Trial · NCT00924170
Phase II Trial of LMB-2, Fludarabine and Cyclophosphamide for Adult T-Cell Leukemia
NCT00924170, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-09-08
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ConductScience Library. Phase II Trial of LMB-2, Fludarabine and Cyclophosphamide for Adult T-Cell Leukemia. Trials, record NCT00924170. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00924170
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Trial of LMB-2, Fludarabine and Cyclophosphamide for Adult T-Cell Leukemia
- NCT number
- NCT00924170
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Adult T-Cell Leukemia (ATL)
- Interventions
- LMB-2, Fludarabine, Cyclophosphamide
- First posted
- 2009-06-18
- Last updated
- 2023-11-14
- Results first posted
- 2017-09-08
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Minimally Durable Clinical Response Rate | 8 weeks | Response is based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma and must last \>8 weeks to meet the primary endpoint of the study. Complete remission (CR) is 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 definitely assignable to the lymphoma. Partial response is reduction by ≥50% of leukemia cell count or ≥50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesion. Stable disease is neither a response nor progressive disease. Progressive disease is appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count. |
| Secondary | Peak Level of LMB-2 in Adult T-Cell Lymphoma | First 24 hours after the dose given on Cycle 2, day 1 | The maximum analyte concentration in serum was reported using a cytotoxicity assay measuring the level of LMB-2 in the plasma and using purified LMB-2 as a standard curve. |
| Secondary | Progression Free Survival (PFS) | 70 months | PFS was determined by the Kaplan Meier method beginning at the on study date and continuing until progression or last follow-up without progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count. |
| Secondary | Overall Survival (OS) | 70 months | OS is the time between the first day of treatment to the day of disease progression. Progressive disease is assessed by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma, and is the appearance of new lesions, or an increase of 50% or greater in the sum of the product of the perpendicular diameters of the measurable lesions or persistent (at least two determinations) doubling of the peripheral blood leukemic cell count. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events | 7 years and 12 days | Here is the number 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. |
| Secondary | Number of Participants With Dose Limiting Toxicity (DLT) | 30 days after last dose of LMB2 | DLT is a grade II-IV LMB-2 or fludarabine and cyclophosphamide (FC)-related toxicity, except vascular leak syndrome, alopecia, grade II-III allergic reaction with asymptomatic bronchospasm or urticarial is considered DLT. Grade III aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and fever are not considered DLT. Grade IV creatine phosphokinase associated with any other DLT or not resolving to \<grade II within 2 weeks is considered DLT. Hematologic toxicity is not considered DLT unless it fails to resolve to \<grade 2 or baseline by day 18 after cycle 1 or after day 25 after cycles 2-7. DLT from hepatotoxicity, creatine phosphokinase, and vascular leak syndrome is assumed from LMB-2, and hematologic toxicity from fludarabine and cyclophosphamide. Grade III proteinuria lasting \<2 weeks after the last dose of LMB-2 is not considered DLT, and needs to resolve to grade 0-2 prior to retreatment. |
| Secondary | Soluble Cluster of Differentiation 25 (sCD25) Between Responders and Nonresponders | First 24 hours after the dose given on Cycle 2, day 1 | Tumor tissue, including lymph node or skin biopsies was examined and analysis performed by flow cytometry to determine the amount of cancer cells in the body by measuring proteins which fall off cancer cells and go into the blood. |
| Secondary | Area Under the Plasma Concentration (AUC) - LMB2 | First 24 hours after the dose given on Cycle 2, day 1 | AUC is a measure of the plasma concentration of drug over time. It is used to characterize drug absorption. Plasma levels were analyzed by cytotoxicity assay. |
| Secondary | Post Treatment Effects of LMB-2 + Fludarabine and Cyclophosphamide (FC) on Normal B and T Cell Subsets by Flow Cytometry | First 24 hours after the dose given on Cycle 2, day 1 | Peripheral blood was obtained and analyzed by flow cytometry. |
| Secondary | Percentage of Patients Who Developed Neutralizing Antibodies After One or More Cycles of LMB-2 | First 24 hours after the dose given on Cycle 2, day 1 | Blood was drawn prior to each cycle of LMB-2 to determine if the level, \>75% neutralization of 1000ng/ml of LMB-2 of neutralizing antibodies is too high to give additional LMB-2. Analysis was performed by cytotoxicity assay. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Minimally Durable Clinical Response Rate | 8 weeks | All 10 patients receiving LMB-2 and at least 25+250 mg/m\^2 Fludarabine/Cyclophosphamide (FC) were evaluable for response.~Of the 8 other patients, only 5 received LMB-2 and were therefore evaluable for response. | percentage of participants | NUMBER |
| SECONDARY | Peak Level of LMB-2 in Adult T-Cell Lymphoma | First 24 hours after the dose given on Cycle 2, day 1 | ng/mL | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) | 70 months | Months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | 70 months | One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. | Months | MEDIAN |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events | 7 years and 12 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Dose Limiting Toxicity (DLT) | 30 days after last dose of LMB2 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Soluble Cluster of Differentiation 25 (sCD25) Between Responders and Nonresponders | First 24 hours after the dose given on Cycle 2, day 1 | The number 8 represents the number of responders in the Arm/Group and the number 2 represents the number of non-responders in the Arm/Group. | pg/ml | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration (AUC) - LMB2 | First 24 hours after the dose given on Cycle 2, day 1 | Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2 | µg/-min/mL | MEDIAN |
