TriangleNCT00061945 · STUDY IN CONTEXT
Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
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 complete remission (CR) requires the following: an absolute neutrophil count (segs and bands) \> 1500/μl, no circulating blasts, platelets \> 100,000/μl; bone marrow cellularity \> 20% with trilineage hematopoiesis, and \< 5% marrow blast cells, none of which appear neoplastic. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement).
The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data.
The primary endpoint is the number of participants who are able to proceed to course V within two - six weeks of completion of course IV.
Minimal Residual Disease measures the presence of of circulating leukemia cells in the body. Patients that report a Complete Response (CR) during treatment are further tested to determine the presence of small amounts of circulating leukemia cells. Here we report the number of patients who were MRD negative.
Disease Free Survival (DFS) is defined as the time from a Complete Response (CR) until death or relapse. The date of last clinical assesment will be used as the censor date for patients with no death or relapse. The DFS will be estimated using the Kaplan-Meier method with confidence intervals presented.
Overall Survival is defines as the time from registration to death due to any cause. It is estimated using the Kaplan-Meier method with confidence intervals presented.
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-undifferentiated-leukemia
- nct id
- NCT00061945
- trial label
- Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
- 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-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0005
- source section id
- NCT00061945-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants Achieving Complete Remission
- endpoint definition
- A complete remission (CR) requires the following: an absolute neutrophil count (segs and bands) \> 1500/μl, no circulating blasts, platelets \> 100,000/μl; bone marrow cellularity \> 20% with trilineage hematopoiesis, and \< 5% marrow blast cells, none of which appear neoplastic. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement).
- time origin
- 9 years
- analysis role
- post-hoc
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Three participants were deemed ineligible and excluded from 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-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0000
- source section id
- NCT00061945-om-0000
- source outcome index
- 0
- endpoint
- Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)
- endpoint definition
- The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data.
- time origin
- 6 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from 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-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0001
- source section id
- NCT00061945-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II)
- endpoint definition
- The primary endpoint is the number of participants who are able to proceed to course V within two - six weeks of completion of course IV.
- time origin
- 8 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from 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-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0002
- source section id
- NCT00061945-om-0002
- source outcome index
- 2
- endpoint
- Minimal Residual Disease (MRD) During Treatment With Alemtuzumab (Phase II)
- endpoint definition
- Minimal Residual Disease measures the presence of of circulating leukemia cells in the body. Patients that report a Complete Response (CR) during treatment are further tested to determine the presence of small amounts of circulating leukemia cells. Here we report the number of patients who were MRD negative.
- time origin
- 9 years 4 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients who reported a Complete Response (CR) during treatment and were analyzed for the presence of circulating leukemia cells.
- 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-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0003
- source section id
- NCT00061945-om-0003
- source outcome index
- 3
- endpoint
- Disease-free Survival, for Only Complete Response Patients
- endpoint definition
- Disease Free Survival (DFS) is defined as the time from a Complete Response (CR) until death or relapse. The date of last clinical assesment will be used as the censor date for patients with no death or relapse. The DFS will be estimated using the Kaplan-Meier method with confidence intervals presented.
- time origin
- 9 years 4 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who received protocol treatment and had a complete response (CR) during treatment were included in this analysis. Phase I patients, who achieved complete response, were included with the phase II patients, who achieved complete response, for 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-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0004
- source section id
- NCT00061945-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival
- endpoint definition
- Overall Survival is defines as the time from registration to death due to any cause. It is estimated using the Kaplan-Meier method with confidence intervals presented.
- time origin
- 9 years 4 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who registered, received protocol treatment, and were eligible were evaluated for this endpoint. Phase I patients were included with the phase II patients for 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-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Phase I - Alemtuzumab and Combination Chemotherapy
- regimen
- See detailed description or participant flow.
- analyzed count
- 24
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00061945-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Phase II - Alemtuzumab and Combination Chemotherapy
- regimen
- See detailed description or participant flow.
- analyzed count
- 65
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00061945-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Phase II - Alemtuzumab and Combination Chemotherapy
- regimen
- See detailed description or participant flow.
- analyzed count
- 51
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00061945-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Phase I - Alemtuzumab and Combination Chemotherapy
- regimen
- See detailed description or participant flow.
- analyzed count
- 92
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00061945-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Phase II - Alemtuzumab and Combination Chemotherapy
- regimen
- See detailed description or participant flow.
- analyzed count
- 145
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00061945-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Phase I - Alemtuzumab and Combination Chemotherapy
- regimen
- See detailed description or participant flow.
- analyzed count
- 116
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00061945-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Phase II - Alemtuzumab and Combination Chemotherapy
- regimen
- See detailed description or participant flow.
- analyzed count
- 181
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00061945-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Phase I - Alemtuzumab and Combination Chemotherapy
- regimen
- See detailed description
- analyzed count
- 116
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00061945-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT00061945
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Phase II - Alemtuzumab and Combination Chemotherapy
- regimen
- See detailed description
- analyzed count
- 181
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00061945-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT00061945
- harm key
- EG000
- source section id
- NCT00061945-ae
- event group key
- EG000
- event group label
- Phase I - Alemtuzumab and Combination Chemotherapy
- serious affected
- 60
- serious at risk
- 119
- other affected
- 99
- other at risk
- 119
- frequency threshold
- 0
- collection period
- Source null
- 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-undifferentiated-leukemia
- nct id
- NCT00061945
- harm key
- EG001
- source section id
- NCT00061945-ae
- event group key
- EG001
- event group label
- Phase II - Alemtuzumab and Combination Chemotherapy
- serious affected
- 98
- serious at risk
- 181
- other affected
- 152
- other at risk
- 181
- frequency threshold
- 0
- collection period
- Source null
- 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