TriangleNCT00368355 · STUDY IN CONTEXT
T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts
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
To evaluate the effect of T-cell depletion by positive selection for CD34 on immune reconstitution, which will be determined from total lymphocyte count, from T and B cell numbers and from T cell subset analyses.
Percentage of participants with hematopoietic engraftment post-transplant. Engraftment is defined as the first day absolute neutrophil counts exceeded 0.5 X 10\^9/ml.
Number of participants who experience organ failure or severe infections (defined as Grade III/IV by NCI CTC for Adverse Events (CTCAE), version 2.0)
Percentage of participants with Grade III/IV acute GVHD. Severe GVHD is defined as Grade III/IV acute GVHD.
Number of participants with acute GVHD graded by the method of Przepiorka et al, which evaluates skin involvement, lower and upper GI, and liver function (bilirubin), each being graded in stages from 0 to 4, where 0 means no acute GVHD, and 4 is the highest stage of acute GVHD
Number of participants with chronic GVHD graded by the method of Przepiorka et al, which evaluates skin, joints, oral, ocular, hepatic, esophagus, GI, respiratory, platelet, and musculoskeletal involvement, in stages from 0 to 3.
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-acute-myeloid-leukemia
- nct id
- NCT00368355
- trial label
- T Cell Depletion for Recipients of HLA Haploidentical Related Donor Stem Cell Grafts
- 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-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0005
- source section id
- NCT00368355-om-0005
- source outcome index
- 5
- endpoint
- Immune Reconstitution
- endpoint definition
- To evaluate the effect of T-cell depletion by positive selection for CD34 on immune reconstitution, which will be determined from total lymphocyte count, from T and B cell numbers and from T cell subset analyses.
- time origin
- 1 Year
- analysis role
- exploratory
- reporting status
- NOT_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-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0000
- source section id
- NCT00368355-om-0000
- source outcome index
- 0
- endpoint
- Engraftment Rate After Transplant
- endpoint definition
- Percentage of participants with hematopoietic engraftment post-transplant. Engraftment is defined as the first day absolute neutrophil counts exceeded 0.5 X 10\^9/ml.
- time origin
- 28 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- A participant is evaluable for engraftment if the participant underwent transplant and either completed 28 days observation or engrafted. Of the 46 participants at baseline, one in CLINIMACS group did not undergo transplant and one in ISOLEX group died 5 days after transplant.Thus, 2 participants were not included in the analysis.
- 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-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0001
- source section id
- NCT00368355-om-0001
- source outcome index
- 1
- endpoint
- Early Post BMT Toxicities
- endpoint definition
- Number of participants who experience organ failure or severe infections (defined as Grade III/IV by NCI CTC for Adverse Events (CTCAE), version 2.0)
- time origin
- 100 Days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Of the 46 participants at baseline, one participant in CLINIMACS Device group did not undergo haploidentical stem cell transplant and was not included in this analysis.
- 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-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0002
- source section id
- NCT00368355-om-0002
- source outcome index
- 2
- endpoint
- Severe GVHD Rate
- endpoint definition
- Percentage of participants with Grade III/IV acute GVHD. Severe GVHD is defined as Grade III/IV acute GVHD.
- time origin
- 100 Days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- A participant is evaluable for acute GVHD if the participant engrafted and either completed 100 days observation after transplant or experienced acute GVHD. Of the 46 participants at baseline, eight participants in CLINIMACS and five in ISOLEX were not evaluable for acute GVHD and were not included in this analysis.
- 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-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0003
- source section id
- NCT00368355-om-0003
- source outcome index
- 3
- endpoint
- Patients With Acute GVHD
- endpoint definition
- Number of participants with acute GVHD graded by the method of Przepiorka et al, which evaluates skin involvement, lower and upper GI, and liver function (bilirubin), each being graded in stages from 0 to 4, where 0 means no acute GVHD, and 4 is the highest stage of acute GVHD
- time origin
- First 100 Days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- A participant is evaluable for acute GVHD if the participant engrafted and either completed 100 days observation after transplant or experienced acute GVHD. Of the 46 participants at baseline, eight participants in CLINIMACS and five in ISOLEX were not evaluable for acute GVHD and were not included in this analysis.
- 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-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0004
- source section id
- NCT00368355-om-0004
- source outcome index
- 4
- endpoint
- Patients With Chronic GVHD
- endpoint definition
- Number of participants with chronic GVHD graded by the method of Przepiorka et al, which evaluates skin, joints, oral, ocular, hepatic, esophagus, GI, respiratory, platelet, and musculoskeletal involvement, in stages from 0 to 3.
- time origin
- Up to 1 Year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients surviving more than 100 days were evaluable for chronic GvHD. Of the 46 participants at baseline, eight participants in CLINIMACS and six in ISOLEX were not evaluable for chronic GVHD and were not included in this analysis.
- 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-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0000
- arm key
- OG000
- arm label
- CLINIMACS Device
- regimen
- Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00368355-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0000
- arm key
- OG001
- arm label
- ISOLEX Device
- regimen
- Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00368355-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0001
- arm key
- OG000
- arm label
- CLINIMACS Device
- regimen
- Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00368355-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0001
- arm key
- OG001
- arm label
- ISOLEX Device
- regimen
- Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
- analyzed count
- 28
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00368355-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0002
- arm key
- OG000
- arm label
- CLINIMACS Device
- regimen
- Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00368355-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0002
- arm key
- OG001
- arm label
- ISOLEX Device
- regimen
- Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00368355-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0003
- arm key
- OG000
- arm label
- CLINIMACS Device
- regimen
- Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00368355-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0003
- arm key
- OG001
- arm label
- ISOLEX Device
- regimen
- Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
- analyzed count
- 23
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00368355-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0004
- arm key
- OG000
- arm label
- CLINIMACS Device
- regimen
- Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the CLINIMACS Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00368355-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia
- nct id
- NCT00368355
- outcome key
- om-0004
- arm key
- OG001
- arm label
- ISOLEX Device
- regimen
- Subjects will receive transplant conditioning with Ara-C, Cyclophosphamide, Campath-1H, Total Body Irradiation and will then receive T cell depleted stem cell infusion processed by the ISOLEX Device Ara-C: day-8 through day-5 3 g/m2 q 12 hours Cyclophosphamide: day-7 and day-6 45 mg/kg Campath-1H: day-3 through day-1 Dosing for children: 5 - 15kg : 3mg IV in 30ml NS 15.1 - 30kg : 5mg IV in 50ml NS \>30 kg : 10mg IV in 100ml NS Adults will receive 10mg IV in 100ml NS Total Body Irradiation: day-4 through day-1 175 cGy x 2 at 24 cGy/min Stem Cell Infusion: Stem cells are infused on day 0
- analyzed count
- 22
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00368355-om-0004#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia
- nct id
- NCT00368355
- harm key
- EG000
- source section id
- NCT00368355-ae
- event group key
- EG000
- event group label
- CLINIMACS Device
- serious affected
- 14
- serious at risk
- 18
- other affected
- 13
- other at risk
- 18
- frequency threshold
- 0
- collection period
- Adverse events were collected from the time participants started preparative regimen to 100 days post transplant.
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia
- nct id
- NCT00368355
- harm key
- EG001
- source section id
- NCT00368355-ae
- event group key
- EG001
- event group label
- ISOLEX Device
- serious affected
- 15
- serious at risk
- 28
- other affected
- 23
- other at risk
- 28
- frequency threshold
- 0
- collection period
- Adverse events were collected from the time participants started preparative regimen to 100 days post transplant.
- 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