Trial · NCT00077922
Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia
NCT00077922, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2012-11-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia. Trials, record NCT00077922. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00077922
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Anti-Tac(Fv)-PE38 (LMB-2) to Treat Chronic Lymphocytic Leukemia
- NCT number
- NCT00077922
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Leukemia, Lymphocytic, Chronic
- Interventions
- LMB-2
- First posted
- 2004-02-13
- Last updated
- 2018-01-23
- Results first posted
- 2012-11-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate | Patients were followed for at least 30 days after last treatment. Because the study allows 6 treatment cycles, this can be up to 7 months. | Response is measured by the 1996 National Cancer Institute (NCI) Working Group Criteria (NCIWG). Complete response is defined as no hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must resolve to \<1.0cm of 1-1.5cm at baseline, or \<1.5cm if \>1.5cm at baseline. Partial response is \>=50% decrease in peripheral blood lymphocytes count from the pretreatment baseline value. Progressive disease is \>=50% increase in the sum of the products of the greatest perpendicular dimensions of a t least 2 lymph nodes on two consecutive examinations 2 weeks apart (at least 1 node must be \>=2cm) or appearance of new palpable lymph nodes. Stable disease is characterized by not meeting the above criteria. For additional details about the NCIWG, see the protocol link module. |
| Secondary | Number of Participants With Adverse Events | 54 months | Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate | Patients were followed for at least 30 days after last treatment. Because the study allows 6 treatment cycles, this can be up to 7 months. | Participants | NUMBER | |
| SECONDARY | Number of Participants With Adverse Events | 54 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 |
|---|---|---|---|---|---|
| Response Rate | LMB-2 in Chronic Lymphocytic Leukemia | Complete Response | 0 | Participants | |
| Response Rate | LMB-2 in Chronic Lymphocytic Leukemia | Partial Response | 1 | Participants | |
| Response Rate | LMB-2 in Chronic Lymphocytic Leukemia | Progressive Disease | 3 | Participants | |
| Response Rate | LMB-2 in Chronic Lymphocytic Leukemia | Stable Disease | 11 | Participants | |
| Number of Participants With Adverse Events | LMB-2 in Chronic Lymphocytic Leukemia | 15 | 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 | LMB-2 in Chronic Lymphocytic Leukemia | 15 | |
| Overall Study | COMPLETED | LMB-2 in Chronic Lymphocytic Leukemia | 15 | |
| Overall Study | NOT COMPLETED | LMB-2 in Chronic Lymphocytic Leukemia | 0 |
Source ClinicalTrials.gov
Adverse events132
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 | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | LMB-2 in Chronic Lymphocytic Leukemia | 1 | 15 | 1 |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | LMB-2 in Chronic Lymphocytic Leukemia | 2 | 15 | 2 |
| other | haptoglobin | Blood and lymphatic system disorders | LMB-2 in Chronic Lymphocytic Leukemia | 2 | 15 | 5 |
| other | Hemoglobin | Blood and lymphatic system disorders | LMB-2 in Chronic Lymphocytic Leukemia | 9 | 15 | 71 |
| other | Leukocytes (total WBC) | Blood and lymphatic system disorders | LMB-2 in Chronic Lymphocytic Leukemia | 1 | 15 | 4 |
| other | Neutrophils/granulocytes (ANC/AG) | Blood and lymphatic system disorders | LMB-2 in Chronic Lymphocytic Leukemia | 8 | 15 | 30 |
| other | Platelets | Blood and lymphatic system disorders | LMB-2 in Chronic Lymphocytic Leukemia | 7 | 15 | 48 |
| other | Supraventricular and nodal arrhythmia::Sinus tachycardia | Cardiac disorders | LMB-2 in Chronic Lymphocytic Leukemia | 3 | 15 | 3 |
| other | Hypotension | Cardiac disorders | LMB-2 in Chronic Lymphocytic Leukemia | 3 | 15 | 4 |
| other | Pericardial effusion (non-malignant) | Cardiac disorders | LMB-2 in Chronic Lymphocytic Leukemia | 3 | 15 | 3 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LMB-2 in Chronic Lymphocytic Leukemia | 0 | 15 |
| Total, other adverse events | LMB-2 in Chronic Lymphocytic Leukemia | 15 | 15 |
| Total, serious adverse events | LMB-2 in Chronic Lymphocytic Leukemia | 7 | 15 |
Source ClinicalTrials.gov
Papers3
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/NCT00077922
GET https://conductscience.org/api/trials/v1/NCT00077922/events?page=2