TriangleNCT00698685 · STUDY IN CONTEXT
Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation
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
The number of participants with donor hematopoietic engraftment at day 100 is reported in the data table, and the actuarial probability is calculated using the Kaplan-Meier product-limit estimate statistic, as reported in the statistical analysis section below.
The primary safety outcome is indicated by the number of participants who died at or before Day 100 after transplant for any reason other than relapse of disease (Leukemia, Lymphoma, Hodgkin's disease, Hematologic Neoplasms, Multiple Myeloma, Renal Cell Carcinoma).
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-renal-cell-cancer
- nct id
- NCT00698685
- trial label
- Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation
- 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
- 2
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT00698685
- outcome key
- om-0000
- source section id
- NCT00698685-om-0000
- source outcome index
- 0
- endpoint
- Actuarial Probability of Donor Hematopoietic Engraftment (Defined as at Least 50% Donor DNA in Bone Marrow at Day 100).
- endpoint definition
- The number of participants with donor hematopoietic engraftment at day 100 is reported in the data table, and the actuarial probability is calculated using the Kaplan-Meier product-limit estimate statistic, as reported in the statistical analysis section below.
- time origin
- Day 100 after transplant.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who completed treatment and underwent allogeneic transplant.
- 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-renal-cell-cancer
- nct id
- NCT00698685
- outcome key
- om-0001
- source section id
- NCT00698685-om-0001
- source outcome index
- 1
- endpoint
- Non-relapse Mortality at or Before Day 100
- endpoint definition
- The primary safety outcome is indicated by the number of participants who died at or before Day 100 after transplant for any reason other than relapse of disease (Leukemia, Lymphoma, Hodgkin's disease, Hematologic Neoplasms, Multiple Myeloma, Renal Cell Carcinoma).
- time origin
- Day 100 after transplant
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least 1 day of treatment.
- 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-renal-cell-cancer
- nct id
- NCT00698685
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Preparative Regimen of Pentostatin and Alemtuzumab
- regimen
- Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic \[related or unrelated\] Hematopoietic SCT. Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00698685-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT00698685
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Preparative Regimen of Pentostatin and Alemtuzumab
- regimen
- Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic \[related or unrelated\] Hematopoietic SCT. Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00698685-om-0001#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer
- nct id
- NCT00698685
- harm key
- EG000
- source section id
- NCT00698685-ae
- event group key
- EG000
- event group label
- Preparative Regimen of Pentostatin and Alemtuzumab
- serious affected
- 8
- serious at risk
- 13
- other affected
- 13
- other at risk
- 13
- frequency threshold
- 5
- collection period
- Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
- event definition
- Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
- 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