Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients (NCT02228096) | Clinical Trial Compass
CompletedPhase 2
Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients
United States75 participantsStarted 2014-08-14
Plain-language summary
This was a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell acute lymphoblastic leukemia, who were refractory to standard chemotherapy regimen or relapsed after allogeneic stem cell transplant.
Who can participate
Age range3 Years – 21 Years
SexALL
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Inclusion criteria
✓. 2nd or greater Bone Marrow (BM) relapse OR
✓. Any BM relapse after allogeneic SCT and must be \> 6 months from SCT at the time of CTL019 infusion OR
✓. Refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen chemotherapy regimen or chemorefractory as defined by not achieving a CR after 1 cycle of standard chemotherapy for relapse leukemia OR
✓. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI), or if TKI therapy is contraindicated OR
✓. Ineligible for allogeneic SCT
✓. Renal function defined as (Calculated creatinine clearance or radioisotope Glomerular Filtration Rate (GFR) \> 60 mL/min/1.73 m2 OR serum creatinine based on age/gender
✓. Alanine Aminotransferase (ALT) \<= 5 times the upper limit of normal (ULN) for age;
✓. Bilirubin \< 2.0 mg/dL;
Exclusion criteria
✕. Steroids: Therapeutic systemic doses of steroids must be stopped \> 72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: \< 12 mg/m2/day hydrocortisone or equivalent
✕. Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \> 6 weeks prior to CTL019 infusion
✕
What they're measuring
1
Overall Remission Rate (ORR) Per Independent Review Committee (IRC) (for ALL Participants)
Timeframe: within 6 months after CTL019 infusion
2
Overall Remission Rate (ORR) Per Local Investigator Assessment (for Lymphoblastic Lymphoma Patients Only)
. GVHD therapies: Any systemic drug used for GVHD must be stopped \> 4 weeks prior to CTL019 infusion to confirm that GVHD recurrence is not observed (e.g. calcineurin inhibitors, methotrexate or other chemotherapy drugs, mycophenolate, rapamycin, thalidomide, or immunosuppressive antibodies such as anti-CD20 (rituximab), anti-tumor necrosis factor \[anti-TNF\], anti-interleukin 6 \[anti-IL6\] or anti-interleukin 6 receptor \[anti-IL6R\], systemic steroids)
✕. Chemotherapy:
✕. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are NOT acceptable methods of contraception
✕. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
✕. Male sterilization (at least 6 months prior to screening). For female patients on the study the vasectomized male partner should be the sole partner for that patient
✕. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception