Trial · NCT01392989
Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders
NCT01392989, Phase 2, Completed, Everett Meyer; results first posted 2019-05-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders. Trials, record NCT01392989. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01392989
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders
- NCT number
- NCT01392989
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- Everett Meyer
- Conditions
- Neural Tube Defects, Anemia, Leukemia, Myeloid, Bone Marrow Transplant Failure, Myelodysplastic Syndromes (MDS), Myeloproliferative Disorders
- Interventions
- CIK cells, Cyclosporine, Mycophenolate Mofetil, Thymoglobulin, Total Lymphoid Irradiation (TLI)
- First posted
- 2011-07-13
- Last updated
- 2019-05-07
- Results first posted
- 2019-05-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Full Donor Chimerism (FDC) | 90 days | Proportion of patients achieving full donor T-cell chimerism (FDC) by on or before Day 90 post non-myeloablative allogeneic transplant with allogeneic cytokine-induced killer (CIK) cells will be determined. FDC is defined as the attainment of \>95% donor type CD3+ cells. The outcome will be reported as number of participants who achieved full donor chimerism, a number without dispersion. |
| Secondary | Overall Survival (OS) | 2 years | Overall survival (OS) is an expression of the number of participants that remain alive 2 years after cytokine-induced killer (CIK) infusion. The outcome will be reported as the number of participants alive 2 years after CIK infusion, a number without dispersion. |
| Secondary | Event-free Survival (EFS) Rate | 2 years | Event-free Survival (EFS) rate will be assessed on all enrolled participants and is defined as the duration of time after cytokine-induced killer (CIK) cell infusion that the participants remain alive with experiencing relapse, Grade 3 to 4 acute graft vs host disease (aGVHD), or death. The outcome will be reported as the number of participants, stratified by receipt of CIK cells, that did not experience a specified event, a number without dispersion. |
| Secondary | Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year | 1 year | Acute graft vs host disease (aGvHD) Grade 2 to 4 was staged \& graded using modified Keystone criteria, as below. The outcome is reported as the number of participants that experience Grade 2 to 4 aGvHD within 100 days and 1 year. * Stage 1: Skin: rash \< 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea 500 to 1000 mL/day or persistent nausea with positive biopsy for GvHD * Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea 1000 to 1500 mL/day. * Stage 3: Skin: rash \> 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea \> 1500 mL/day. * Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin \> 15 mg/dL. Gut: severe abdominal pain with or without ileus Grade of aGvHD was determined as follows. * Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage * Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut * Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut * Grade 4: Stage 4 Skin + or Stage 2 |
| Secondary | Pre-transplant Expression of Natural-killer Group 2, Member D (NKG2D) Ligands | Pre-transplant | Pre-transplant expression of natural-killer group 2, member D (NKG2D) ligands MIC A, MIC B, and the UL16 binding proteins (ULBPs) will be assessed in participants' bone marrow aspirates. The outcomes is expressed as the number of participants whose expression level for each ligand was elevated compared to background, represented by the known levels for individual without cancer. |
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 | Full Donor Chimerism (FDC) | 90 days | Cytokine-induced killer (CIK) cells were infused in a subset of participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | 2 years | Cytokine-induced killer (CIK) cells were infused in a subset of participants. Participants that did not receive CIK cells were not included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Event-free Survival (EFS) Rate | 2 years | All participants are reported. Cytokine-induced killer (CIK) cells were infused in a subset of participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year | 1 year | Cytokine-induced killer (CIK) cells were infused in a subset of participants. Results are reported for both subsets and collectively, at 2 time points. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pre-transplant Expression of Natural-killer Group 2, Member D (NKG2D) Ligands | Pre-transplant | Insufficient tumor sample materials from the pre-transplant diagnostic bone marrow aspirate was available for the research analysis. No analysis was conducted. |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Full Donor Chimerism (FDC) | Allogeneic Cytokine Induced Killer Cells (CIK) | 6 | Participants | ||
