Trial · NCT00924326
CAR T Cell Receptor Immunotherapy for Patients With B-cell Lymphoma
NCT00924326, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-03-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CAR T Cell Receptor Immunotherapy for Patients With B-cell Lymphoma. Trials, record NCT00924326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00924326
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CAR T Cell Receptor Immunotherapy for Patients With B-cell Lymphoma
- NCT number
- NCT00924326
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Primary Mediastinal B-cell Lymphoma, Diffuse, Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma Transformed From Follicular Lymphoma, Mantle Cell
- Interventions
- Fludarabine, Cyclophosphamide, Anti-cluster of differentiation 19 (CD19)-CAR PBL, Aldesleukin, Fludarabine, Cyclophosphamide
- First posted
- 2009-06-18
- Last updated
- 2022-01-12
- Results first posted
- 2019-03-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma | Scans performed at 6 weeks, 12 weeks and every 3-6 months for approximately 2 years | Participants were assessed by the Response Criteria for Malignant Lymphoma. Complete Remission (CR) is complete disappearance of all detectable evidence of disease and disease-related symptoms if present before therapy. Partial Remission (PR) requires ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of nodes, liver or spleen and no new sites of disease. Progressive disease (PD) is defined by ≥50% increase from nadir in the sum of the products of at least two lymph nodes, or if a single node is involved at least a 50% increase in the product of the diameters of this one node; and appearance of a new lesion greater than 1.5 cm in any axis even if other lesions are decreasing in size. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). | Date treatment consent signed to date off study, approximately 101 months and 17 days. | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). 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
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma | Scans performed at 6 weeks, 12 weeks and every 3-6 months for approximately 2 years | 1x10\^9-1x10\^10 Cells/kg + High-dose Interleukin-2 Retreat Arm/Group: 3 participants in group 1 (1x10e9-1x10e10 cells/kg + high-dose IL2)) initially responded but were then retreated in group 2 after progression. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). | Date treatment consent signed to date off study, approximately 101 months and 17 days. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma | 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 | Complete Remission | 2 | Participants | |
| Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma | 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat | Complete Remission | 3 | Participants | |
| Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma | 0.5x10^7 Cells/kg | Complete Remission | 2 | Participants | |
| Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma | 2.5x10^6 Cells/kg | Complete Remission | 3 | Participants | |
| Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma | 1.0x10^6 Cells/kg | Complete Remission | 3 | Participants | |
| Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma | 1.0x10^6 Cells/kg (Reduced Chemo) | Complete Remission | 2 | Participants | |
| Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma | 2.0x10^6 Cells/kg (Reduced Chemo) | Complete Remission | 6 | Participants | |
| Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma | 6.0x10^6 Cells/kg (Reduced Chemo) | Complete Remission | 0 | Participants | |
| Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma | 2.0x10^6 Cells/kg (Moderate Chemo) | Complete Remission | 2 | Participants | |
| Number of Participants With a Response Assessed by the Response Criteria for Malignant Lymphoma | 2.0x10^6 Cells/kg (9-12 Days Culture) | Complete Remission | 2 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Administration | STARTED | 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 | 8 | |
| Dose Administration | STARTED | 0.5x10^7 Cells/kg | 2 | |
| Dose Administration | STARTED | 2.5x10^6 Cells/kg | 5 | |
| Dose Administration | STARTED | 1.0x10^6 Cells/kg | 6 | |
| Dose Administration | STARTED | 1.0x10^6 Cells/kg (Reduced Chemo) | 7 | |
| Dose Administration | STARTED | 2.0x10^6 Cells/kg (Reduced Chemo) | 10 | |
| Dose Administration | STARTED | 6.0x10^6 Cells/kg (Reduced Chemo) | 1 | |
| Dose Administration | STARTED | 2.0x10^6 Cells/kg (Moderate Chemo) | 2 | |
| Dose Administration | STARTED | 2.0x10^6 Cells/kg (9-12 Days Culture) | 2 | |
| Dose Administration | COMPLETED | 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 | 8 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events1,170
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 | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 | 0 | 8 | 0 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat | 0 | 3 | 0 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | 0.5x10^7 Cells/kg | 0 | 2 | 0 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | 2.5x10^6 Cells/kg | 0 | 5 | 0 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | 1.0x10^6 Cells/kg | 0 | 6 | 0 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | 1.0x10^6 Cells/kg (Reduced Chemo) | 1 | 7 | 1 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | 2.0x10^6 Cells/kg (Reduced Chemo) | 1 | 10 | 1 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | 6.0x10^6 Cells/kg (Reduced Chemo) | 0 | 1 | 0 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | 2.0x10^6 Cells/kg (Moderate Chemo) | 0 | 2 | 0 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | 2.0x10^6 Cells/kg (9-12 Days Culture) | 0 | 2 | 0 |
1 to 10 of 1,170Source ClinicalTrials.gov
See all 1,170 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 | 1 | 8 |
| Total, all-cause mortality | 1x10^9-1x10^10 Cells/kg + High-dose Interleukin-2 Retreat | 0 | 3 |
| Total, all-cause mortality | 0.5x10^7 Cells/kg | 0 | 2 |
| Total, all-cause mortality | 2.5x10^6 Cells/kg | 1 | 5 |
| Total, all-cause mortality | 1.0x10^6 Cells/kg | 0 | 6 |
| Total, all-cause mortality | 1.0x10^6 Cells/kg (Reduced Chemo) | 0 | 7 |
| Total, all-cause mortality | 2.0x10^6 Cells/kg (Reduced Chemo) | 0 | 10 |
| Total, all-cause mortality | 6.0x10^6 Cells/kg (Reduced Chemo) | 0 | 1 |
| Total, all-cause mortality | 2.0x10^6 Cells/kg (Moderate Chemo) | 0 | 2 |
| Total, all-cause mortality | 2.0x10^6 Cells/kg (9-12 Days Culture) | 0 | 2 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers10
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/NCT00924326
GET https://conductscience.org/api/trials/v1/NCT00924326/results?page=2