CTL019 cells leukapheresis
Conditions
Interventions
None listed
Sponsors
Novartis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent, or signed parental permission form and assent form (as applicable), must be obtained prior to any study procedures 2. Males and females * 18 years of age at the time of initial diagnosis and weighing * 40 kg who are eligible to undergo a PBMC collection by apheresis for potential future CTL019 manufacturing for use in a CTL019 trial 3. CD19 expressing malignancy for which a CTL019 treatment protocol is currently enrolling or under IRB/EC review 4. Hemoglobin level * 9.0 g/dL at screening. Transfusion support can be provided within 24 hours of starting the apheresis procedure to meet this criterion 5. Platelet count * 50,000/microliter at screening. Transfusion support can be provided within 24 hours of starting the apheresis procedure to meet this criterion 6. Prothrombin Time (PT)/ Partial Thromboplastin Time (PTT) * 1.5 x ULN at screening. Transfusion support can be provided within 24 hours of starting the apheresis procedure to meet this criterion 7. Peripheral blood absolute lymphocyte count (ALC) * 500/microliter at screening or if ALC
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test at screening 3. Human Immunodeficiency Virus (HIV) infection at screening 5. Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD) at screening 6. Any patient that in the opinion of the investigator is not medically stable to undergo the apheresis procedure or will not comply with the visit schedules or procedures 7. Treatment with any prior gene therapy product 8. Patient has participated in a research study using an investigational agent within the last 30 days prior to screening 9. Patient should not have received long-acting growth factors or drugs used for cell mobilization (e.g. Neulastsa/pegflilgrastim) within 14 days of the eukapheresis procedure. Use of short-acting growth factors of drugs used for cell mobilization (e.g. G-CSF/Neupogen/filgrastim, plerixafor) must be * 5 days leukapheresis procedure 11. The following treatments/medications are excluded: **Chemotherapy: **-Cytotoxic chemotherapy drugs must not be given within 2 weeks of apheresis - Intrathecal chemotherapy (IT): Recommend holding IT prior to leukapheresis collection. If clinically indicated, IT Ara-C may be given and leukapheresis collection started any time following IT Ara-C. Leukapheresis collection may be started * 7 days after IT methotrexate (MTX) **- Pegylated-asparaginase must be stopped >4 weeks prior to apheresis **Low dose daily or weekly maintenance chemotherapy should be stopped * 2 weeks prior to apheresis - Clofarabine may be associated with prolonged lymphopenia. This should be taken into consideration when evaluation the optimal timing for leukapheresis collection. An interval of * 8 weeks from the patient*s last clofarabine treatment is recommended -Short-acting drugs(e.g tyrosine kinase inhibitors, ibrutinib and hydroxyurea) must not be given within a 72 hour window of the leukapheresis procedure **Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to apheresis. However, the following physiological replacement doses of steroids are allowed: * 12 mg/m2/day hydrocortisone or equivalent **Immunomodulatory drugs (e.g. IFN-gamma, anti-TNF-alpha): should be stopped * 2 weeks prior to apheresis **Allogeneic cellular therapy: - Must be * 3 months from allogeneic stem cell transplant at the time of leukapheresis. - Must not have presence of grade 2 to 4 acute graft-versus-host disease (GVHD) or extensive chronic GVHD. - Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to apheresis **GVHD therapies: Any drug used to prevent or treat GVHD must be stopped > 2 weeks prior to apheresis (e.g. calcineurin inhibitors, methotrexate or other chemotherapy drugs, mycophenolate, rapamycin, thalidomide, or immunosuppressive antibodies such as anti-TNF-*, anti-IL6 or anti-IL6R). Topical steroids for localized treatment of GVHD are allowed - Anti T-cell Directed Therapy: Administration of any T cell lytic or toxic agent (e.g. alemtuzumab) is strongly discouraged since residual lytic levels may destroy T-cells in the leukapheresis collection and/or prevent their in vitro CTL019 manufacturing. <b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is the collection of PBMCs for potential utilization in a CTL019 research protocol via standardized procedures for apheresis, cryopreservation (if required), and storage (if required). | — |
Secondary
| Measure | Time frame |
|---|---|
| * Characterize the immunophenotype and the yield of total nucleated cells in the collected apheresed product * Assess the association between the total nucleated cells obtained from each apheresis unit and baseline peripheral white blood cell counts, CD3 cell counts, as well as total blood volume processed * Describe the AE profile of patients during the apheresis procedures until the end of Day 2 following apheresis | — |
Countries
Netherlands
Outcome results
None listed