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CompletedNCT01300572Updated Dec 10, 2019Results posted

Yttrium-90 Anti-CD45 Monoclonal Antibody BC8 Followed by Donor Stem Cell Transplant in Treating Patients With High-Risk AML, ALL, or MDS

A Phase 1 interventional study of Allogeneic Bone Marrow Transplantation and Allogeneic Hematopoietic Stem Cell Transplantation in Chronic Myelomonocytic Leukemia, Previously Treated Myelodysplastic Syndrome and Recurrent Adult Acute Lymphoblastic Leukemia, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-10.

Sponsored by Fred Hutchinson Cancer Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase I trial studies the side effects and maximum tolerated dose of yttrium Y 90 anti-cluster of differentiation 45 (CD45) monoclonal antibody BC8 (90Y-BC8) followed by donor stem cell transplant in treating patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) that is likely to come back or spread. Giving chemotherapy drugs, such as fludarabine phosphate (FLU), and total-body irradiation (TBI) before a donor peripheral blood stem cell (PBSC) or bone marrow transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies, such as 90Y-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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving FLU, 90Y-BC8, and TBI before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

Read the detailed description

PRIMARY OBJECTIVES:

I. To estimate the maximum tolerated dose (MTD) of radiation delivered via 90Y-DOTA-BC8 (90Y-BC8) when combined with FLU and 2 Gy TBI as a preparative regimen for patients aged >= 18 with advanced AML, ALL, and high-risk MDS.

SECONDARY OBJECTIVES:

I. To determine disease response and duration of remission.

II. To determine the rates of engraftment and donor chimerism resulting from this combined preparative regimen, and to correlate level of donor chimerism with estimated radiation doses delivered to hematopoietic tissues via antibody.

OUTLINE:

PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12 and FLU intravenously (IV) over 30 minutes on days -4 to -2.

TRANSPLANTATION: Patients undergo TBI followed by allogeneic PBSC or bone marrow transplant on day 0.

GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive mycophenolate mofetil orally (PO) or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180.

After completion of study treatment, patients are followed up at 6, 9, 12, 18, and 24 months, and then annually thereafter.

02

Conditions studied

  • Chronic Myelomonocytic Leukemia
  • Previously Treated Myelodysplastic Syndrome
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Refractory Anemia With Excess Blasts
  • Secondary Acute Myeloid Leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 16 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have advanced AML, ALL or high-risk MDS meeting one of the following descriptions:

    • AML or ALL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen)
    • AML or ALL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens)
    • AML evolved from myelodysplastic or myeloproliferative syndromes; or
    • MDS expressed as refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria
  • Patients not in remission must have CD45-expressing leukemic blasts; patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up >= 95% of nucleated cells in the marrow)
  • Patients should have a circulating blast count of less than 10,000/mm\^3 (control with hydroxyurea or similar agent is allowed)
  • Patients must have an estimated creatinine clearance greater than 50/ml per minute (serum creatinine value must be within 28 days prior to registration)
  • Bilirubin \< 2 times the upper limit of normal
  • Aspartate aminotransferase (AST) and alanine transaminase (ALT) \< 2 times the upper limit of normal
  • Eastern Cooperative Oncology Group (ECOG) =\< 2 or Karnofsky >= 70
  • Patients must have an expected survival of > 60 days and must be free of active infection

  • Patients must have an human leukocyte antigen (HLA)-identical sibling donor or an HLA-matched unrelated donor who meets standard Seattle Cancer Care Alliance (SCCA) and/or National Marrow Donor Program (NMDP) or other donor center criteria for PBSC or bone marrow donation, as follows:

    • Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing

    • Unrelated donor:

      • Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR mismatched for a single allele without antigen mismatching at HLA-A, B or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing
      • Doors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; this determination is based on the standard practice of the individual institution; 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 transplant (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 and HLA class I allele mismatch, 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
      • Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch; i.e., the patient is A*0101 and the donor is A*0102, and this type of mismatch is not allowed
  • DONOR: Donors must meet HLA matching criteria and standard SCCA and/or National Marrow Donor Program (NMDP) or other donor center criteria for PBSC or bone marrow donation

Exclusion criteria

Exclusion Criteria:

