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Phase II clinical study for sequential treatment of refractory and recurrent B-cell lymphoma in children and adolescents with different B-cell targets

Phase II clinical study for sequential treatment of refractory and recurrent B-cell lymphoma in children and adolescents with different B-cell targets

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030954
Enrollment
Unknown
Registered
2020-03-19
Start date
2020-03-16
Completion date
Unknown
Last updated
2020-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood disease

Interventions

Case series:CART cell infusion

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. With pathological diagnosis of B-cell tumor with positive target markers, primary drug resistance, tumor progression, recurrence during chemotherapy or tumor recurrence after discontinuation, no response for 1 course of chemotherapy, and partial remission cannot be obtained (standard reference NCCN guidelins, version 4, 2014) or chemotherapy 2 course can not achieve complete remission; 2. Aged 1-18 years (including 18 years); 3. A self-knowledgeable 18-year-old patient voluntarily signs the informed consent form, and the legal representative (guardian) of a child patient under 18 years old voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Combining one or more of the following complications, the patient's condition is in a serious state: (1) High tumor burden, extensive affected areas, corresponding complications, and affecting normal organ function, such as: hyperleukemia, moderate-large amount of serous fluid, severe hypoproteinemia, severe electrolyte disturbance, acid-base balance Disorders, coagulopathy, etc .; (2) Huge tumors compress the surrounding tissues and organs, causing obvious complications, such as airway compression or obstruction, superior vena cava obstruction syndrome, intussusception, incomplete intestinal obstruction, urinary retention, etc .; (3) Central nervous system invasion with or without increased intracranial pressure, such as headache, vomiting, lethargy, irritability, etc.; (4) Combined with hemophagocytic syndrome; (5) Tumor lysis syndrome with varying degrees of electrolyte disturbance, hyperuricemia (blood uric acid> 500umol / L), hyperlactate dehydrogenase (LDH> 500U/L), etc.; (6) Those who have increased breathing, wheezing, or difficulty breathing due to various reasons; (7) Arrhythmias caused by various reasons without severe hemodynamic changes; (8) Patients with myelosuppression caused by bone marrow suppression after chemotherapy with fever, severe reduction of platelets 5.5mmol/L), hyperphosphatemia (blood phosphorus> 1.61 mmol/L), hypocalcemia (serum calcium <2mmol/L or free <1mmol/L), hyperuricemia, impaired renal function, hypertension, oliguria and even anuria; (4) Tumor lysis syndrome secondary to recurrent leukoencephalopathy in the back of the brain; (5) Granulocyte deficiency caused by severe bone marrow suppression after chemotherapy with infection, sepsis, shock, electrolyte disturbances, acid-base balance disorders, severe lung infections, gastrointestinal mucositis, skin and soft tissue infections, etc .; platelet extremely reduced <10,000 mm3 patients with different degrees of bleeding; (6) bleeding of vital organs and life-threatening people, such as pulmonary hemorrhage and cerebral hemorrhage; (7) People with various arrhythmias and hemodynamic changes; (8) Shock, DIC, acute heart, liver, kidney failure and respiratory failure caused by various causes.

Design outcomes

Primary

MeasureTime frame
Safety index;

Countries

China

Contacts

Public ContactYonghong Zhang

Beijing Boren Hospital

zhangyongh@borenhospital.com+86 13701251969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026