Information to Discuss with Your Doctor: B-cell ALL or CLL

You may be eligible for a study using genetically modified T cells (CTL019 cells - previously called CART 19) to treat B-cell ALL or CLL. Please print this form and discuss your eligibility with your physician.

B-cell ALL Eligibility criteria:

  1. Relapsed or refractory B-cell ALL
    1. 1st or greater BM relapse OR
    2. Any marrow relapse after allogeneic HSCT and ≥ 100 days from stem cell transplant OR
    3. For patients with refractory disease:
      1. < 60 years old that have not achieved a CR after ≥ 2 or more chemotherapy regimens
      2. ≥ 60 years old that have not achieved a CR after 1 prior chemotherapy regimen
    4. Patients with Ph+ ALL are eligible if they are intolerant to or have failed tyrosine kinase inhibitor therapy
  2. Adequate organ function
  3. Bone marrow with ≥ 5% lymphoblasts
  4. Male or female age ≥ 18 years
  5. A ECOG Performance Status that is either 0 or 1
  6. No contraindications for leukapheresis

All potential study candidates must meet all study specified eligibility criteria in order to be enrolled in the study, including reasonable organ function.

CLL Eligibility criteria:

  1. Documented CD19+ CLL or SLL
  2. At least 2 prior chemotherapy regimens, not including single agent monoclonal antibody (rituxan) therapy. Single agent ofatumumab will be counted as a regimen. Patients with high risk disease manifested by deletion chromosome 17p will be eligible if they fail to achieve a CR to initial therapy or progress within 2 years of 1 prior regimen.
  3. Patients who progress within 2 years after the second or higher line of therapy will be eligible. For instance, patients who had progression < 2 years after second or greater line therapy, but who have responded to their most recent treatment (3rd line or higher) will be eligible.
  4. Subject is not appropriate candidate for a potentially curative allogeneic SCT due to the state of disease, co-morbid illness, lack of an available donor, or patient declines
  5. Expected survival > 12 weeks
  6. Performance status (ECOG) 0 or 1
  7. Age >/= 18 years
  8. Adequate organ system function
  9. Any relapse after prior autologous SCT will make patient eligible regardless of other prior therapy
  10. Patients with relapsed disease after prior allogeneic SCT (myeloablative or nonmyeloablative) will be eligible if they meet all other inclusion criteria and:
    1. Have no active GVHD and require no immunosuppression
    2. Are more than 6 months from transplant
  11. No contraindications for leukapheresis
  12. Left Ventricular Ejection fraction >40%

If you meet these eligibility criteria, you or your physician may contact our Clinical Trial Information Service at 1-855-216-0098, Monday through Friday, 8:30 am to 5:30 pm ET or email PennCancerTrials@emergingmed.com.