Trial · NCT00354172
Donor Umbilical Cord Blood Natural Killer Cells, Aldesleukin and Umbilical Cord Blood Transplant in Patients With Refractory Hematologic Cancers.
NCT00354172, Phase 2, Terminated, Masonic Cancer Center, University of Minnesota; results first posted 2009-12-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Donor Umbilical Cord Blood Natural Killer Cells, Aldesleukin and Umbilical Cord Blood Transplant in Patients With Refractory Hematologic Cancers. Trials, record NCT00354172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00354172
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Donor Umbilical Cord Blood Natural Killer Cells, Aldesleukin and Umbilical Cord Blood Transplant in Patients With Refractory Hematologic Cancers.
- NCT number
- NCT00354172
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Leukemia, Myelodysplastic Syndromes
- Interventions
aldesleukin, filgrastim, natural killer cell (NK) therapy, cyclophosphamide, cyclosporine, fludarabine phosphate, methylprednisolone, mycophenolate mofetil, Umbilical Cord Blood Transplantation (UCBT), Total body irradiation (TBI)
- First posted
- 2006-07-20
- Last updated
- 2017-12-28
- Results first posted
- 2009-12-31
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months | 6 Months Post Transplant | Number of patients who were alive and free of disease (malignancy) at 6 months after transplant. |
| Secondary | Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months | 12 Months Post transplant | Number of patients who were alive and free of disease (malignancy) at 12 months after transplant. |
| Secondary | Number of Patients Who Were Disease-free and Alive at 24 Months | 24 Months Post transplant | Number of patients who were alive and free of disease (malignancy) at 24 months after transplant. |
| Secondary | Number of Participants (Patients) Who Died Due to Transplant. | 6 Months Post Transplant | Patients who had transplant-related mortality (TRM). TRM = adverse event(s) that occur(s) after the patient has received a transplant, the principal investigator decides it is related to the procedure and the patient dies within 6 months. |
| Secondary | Number of Participants (Patients) Who Attained Neutrophil Engraftment | Day 42 Post Transplant | Defined as absolute neutrophils (ANC) \> 5 x 10\^8/Liter for 3 consecutive days. ANC is the real number of white blood cells (WBCs) that are neutrophils. The absolute neutrophil count is commonly called the ANC. The ANC is not measured directly. It is derived by multiplying the WBC count times the percent of neutrophils in the differential WBC count. The percent of neutrophils consists of the segmented (fully mature) neutrophils) + the bands (almost mature neutrophils). The normal range for the ANC = 1.5 to 8.0 (1,500 to 8,000/mm3). |
| Secondary | Number of Participants (Patients) Who Attained Platelet Engraftment | 1 Year Post Transplant | Platelet engraftment is defined as platelet counts \> 50 x 10\^9/Liter for 3 consecutive days. |
| Secondary | Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV | Day 100 Post Transplant | Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. |
| Secondary | Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV | Day 100 post transplant | Graft-versus-host disease (GVHD) is a common complication of transplantation in which functional immune cells in the transplanted marrow recognize the recipient as foreign and mount an immunologic attack. The acute or fulminant form of the disease (aGVHD) is normally observed within the first 100 days post-transplant, and is a major challenge to transplants owing to associated morbidity and mortality. Acute GVHD is staged as follows: overall grade (skin-liver-gut) with each organ staged individually from a low of I to a high of IV. Patients with grade IV GVHD usually have a poor prognosis. |
| Secondary | Number of Participants (Patients) With Chronic Graft-Versus-Host Disease | Day 100 through 1 Year Post Transplant | The chronic form of graft-versus-host-disease (cGVHD) normally occurs after 100 days. The appearance of moderate to severe cases of cGVHD adversely influences long-term survival. |
