Status:
COMPLETED
CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Alaunos Therapeutics
Conditions:
Lymphoma
B-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Sometimes researchers change the DNA (genetic material in cells) of donated T cells (white blood cells that support the immune system) using a process called "gene transfer." Gene transfer involves dr...
Detailed Description
Study Plan: This study has 3 steps: chemotherapy, a stem cell transplant, and gene transfer. If the disease relapses (returns) during the study, you may receive the T-cell infusion without having a s...
Eligibility Criteria
Inclusion
- Patients with a history of CD19+ lymphoid malignancies that are beyond first remission or primary refractory to treatment.
- Age 18 to 75 years.
- Zubrod performance 0-1 or Karnofsky greater than or equal to 80%.
- Patient able to provide written informed consent.
- Patient able to provide written informed consent for the long-term follow-up gene therapy study.
- Eligibility at time of transplant conditioning regimen (criteria 6-13): Zubrod performance 0-1 or Karnofsky greater than or equal to 80%.
- Left ventricular ejection fraction \>/= 40%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
- No symptomatic pulmonary disease. FEV1, FVC and DLCO \>/= 50% of expected, corrected for hemoglobin.
- Serum creatinine \</= 1.8mg/dL or creatinine clearance \>/= 40 cc/min.
- Adequate hepatic function, as defined by SGPT \<3 X upper limit of normal; serum bilirubin and alkaline phosphatase \<2 X upper limit of normal, or considered not clinically significant.
- If positive Hepatitis B and/or Hepatitis C serology, discuss with Principal Investigator or designee and consider liver biopsy.
- No pleural/pericardial effusion or ascites estimated to be \>1L.
- Not breast feeding or pregnant. Pregnancy determined by a positive beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Eligibility at time of T-cell infusion (criteria 14-15): No systemic corticosteroids within 3 days prior to T-cell infusion.
- Not experiencing any new Grade \>2 (CTC version 4) adverse neurologic, pulmonary, cardiac, gastrointestinal, renal or hepatic (excluding albumin) event within 24 hours prior to T-cell infusion.
- Eligibility criteria for administration of IL-2 after T-cell infusion: Absence of new adverse event of grade \>2 (CTC vs. 4) involving cardiopulmonary, hepatic (excluding albumin), gastrointestinal, neurologic, or renal toxicity probably or definitely attributed to infused T cells within one week of cells.
Exclusion
- Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Patients with known allergy to bovine or murine products.
- Positive serology for HIV.
Key Trial Info
Start Date :
June 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00968760
Start Date
June 20 2011
End Date
April 23 2020
Last Update
December 19 2023
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030