- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01392989
Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders
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 Overview
Status
Conditions
Detailed Description
Primary Objectives:
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.
Secondary Objectives:
- 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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA, RECIPIENT WITH MYELODYSPLASTIC SYNDROME (MDS)
Diagnosis of MDS classifiable by the World Health Organization (WHO) on the basis of:
- Refractory anemia
- Refractory anemia with excess blasts-1
- Refractory anemia with excess blasts-2
- Refractory cytopenia with multi-lineage dysplasia
- Refractory cytopenia with multi-lineage dysplasia and ringed sideroblasts
- Chronic myelomonocytic leukemia (CMML)
- MDS transformed to acute leukemia
- MDS-unclassified
- Participants with advanced MDS must have < 10% marrow blasts prior to receiving conditioning with TLI/ATG, documented by marrow examination within 1 month prior.
- Participants with evolution to acute leukemia (AML) must be in a morphologic leukemia free-state (MLFS) with blasts < 5%
INCLUSION CRITERIA, RECIPIENT WITH MYELOPROLIFERATIVE DISORDER (MPD)
Diagnosis of MPD on the basis of:
- Idiopathic myelofibrosis
- Polycythemia vera
- Essential thrombocythemia
- Chronic myelomonocytic leukemia (CML)
- CML, Philadelphia chromosome-negative
- Chronic neutrophilic leukemia
- Chronic eosinophilic leukemia
- Hypereosinophilic cyndrome
- Systemic mastocytosis
- < 10% marrow blasts prior to receiving conditioning with TLI/ATG, documented by marrow examination within 1 month prior.
- Participants with evolution to acute leukemia (AML) must be in a morphologic leukemia free-state (MLFS) with blasts < 5%. Presence of residual dysplastic features following cytoreductive therapy is acceptable.
INCLUSION CRITERIA, RECIPIENT WITH THERAPY-RELATED MYELOID NEOPLASM (t MDS)
- < 10% marrow blasts prior to receiving conditioning with TLI/ATG, documented by marrow examination within 1 month prior.
- Morphologic leukemia free-state with blasts < 5 %.
- Age > 50 years, or < 50 years of age but at high-risk for regimen-related toxicity associated with conventional myeloablative transplants due to pre-existing medical conditions or prior therapy
- Availability of a fully HLA-matched or single antigen/allele mismatched sibling or unrelated donor
- Prior malignancy diagnosed > 5 years ago without evidence of disease, or < 5 years ago with life expectancy of > 5 years are eligible (prior malignancy is not a requirement)
INCLUSION CRITERIA, DONOR
- Donors must be HLA-matched or one allele mismatched.
- Donor age < 75 (EXCEPTION by Principal Investigator discretion)
- Must consent to PBSC mobilization with G-CSF; apheresis; and collection and donation of plasma
- Donor must consent to placement of a central venous catheter in the event that peripheral venous access is limited.
EXCLUSION CRITERIA, RECIPIENT
Any of the following:
- Uncontrolled CNS involvement with disease
- Pregnant
- Cardiac function: ejection fraction (EF) < 35% or uncontrolled cardiac failure
- Diffusing capacity of the lungs for carbon monoxide (DLCO) < 40% predicted
- Bilirubin > 3 mg/dL
- Aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN)
- Alanine aminotransferase (ALT) > 3x ULN
- Estimated creatinine clearance < 50 mL/min
- Karnofsky performance score (KPS) < 70%
- Documented fungal disease that is progressive despite treatment
- HIV-positive
EXCLUSION CRITERIA, DONOR
Any of the following:
- Identical twin to recipient
- Pregnant or lactating
- Prior malignancy within the preceding 5 years (EXCEPTION: non-melanoma skin cancers)
- HIV seropositivity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Standard of care
Other Names:
5 mg/kg, po
Other Names:
15 mg/kg, oral
Other Names:
7.5 mg/kg, IV
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
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.
|
2 years
|
Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year
Time Frame: 1 year
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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.
|
1 year
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Pre-transplant Expression of Natural-killer Group 2, Member D (NKG2D) Ligands
Time Frame: Pre-transplant
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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.
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Pre-transplant
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Everett Meyer, MD, PhD, Stanford University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Disease
- Congenital Abnormalities
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Leukemia
- Nervous System Malformations
- Syndrome
- Myelodysplastic Syndromes
- Leukemia, Myeloid
- Preleukemia
- Myeloproliferative Disorders
- Neural Tube Defects
- Spinal Dysraphism
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Antitubercular Agents
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Mycophenolic Acid
- Thymoglobulin
- Antilymphocyte Serum
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- IRB-18127
- SU-04202010-5724 (Other Identifier: Stanford University)
- BMT217 (Other Identifier: OnCore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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