  • Circulating human anti-mouse antibody (HAMA)
  • Prior radiation to maximally tolerated levels to any critical normal organ, or > 20 Gy prior radiation to large areas of the bone marrow (e.g., external radiation therapy to whole pelvis)
  • Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects
  • Left ventricular ejection fraction \< 35%
  • Corrected diffusion lung capacity of carbon monoxide (DLCO) \< 35% or receiving supplemental continuous oxygen
  • Liver abnormalities: 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
  • Patients who are known to be seropositive for human immunodeficiency virus (HIV)
  • Perceived inability to tolerate diagnostic or therapeutic procedures
  • Active central nervous system (CNS) leukemia at time of treatment
  • Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin positive [HCG+]) or breast feeding
  • Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant
  • Inability to understand or give an informed consent
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Y-90-BC8 & Allogeneic Transplant

    PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180.

    Procedure: Allogeneic Bone Marrow Transplantation · Procedure: Allogeneic Hematopoietic Stem Cell Transplantation · Drug: Cyclosporine · Drug: Fludarabine Phosphate · Biological: Indium In 111 Anti-CD45 Monoclonal Antibody BC8 · Other: Laboratory Biomarker Analysis · Drug: Mycophenolate Mofetil · Procedure: Peripheral Blood Stem Cell Transplantation · Other: Pharmacological Study · Radiation: Total-Body Irradiation · Radiation: Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8

Interventions

  • ProcedureAllogeneic Bone Marrow Transplantation

    Undergo allogeneic bone marrow transplant

    Also known as: Allo BMT, Allogeneic BMT

  • ProcedureAllogeneic Hematopoietic Stem Cell Transplantation

    Undergo allogeneic PBSC or bone marrow transplant

    Also known as: allogeneic stem cell transplantation, HSC, HSCT

  • DrugCyclosporine

    Given PO or IV

    Also known as: 27-400, Ciclosporin, CsA, Cyclosporin, Cyclosporin A, Gengraf, Neoral, OL 27-400, Sandimmun, Sandimmune, SangCya

  • DrugFludarabine Phosphate

    Given IV

    Also known as: 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, Fludara, SH T 586

  • BiologicalIndium In 111 Anti-CD45 Monoclonal Antibody BC8

    Given IV (dosimetric dose)

    Also known as: In 111 MOAB BC8, In 111 Monoclonal Antibody BC8, Indium In 111 Monoclonal Antibody BC8, monoclonal antibody BC8, indium In 111

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • DrugMycophenolate Mofetil

    Given PO or IV

    Also known as: Cellcept, MMF

  • ProcedurePeripheral Blood Stem Cell Transplantation

    Undergo allogeneic PBSC transplant

    Also known as: PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplantation

  • OtherPharmacological Study

    Correlative studies

  • RadiationTotal-Body Irradiation

    Undergo TBI

    Also known as: TOTAL BODY IRRADIATION, Whole-Body Irradiation

  • RadiationYttrium Y 90 Anti-CD45 Monoclonal Antibody BC8

    Given via central line (therapeutic dose)

    Also known as: 90Y Anti-CD45 MoAb BC8

06

What researchers measure

Primary outcomes

  1. The MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS.

    The MTD will be defined as the dose that is associated with a true DLT rate of 25%. The highest dose achieved was 28 Gy but none of the patients experienced a DLT. Thus, the MTD was not reached.

    Time frame: Within the first 30 days following transplant

Secondary outcomes

  1. Achievement of Remission

    Number of participants who are in complete remission (CR) 4 weeks after transplant. CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following: 1. Normal bone marrow with blasts \<5% with normal cellularity, normal megakaryopoiesis, \> 15% erythropoiesis and \> 25% granulocytopoiesis 2. Normalization of blood counts (no blasts, platelets \> 100000/mm3, granulocytes \>1500/mm3) 3. No extramedullary disease.

    Time frame: 4 weeks after transplant

  2. Disease-free Survival

    Number of study participants who are alive and remains in complete remission after transplant.

    Time frame: 100 days after transplant

  3. Duration of Remission

    Median time to relapse after achieving complete remission (CR). CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following: 1. Normal bone marrow with blasts \<5% with normal cellularity, normal megakaryopoiesis, \> 15% erythropoiesis and \> 25% granulocytopoiesis 2. Normalization of blood counts (no blasts, platelets \> 100000/mm3, granulocytes \>1500/mm3) 3. No extramedullary disease. Relapse Criteria: 1. After CR: \>5% blasts in the bone marrow and/or peripheral blood 2. After partial remission (PR): increase of blasts cells in the marrow to \>50% of those during PR 3. Extramedullary disease confirmed cytologically or histologically.

