Residual disease driven strategy for CARCIK (CD19) in adults/pediatric BCP-A
- Conditions
- MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]Refractory or relapsed acute B-cell lymphoblastic leukemia after haematopoietic stem cell transplantation
- Registration Number
- EUCTR2020-005025-85-IT
- Lead Sponsor
- FONDAZIONE TETTAMANTI M.DE MARCHI ONLUS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 33
1. Children (1-17) and adults (18-75 years old);
2. Relapsed or refractory adult and pediatric BCP-ALL as defined for the presence of bone marrow with = 5% lymphoblasts by morphologic assessment, or if <5%, with at least 1% of molecular disease at PCR;
3. Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
4. Bone marrow with = 5% lymphoblasts by morphologic assessment at screening, or if <5%, with at least 1% of molecular disease at PCR;
5. No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
6. No longer taking immunosuppressive agents for at least 30 days prior to infusion;
7. No evidence of concomitant life-threatening infectious disease;
8. Life expectancy > 60 days;
9. Lansky/Karnofsky scores > 60;
10. Absence of severe renal disease (creatinine > x 3 normal for age);
11. Absence of severe hepatic disease (direct bilirubin > 3 mg/dl or SGOT > 500);
12. Patient/guardian able to give informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
1. GVHD Grades II-IV for patients who had previously been transplanted;
2. Any cell therapy in the last 30 days;
3. Patient with concomitant life-threatening infectious disease;
4. Lansky/Karnofsky score <60;
5. Patients with hepatic or renal disease as specific above;
6. Pregnant or breast feeding females;
7. Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
8. Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met;
9. HIV/HBV/HCV Infection: Seropositive for HIV antibody. Seropositive for hepatitis C or positive for Hepatitis B surface antigen (HBsAG);
10. Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, congestive heart failure, unstable angina pectoris and cardiac arrhythmia;
11. Active Central Nervous System (CNS) involvement by malignancy, defined as CNS-3 per National Comprehensive Cancer Network (NCCN) guidelines. Note: Patients with history of CNS disease that has been effectively treated will be eligible
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Confirm the high overall response rate at day 28 after the first CARCIK-CD19 infusion,<br>Improve the duration of response of patients treated with CARCIK -CD19 cells;Secondary Objective: 1.Overall Survival (OS).<br>2.Safety of the second administration of CARCIK-CD19.<br>3.Safety of autologous CARCIK-CD19 cells.<br>4.Safety of cordblood CARCIK-CD19 cells;Primary end point(s): ORR at 28 days after the first CARCIK-CD19 administration<br>DOR from day 70 for patients who achieved and maintained remission after the first or the second CARCIK-CD19 administration;Timepoint(s) of evaluation of this end point: 1 month
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall survival (from time infusion to death)<br>Safety of the second administration of allogeneic CARCIK-CD19 cells<br>Safety of autologous CARCIK-CD19 cells<br>Safety of cordblood CARCIK-CD19 cells.;Timepoint(s) of evaluation of this end point: 36 months