Trial · NCT01027702
Donor Lymphocyte Infusion After Alternative Donor Transplantation
NCT01027702, Phase 1, Phase 2, Terminated, Wake Forest University Health Sciences; results first posted 2017-11-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Donor Lymphocyte Infusion After Alternative Donor Transplantation. Trials, record NCT01027702. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01027702
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Donor Lymphocyte Infusion After Alternative Donor Transplantation
- NCT number
- NCT01027702
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Immunodeficiency
- Interventions
- Infusion of donor lymphocytes
- First posted
- 2009-12-09
- Last updated
- 2022-04-22
- Results first posted
- 2017-11-08
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 Participants With Immune Recovery Following Transplantation | 120 days after transplant | Immune recovery was measured by CD4+ cells \> 100/μL by Day 120 following transplantation |
| Primary | Incidence and Severity of GVHD | 180 days after transplant | Patients were evaluated for acute GVHD due to prophylactic DLI between the day of prophylactic DLI infusion and Day +180 after transplant. GVHD was graded using standard criteria. |
| Secondary | Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD) | 1 year | Subjects were actively monitored for adenovirus, cytomegalovirus (CMV), human herpes virus 6 (HHV6), and Epstein-Barr virus (EBV) as part of standard post-transplant care. All infections were collected from date of DLI until 1 year after transplant. |
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 Participants With Immune Recovery Following Transplantation | 120 days after transplant | Patients who received subsequent therapy, such as therapeutic DLI (eg. for treatment of viral infection or relapse), chemotherapy, or a PBSC infusion were considered not evaluable as this could interfere with response assessments. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence and Severity of GVHD | 180 days after transplant | Patients that had not had grade II-IV acute GVHD following prophylactic DLI but received therapeutic DLI (eg. for treatment of viral infection or relapse), chemotherapy, or a PBSC infusion prior to Day +180 were considered not evaluable because these therapies may cause or prevent GVHD and affect the determination of this endpoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD) | 1 year | Patients who relapsed and received subsequent chemotherapy were no longer followed for infections as these therapies increase the risk of infections. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group56
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 Immune Recovery Following Transplantation | MMRD: 3 x 10^4/kg DLI + MTX to Day +24 | 1 | Participants | ||
| Number of Participants With Immune Recovery Following Transplantation | MMRD: 3 x 10^4/kg DLI + MTX to Day +52 | 1 | Participants | ||
| Number of Participants With Immune Recovery Following Transplantation | MMRD: 4 x 10^4/kg DLI + MTX to Day +52 | 1 | Participants | ||
| Number of Participants With Immune Recovery Following Transplantation | MMRD: 4 x 10^4/kg DLI + MTX to Day +80 | 4 | Participants | ||
| Number of Participants With Immune Recovery Following Transplantation | MMRD: 5 x 10^4/kg DLI + MTX to Day +80 | 6 | Participants | ||
| Number of Participants With Immune Recovery Following Transplantation | MUD: 3 x 10^4/kg DLI + MTX to Day +24 | 1 | Participants | ||
| Number of Participants With Immune Recovery Following Transplantation | MUD: 3 x 10^4/kg DLI + MTX to Day +52 | 1 | Participants | ||
| Incidence and Severity of GVHD | MMRD: 3 x 10^4/kg DLI + MTX to Day +24 | No GVHD/ Grade I GVHD | 2 | Participants | |
| Incidence and Severity of GVHD | MMRD: 3 x 10^4/kg DLI + MTX to Day +52 | No GVHD/ Grade I GVHD | 1 | Participants | |
| Incidence and Severity of GVHD | MMRD: 4 x 10^4/kg DLI + MTX to Day +52 | No GVHD/ Grade I GVHD | 1 | Participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MMRD: 3 x 10^4/kg DLI + MTX to Day +24 | 4 | |
| Overall Study | STARTED | MMRD: 3 x 10^4/kg DLI + MTX to Day +52 | 4 | |
| Overall Study | STARTED | MMRD: 4 x 10^4/kg DLI + MTX to Day +52 | 3 | |
| Overall Study | STARTED | MMRD: 4 x 10^4/kg DLI + MTX to Day +80 | 14 | |
| Overall Study | STARTED | MMRD: 5 x 10^4/kg DLI + MTX to Day +80 | 10 | |
| Overall Study | STARTED | MUD: 3 x 10^4/kg DLI + MTX to Day +24 | 1 | |
| Overall Study | STARTED | MUD: 3 x 10^4/kg DLI + MTX to Day +52 | 2 | |
| Overall Study | COMPLETED | MMRD: 3 x 10^4/kg DLI + MTX to Day +24 | 3 | |
| Overall Study | COMPLETED | MMRD: 3 x 10^4/kg DLI + MTX to Day +52 | 2 | |
| Overall Study | COMPLETED | MMRD: 4 x 10^4/kg DLI + MTX to Day +52 | 2 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events38
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 | Neutropenia | Investigations | Infusion of Donor Lymphocytes | 12 | 38 | |
| other | Platelet count decreased | Investigations | Infusion of Donor Lymphocytes | 10 | 38 | |
| other | Leukopenia | Investigations | Infusion of Donor Lymphocytes | 8 | 38 | |
| other | Relapse | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Infusion of Donor Lymphocytes | 6 | 25 | |
| other | Hypoxia | Respiratory, thoracic and mediastinal disorders | Infusion of Donor Lymphocytes | 5 | 38 | |
| other | Rash | Skin and subcutaneous tissue disorders | Infusion of Donor Lymphocytes | 4 | 38 | |
| other | Thrombotic microangiopathy | Blood and lymphatic system disorders | Infusion of Donor Lymphocytes | 3 | 38 | |
| other | Thrombotic microangiopathy | Blood and lymphatic system disorders | Infusion of Donor Lymphocytes | 3 | 38 | |
| other | ALT elevated | Metabolism and nutrition disorders | Infusion of Donor Lymphocytes | 2 | 38 | |
| other | Hemorrage, GU- urinary NOS | Renal and urinary disorders | Infusion of Donor Lymphocytes | 2 | 38 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Infusion of Donor Lymphocytes | 12 | 38 |
| Total, other adverse events | Infusion of Donor Lymphocytes | 27 | 38 |
| Total, serious adverse events | Infusion of Donor Lymphocytes | 32 | 38 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29047161 | DERIVED |
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/NCT01027702
GET https://conductscience.org/api/trials/v1/NCT01027702/results?page=2