    Time frame: 1 year

  4. Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor

    The amount of energy absorbed per unit weight of the organ or tissue is called absorbed dose and is expressed in units of gray (Gy). One gray dose is equivalent to one joule radiation energy absorbed per kilogram of organ or tissue weight.

    Time frame: Approximately day -20 to day -12 prior to transplant

  5. Overall Survival

    Number of participants who are still alive after transplant with or without disease.

    Time frame: Up to 5 years

  6. Rates of Acute GvHD

    Number of participants who developed acute GVHD post-transplant, aGVHD stages: Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

    Time frame: Up to 84 days post-transplant

  7. Rates of Donor Chimerism

    Number of participants who has 100% donor chimerism within 100 days after transplant

    Time frame: Up to 100 days post-transplant

  8. Rates of Engraftment

    Average number of days to ANC \>= 500 after transplant

    Time frame: Up to 84 days post-transplant

  9. Rates of Non-relapse Mortality

    Transplant-related deaths within 100 days after transplant

    Time frame: Within the first 100 days following transplant

07

Results

Posted Jan 25, 2019
Limitations and caveats
The highest dose achieved was 28 Gy but none of the patients experienced a DLT. Thus, the MTD was not reached.

Participant flow

This protocol is open to participants age 18 and above, of either gender and any race/ethnicity. The study is looking at the use of Y-90-DOTA-BC8 in conjunction with a standard reduced-intensity transplant regimen.

Participant flow — Overall Study
MilestoneTreatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
Started16
Completed15
Not completed1
Withdrew: Hama + post dosimetry1

Outcome measures

PrimaryThe MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS.

The MTD will be defined as the dose that is associated with a true DLT rate of 25%. The highest dose achieved was 28 Gy but none of the patients experienced a DLT. Thus, the MTD was not reached.

Time frame:
Within the first 30 days following transplant
Reported as:
Number · Gy
The MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS.
GyTreatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
The MTD of Radiation Delivered Via 90Y-DOTA-BC8 When Combined With FLU and 2 Gy TBI as a Preparative Regimen for Patients Aged ≥ 18 With Advanced AML, ALL, and High-risk MDS.28
SecondaryAchievement of Remission

Number of participants who are in complete remission (CR) 4 weeks after transplant. CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following: 1. Normal bone marrow with blasts \<5% with normal cellularity, normal megakaryopoiesis, \> 15% erythropoiesis and \> 25% granulocytopoiesis 2. Normalization of blood counts (no blasts, platelets \> 100000/mm3, granulocytes \>1500/mm3) 3. No extramedullary disease.

Time frame:
4 weeks after transplant
Reported as:
Count of participants · Participants
Achievement of Remission
ParticipantsTreatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
Achievement of Remission13
SecondaryDisease-free Survival

Number of study participants who are alive and remains in complete remission after transplant.

Time frame:
100 days after transplant
Reported as:
Number · participants
Disease-free Survival
participantsTreatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
Disease-free Survival7
SecondaryDuration of Remission

Median time to relapse after achieving complete remission (CR). CR is defined as complete resolution of all signs of myelodysplasia or leukemia for at least 4 weeks with all of the following: 1. Normal bone marrow with blasts \<5% with normal cellularity, normal megakaryopoiesis, \> 15% erythropoiesis and \> 25% granulocytopoiesis 2. Normalization of blood counts (no blasts, platelets \> 100000/mm3, granulocytes \>1500/mm3) 3. No extramedullary disease. Relapse Criteria: 1. After CR: \>5% blasts in the bone marrow and/or peripheral blood 2. After partial remission (PR): increase of blasts cells in the marrow to \>50% of those during PR 3. Extramedullary disease confirmed cytologically or histologically.

Time frame:
1 year
Reported as:
Median · days
Duration of Remission
daysTreatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
Duration of Remission213 (69 to 351)
SecondaryEstimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor

The amount of energy absorbed per unit weight of the organ or tissue is called absorbed dose and is expressed in units of gray (Gy). One gray dose is equivalent to one joule radiation energy absorbed per kilogram of organ or tissue weight.

