV over 1 hour on days -6 to -5 and 3 to 4, and thymoglobulin IV over 4-6 hours on days -4 to -2. Patients undergo TBI on day -1 and hematopoietic cell transplant on day 0. Beginning day 5, patients also receive mycophenolate mofetil PO or IV thrice daily every 8 hours up to day 35 if no GVHD present and sirolimus PO daily until day 365. Patients undergo blood sample collection and may undergo bone marrow aspiration throughout the study. Receives: Biological: Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10; Drug: Fludarabine; Drug: Cyclophosphamide; Biological: Lapine T-Lymphocyte Immune Globulin; Radiation: Total-Body Irradiation; Procedure: Hematopoietic Cell Transplantation; Drug: Mycophenolate Mofetil; Drug: Sirolimus; Procedure: Bone Marrow Aspiration; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft rejection (arm A)
Defined as establishment of < 5% donor chimerism of CD3+ T cells and <5% donor chimerism of CD33+ myeloid cells at day 80-100 after hematopoietic cell transplant (HCT) following an human leukocyte antigen (HLA)-matched related or unrelated graft or an unrelated graft with a single HLA-class 1 allele mismatch or DQB1 antigen or allele mismatch.
Measured: Up to 5 years post-transplant
Graft rejection (arm B)
Defined as establishment of < 5% donor chimerism of CD3+ T cells and < 5% donor chimerism of CD33+ myeloid cells at day 80-100 after HCT following an HLA-haploidentical related donor or an unrelated donor mismatched for a single HLA-class 1 antigen or a single HLA-DRB1 allele.
Measured: Up to 5 years post-transplant
Secondary outcomes (5)
Transplant related mortality
Measured: At day 100 post-transplant
Overall survival
Measured: At 1 year post-transplant
Rate of acute graft versus host disease (GVHD)
Measured: At day 100 post-transplant
Rate of chronic GVHD
Measured: At 1 year post-transplant
Donor chimerism
Measured: At day 28, day 84, and 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start16 Jun 2020
- Primary completion9 Jan 2028 (estimated)
- Study completion9 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Phuong Vo, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083183
- Sponsor's protocol ID
- RG1005632
- Other IDs
- NCI-2019-05727, 9524, P01HL122173-01
- Status last verified
- Jun 2026
- First submitted
- 6 Sep 2019
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Astatine-211-Labeled BC8-B10 Monoclonal Antibody as Reduced Intensity Conditioning for Nonmalignant Diseases
- ClinicalTrials.gov ID
- NCT04083183
- Acronym / sponsor ID
- RG1005632
- Conditions
- Non-Malignant Neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 9 Jan 2028 (estimated)
- Study completion
- 9 Jan 2028 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial studies the best dose of total body irradiation with astatine-211 BC8-B10 monoclonal antibody for the treatment of patients with nonmalignant diseases undergoing hematopoietic cell transplant. Radiation therapy uses high energy gamma rays to kill cancer cells and shrink tumors. Astatine-211-labeled BC8-B10 monoclonal antibody is a monoclonal antibody, called anti-CD45 monoclonal antibody BC8-B10, linked to a radioactive/toxic agent called astatine 211. Anti-CD45 monoclonal antibody BC8-B10 is attached to CD45 antigen positive cancer cells in a targeted way and delivers astatine 211 to kill them. Giving astatine-211 BC8-B10 monoclonal antibody and total-body irradiation before a donor stem cell transplant may help 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.
Detailed description
OUTLINE:
Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 intravenously (IV) on any day between days -10 and -7, fludarabine IV on days -6 to -2, cyclophosphamide IV over 1 hour on days -6 to -5 and 3 to 4, and thymoglobulin IV over 4-6 hours on days -4 to -2. Patients undergo TBI on day -1 and hematopoietic cell transplant on day 0. Beginning day 5, patients also receive mycophenolate mofetil orally (PO) or IV thrice daily every 8 hours up to day 35 if no GVHD present and sirolimus PO daily until day 365. Patients undergo blood sample collection and may undergo bone marrow aspiration throughout the study.
After completion of study treatment, patients are followed up at 1 and 2 years and then periodically for up to 5 years.
