Referring for CAR T-Cell Therapy
Below are guidelines we use to assess patients for CAR T-cell therapy as standard care. Additional criteria may apply for clinical trials:
CAR T for Lymphoma
- Histologically confirmed diagnosis of DLBCL, primary mediastinal B-cell lymphoma, high grade B-cell lymphoma, or DLBCL arising from follicular lymphoma that has either not responded to, or relapsed after, second or greater lines of systemic therapy.
Therapy must have included an anti-CD20 antibody and an anthracycline.
- No history of, or active CNS lymphoma or other significant CNS disease or brain injury
- Adequate organ function (e.g., ANC > 1000, platelet count > 50K, ALC > 100, CrCl > 55, ALT and AST
< 2.5 ULN, Tbili < 1.5, except for patients with Gilbert's)
- Adequate cardiac function (e.g., Cardiac EF > 50%)
- Adequate pulmonary function (e.g., Baseline O2 saturation > 92%)
- No history of malignancy expected to shorten one's life expectancy, other than lymphoma
- Absence of malignancy in the past 3 years other than nonmelanoma skin cancer or carcinoma in situ
- No history of autologous stem cell transplant within 6 weeks of CAR T-cell infusion
- No history of autoimmune disease requiring systemic immunosuppression in the past 1 years
- No active hepatitis B or C infection
- HIV negative or controlled HIV disease (defined as undetectable viral load and CD4 count > 250)
CAR T for Leukemia
- Confirmed diagnosis of B-cell acute lymphoblastic leukemia (ALL) that has either not responded or relapsed after at least two lines of prior treatment.
- Adequate organ, cardiac, and pulmonary function (must meet established criteria/measures)
- Age 25 years or younger
Preparing Patients for CAR T-Cell Therapy
While CAR T-cell therapy is a promising treatment, it is also a complex, lengthy process with the risk of serious side effects. It is important that you and your patients understand:
- Once CAR T-cell therapy is determined to be appropriate treatment, we collect the patient's T cells through leukapheresis. The T cells are then sent to a lab, either a Dana-Farber or off-site, to be engineered to express the target specific for the
patient's cancer. This manufacturing process generally takes two to three weeks.
- Patients may receive lymphodepleting chemotherapy in the days prior to their CAR T-cell infusion, to make room in their immune system for the CAR T cells to expand and proliferate.
- Most patients are hospitalized for one to three weeks to monitor for side effects.
- Potential serious side effects may include fevers, chills, low blood pressure, difficulty breathing, confusion, difficulty speaking or understanding language, or stupor. Our teams are specially trained to address these side effects, though patients
may be quite ill for a period of time while in the hospital.
- Patients must remain within two hours of Dana-Farber/Brigham and Women's for four weeks after their CAR T-cell infusion for rapid management of side effects after discharge. A caregiver is required to stay with the patient during this period.
We welcome the opportunity to discuss patients for whom CAR T-cell therapy may be appropriate. Contact us at 877-801-2278 or firstname.lastname@example.org.
Our team works collaboratively with referring oncologists after CAR T-cell therapy. We provide guidance on what to watch for, and recommended follow-up care. To monitor the long-term effectiveness of CAR T-cell therapy, patients will require follow-up
care for up to 15 years.