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Phase III study for autologous cytokine-induced killer cells (CIK) treating acute leukemia

Phase III study for autologous cytokine-induced killer cells (CIK) treating acute leukemia

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023630
Enrollment
Unknown
Registered
2019-06-04
Start date
2019-06-06
Completion date
Unknown
Last updated
2019-06-11

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

Conditions

acute leukemia

Interventions

Experimental group:Autologous CIK treatment
Control group:Conventional treatment

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with low-risk acute leukemia, who achieved first complete remission (CR) after chemotherapy and who had sustained complete remission (CCR) = 4 months (US NCCN 2015.2 standard); 2. The last chemotherapy, whole body radiotherapy is over 2 weeks; 3. Hemoglobin (Hb) = 80g/L, white blood cell count (WBC) = 2.5 × 10^9/L, platelet count = 50 ×10^9/L; 4. Age 2-70 years old; 5. The patient has the ability to self-knowledge and can sign informed and voluntary consent forms; 6. The patient or his client, the guardian of the child patient, joins the study after signing the informed and voluntary consent form.

Exclusion criteria

Exclusion criteria: 1. Intracranial hypertension or unconsciousness; 2. Symptomatic heart failure or severe arrhythmia; 3. Respiratory failure; 4. with other types of malignant neoplasms; 5. T-lymphocytic acute leukemia; 6. Diffuse vascular internal coagulation; 7. Serum creatinine and / or urea nitrogen = 1.5 times the normal value; 8. Serum total bilirubin = 1.5 times normal; 9. Sepsis or other uncontrollable infections; 10. Uncontrollable diabetes; 11. Severe mental disorders; 12. The WHO physical status classification is =3. 13. Those who are allergic to IL2. 14. Organ transplant recipients. 15. Pregnant and lactating women. Both the study group and the control patients must meet the inclusion criteria and do not meet the exclusion criteria. Each paired case must meet the following conditions: 1. The age difference does not exceed 3 years old; 2. Morphology, immunology, cytogenetics, genotyping at the time of initial diagnosis; 3. Clinical features at the time of initial diagnosis: including features of hepatosplenomegaly, extramedullary leukemia, and whether it is hyperleukocytic leukemia; 4. The time required to achieve complete remission (CR) is similar; 5. The number of chemotherapy courses, chemotherapy regimens and doses before the selection are similar; 6. Pre-selection CR status: including CCR time (CCR time before the selection is not more than 3 months), whether all extramedullary leukemia has occurred; 7. There are similar co-morbidities such as hepatitis C and hepatitis B.

Design outcomes

Primary

MeasureTime frame
SAFETY;Bone marrow and peripheral blood tumor cell ratio;

Countries

China

Contacts

Public ContactTONG CHUNRONG

Beijing Boren Hospital

dongq@borenhospital.com+86 15210562236

Outcome results

None listed

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