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Phase II study of autologous anti-CD19 chimeric antigen receptor T cells treating refractory and relapsed B acute lymphoblastic leukemia

Phase II study of autologous anti-CD19 chimeric antigen receptor T cells treating refractory and relapsed B acute lymphoblastic leukemia

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-16009259
Enrollment
Unknown
Registered
2016-09-24
Start date
2016-09-23
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

refractory or relapsed B acute lymphoblastic leukemia

Interventions

Sponsors

Hebei Yanda Ludaopei Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with relapsed leukemia during chemotherapy or with primary drug resistance leukemia who have been diagnosed as CD19+ B-cell acute lymphoblastic leukemia, or patients with hematologic relapse after drug withdrawal who can't achieve CR after 1 cycle of chemotherapy; 2. Aged 3 to 60 years; 3. Lymphoblast and prolymphocyte in blood <30% examined by morphology; 4. Patients or the clients authorized by patients sign the consent form,or pediatric patients' legal guardians sign the consent form and are voluntary to participate in the clinical trials.

Exclusion criteria

Exclusion criteria: Intracranial hypertension or unconsciousness; Symptomatic heart failure or severe cardiac arrhythmia; Respiratory failure; CD19 negative hematologic malignancy; Disseminated intravascular coagulation; Serum creatinine and/or urea nitrogen=1.5 ×normal; Sepsis or other uncontrolled active infection; Uncontrolled diabetes; Severe mental disorder; WHO physical status classification level=3; Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
safety;Ratio of bone marrow and peripheral B leukemia cells;

Countries

China

Contacts

Public ContactChunrong Tong

Hebei Yanda Ludaopei Hospital

tongcr.21@163.com+86 13601301042

Outcome results

None listed

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