TriangleNCT01678443 · STUDY IN CONTEXT
Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.
Overall Response Rate
Overall Survival
Progression-free Survival
Derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of 90Y.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01678443
- trial label
- Monoclonal Antibody Therapy Before Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoid Malignancies
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01678443
- outcome key
- om-0000
- source section id
- NCT01678443-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45
- endpoint definition
- A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.
- time origin
- Up to 30 days after receiving study drug
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01678443
- outcome key
- om-0001
- source section id
- NCT01678443-om-0001
- source outcome index
- 1
- endpoint
- Overall Response Rate
- endpoint definition
- Overall Response Rate
- time origin
- Up to 6 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01678443
- outcome key
- om-0002
- source section id
- NCT01678443-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival
- endpoint definition
- Overall Survival
- time origin
- Up to 6 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01678443
- outcome key
- om-0003
- source section id
- NCT01678443-om-0003
- source outcome index
- 3
- endpoint
- Progression-free Survival
- endpoint definition
- Progression-free Survival
- time origin
- Up to 6 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01678443
- outcome key
- om-0004
- source section id
- NCT01678443-om-0004
- source outcome index
- 4
- endpoint
- Tumor to Normal Organ Ratios
- endpoint definition
- Derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of 90Y.
- time origin
- Up to 6 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- This outcome measure was not done. Only two patients were enrolled before the study was closed early. Tumor to normal organ ratios was not determined due to small sample size.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01678443
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
- regimen
- 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. indium In 111 anti-CD45 monoclonal antibody BC8: Given IV yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01678443-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01678443
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
- regimen
- 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. indium In 111 anti-CD45 monoclonal antibody BC8: Given IV yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01678443-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01678443
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
- regimen
- 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. indium In 111 anti-CD45 monoclonal antibody BC8: Given IV yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01678443-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01678443
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
- regimen
- 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. indium In 111 anti-CD45 monoclonal antibody BC8: Given IV yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01678443-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01678443
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
- regimen
- 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. indium In 111 anti-CD45 monoclonal antibody BC8: Given IV yttrium Y 90 anti-CD45 monoclonal antibody BC8: Given IV peripheral blood stem cell transplantation: Undergo autologous peripheral blood stem cell transplant
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01678443-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-t-cell-large-granular-lymphocyte-leukemia
- nct id
- NCT01678443
- harm key
- EG000
- source section id
- NCT01678443-ae
- event group key
- EG000
- event group label
- Treatment (Yttrium-90 Anti-CD45 Monoclonal Antibody BC8)
- serious affected
- 0
- serious at risk
- 2
- other affected
- 2
- other at risk
- 2
- frequency threshold
- 0
- collection period
- 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
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice