TriangleNCT00068718 · STUDY IN CONTEXT
Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Donor Hematopoietic Cell Transplant
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
Percentage of Participants with Grade IV Acute GVHD
Percentage patients with graft rejection.
CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever \>38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. CMML, AML, ALL \>30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia. CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
Percentage of Participants with II-IV Acute GVHD
Percentage of Participants with infections.
Percentage patients surviving 1 year post-transplant.
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-chronic-myeloid-leukemia
- nct id
- NCT00068718
- trial label
- Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Donor Hematopoietic Cell Transplant
- 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
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00068718
- outcome key
- om-0000
- source section id
- NCT00068718-om-0000
- source outcome index
- 0
- endpoint
- Safety of DLI Following a Non-myeloablative Transplant, Defined as Incidence of Grade IV Acute GVHD
- endpoint definition
- Percentage of Participants with Grade IV Acute GVHD
- time origin
- 100 days after DLI
- 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-chronic-myeloid-leukemia
- nct id
- NCT00068718
- outcome key
- om-0001
- source section id
- NCT00068718-om-0001
- source outcome index
- 1
- endpoint
- Incidence of Graft Rejection
- endpoint definition
- Percentage patients with graft rejection.
- time origin
- 100 days after DLI
- 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-chronic-myeloid-leukemia
- nct id
- NCT00068718
- outcome key
- om-0002
- source section id
- NCT00068718-om-0002
- source outcome index
- 2
- endpoint
- Incidence of Relapse/Progression
- endpoint definition
- CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever \>38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. CMML, AML, ALL \>30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia. CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
- time origin
- 1 year after DLI
- 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-chronic-myeloid-leukemia
- nct id
- NCT00068718
- outcome key
- om-0003
- source section id
- NCT00068718-om-0003
- source outcome index
- 3
- endpoint
- Incidence of Grade II-IV GVHD in Patients Undergoing DLI Following a Non-myeloablative Transplant
- endpoint definition
- Percentage of Participants with II-IV Acute GVHD
- time origin
- 100 days after DLI
- 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-chronic-myeloid-leukemia
- nct id
- NCT00068718
- outcome key
- om-0004
- source section id
- NCT00068718-om-0004
- source outcome index
- 4
- endpoint
- Incidence of Infections in Patients Undergoing DLI Following a Non-myeloablative Transplant
- endpoint definition
- Percentage of Participants with infections.
- time origin
- 100 days after DLI
- 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-chronic-myeloid-leukemia
- nct id
- NCT00068718
- outcome key
- om-0005
- source section id
- NCT00068718-om-0005
- source outcome index
- 5
- endpoint
- Overall Survival
- endpoint definition
- Percentage patients surviving 1 year post-transplant.
- time origin
- 1 year after DLI
- 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00068718
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (DLI)
- regimen
- Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented. Therapeutic Allogeneic Lymphocytes: Given IV
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00068718-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00068718
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (DLI)
- regimen
- Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented. Therapeutic Allogeneic Lymphocytes: Given IV
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00068718-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00068718
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (DLI)
- regimen
- Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented. Therapeutic Allogeneic Lymphocytes: Given IV
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00068718-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00068718
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (DLI)
- regimen
- Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented. Therapeutic Allogeneic Lymphocytes: Given IV
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00068718-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00068718
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (DLI)
- regimen
- Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented. Therapeutic Allogeneic Lymphocytes: Given IV
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00068718-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00068718
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment (DLI)
- regimen
- Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented. Therapeutic Allogeneic Lymphocytes: Given IV
- analyzed count
- 35
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00068718-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-chronic-myeloid-leukemia
- nct id
- NCT00068718
- harm key
- EG000
- source section id
- NCT00068718-ae
- event group key
- EG000
- event group label
- Treatment (DLI)
- serious affected
- 6
- serious at risk
- 35
- other affected
- 7
- other at risk
- 35
- frequency threshold
- 0
- collection period
- AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
- 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