Note: National Heart, Lung, and Blood Institute (NHLBI) funding for this study ended in 2022.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT) | Experimental | Biological: Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10, Drug: Fludarabine, Drug: Cyclophosphamide, Biological: Lapine T-Lymphocyte Immune Globulin, Radiation: Total-Body Irradiation, Procedure: Hematopoietic Cell Transplantation, Drug: Mycophenolate Mofetil, Drug: Sirolimus, Procedure: Bone Marrow Aspiration, Procedure: Biospecimen CollectionPatients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 IV on any day between days -10 and -7, fludarabine IV on days -6 to -2, cyclophosphamide IV over 1 hour on days -6 to -5 and 3 to 4, and thymoglobulin IV over 4-6 hours on days -4 to -2. Patients undergo TBI on day -1 and hematopoietic cell transplant on day 0. Beginning day 5, patients also receive mycophenolate mofetil PO or IV thrice daily every 8 hours up to day 35 if no GVHD present and sirolimus PO daily until day 365. Patients undergo blood sample collection and may undergo bone marrow aspiration throughout the study. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Age >= 18 years and < 50 years
- Nonmalignant disease treatable by allogeneic hematopoietic cell transplantation (HCT). Patients with a nonmalignant disease that is not clearly defined must be approved by the principal investigator (PI)
- Karnofsky score >= 70
- Patients must have normal elastography
- If ferritin is elevated, patient must have less than 7 mg/g liver iron concentration on liver T2 magnetic resonance imaging (MRI)
Key exclusion criteria (14 listed)
- Patients with Fanconi Anemia
- Impaired cardiac function as evidenced by ejection fraction < 35% (or, if unable to obtain ejection fraction, shortening fraction of < 26%) or cardiac insufficiency requiring treatment or symptomatic coronary artery disease. Patients with a shortening fraction of < 26% may be enrolled if approved by a cardiologist. In addition, patients with poorly controlled hypertension on multiple anti-hypertensive medications, symptomatic coronary artery disease, or patients on cardiac medications for antiarrhythmic or inotropic effects are excluded
- Impaired pulmonary function as evidenced by carbon monoxide diffusing capability test (DLCO) < 35% of predicted or receiving supplemental continuous oxygen. In addition, if patients are unable to perform pulmonary function tests, then O2 saturation < 92% on room air
- Impaired renal function as evidenced by estimated creatinine clearance less than 50 ml/min or serum creatinine > 2 x upper normal limit or dialysis-dependent. Serum creatinine value must be within 28 days prior to start of conditioning
- Impaired liver function as evidenced by abnormal hepatic function within 2 months prior to the astatine-211 infusion date defined as a total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) > 2 times the upper limit of normal (with the exception of elevated total bilirubin level, predominantly indirect bilirubin, in patients with hemoglobinopathy due to acute and/or chronic hemolysis). In addition, patients with the following liver abnormalities are excluded: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease
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 |
|---|---|---|
| Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10Also: Astatine 211-Labeled Anti-CD45 Monoclonal Antibody BC8-B10, Astatine At 211 MAb BC8-B10, At 211 Anti-CD45 Monoclonal Antibody BC8-B10, At 211 MAb BC8-B10Given IV | Biological | Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT) |
| FludarabineAlso: 2-Fluorovidarabine, 21679-14-1, 9-Beta-D-arabinofuranosyl-2-fluoro-9H-purin-6-amine, 9-Beta-D-arabinofuranosyl-2-fluoroadenineGiven IV | Drug | Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT) |
| CyclophosphamideAlso: Carloxan, Ciclofosfamida, Ciclofosfamide, CicloxalGiven IV | Drug | Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT) |
| Lapine T-Lymphocyte Immune GlobulinAlso: Anti-thymocyte Globulin Rabbit, Grafalon, Rabbit Anti-Human Thymocyte Globulin (RATG), Rabbit Anti-Thymocyte GlobulinGiven IV | Biological | Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT) |
| Total-Body IrradiationAlso: TBI, TOTAL BODY IRRADIATION, Whole Body Irradiation, Whole-Body IrradiationUndergo TBI | Radiation | Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT) |
| Hematopoietic Cell TransplantationAlso: HCT, Hematopoietic Stem Cell Transplantation, HSCT, Stem Cell TransplantUndergo hematopoietic cell transplantation | Procedure or surgery | Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT) |
| Mycophenolate MofetilAlso: Cellcept, MMF, 115007-34-6Given PO or IV | Drug | Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT) |
| SirolimusAlso: RAPA, Rapamune, Rapamycin, SILA 9268AGiven PO | Drug | Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT) |
| Bone Marrow AspirationUndergo bone marrow aspiration | Procedure or surgery | Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT) |
| Biospecimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT) |
Primary outcome
Graft rejection (arm A)
Time frame: Up to 5 years post-transplant
Defined as establishment of < 5% donor chimerism of CD3+ T cells and <5% donor chimerism of CD33+ myeloid cells at day 80-100 after hematopoietic cell transplant (HCT) following an human leukocyte antigen (HLA)-matched related or unrelated graft or an unrelated graft with a single HLA-class 1 allele mismatch or DQB1 antigen or allele mismatch.
Graft rejection (arm B)
Time frame: Up to 5 years post-transplant
Defined as establishment of < 5% donor chimerism of CD3+ T cells and < 5% donor chimerism of CD33+ myeloid cells at day 80-100 after HCT following an HLA-haploidentical related donor or an unrelated donor mismatched for a single HLA-class 1 antigen or a single HLA-DRB1 allele.
5 secondary outcomes
Transplant related mortality
Time frame: At day 100 post-transplant
Overall survival
Time frame: At 1 year post-transplant
Rate of acute graft versus host disease (GVHD)
Time frame: At day 100 post-transplant
Rate of chronic GVHD
Time frame: At 1 year post-transplant
Donor chimerism
Time frame: At day 28, day 84, and 1 year post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Phuong Vo principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10, Fludarabine and Cyclophosphamide in people with Non-Malignant Neoplasm, run by Fred Hutchinson Cancer Center 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 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phuong Vo (206-667-2749, ptvo@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft rejection (arm A) (time frame: Up to 5 years post-transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.