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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


Phase 1
18 Years
70 Years
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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


Transplant eligible patients with relapsed and refractory aggressive B-NHL will be
eligible if criteria met per below.

Inclusion Criteria:



- Patients > or = to 18 and < or = to 70 years old with relapsed or refractory DLBCL or
transformed B-NHL 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 following > or = to 2 cycles
of salvage chemotherapy, though still achieving chemosensitive status per 1999
IWG criteria (section 12.2 and 12.383).

- Creatinine < or = 1.5 mg/100 ml (or measured 24 hour creatinine clearance of > or =
to 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,

- Granulocytes >1,000/mm3, platelets >50,000/mm3, hemoglobin >8.0g/dl.

- 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 < or = to 70 (see appendix VI).

- Patients previously treated with 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerated dose (MTD)

Outcome Description:

will be assessed utilizing a standard 3+3 cell dose escalation to determine the maximum tolerated dose of CD19+ CAR T cells

Outcome Time Frame:

2 years

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

12-117

NCT ID:

NCT01840566

Start Date:

April 2013

Completion Date:

April 2015

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Relapsed
  • Refractory
  • Autologous Stem Cell Transplantation
  • HIGH DOSE CHEMOTHERAPY
  • 19-28z T cells/kg
  • 12-117
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021