NCT Number: NCT01840566
High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma
The purpose of this study is to test the safety of delivering the patients' own immune cells, called T cells, after the high-dose chemotherapy (HDT) and autologous stem cell transplantation (ASCT).
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Transplant eligible patients will be eligible if criteria met per below.
Inclusion criteria
- Patients ≥ 18 years of age with aggressive B-cell non-Hodgkin lymphoma subtypes including, relapsed or refractory diffused large B-cell lymphoma (DLBCL), and transformed follicular lymphoma meeting at least one of the following criteria:
- Bone marrow involvement at the time of relapse or refractory disease and not appropriate for allogeneic transplantation.
- PET positive disease outside of one radiation port unless single-port disease treated with prior radiotherapy within the port, following > or = to 2 cycles of salvage chemotherapy, still achieving chemosensitive status 1999 IWG criteria (section 12.2 and 12.383).
- Creatinine ≤ 1.5 mg/100 ml (or measured 24 hour creatinine clearance of ≥ 50 cc/min)
- Bilirubin <2.0 mg/100 ml, AST and ALT <3x the upper-limit of normal, PT and PTT < 2x normal outside the setting of stable chronic anticoagulation therapy,
- Adequate cardiac function (LVEF>40%) as assessed by ECHO or MUGA scan performed within 1 month of treatment.
- Adequate pulmonary function as assessed by DLCO of > or = to 45% adjusted for hemoglobin.
- Life expectancy of > 3 months.
Exclusion criteria
- Karnofsky performance status ≤ 70 (see appendix VI).
- Patients with other aggressive B-cell malignancies including, but not limited to: Burkitt lymphoma, transformed CLL/SLL and transformed marginal zone lymphoma that are not included in 6.1 inclusion criteria.
- Patients previously treated with autologous or allogeneic bone marrow or stem cell transplantation are ineligible.
- Other past or current malignancy unless in the opinion of the investigator it does not contraindicate participation in the study.
- Uncontrolled bacterial, viral or fungal infection.
- Patients with HIV, active hepatitis B or hepatitis C infection.
Treatment and study plan
etoposide
DrugCytarabine
Drugmelphalan
DrugPegfilgrastim
Biological19-28z T CELLS
BiologicalAutologous Stem Cell Transplantation
ProcedurePrimary outcomes
-
maximum tolerated dose (MTD)
Time frame: 2 years
will be assessed utilizing a standard 3+3 cell dose escalation to determine the maximum tolerated dose of CD19+ CAR T cells
-
safety
Time frame: 2 years
Toxicity will be graded on a scale of 1 to 5 as described by the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Secondary outcomes
-
2 year progression-free (PFS)
Time frame: 2 years
-
overall survival (os)
Time frame: 2 years
Sponsors and collaborators
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Registry information
Official study title
A Phase I Trial of High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma
Important dates
- Study start
- 2013
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Apr 25, 2013
- Registry last updated
- May 28, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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