TriangleNCT01640301 · STUDY IN CONTEXT
Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Do
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
Response is assessed throughout the 1 year post treatment timeframe. Morphologic criteria for response: Complete Response (CR) = Bone Marrow blasts \<5%; no blasts with Auer rods; no extramedullary disease. Transfusion independent. Platelets ≥ 100,000/μl Absolute neutrophil count \>1000/μl (CRi: incomplete hematologic recovery CRp: incomplete platelet recovery) Partial Response (PR) = Decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow and the normalization of blood counts as for CR. (PRi and PRp if incomplete hematologic or platelet recovery) Stable Disease (SD) = Failure to achieve at least PR, but no evidence of progression for \>4 weeks.
Efficacy, in Terms of Relapse Rate (Arm I)
Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm I)
Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm II)
Count of Participants Who Experienced Grade III-IV Acute Graft Versus Host Disease (GVHD) (Arm II)
Count of Participants Who Experienced Grade III-IV Acute Graft-versus-host Disease (GVHD) (Arm I)
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-myeloid-neoplasm
- nct id
- NCT01640301
- trial label
- Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Do
- 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
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-neoplasm
- nct id
- NCT01640301
- outcome key
- om-0000
- source section id
- NCT01640301-om-0000
- source outcome index
- 0
- endpoint
- Anti-leukemic Potential Efficacy, in Terms of Duration of Response (Arm II)
- endpoint definition
- Response is assessed throughout the 1 year post treatment timeframe. Morphologic criteria for response: Complete Response (CR) = Bone Marrow blasts \<5%; no blasts with Auer rods; no extramedullary disease. Transfusion independent. Platelets ≥ 100,000/μl Absolute neutrophil count \>1000/μl (CRi: incomplete hematologic recovery CRp: incomplete platelet recovery) Partial Response (PR) = Decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow and the normalization of blood counts as for CR. (PRi and PRp if incomplete hematologic or platelet recovery) Stable Disease (SD) = Failure to achieve at least PR, but no evidence of progression for \>4 weeks.
- time origin
- Up to 1 year
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 4 patients in Arm II did not relapse and were not assessed. 1 pt progressed at their D365 visit timepoint which landed on D367. They were included in the count of participants that passed within their 1 year follow-up timeframe.
- 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-myeloid-neoplasm
- nct id
- NCT01640301
- outcome key
- om-0001
- source section id
- NCT01640301-om-0001
- source outcome index
- 1
- endpoint
- Efficacy, in Terms of Relapse Rate (Arm I)
- endpoint definition
- Efficacy, in Terms of Relapse Rate (Arm I)
- time origin
- At 1 year post-transplant
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- No patients in Arm I relapsed, so overall number of participants analyzed is 0
- 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-myeloid-neoplasm
- nct id
- NCT01640301
- outcome key
- om-0002
- source section id
- NCT01640301-om-0002
- source outcome index
- 2
- endpoint
- Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm I)
- endpoint definition
- Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm I)
- time origin
- Up to 1 year
- 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-myeloid-neoplasm
- nct id
- NCT01640301
- outcome key
- om-0003
- source section id
- NCT01640301-om-0003
- source outcome index
- 3
- endpoint
- Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm II)
- endpoint definition
- Count of Participants Who Experienced Chronic Graft Versus Host Disease (GVHD) (Arm II)
- time origin
- Up to 1 year
- 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-myeloid-neoplasm
- nct id
- NCT01640301
- outcome key
- om-0004
- source section id
- NCT01640301-om-0004
- source outcome index
- 4
- endpoint
- Count of Participants Who Experienced Grade III-IV Acute Graft Versus Host Disease (GVHD) (Arm II)
- endpoint definition
- Count of Participants Who Experienced Grade III-IV Acute Graft Versus Host Disease (GVHD) (Arm II)
- time origin
- Up to 1 year following infusion per patient
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 2 patients were unevaluable for this outcome due to old documentation, unable to discern if the patient had acute GvHD greater than or equal to grade 3.
- 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-myeloid-neoplasm
- nct id
- NCT01640301
- outcome key
- om-0005
- source section id
- NCT01640301-om-0005
- source outcome index
- 5
- endpoint
- Count of Participants Who Experienced Grade III-IV Acute Graft-versus-host Disease (GVHD) (Arm I)
- endpoint definition
- Count of Participants Who Experienced Grade III-IV Acute Graft-versus-host Disease (GVHD) (Arm I)
- time origin
- Up to 1 year
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients were evaluated for aGvHD greater than or equal to Grade 3
- 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-myeloid-neoplasm
- nct id
- NCT01640301
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)
- regimen
- Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.
- analyzed count
- 9
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01640301-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-neoplasm
- nct id
- NCT01640301
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Group 1 (Avelumab and MHC Class I Up-regulation)
- regimen
- Patients who do not have a HLA type for which T cells can be generated or for whom T cells cannot be generated for technical issues receive avelumab intravenously (IV) over 1 hour every 2 weeks for 12 months. Within 7-10 days after completion of 1-3 doses of avelumab, patients receive MHC class I up-regulation intervention comprising either localized radiation therapy or recombinant interferon beta via intra-tumor injection.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01640301-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-neoplasm
- nct id
- NCT01640301
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Group 1 (Avelumab and MHC Class I Up-regulation)
- regimen
- Patients who do not have a HLA type for which T cells can be generated or for whom T cells cannot be generated for technical issues receive avelumab intravenously (IV) over 1 hour every 2 weeks for 12 months. Within 7-10 days after completion of 1-3 doses of avelumab, patients receive MHC class I up-regulation intervention comprising either localized radiation therapy or recombinant interferon beta via intra-tumor injection.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01640301-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-neoplasm
- nct id
- NCT01640301
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)
- regimen
- Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01640301-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-neoplasm
- nct id
- NCT01640301
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)
- regimen
- Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01640301-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-neoplasm
- nct id
- NCT01640301
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Group 1 (Avelumab and MHC Class I Up-regulation)
- regimen
- Patients who do not have a HLA type for which T cells can be generated or for whom T cells cannot be generated for technical issues receive avelumab intravenously (IV) over 1 hour every 2 weeks for 12 months. Within 7-10 days after completion of 1-3 doses of avelumab, patients receive MHC class I up-regulation intervention comprising either localized radiation therapy or recombinant interferon beta via intra-tumor injection.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01640301-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-myeloid-neoplasm
- nct id
- NCT01640301
- harm key
- EG000
- source section id
- NCT01640301-ae
- event group key
- EG000
- event group label
- Arm I (High-risk for Relapse After HCT)
- serious affected
- 5
- serious at risk
- 13
- other affected
- 12
- other at risk
- 13
- frequency threshold
- 0
- collection period
- Up to 1 year post infusion per patient
- event definition
- Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
- undenominated 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-myeloid-neoplasm
- nct id
- NCT01640301
- harm key
- EG001
- source section id
- NCT01640301-ae
- event group key
- EG001
- event group label
- Arm II (Relapsed After HCT)
- serious affected
- 5
- serious at risk
- 15
- other affected
- 15
- other at risk
- 15
- frequency threshold
- 0
- collection period
- Up to 1 year post infusion per patient
- event definition
- Toxicities were according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
- 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