Trial · NCT00580034
Allo Non-Myeloablative SCT Utilizing Mis-Matched Family Member Stem Cells Purged Using Campath
NCT00580034, Phase 2, Completed, David Rizzieri, MD; results first posted 2014-06-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Allo Non-Myeloablative SCT Utilizing Mis-Matched Family Member Stem Cells Purged Using Campath. Trials, record NCT00580034. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00580034
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Allo Non-Myeloablative SCT Utilizing Mis-Matched Family Member Stem Cells Purged Using Campath
- NCT number
- NCT00580034
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 176 participants, actual
- Lead sponsor
- David Rizzieri, MD
- Conditions
- Lymphoma, Myeloma, Leukemia, Myelodysplasia, Solid Tumors
- Interventions
- Campath Purged Non-myeloablative ASCT, Donor Apheresis
- First posted
- 2007-12-24
- Last updated
- 2014-06-03
- Results first posted
- 2014-06-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Toxicity | 1 year | Acute graft versus host disease (GVHD) was graded according to the consensus criteria and common terminology criteria (CTC) v3.0 was used for all other toxicities. Recognizing that acute GVHD pathology in the non-ablative and donor lymphocyte infusion (DLI) setting may occur late, we tabulated skin, gut and liver toxicity consistent with acute GVHD (aGVHD) at anytime in the year following the infusion as aGVHD. Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently. |
| Primary | Overall Survival (OS) | 8 years | Estimate toxicity and overall survival rates in subjects treated with a non-myeloablative preparative regimen followed by matched related allogeneic stem cells for allogeneic transplantation. |
| Secondary | Response | 2 years | Response Assessment included physical exam and evaluation of peripheral blood and bone marrow. There's no widely accepted criteria for response other than complete response (CR). CR for malignant hematologic diseases is met if all the following are met for \>/= 1 month: a) absence of pathologic lymphadenopathy by physical and radiographic exam b) absence of constitutional symptoms due to disease c) Polymorphonuclear leukocyte count \>1,500/uL; platelet count \>50,000/uL; and hemoglobin \>10.0 g/dL d) bone marrow aspirate/biopsy done after (a) through (c) have been met, \>/= 30% cellularity and an absence of abnormal lymphoid nodules or cells by flow cytometry, cytogenetics, etc. e) molecular markers of disease must be negative by polymerase chain reaction, Fluorescence in situ hybridization, cytogenetics etc. CR for solid tumors requires complete resolution of disease on physical exam and radiographs. CR for marrow failure is normal white cell, platelet and hematocrit values. |
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 | Toxicity | 1 year | Cohort of subjects on the study who received \>/=1 donor lymphocyte infusion (DLI). DLI doses thus ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered evaluable from the day of first donor lymphocyte (DLI) infusion. Results are not exclusive. | participants | NUMBER |
| PRIMARY | Overall Survival (OS) | 8 years | Subjects who completed CAMPATH regimen + 45 days, until disease progression, or death. | months | MEAN |
| SECONDARY | Response | 2 years | Cohort of subjects on the study who actually received \>/=1 donor lymphocyte infusion (DLI). DLI doses ranged from 1×104 CD3+ cells/kg to 3.27 ×108 CD3+ cells/kg. Subjects were considered for a second and third DLI 8 weeks apart if they did not have \>grade 2 toxicity from the initial DLI, donor availability, and insurance approved the infusion. | months | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Toxicity | Campath Purged Non-myeloablative ASCT | Acute Graft versus Host Disease (aGvHD) | 5 | participants | |
| Toxicity | Campath Purged Non-myeloablative ASCT | Sepsis | 3 | participants | |
| Toxicity | Campath Purged Non-myeloablative ASCT | Infection | 10 | participants | |
| Toxicity | Campath Purged Non-myeloablative ASCT | Graft Failure | 17 | participants | |
| Toxicity | Campath Purged Non-myeloablative ASCT | Cardiac | 3 | participants | |
| Toxicity | Campath Purged Non-myeloablative ASCT | Multi-organ failure | 1 | participants | |
| Toxicity | Campath Purged Non-myeloablative ASCT | Hepatic Veno-Occlusive Disease | 1 | participants | |
| Toxicity | Campath Purged Non-myeloablative ASCT | Post-transplant lymphoproliferative disorder | 2 | participants | |
| Toxicity | Campath Purged Non-myeloablative ASCT | Acute respiratory distress syndrome | 2 | participants | |
| Overall Survival (OS) | Campath Purged Non-myeloablative ASCT | 20 | Full Range 0.03 to 101 | months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Campath Purged Non-myeloablative ASCT | 88 | |
| Overall Study | STARTED | Donor Apheresis | 88 | |
| Overall Study | COMPLETED | Campath Purged Non-myeloablative ASCT | 78 | |
| Overall Study | COMPLETED | Donor Apheresis | 88 | |
| Overall Study | NOT COMPLETED | Campath Purged Non-myeloablative ASCT | 10 | |
| Overall Study | NOT COMPLETED | Donor Apheresis | 0 |
Source ClinicalTrials.gov
Adverse events16
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 | Failure to Engraft | Blood and lymphatic system disorders | Campath Purged Non-myeloablative ASCT | 16 | 88 | 17 |
| other | Cardiac Left Ventricular Function | Blood and lymphatic system disorders | Campath Purged Non-myeloablative ASCT | 6 | 88 | 7 |
| other | Rash / desquamation | Blood and lymphatic system disorders | Campath Purged Non-myeloablative ASCT | 6 | 88 | 6 |
| other | Diarrhea | Blood and lymphatic system disorders | Campath Purged Non-myeloablative ASCT | 9 | 88 | 10 |
| other | Vomiting | Blood and lymphatic system disorders | Campath Purged Non-myeloablative ASCT | 5 | 88 | 5 |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Campath Purged Non-myeloablative ASCT | 29 | 88 | 36 |
| other | Infection - other | Infections and infestations | Campath Purged Non-myeloablative ASCT | 10 | 88 | 10 |
| other | Infection - with grade 3 or 4 neutrophils | Infections and infestations | Campath Purged Non-myeloablative ASCT | 35 | 88 | 65 |
| other | Infection - grade 1 or 2 neutrophils | Infections and infestations | Campath Purged Non-myeloablative ASCT | 12 | 88 | 25 |
| other | Infection - without febrile neutropenia | Infections and infestations | Campath Purged Non-myeloablative ASCT | 30 | 88 | 64 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Campath Purged Non-myeloablative ASCT | ||
| Total, other adverse events | Campath Purged Non-myeloablative ASCT | 71 | 88 |
| Total, serious adverse events | Campath Purged Non-myeloablative ASCT | 75 | 88 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18850014 | RESULT |
Source PubMed
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/NCT00580034
GET https://conductscience.org/api/trials/v1/NCT00580034/registered