Time frame:
Approximately day -20 to day -12 prior to transplant
Reported as:
Mean · Gy
Estimation of Absorbed Radiation Doses to Normal Organs, Marrow and Tumor
GyTreatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
Average absorbed dose to the marrow11.4 ± 9.2
Average absorbed dose to the liver17.2 ± 6.8
Average abosorbed dose total body3.1 ± 5.7
Average absorbed dose to the spleen70 ± 43
SecondaryOverall Survival

Number of participants who are still alive after transplant with or without disease.

Time frame:
Up to 5 years
Reported as:
Count of participants · Participants
Overall Survival
ParticipantsTreatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
Overall Survival7
SecondaryRates of Acute GvHD

Number of participants who developed acute GVHD post-transplant, aGVHD stages: Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Time frame:
Up to 84 days post-transplant
Reported as:
Count of participants · Participants
Rates of Acute GvHD
ParticipantsTreatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
Grade 0 acute GVHD4
Grade I acute GVHD1
Grade II acute GVHD6
Grade III acute GVHD2
Grade IV acute GVHD1
SecondaryRates of Donor Chimerism

Number of participants who has 100% donor chimerism within 100 days after transplant

Time frame:
Up to 100 days post-transplant
Reported as:
Count of participants · Participants
Rates of Donor Chimerism
ParticipantsTreatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
Rates of Donor Chimerism14
SecondaryRates of Engraftment

Average number of days to ANC \>= 500 after transplant

Time frame:
Up to 84 days post-transplant
Reported as:
Mean · days
Rates of Engraftment
daysTreatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
Rates of Engraftment16 ± 6.0
SecondaryRates of Non-relapse Mortality

Transplant-related deaths within 100 days after transplant

Time frame:
Within the first 100 days following transplant
Reported as:
Count of participants · Participants
Rates of Non-relapse Mortality
ParticipantsTreatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
Severe refractory GVHD1
Bacterial infection1

Adverse events

Collected over Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)5/15 (33.3%)9/15 (60%)11/15 (73.3%)
Most frequent serious events
Showing 10 of 16
Most frequent serious events
EventTreatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
Febrile neutropeniaBlood and lymphatic system disorders7/15
VomitingGastrointestinal disorders1/15
Creatinine increasedInvestigations1/15
AnorexiaMetabolism and nutrition disorders1/15
Atrial fibrillationCardiac disorders1/15
Oral painGastrointestinal disorders1/15
Abdominal painGastrointestinal disorders1/15
FeverGeneral disorders1/15
Skin infectionInfections and infestations1/15
HypokalemiaMetabolism and nutrition disorders1/15
Most frequent other events
Showing 10 of 64
Most frequent other events
EventTreatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
NauseaGastrointestinal disorders9/15
DiarrheaGastrointestinal disorders6/15
FatigueGeneral disorders6/15
Allergic reactionImmune system disorders6/15
Rash maculo-papularSkin and subcutaneous tissue disorders6/15
VomitingGastrointestinal disorders5/15
MyalgiaMusculoskeletal and connective tissue disorders5/15
Edema limbsGeneral disorders4/15
AnorexiaMetabolism and nutrition disorders4/15
HypomagnesemiaMetabolism and nutrition disorders4/15

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
<=18 years0
Between 18 and 65 years8
>=65 years8
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
Female8
Male8
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
Hispanic or Latino0
Not Hispanic or Latino16
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White16
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Fred Hutch/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
09

References and documents

Publications

  • Vo P, Gooley TA, Rajendran JG, Fisher DR, Orozco JJ, Green DJ, Gopal AK, Haaf R, Nartea M, Storb R, Appelbaum FR, Press OW, Pagel JM, Sandmaier BM. Yttrium-90-labeled anti-CD45 antibody followed by a reduced-intensity hematopoietic cell transplantation for patients with relapsed/refractory leukemia or myelodysplasia. Haematologica. 2020 Jun;105(6):1731-1737. doi: 10.3324/haematol.2019.229492. Epub 2019 Oct 3. PubMed 31582553 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 8, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01300572
Lead sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Brenda Sandmaier (Principal Investigator, Fred Hutchinson Cancer Center) — Principal investigator
First posted
Feb 21, 2011
Start date
Jan 2012
Primary completion
Oct 29, 2017
Completion
Nov 22, 2019
Results posted
Jan 25, 2019
Last update
Dec 10, 2019

Study contacts

Brenda Sandmaier
principal investigator · Fred Hutch/University of Washington Cancer Consortium

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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