Autologous CD19-specific T Cells Infusion
This study is currently recruiting participants.
Verified February 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00968760
First received: August 28, 2009
Last updated: February 14, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The goal of this clinical research study is to learn if an investigational type of gene transfer can be given reliably and safely in patients with advanced B-cell lymphoma. B cells are a type of white blood cell that fights infection and disease. Lymphoma is a type of cancer that affects the immune system, including B cells.
The gene transfer involves drawing blood, separating out T cells (white blood cells that fight infection and disease), changing the T cells' DNA (genetic material) in a specific way, and returning the changed T cells back to the body.
Researchers want to learn the highest dose of the changed T cells that can be given safely. Researchers also want to learn how long the changed T cells remain in the participant's body, and if the changed T cells can reliably treat B-cell lymphoma. Finally, researchers want to learn if interleukin-2 (IL-2) can help the changed T cells last longer in the body.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma B-cell Lymphoma |
Procedure: Leukapheresis Procedure: Stem Cell Transplant Procedure: CD19-specific T Cell Infusion Drug: IL-2 Drug: Carmustine Drug: Etoposide Drug: Cytarabine Drug: Melphalan Drug: Rituximab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies After Autologous Hematopoietic Stem Cell Transplantation |
Resource links provided by NLM:
Drug Information available for:
Cytarabine
Melphalan
Carmustine
Melphalan hydrochloride
Etoposide
Aldesleukin
Etoposide phosphate
Rituximab
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) of T-cells ± IL-2 [ Time Frame: Continuously monitored up to infusions (+14 days) then at 1 day, 3 days, 1 week, and 2 weeks after T cell infusion ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CD19-specific T cell Infusion without IL-2
Group 1 - low dose of T cells without IL-2. Group 3 - higher dose of T cells without IL-2. |
Procedure: Leukapheresis
Leukapheresis #1 - For Collecting T Cells Leukapheresis #2 - For Collecting Stem Cells, month following #1 Blood drawn through vein, passed through a machine to collect specific blood cells, then remaining blood returned, about 3 hours to complete. Stem cell infusion by vein over 30-45 minutes on Day 0
Other Name: SCT
Procedure: CD19-specific T Cell Infusion
T Cell Infusion (Gene Transfer) by vein over 15-30 minutes sometime between Day +2 through Day +7.
Drug: Carmustine
300 mg/m^2 IV over 1 hour on Day -6
Other Names:
Drug: Etoposide
200 mg/m^2 IV over 3 hours every 12 hours on Days -5 to -2
Other Name: VePesid
Drug: Cytarabine
200 mg/m^2 IV over 1 hour every 12 hours on Days -2 to -5
Other Names:
Drug: Melphalan
140 mg/m^2 IV over 30 minutes on Day -1
Other Name: Alkeran
Drug: Rituximab
375 mg/m^2 IV over 4 to 6 hours on Day +1 and +8
Other Name: Rituxan
|
|
Experimental: CD19-specific T cell Infusion with IL-2
Group 2 - higher dose of T cells with IL-2. Group 4 - higher dose of T cells with IL-2. |
Procedure: Leukapheresis
Leukapheresis #1 - For Collecting T Cells Leukapheresis #2 - For Collecting Stem Cells, month following #1 Blood drawn through vein, passed through a machine to collect specific blood cells, then remaining blood returned, about 3 hours to complete. Stem cell infusion by vein over 30-45 minutes on Day 0
Other Name: SCT
Procedure: CD19-specific T Cell Infusion
T Cell Infusion (Gene Transfer) by vein over 15-30 minutes sometime between Day +2 through Day +7.
Drug: IL-2
Group 2 or 4, IL-2 dose of 0.3 x 10^6 U/m^2 injected under skin, once a day for up to 14 days; first dose on day of T cell infusion.
Other Names:
Drug: Carmustine
300 mg/m^2 IV over 1 hour on Day -6
Other Names:
Drug: Etoposide
200 mg/m^2 IV over 3 hours every 12 hours on Days -5 to -2
Other Name: VePesid
Drug: Cytarabine
200 mg/m^2 IV over 1 hour every 12 hours on Days -2 to -5
Other Names:
Drug: Melphalan
140 mg/m^2 IV over 30 minutes on Day -1
Other Name: Alkeran
Drug: Rituximab
375 mg/m^2 IV over 4 to 6 hours on Day +1 and +8
Other Name: Rituxan
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with a history of CD19+ lymphoid malignancies including: non-Hodgkin's Lymphoma (NHL), small lymphocytic lymphoma (SLL), follicular lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia, or mantle cell lymphoma that are beyond first relapse or primary refractory to treatment.
- Age 18 to 65 years.
- Zubrod performance 0-2 or Karnofsky of 50% to 100%.
- Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent.
- Patient or patient's legal representative, parent(s) or guardian 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 0-2 or Karnofsky of 50% to 100%.
- 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 Criteria:
- Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Active CNS disease in patient with history of CNS malignancy.
- Patients with known allergy to bovine or murine products.
- Positive serology for HIV.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968760
Contacts
| Contact: Partow Kebriaei, MD | 713-745-0663 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Partow Kebriaei, MD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Partow Kebriaei, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00968760 History of Changes |
| Other Study ID Numbers: | 2007-0635 |
| Study First Received: | August 28, 2009 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
CD19+ lymphoid malignancies non-Hodgkin's Lymphoma NHL small lymphocytic lymphoma SLL follicular lymphoma mantle cell lymphoma gene cell transfer CD19-specific T cells Stem Cell Transplant T Cell Infusion |
Chemotherapy Leukapheresis BCNU carmustine Cytarabine Etoposide Interleukin-2 Proleukin Melphalan Rituximab T cell therapy |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Carmustine Melphalan Etoposide phosphate Aldesleukin Rituximab Cytarabine |
Etoposide Interleukin-2 Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013