Trial · NCT00061048
Campath-1H for Treating Adult T-Cell Leukemia/Lymphoma
NCT00061048, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2011-06-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Campath-1H for Treating Adult T-Cell Leukemia/Lymphoma. Trials, record NCT00061048. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00061048
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Campath-1H for Treating Adult T-Cell Leukemia/Lymphoma
- NCT number
- NCT00061048
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Acute T-Cell Leukemia-Lymphoma
- Interventions
- Alemtuzumab
- First posted
- 2003-05-21
- Last updated
- 2012-10-31
- Results first posted
- 2011-06-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | 60 months | Overall response rate is defined as the percentage of participants with response and utilizes the International Standardized workshop definition. Complete response(CR)-Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma. Please see the protocol Link module for the full criteria if desired. |
| Primary | Overall Survival | 60 months | Time between the first day of treatment to the day of death. |
| Primary | Time to Progression | 60 months | Time between the first day of treatment to the day of disease progression which is defined as a persistent (at least two determinations) doubling of the peripheral blood leukemic cell count, the development of new lesions, or Ca elevations that are uncontrolled by conventional therapeutic procedures. |
| Secondary | Cell Surface Expression of CD52 on Tumor Cells | 6 months | The CD52 antibody-binding capacity (ABC) value is the measurement of the mean value of the maximum capacity of each cell to bind the anti-CD52 and when determined under conditions of saturating levels of antibody measures number of mean surface CD52 antigens per cell. CD52 ABC is negative when 100% saturation by therapeutic antibody is achieved. |
| Secondary | The Number of Participants With Adverse Events | 18 months | Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate | 60 months | percentage of participants | NUMBER | |
| PRIMARY | Overall Survival | 60 months | months | MEDIAN | |
| PRIMARY | Time to Progression | 60 months | months | MEDIAN | |
| SECONDARY | Cell Surface Expression of CD52 on Tumor Cells | 6 months | ABC value | MEAN | |
| SECONDARY | The Number of Participants With Adverse Events | 18 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 52 | 95% Confidence Interval 32.5 to 70.6 | percentage of participants | |
| Overall Survival | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 5.9 | 95% Confidence Interval 4.7 to 8.7 | months | |
| Time to Progression | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 2.0 | 95% Confidence Interval 1.0 to 3.9 | months | |
| Cell Surface Expression of CD52 on Tumor Cells | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 82.15 | Standard Deviation 13.7 | ABC value | |
| The Number of Participants With Adverse Events | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 8 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 29 | |
| Overall Study | COMPLETED | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 7 | |
| Overall Study | NOT COMPLETED | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 22 |
Source ClinicalTrials.gov
Adverse events118
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 | ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 2 | 29 | 2 |
| other | ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 2 | 29 | 2 |
| other | BLOOD/BONE MARROW:: Hemoglobin | Investigations | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 20 | 29 | 81 |
| other | BLOOD/BONE MARROW:: Leukocytes (total WBC) | Investigations | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 15 | 29 | 106 |
| other | BLOOD/BONE MARROW:: Lymphopenia | Investigations | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 18 | 29 | 26 |
| other | BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC) | Investigations | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 11 | 29 | 54 |
| other | BLOOD/BONE MARROW:: Platelets | Investigations | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 16 | 29 | 41 |
| other | CARDIOVASCULAR (ARRHYTHMIA):: Cardiovascular/Arrhythmia-Other (irregular heartbeat)) | Cardiac disorders | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 1 | 29 | 1 |
| other | CARDIOVASCULAR (ARRHYTHMIA):: Sinus bradycardia | Cardiac disorders | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 1 | 29 | 2 |
| other | CARDIOVASCULAR (ARRHYTHMIA):: Sinus tachycardia | Cardiac disorders | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 5 | 29 | 13 |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | ||
| Total, other adverse events | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 29 | 29 |
| Total, serious adverse events | Campath-1H Treatment of Adult T-cell Leukemia (ATL) | 8 | 29 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00061048
GET https://conductscience.org/api/trials/v1/NCT00061048/events?page=2