Study Stopped
Development of other studies led to termination without recruitment.
Infusion of Expanded Cord Blood T Cells
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
The goal of this clinical research study is to learn if treating umbilical cord blood with growth factors before a transplant can help to improve the body's ability to accept the cord blood transplants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2009
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 3, 2009
CompletedFirst Posted
Study publicly available on registry
September 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedOctober 11, 2012
October 1, 2012
2 years
September 3, 2009
October 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD)
Days 14 to 100
Study Arms (2)
Regimen 1: No TBI
EXPERIMENTALHigh Dose Chemotherapy without Total Body Irradiation (TBI)
Regimen 2: TBI
EXPERIMENTALHigh Dose Chemotherapy with Total Body Irradiation (TBI)
Interventions
140 mg/m\^2 by vein over 30 minutes as a single dose on Day -8
40 mg/m\^2 by vein over about 30 minutes 1 time each day on Days -6 through -3.
Regimen 1: 375 mg/m\^2 may be given by vein over 4 - 6 hours on Day -9 if needed Regimen 2: 375 mg/m\^2 may be given by vein over 4 - 6 hours on Day -8 if needed
60 mg/m\^2 by vein over 1-2 hours as a single dose on Day -3.
Regimen 1: 1.25 and 1.75 mg/kg by vein over 4-6 hours on the Days -4 and -3. Regimen 2: 0.5, 1.0 and 1.5 mg/kg by vein over 4-6 hours on respective Days -3, -2, and -1.
15 mg/kg pills twice a day starting on day -3, and continued until Day 100+ after transplant (1 gram may be given by vein if necessary).
0.03 mg/kg by vein Day -2 as 24 hour continuous infusion for several weeks. After stem cell transplant, tacrolimus given by mouth 2 times a day for up to 6 months.
Cord blood infusion of larger portion through vein using Central Venous Catheter (CVC) on Day 0.
5 mcg/kg day subcutaneously (may round up to the next vial) beginning on day +1 and continuing till absolute neutrophil count is \> 2.5 x 10e\^9/L.
Infusion by vein of treated cord blood beginning dose of 1 x 10e\^5 T cells/kg on Day 14+.
Eligibility Criteria
You may qualify if:
- Patient must have one of the following hematologic malignancies:
- AML
- ALL
- CML
- NHL
- HD, or
- CLL (Select from Criteria #2 through #7)
- Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS; Myelodysplastic syndromes with International Prognostic Scoring System score \>2 or myelodysplasia that has not responded to chemotherapy): induction failure, high-risk for relapse 1st remission (with high-risk cytogenetics or FLT3 mutation), 2nd or 3rd complete remission, or 2nd relapse with less than 10% blasts in the bone marrow and/or peripheral blood.
- Acute Lymphoblastic Leukemia (ALL): induction failure, 1st complete remission with Philadelphia chromosome or translocation, 2nd or 3rd complete remission, or 2nd relapse with less than 10% blasts in the bone marrow and/or peripheral blood.
- Chronic Myelogenous Leukemia (CML) second chronic phase, accelerated phase or blast crisis with less than 10% blasts in the bone marrow and/or peripheral blood and failure of at least one tyrosine kinase inhibitor.
- Non-Hodgkin's Lymphoma (NHL): Induction failures, second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant).
- Hodgkin's Disease (HD): Induction failures, second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant).
- Chronic Lymphocytic Leukemia (CLL): Failure of one multi-agent regimen including fludarabine or other nucleoside analog
- Patient's Age Criteria: Age \>/= 6 months and \</= 55 years
- Performance score of \< 3 (Zubrod score).
- +9 more criteria
You may not qualify if:
- HIV positive (due to the extreme immunosuppressive nature of allogeneic stem cell transplant)
- Patient with active (untreated) CNS disease
- Availability of an appropriate, willing, HLA-matched related marrow donor
- Active invasive infections.
- Pregnant or breast-feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Laura L. Worth, MD, PHD
UT MD Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2009
First Posted
September 4, 2009
Study Start
September 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
October 11, 2012
Record last verified: 2012-10