Trial · NCT00321555
LMB-2 to Treat Hairy Cell Leukemia
NCT00321555, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-04-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LMB-2 to Treat Hairy Cell Leukemia. Trials, record NCT00321555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00321555
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LMB-2 to Treat Hairy Cell Leukemia
- NCT number
- NCT00321555
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Hairy Cell Leukemia
- Interventions
- Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin
- First posted
- 2006-05-04
- Last updated
- 2023-11-14
- Results first posted
- 2019-04-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Obtain Partial Response/Complete Remission | 6 months | Partial response requires all of the following for a period of at least 4 weeks: ≥50% decrease in hairy cell count from pretreatment baseline value by flow cytometry. ≥50% reduction in abnormal hepatosplenomegaly by computed tomography or physical exam. No growth in lymphadenopathy. Neutrophils ≥1,500/µL or 50% improvement over baseline without growth factors for at least 4 weeks. Platelets ≥100,000/µL or 50% improvement over baseline. Complete remission requires all of the following: no evidence of leukemic cells by routine hematoxylin and eosin stains of the peripheral blood and bone marrow. No hepatomegaly, splenomegaly, or lymphadenopathy (not \>2 cm in short axis) by physical examination and appropriate radiographic techniques. Normal complete blood count as exhibited by Neutrophils ≥1,500/µL, Platelets ≥100,000/µL, and Hemoglobin ≥11.0g/dL without transfusions or growth factors for at least 4 weeks. |
| Secondary | Duration of Response | Participants were assessed at 5.0658, 12.0066, 20.1645, 26.9079, 35.0987, and 45.1316 months | Duration of response is the duration that the patients qualifies for at least a Partial Response (PR). Partial response requires all of the following for a period of at least 4 weeks: ≥50% decrease in hairy cell count from pretreatment baseline value by flow cytometry. ≥50% reduction in abnormal hepatosplenomegaly by computed tomography or physical exam. No growth in lymphadenopathy. Neutrophils ≥1,500/µL or 50% improvement over baseline without growth factors for at least 4 weeks. Platelets ≥100,000/µL or 50% improvement over baseline. Hemoglobin ≥11.0 g/dL or 50% improvement over baseline without transfusions or growth factors for at least 4 weeks. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 83 months and 15 days. | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who Obtain Partial Response/Complete Remission | 6 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Duration of Response | Participants were assessed at 5.0658, 12.0066, 20.1645, 26.9079, 35.0987, and 45.1316 months | months | MEDIAN | |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | Date treatment consent signed to date off study, approximately 83 months and 15 days. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Who Obtain Partial Response/Complete Remission | LMB-2 to Treat Hairy Cell Leukemia | Complete Remission | 1 | Participants | |
| Number of Patients Who Obtain Partial Response/Complete Remission | LMB-2 to Treat Hairy Cell Leukemia | Partial Response | 5 | Participants | |
| Duration of Response | LMB-2 to Treat Hairy Cell Leukemia | 23.5 | 95% Confidence Interval 5.1 to 45.1 | months | |
| Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) | LMB-2 to Treat Hairy Cell Leukemia | 13 | 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 to Treat Hairy Cell Leukemia | 15 | |
| Overall Study | COMPLETED | LMB-2 to Treat Hairy Cell Leukemia | 9 | |
| Overall Study | NOT COMPLETED | LMB-2 to Treat Hairy Cell Leukemia | 6 |
Source ClinicalTrials.gov
Adverse events73
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 | Abdominal distension | Gastrointestinal disorders | LMB-2 to Treat Hairy Cell Leukemia | 2 | 15 | 2 |
| other | Alanine aminotransferase increased | Investigations | LMB-2 to Treat Hairy Cell Leukemia | 4 | 15 | 9 |
| other | Allergic reaction | Immune system disorders | LMB-2 to Treat Hairy Cell Leukemia | 1 | 15 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | LMB-2 to Treat Hairy Cell Leukemia | 1 | 15 | 2 |
| other | Anemia | Blood and lymphatic system disorders | LMB-2 to Treat Hairy Cell Leukemia | 5 | 15 | 12 |
| other | Anorexia | Metabolism and nutrition disorders | LMB-2 to Treat Hairy Cell Leukemia | 1 | 15 | 1 |
| other | Aspartate aminotransferase increased | Investigations | LMB-2 to Treat Hairy Cell Leukemia | 5 | 15 | 11 |
| other | Atrial fibrillation | Cardiac disorders | LMB-2 to Treat Hairy Cell Leukemia | 1 | 15 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | LMB-2 to Treat Hairy Cell Leukemia | 2 | 15 | 2 |
| other | Blood bilirubin increased | Investigations | LMB-2 to Treat Hairy Cell Leukemia | 1 | 15 | 1 |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LMB-2 to Treat Hairy Cell Leukemia | 2 | 15 |
| Total, other adverse events | LMB-2 to Treat Hairy Cell Leukemia | 13 | 15 |
| Total, serious adverse events | LMB-2 to Treat Hairy Cell Leukemia | 4 | 15 |
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/NCT00321555
GET https://conductscience.org/api/trials/v1/NCT00321555/events?page=2