| Overall Survival (OS) | Allogeneic Cytokine Induced Killer Cells (CIK) | 16 | Participants | ||
| Event-free Survival (EFS) Rate | Allogeneic Cytokine Induced Killer Cells (CIK) | CIK-infused participants | 14 | Participants | |
| Event-free Survival (EFS) Rate | Allogeneic Cytokine Induced Killer Cells (CIK) | Non-CIK-infused participants | 4 | Participants | |
| Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year | Allogeneic Cytokine Induced Killer Cells (CIK) | All participants within 100 days | 9 | Participants | |
| Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year | Allogeneic Cytokine Induced Killer Cells (CIK) | All participants within 1 year | 11 | Participants | |
| Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year | Allogeneic Cytokine Induced Killer Cells (CIK) | CIK-infused participants within 100 days | 3 | Participants | |
| Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year | Allogeneic Cytokine Induced Killer Cells (CIK) | CIK-infused participants within 1 year | 5 | Participants | |
| Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year | Allogeneic Cytokine Induced Killer Cells (CIK) | Non-CIK-infused participants within 100 days | 6 | Participants | |
| Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year | Allogeneic Cytokine Induced Killer Cells (CIK) | Non-CIK-infused participants within 1 year | 6 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Total Lymphoid Irradiation (TLI) | STARTED | Allogeneic Cytokine Induced Killer Cells (CIK) | 44 | |
| Total Lymphoid Irradiation (TLI) | COMPLETED | Allogeneic Cytokine Induced Killer Cells (CIK) | 44 | |
| Total Lymphoid Irradiation (TLI) | NOT COMPLETED | Allogeneic Cytokine Induced Killer Cells (CIK) | 0 | |
| CIK Cell Infusion | STARTED | Allogeneic Cytokine Induced Killer Cells (CIK) | 31 | |
| CIK Cell Infusion | COMPLETED | Allogeneic Cytokine Induced Killer Cells (CIK) | 31 | |
| CIK Cell Infusion | NOT COMPLETED | Allogeneic Cytokine Induced Killer Cells (CIK) | 0 |
Source ClinicalTrials.gov
Adverse events69
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 | Serum sickness | Immune system disorders | Allogeneic Cytokine Induced Killer Cells (CIK) | 13 | 44 | 16 |
| other | Hemolysis | Blood and lymphatic system disorders | Allogeneic Cytokine Induced Killer Cells (CIK) | 1 | 44 | 1 |
| other | Cardiac disorders - Other, cardiac bigeminy | Cardiac disorders | Allogeneic Cytokine Induced Killer Cells (CIK) | 1 | 44 | 1 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Allogeneic Cytokine Induced Killer Cells (CIK) | 3 | 44 | 3 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Allogeneic Cytokine Induced Killer Cells (CIK) | 3 | 44 | 3 |
| other | Buttock Pain | Musculoskeletal and connective tissue disorders | Allogeneic Cytokine Induced Killer Cells (CIK) | 1 | 44 | 1 |
| other | Neck Pain | Musculoskeletal and connective tissue disorders | Allogeneic Cytokine Induced Killer Cells (CIK) | 1 | 44 | 1 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Allogeneic Cytokine Induced Killer Cells (CIK) | 2 | 44 | 2 |
| other | Headache | Nervous system disorders | Allogeneic Cytokine Induced Killer Cells (CIK) | 4 | 44 | 6 |
| other | Dizziness | Nervous system disorders | Allogeneic Cytokine Induced Killer Cells (CIK) | 1 | 44 | 1 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Allogeneic Cytokine Induced Killer Cells (CIK) | 24 | 44 |
| Total, other adverse events | Allogeneic Cytokine Induced Killer Cells (CIK) | 44 | 44 |
| Total, serious adverse events | Allogeneic Cytokine Induced Killer Cells (CIK) | 27 | 44 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30951840 | 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/NCT01392989
GET https://conductscience.org/api/trials/v1/NCT01392989/events?page=2