| Secondary | Number of Participants (Patients) Who Died by 12 Months | 1 year Post Transplant | Number of patients who died after receiving treatment within 12 months post transplant. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months | 6 Months Post Transplant | One patient did not receive umbilical cord transplant and was not included in this Evaluable patient group. | Participants | NUMBER |
| SECONDARY | Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months | 12 Months Post transplant | Participants | NUMBER | |
| SECONDARY | Number of Patients Who Were Disease-free and Alive at 24 Months | 24 Months Post transplant | Participants | NUMBER | |
| SECONDARY | Number of Participants (Patients) Who Died Due to Transplant. | 6 Months Post Transplant | Participants | NUMBER | |
| SECONDARY | Number of Participants (Patients) Who Attained Neutrophil Engraftment | Day 42 Post Transplant | Participants | NUMBER | |
| SECONDARY | Number of Participants (Patients) Who Attained Platelet Engraftment | 1 Year Post Transplant | Participants | NUMBER | |
| SECONDARY | Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV | Day 100 Post Transplant | Participants | NUMBER | |
| SECONDARY | Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV | Day 100 post transplant | Participants | NUMBER | |
| SECONDARY | Number of Participants (Patients) With Chronic Graft-Versus-Host Disease | Day 100 through 1 Year Post Transplant | Participants | NUMBER | |
| SECONDARY | Number of Participants (Patients) Who Died by 12 Months | 1 year Post Transplant | Participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants (Patients) Who Were Disease-free and Alive at 6 Months | Evaluable Patients | 2 | Participants | ||
| Number of Participants (Patients) Who Were Disease-free and Alive at 12 Months | Evaluable Patients | 1 | Participants | ||
| Number of Patients Who Were Disease-free and Alive at 24 Months | Evaluable Patients | 0 | Participants | ||
| Number of Participants (Patients) Who Died Due to Transplant. | Evaluable Patients | 4 | Participants | ||
| Number of Participants (Patients) Who Attained Neutrophil Engraftment | Evaluable Patients | 13 | Participants | ||
| Number of Participants (Patients) Who Attained Platelet Engraftment | Evaluable Patients | 5 | Participants | ||
| Number of Participants (Patients) With Acute Graft-versus-host Disease (GVHD) Grade II-IV | Evaluable Patients | 6 | Participants | ||
| Number of Participants (Patients) With Acute Graft-versus-Host Disease at Grade III-IV | Evaluable Patients | 1 | Participants | ||
| Number of Participants (Patients) With Chronic Graft-Versus-Host Disease | Evaluable Patients | 1 | Participants | ||
| Number of Participants (Patients) Who Died by 12 Months | Evaluable Patients | 14 | Participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Patients Treated for Refractory Hematologic Cancers | 16 | |
| Overall Study | COMPLETED | Patients Treated for Refractory Hematologic Cancers | 15 | |
| Overall Study | NOT COMPLETED | Patients Treated for Refractory Hematologic Cancers | 1 |
Source ClinicalTrials.gov
Adverse events7
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 |
|---|---|---|---|---|---|---|
| serious | Cardiac failure | Cardiac disorders | Patients Treated for Refractory Hematologic Cancers | 1 | 16 | 1 |
| serious | Death | Blood and lymphatic system disorders | Patients Treated for Refractory Hematologic Cancers | 4 | 16 | 4 |
| serious | Disease relapse | Blood and lymphatic system disorders | Patients Treated for Refractory Hematologic Cancers | 4 | 16 | 5 |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | Patients Treated for Refractory Hematologic Cancers | 1 | 16 | 2 |
| serious | Hemorrhage, lung | Respiratory, thoracic and mediastinal disorders | Patients Treated for Refractory Hematologic Cancers | 2 | 16 | 2 |
| serious | Hepatic portal vein flow occluded | Hepatobiliary disorders | Patients Treated for Refractory Hematologic Cancers | 1 | 16 | 2 |
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | Patients Treated for Refractory Hematologic Cancers | 3 | 16 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patients Treated for Refractory Hematologic Cancers | ||
| Total, other adverse events | Patients Treated for Refractory Hematologic Cancers | 0 | 0 |
| Total, serious adverse events | Patients Treated for Refractory Hematologic Cancers | 16 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00354172
GET https://conductscience.org/api/trials/v1/NCT00354172/registered