Trial · NCT00074490
Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers
NCT00074490, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2018-12-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers. Trials, record NCT00074490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00074490
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Donor Stem Cell Transplant With No or Low-Intensity Chemotherapy Using Sirolimus and Treated Immune Cells to Treat Blood and Lymph Cancers
- NCT number
- NCT00074490
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 442 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Lymphoma, Leukemia, Myeloproliferative Disorders, Multiple Myleoma, Myelodysplastic Syndrome
- Interventions
Rituximab, Fludarabine, Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Peripheral blood stem cell (PBSC) transplantation, T cell donor lymphocyte infusion (DLI) with unmanipulated donor T cells, Prednisone, Allogeneic hematopoietic stem cell transplant (HSCT), Filgrastim, T-Rapa cell Donor Lymphocyte Infusion (DLI)
- First posted
- 2003-12-15
- Last updated
- 2018-12-31
- Results first posted
- 2018-12-31
- Limitations and caveats
118 subjects were enrolled on this study on cohorts no longer represented in the protocol due to amendments. Of the 118, 50% were participants and 50% were donors. These participants are not represented in the data being reported.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients to Receive T Cell Infusion | first 100 days post-transplant | T cells administered by intravenous infusion after patient received transplant. |
| Primary | Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD) | first 100 days post-transplant | GVHD of the skin, liver and gut were graded on a scale of 1, 2, 3, and 4 (e.g. the grades are not added together) using the National Institutes of Health Consensus Criteria. Grade 1 is minimal GVHD, Grade 2 is moderate GVHD, Grade 3 is severe GVHD and Grade 4 is very severe GVHD. Grade 4 is a worse outcome than Grade 1. |
| Secondary | Detection of of Post-transplantation Cluster of Differentiation 4 (CD4)+ and CD8+ T-cell Production of T Helper 1 -2 (Th1-Th2)-Type Cytokines | First 100 days post-transplant | Detection of cytokine secretion was done by enzyme-linked immunosorbent assay. |
| Secondary | Percentage of Patients With Opportunistic Infection | First 100 days post-transplant | Participants are susceptible to opportunistic infections such as bacterial, fungal, viral, protozoan infections and more due to immune suppression from chemotherapy drugs used to treat their disease. |
| Secondary | Count 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 5 years | 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
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients to Receive T Cell Infusion | first 100 days post-transplant | percentage of patients | NUMBER | |
| PRIMARY | Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD) | first 100 days post-transplant | percentage of patients | NUMBER | |
| SECONDARY | Detection of of Post-transplantation Cluster of Differentiation 4 (CD4)+ and CD8+ T-cell Production of T Helper 1 -2 (Th1-Th2)-Type Cytokines | First 100 days post-transplant | This outcome measure was not done. Data was not collected for this outcome measure due to premature closure of study. | ||
| SECONDARY | Percentage of Patients With Opportunistic Infection | First 100 days post-transplant | percentage of participants | NUMBER | |
| SECONDARY | Count 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 5 years | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients to Receive T Cell Infusion | Arm IVD Cohort 1 (Th2 DLI) | 100 | percentage of patients | ||
| Percentage of Patients to Receive T Cell Infusion | Arm IVD Cohort 3 (Multiple Th2 DLI) | 100 | percentage of patients | ||
| Percentage of Patients to Receive T Cell Infusion | Arm IVA (12-day Expanded Th2 DLI) | 100 | percentage of patients | ||
| Percentage of Patients to Receive T Cell Infusion | Arm IVB (6-day Expanded Th2 DLI) | 100 | percentage of patients | ||
| Percentage of Patients to Receive T Cell Infusion | Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 100 | percentage of patients | ||
| Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD) | Arm IVD Cohort 1 (Th2 DLI) | 0 | percentage of patients | ||
| Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD) | Arm IVD Cohort 3 (Multiple Th2 DLI) | 11.11 | percentage of patients | ||
| Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD) | Arm IVA (12-day Expanded Th2 DLI) | 10 | percentage of patients | ||
| Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD) | Arm IVB (6-day Expanded Th2 DLI) | 40.91 | percentage of patients | ||
| Percentage of Patients With ≥ Grade 2 Acute Graft Versus Host Disease (GVHD) | Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 40.48 | percentage of patients |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm IVD Cohort 1 (Th2 DLI) | 1 | |
| Overall Study | STARTED | Arm IVD Cohort 3 (Multiple Th2 DLI) | 34 | |
| Overall Study | STARTED | Arm IVA (12-day Expanded Th2 DLI) | 40 | |
| Overall Study | STARTED | Arm IVB (6-day Expanded Th2 DLI) | 44 | |
| Overall Study | STARTED | Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 45 | |
| Overall Study | STARTED | Healthy Donors | 221 | |
| Overall Study | COMPLETED | Arm IVD Cohort 1 (Th2 DLI) | 1 | |
| Overall Study | COMPLETED | Arm IVD Cohort 3 (Multiple Th2 DLI) | 27 | |
| Overall Study | COMPLETED | Arm IVA (12-day Expanded Th2 DLI) | 40 | |
| Overall Study | COMPLETED | Arm IVB (6-day Expanded Th2 DLI) | 44 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,990
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) | Investigations | Arm IVD Cohort 1 (Th2 DLI) | 1 | 1 | 1 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Arm IVD Cohort 3 (Multiple Th2 DLI) | 17 | 34 | 38 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Arm IVA (12-day Expanded Th2 DLI) | 34 | 40 | 53 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Arm IVB (6-day Expanded Th2 DLI) | 29 | 44 | 81 |
| other | ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 36 | 45 | 78 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Arm IVD Cohort 1 (Th2 DLI) | 0 | 1 | 0 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Arm IVD Cohort 3 (Multiple Th2 DLI) | 12 | 34 | 17 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Arm IVA (12-day Expanded Th2 DLI) | 24 | 40 | 43 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Arm IVB (6-day Expanded Th2 DLI) | 20 | 44 | 27 |
| other | AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 24 | 45 | 57 |
1 to 10 of 1,990Source ClinicalTrials.gov
See all 1,990 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm IVD Cohort 1 (Th2 DLI) | 0 | 1 |
| Total, all-cause mortality | Arm IVD Cohort 3 (Multiple Th2 DLI) | 14 | 34 |
| Total, all-cause mortality | Arm IVA (12-day Expanded Th2 DLI) | 22 | 40 |
| Total, all-cause mortality | Arm IVB (6-day Expanded Th2 DLI) | 24 | 44 |
| Total, all-cause mortality | Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 22 | 45 |
| Total, other adverse events | Arm IVD Cohort 1 (Th2 DLI) | 1 | 1 |
| Total, other adverse events | Arm IVD Cohort 3 (Multiple Th2 DLI) | 28 | 34 |
| Total, other adverse events | Arm IVA (12-day Expanded Th2 DLI) | 40 | 40 |
| Total, other adverse events | Arm IVB (6-day Expanded Th2 DLI) | 38 | 44 |
| Total, other adverse events | Arm IVC (6-day Expanded Th2 DLI and High Dose Sirolimus) | 36 | 45 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
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/NCT00074490
GET https://conductscience.org/api/trials/v1/NCT00074490/events?page=2