Trial · NCT00061945
Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
NCT00061945, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2014-04-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia. Trials, record NCT00061945. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00061945
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia
- NCT number
- NCT00061945
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 302 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Acute Undifferentiated Leukemia, B-cell Adult Acute Lymphoblastic Leukemia, B-cell Childhood Acute Lymphoblastic Leukemia, L1 Adult Acute Lymphoblastic Leukemia, L1 Childhood Acute Lymphoblastic Leukemia, L2 Adult Acute Lymphoblastic Leukemia, L2 Childhood Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia, Philadelphia Chromosome Positive Childhood Precursor Acute Lymphoblastic Leukemia, T-cell Adult Acute Lymphoblastic Leukemia, T-cell Childhood Acute Lymphoblastic Leukemia, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Childhood Acute Lymphoblastic Leukemia
- Interventions
allopurinol, cyclophosphamide, daunorubicin hydrochloride, vincristine sulfate, dexamethasone, asparaginase, filgrastim, imatinib mesylate, methotrexate, cytarabine, trimethoprim-sulfamethoxazole, mercaptopurine, leucovorin calcium, alemtuzumab, acyclovir, laboratory biomarker analysis, pharmacological study
- First posted
- 2003-06-06
- Last updated
- 2022-05-03
- Results first posted
- 2014-04-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I) | 6 weeks | 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. |
| Primary | Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II) | 8 months | 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. |
| Secondary | Minimal Residual Disease (MRD) During Treatment With Alemtuzumab (Phase II) | 9 years 4 months | 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. |
| Secondary | Disease-free Survival, for Only Complete Response Patients | 9 years 4 months | 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. |
| Secondary | Overall Survival | 9 years 4 months | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I) | 6 weeks | Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from this analysis. | mg | NUMBER |
| PRIMARY | Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II) | 8 months | Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from this analysis. | participants | NUMBER |
| SECONDARY | Minimal Residual Disease (MRD) During Treatment With Alemtuzumab (Phase II) | 9 years 4 months | Patients who reported a Complete Response (CR) during treatment and were analyzed for the presence of circulating leukemia cells. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease-free Survival, for Only Complete Response Patients | 9 years 4 months | 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. | months | MEDIAN |
| SECONDARY | Overall Survival | 9 years 4 months | 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. | months | MEDIAN |
| POST_HOC | Number of Participants Achieving Complete Remission | 9 years | Three participants were deemed ineligible and excluded from this analysis. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I) | Phase I - Alemtuzumab and Combination Chemotherapy | 30 | mg | ||
| Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II) | Phase II - Alemtuzumab and Combination Chemotherapy | 30 | participants | ||
| Minimal Residual Disease (MRD) During Treatment With Alemtuzumab (Phase II) | Phase II - Alemtuzumab and Combination Chemotherapy | 16 | Participants | ||
| Disease-free Survival, for Only Complete Response Patients | Phase I - Alemtuzumab and Combination Chemotherapy | 58.6 | 95% Confidence Interval 24.8 to 103.8 | months | |
| Disease-free Survival, for Only Complete Response Patients | Phase II - Alemtuzumab and Combination Chemotherapy | 19.8 | 95% Confidence Interval 14.3 to 28.4 | months | |
| Overall Survival | Phase I - Alemtuzumab and Combination Chemotherapy | 33.6 | 95% Confidence Interval 19.8 to 72.1 | months | |
| Overall Survival | Phase II - Alemtuzumab and Combination Chemotherapy | 23.1 | 95% Confidence Interval 18.4 to 32.0 | months | |
| Number of Participants Achieving Complete Remission | Phase I - Alemtuzumab and Combination Chemotherapy | 92 | participants | ||
| Number of Participants Achieving Complete Remission | Phase II - Alemtuzumab and Combination Chemotherapy | 145 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Registration Through Course 3 | STARTED | Phase I - Alemtuzumab and Combination Chemotherapy | 119 | |
| Registration Through Course 3 | STARTED | Phase II - Alemtuzumab and Combination Chemotherapy | 181 | |
| Registration Through Course 3 | COMPLETED | Phase I - Alemtuzumab and Combination Chemotherapy | 25 | |
| Registration Through Course 3 | COMPLETED | Phase II - Alemtuzumab and Combination Chemotherapy | 66 | |
| Registration Through Course 3 | NOT COMPLETED | Phase I - Alemtuzumab and Combination Chemotherapy | 94 | |
| Registration Through Course 3 | NOT COMPLETED | Phase II - Alemtuzumab and Combination Chemotherapy | 115 | |
| Course IV: Alemtuzumab | STARTED | Phase I - Alemtuzumab and Combination Chemotherapy | 25 | |
| Course IV: Alemtuzumab | STARTED | Phase II - Alemtuzumab and Combination Chemotherapy | 66 | |
| Course IV: Alemtuzumab | COMPLETED | Phase I - Alemtuzumab and Combination Chemotherapy | 18 | |
| Course IV: Alemtuzumab | COMPLETED | Phase II - Alemtuzumab and Combination Chemotherapy | 50 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,276
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bone marrow hypocellular | Blood and lymphatic system disorders | Phase I - Alemtuzumab and Combination Chemotherapy | 2 | 119 | 2 |
| other | Bone marrow hypocellular | Blood and lymphatic system disorders | Phase II - Alemtuzumab and Combination Chemotherapy | 0 | 181 | 0 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Phase I - Alemtuzumab and Combination Chemotherapy | 7 | 119 | 7 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Phase II - Alemtuzumab and Combination Chemotherapy | 11 | 181 | 11 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase I - Alemtuzumab and Combination Chemotherapy | 55 | 119 | 74 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Phase II - Alemtuzumab and Combination Chemotherapy | 93 | 181 | 141 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase I - Alemtuzumab and Combination Chemotherapy | 93 | 119 | 352 |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | Phase II - Alemtuzumab and Combination Chemotherapy | 150 | 181 | 650 |
| other | Lymphatic disorder | Blood and lymphatic system disorders | Phase I - Alemtuzumab and Combination Chemotherapy | 2 | 119 | 2 |
| other | Lymphatic disorder | Blood and lymphatic system disorders | Phase II - Alemtuzumab and Combination Chemotherapy | 1 | 181 | 1 |
1 to 10 of 1,276Source ClinicalTrials.gov
See all 1,276 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I - Alemtuzumab and Combination Chemotherapy | ||
| Total, all-cause mortality | Phase II - Alemtuzumab and Combination Chemotherapy | ||
| Total, other adverse events | Phase I - Alemtuzumab and Combination Chemotherapy | 99 | 119 |
| Total, other adverse events | Phase II - Alemtuzumab and Combination Chemotherapy | 152 | 181 |
| Total, serious adverse events | Phase I - Alemtuzumab and Combination Chemotherapy | 60 | 119 |
| Total, serious adverse events | Phase II - Alemtuzumab and Combination Chemotherapy | 98 | 181 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA031946 | Cancer and Leukemia Group B | BERTAGNOLLI, MONICA M | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Phase I - Alemtuzumab and Combination Chemotherapy vs Phase II - Alemtuzumab and Combination Chemotherapy: Number of Participants Achieving Complete Remission | Trial comparisons |
| Phase I - Alemtuzumab and Combination Chemotherapy vs Phase II - Alemtuzumab and Combination Chemotherapy: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00061945
GET https://conductscience.org/api/trials/v1/NCT00061945/events?page=2