| SECONDARY | Post Treatment Effects of LMB-2 + Fludarabine and Cyclophosphamide (FC) on Normal B and T Cell Subsets by Flow Cytometry | First 24 hours after the dose given on Cycle 2, day 1 | One patient did not have flow cytometry measuring it. | Cells/µL | MEDIAN |
| SECONDARY | Percentage of Patients Who Developed Neutralizing Antibodies After One or More Cycles of LMB-2 | First 24 hours after the dose given on Cycle 2, day 1 | Three participants were non-evaluable. One participant withdrew due to inability to receive second cycle, which was the first cycle containing LMB-2. One participant had progressive disease before first cycle of LMB2, and one participant had progressive disease after first cycle of LMB2 | percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group182
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Minimally Durable Clinical Response Rate | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | Overall Response | 80 | 95% Confidence Interval 44.4 to 97.5 | percentage of participants |
| Percentage of Participants With a Minimally Durable Clinical Response Rate | All Other Patients | Overall Response | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Participants With a Minimally Durable Clinical Response Rate | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | Complete Response | 60 | 95% Confidence Interval 26 to 88 | percentage of participants |
| Percentage of Participants With a Minimally Durable Clinical Response Rate | All Other Patients | Complete Response | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Participants With a Minimally Durable Clinical Response Rate | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | Partial Response | 20 | 95% Confidence Interval 2.5 to 55.6 | percentage of participants |
| Percentage of Participants With a Minimally Durable Clinical Response Rate | All Other Patients | Partial Response | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Participants With a Minimally Durable Clinical Response Rate | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | Stable Disease | 20 | 95% Confidence Interval 2.5 to 55.6 | percentage of participants |
| Percentage of Participants With a Minimally Durable Clinical Response Rate | All Other Patients | Stable Disease | 25 | 95% Confidence Interval 3.2 to 65.1 | percentage of participants |
| Percentage of Participants With a Minimally Durable Clinical Response Rate | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | Progressive Disease | 0 | 95% Confidence Interval 0 to 0 | percentage of participants |
| Percentage of Participants With a Minimally Durable Clinical Response Rate | All Other Patients | Progressive Disease | 37.5 | 95% Confidence Interval 8.5 to 75.5 | percentage of participants |
1 to 10 of 182Source ClinicalTrials.gov
See all 182 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 10 | |
| Overall Study | STARTED | All Other Patients | 8 | |
| Overall Study | COMPLETED | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 3 | |
| Overall Study | COMPLETED | All Other Patients | 0 | |
| Overall Study | NOT COMPLETED | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 7 | |
| Overall Study | NOT COMPLETED | All Other Patients | 8 |
Source ClinicalTrials.gov
Adverse events308
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 pain | Gastrointestinal disorders | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 5 | 10 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | All Other Patients | 3 | 8 | 4 |
| other | Activated partial thromboplastin time prolonged | Investigations | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 1 | 10 | 2 |
| other | Activated partial thromboplastin time prolonged | Investigations | All Other Patients | 0 | 8 | 0 |
| other | Agitation | Psychiatric disorders | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 1 | 10 | 1 |
| other | Agitation | Psychiatric disorders | All Other Patients | 0 | 8 | 0 |
| other | Alanine aminotransferase increased | Investigations | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 5 | 10 | 20 |
| other | Alanine aminotransferase increased | Investigations | All Other Patients | 2 | 8 | 2 |
| other | Alkaline phosphatase increased | Investigations | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 7 | 10 | 9 |
| other | Alkaline phosphatase increased | Investigations | All Other Patients | 3 | 8 | 4 |
1 to 10 of 308Source ClinicalTrials.gov
See all 308 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 8 | 10 |
| Total, all-cause mortality | All Other Patients | 6 | 8 |
| Total, other adverse events | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 10 | 10 |
| Total, other adverse events | All Other Patients | 8 | 8 |
| Total, serious adverse events | Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC | 7 | 10 |
| Total, serious adverse events | All Other Patients | 6 | 8 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC vs All Other Patients: Number of Participants With Dose Limiting Toxicity (DLT) | Trial comparisons |
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC vs All Other Patients: Number of Participants With Serious and Non-serious Adverse Events | Trial comparisons |
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC vs All Other Patients: deaths from any cause | Trial comparisons |
| Leukemic Patients Receiving LMB-2 & At Least 25+250 mg/m^2 FC vs All Other Patients: 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/NCT00924170
GET https://conductscience.org/api/trials/v1/NCT00924170/results?page=2