Donor Cord Blood T-Cell Infusion After Stem Cell Transplant in Treating Patients With Relapsed Hematological Malignancies
NCT ID: NCT01630564
Last Updated: 2018-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2013-03-11
2018-05-30
Brief Summary
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Detailed Description
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I. To evaluate the safety and maximum tolerated dose (MTD) of infusion of ex vivo expanded cord blood T cells (CLI), in cord blood (CB) transplant recipients with relapsed hematological malignancies.
SECONDARY OBJECTIVES:
I. To determine the complete remission rate and overall response as a result of CLI infusion.
II. To determine the effect of CLI infusion on the chimerism. III. To evaluate the incidence rate and grade of acute graft-versus-host disease (GvHD) after CLI infusion.
IV. To determine the disease-free survival, cytopenia rate, relapse incidence after CLI infusion.
OUTLINE: This is a dose-escalation study of ex vivo-expanded T-cells.
Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins.
After completion of study treatment, patients are followed up for 100 days.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (T-cell infusion)
Patients undergo ex vivo-expanded umbilical cord blood progenitor cell donor T cell infusion with aldesleukin 11-14 days after T-cell co-stimulation begins.
Aldesleukin
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
Umbilical Cord Blood-Derived Lymphocyte Therapy
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
Interventions
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Aldesleukin
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
Umbilical Cord Blood-Derived Lymphocyte Therapy
Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* UCB recipients with T-cell and/or overall chimerism value of less than 80%, in absence of relapse and have available approximately 400 microliter to 1 ml aliquots or CB wash from previous transplant
* Performance score of at least 80% by Karnofsky or performance status (PS) \< 3 (Eastern Cooperative Oncology Group \[ECOG\]) (age \>= 12 years), or Lansky Play-performance scale of at least 60% or greater (age \< 12 years)
* Negative beta human chorionic gonadotropin (HCG) or urine test in females of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on the study
* Patient or patient's legal representative, parent(s) or guardian able to sign informed consent
Exclusion Criteria
* Patients with active (untreated) central nervous system (CNS) disease
* Any active GVHD
* Active invasive infections
* Pregnant or breast-feeding
6 Months
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sairah Ahmed
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2013-00385
Identifier Type: REGISTRY
Identifier Source: secondary_id
2011-1178
Identifier Type: OTHER
Identifier Source: secondary_id
2011-1178
Identifier Type: -
Identifier Source: org_study_id
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