Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders
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|ClinicalTrials.gov Identifier: NCT01392989|
Recruitment Status : Completed
First Posted : July 13, 2011
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neural Tube Defects Anemia Leukemia, Myeloid Bone Marrow Transplant Failure Myelodysplastic Syndromes (MDS) Myeloproliferative Disorders||Drug: CIK cells Drug: Cyclosporine Drug: Mycophenolate Mofetil Drug: Thymoglobulin Radiation: Total Lymphoid Irradiation (TLI)||Phase 2|
To determine the rate of conversion to FDC following infusion of allogeneic CIK cells among patients with MDS, therapy-related myeloid neoplasms, or MPD who receive non myeloablative preparative regimen of TLI / ATG followed by allogeneic HCT and consolidation with allogeneic CIK cells.
- To determine the 2 year overall survival (OS) and event free survival (EFS)
- To determine the incidence of acute GVHD following infusion of allogeneic CIK cells
- To assess the pre-transplant expression of NKG2D ligands in patients' bone marrow aspirates.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post Transplant Infusion of Allogeneic Cytokine Induced Killer Cells as Consolidative Therapy After Non-Myeloablative Allogeneic Transplantation in Patients With Myelodysplasia or Myeloproliferative Disorders|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||June 7, 2016|
|Actual Study Completion Date :||March 19, 2017|
Experimental: Allogeneic Cytokine-induced Killer Cells (CIK)
Target dose of ≥ 5 x 10e6 CD34+ cells/kg of recipient body weight plus an additional 2 x10e9 mononuclear cells.
Drug: CIK cells
Standard of care
Other Name: Cytokine-induced Killer Cells
5 mg/kg, po
Drug: Mycophenolate Mofetil
15 mg/kg, oral
7.5 mg/kg, IV
Radiation: Total Lymphoid Irradiation (TLI)
- Full Donor Chimerism (FDC) [ Time Frame: 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.
- Overall Survival (OS) [ Time Frame: 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.
- Event-free Survival (EFS) Rate [ Time Frame: 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.
- Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year [ Time Frame: 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
- Pre-transplant Expression of Natural-killer Group 2, Member D (NKG2D) Ligands [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392989
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Everett Meyer, MD, PhD||Stanford University|