CIMAbior® in CD20-positive B-cell Non-Hodgkin Lymphoma

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000251
• Date of registration: 05/09/2017
• Prospective Registration: Yes
• Primary sponsor: Center of Molecular Immunology
• Public title: CIMAbior® in CD20-positive B-cell Non-Hodgkin Lymphoma
• Scientific title: Safety and effectiveness of CIMAbior® in patients with CD20-positive B-cell Non-Hodgkin Lymphoma. Phase IV
• Date of first enrolment: 01/10/2017
• Target sample size: Recruitment for 2 years
• Recruitment status: Pending
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000251-En
• Study type: Interventional
• Study design: Allocation: Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment
• Phase: 4

Countries of recruitment

Cuba

Contacts

• Name: Yaimarelis Saumell Napoles
• Affiliation: Center of Molecular Immunology

• Name: Yaimarelis Saumell Napoles
• Affiliation: Center of Molecular Immunology

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients that fulfill diagnosis criteria
2. Patients who give their informed consent to participate, in writing.
3. Age greater than or equal to 18 years, of any gender.
4. Performance status less than or equal to 2 (ECOG).
5. Patients with laboratory parameters as detailed below:
- Hemoglobin= 100 g/L
- ALC = 3 x 109 cells/L
- ANC = 1,5x109 /L
- platelets =100 x 109/L,
- TGO/TGP= 2.5 time upper normal limits,
- Creatinine and bilirubin = 1.5 time upper normal limits.
- Hepatitis B and C negative antigens
Exclusion criteria: 1. Pregnant or breast-feeding patients.
2. Patients with evidence of NHL dissemination to the central nervous system.
3. Patients with previous history of demyelinating or inflammatory diseases of the CNS or peripheral .
4. Patients with uncontrolled intercurrent diseases, including, but not limited to: hypertension, active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, aortic stenosis, endocarditis, and psychiatric conditions that may limit adherence To the requirements of the test.
5. Patients with HIV positive serology or active hepatitis C or B virus infections.
6. Patients with previous malignancies, except carcinoma in situ of cervix or skin cancer (non-melanoma), correctly treated.
7. Patients with acute allergic conditions, history of severe allergic reactions or attributed to compounds of chemical or biological composition similar to the monoclonal antibody.
8. Patients who are receiving another product under investigation.



Age minimum: 18 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Immune System Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Hemic and Lymphatic Diseases

Lymphoma

Lymphoma, Follicular

Lymphatic Diseases

Lymphoma, B-Cell

Neoplasms

Lymphoproliferative Disorders

CD20+ B-cell non-Hodgkin lymphoma of Low-Grade (Follicular or small lymphocytic lymphoma ) or aggressive (Diffuse large B-cell lymphoma (DLBCL) or Follicular stage III-IV.

Lymphoma, Large B-Cell, Diffuse

Intervention(s)

Rituximab

CIMAbior

Antineoplastic Combined Chemotherapy Protocols

Infusions, Intravenous

All patients will be treated with CIMAbior® (Rituximab biosimilar) 375mg/m2, intravenous infusion.

Group 1: CIMABior® as monotherapy during the induction phase. For patients with low grade non-Hodgkin's lymphoma (follicular or small lymphocytic who are chemoresistant or in their second or subsequent relapse after chemotherapy, they will receive a weekly dose for 4 cycles in the induction stage. They will continue the maintenance phase with the same dose of CIMAbior® every 2 months for 12 cycles.

Group 2: CIMABior® combined with chemotherapy. For not treated patients with stage III-IV follicular non-Hodgkin's lymphoma and patients with diffuse large B-cell non-Hodgkin lymphoma. They will receive induction therapy with CIMABior®, one dose every 21-28 days, concurrent with the fisrt-line chemotherapy used in the usual practice for the treatment of these diseases.

Group 3: CIMABior® as monotherapy direct in the maintenance phase. For patients with low-grade (follicular or small lymphocytic) non-Hodgkin's lymphoma who have responded to induction therapy. They will receive maintenance treatment, at a rate of one dose every two months until completing 12 cycles.

Drug Therapy

Primary Outcome(s)

1. Proportion of patients with severe adverse events and causal relationship (Definitive, Very Likely, Probable and Possible) with CIMAbior® administration. Measurement time: From the first administration of the product and up to 30 days after the last one.
2. Clinical response: complete remission (RC), complete unconfirmed response (RCu), partial remission (PR), stable disease (ES) or disease progression according to standardized criteria for Non-Hodgkin Lymphoma) . Measuring time: 2 years

Secondary Outcome(s)

1. Adverse events (AE). Measurement Time: From the first administration of the product and up to 30 days after the last one.
- Occurrence of adverse events (AE) in the subject (yes / no)
- Description of AE (Type (name of event),
- Duration (difference of dates between start and end of AE)
- Intensity (mild, moderate, severe, threatening or incapacitating, resulting in death).
- Severity of EE (Severe, Not Severe). It is considered serious when: it causes death or threatens the life of the subject, requires / prolongs hospitalization, produces significant or persistent disability / disability, or causes birth defects or congenital anomalies.
- Attitude to treatment (No change, dose modification, temporary interruption of treatment, definitive discontinuation of treatment).- Result (Recovered, Improved, Persistent, Sequels).
- Causal Relationship (Very Likely, Probable, Possible, Unrelated, Unknown).
2. Overall survival -OS (Time in months from the inclusion of the patient to the objective documentation of death). Measurement Time: until death.
3. Progression-free survival-SLP (Time in months from the inclusion of the patient to the objective documentation of progressive disease or death). Measurement Time: 1 year of follow-up or sooner if progression or death occurs.
4. Response against human anti-chimeric antibody-HACA (antibody titers value). Measuring time: up to 12 weeks after the last infusion if monotherapy, or after the last cycle of chemotherapy if combined treatment.

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

Center of Molecular Immunology (CIM) Ministry of Public Health (MINSAP)

Secondary Sponsor(s)

Not applicable