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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

CIMAbiorLNH-IV

Scientific title:

Safety and effectiveness of CIMAbior® in patients with CD20-positive B-cell Non-Hodgkin Lymphoma. Phase IV

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Trials notification

Regulatory instance:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Ana

Midle name:

Victoria

Last name:

de la Torre Santos

Medical Specialty :

Second degree specialist in Oncology

Affiliation:

Celestino Hernandez University Hospital

Postal address:

Avenida Liberacion No. 99, Santa Catalina

City:

Villa Clara

País:

Cuba

Zip Code:

50100

Telephone:

+53-042279442

+53-042272015 ext. 1059

Email address:

anavdelatorre@infomed.sld.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Pinar del Rio. Abel Santamaria Cuadrado Hospital. Dayan Marin Hernandez. MD, Second degree specialist in Hematology

Artemisa. Comandante Pinares Hospital. Anadely Gamez Perez. MD, Second degree specialist in Hematology

Villa Clara. Arnaldo Milian Castro Hospital. Rosa Oliday Rios Jimenez. MD, first degree specialist in Hematology

Matanzas. Faustino Perez Hospital. Nereyda Alvarez Vega. MD, first degree specialist in Hematology

Sancti Spiritus. Camilo Cienfuegos Hospital. Gloritza Rodriguez Matos. MD, first degree specialist in Hematology

Ciego de Avila. Antonio Luaces Iraola Hospital. Yudelvis Perez Falcón. MD, first degree specialist in Hematology

Camaguey. Hospital Maria Curie. Irene Álvarez Montane, MD, first degree specialist in Oncology

Holguín. Lucia Inniguez Landin Hospital. Dr. Leonardo Laguna Salvia, MD, first degree specialist in Hematology

Granma. Celia Sanchez Manduley Hospital. Julio Hechavarria Figueredo. MD, first degree specialist in Hematology

Granma. Carlos Manuel de Cespedes Hospital. Gala Nausica Romero Moratalla. MD, first degree specialist in Internal Medicine

Santiago de Cuba. Juan Bruno Zayas Hospital. Geldris P. Hernandez Galano. MD, first degree specialist in Hematology

Guantanamo. Agostinho Neto Hospital. Dr. Douglas Mendez Romero. MD, first degree specialist in Hematology

Research ethics committees:

Celestino Hernandez Robau Hospital, August 18, 2017

Abel Santamaria Cuadrado Hospital, in process

Comandante Pinares Hospital, in process

Arnaldo Milian Castro Hospital, in process

Faustino Perez Hospital, in process

Camilo Cienfuegos Hospital, in process

Antonio Luaces Iraola Hospital, in process

Maria Curie hHospital, in process

Lucia Inniguez Landin Hospital, in process

Celia Sanchez Manduley Hospital, in process

Carlos Manuel de Cespedes Hospital, in process

Juan Bruno Zayas Hospital, in process

Agostinho Neto Hospital, in process

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

01/10/2017

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

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.

Health condition(s) code:

Lymphoma, Large B-Cell, Diffuse

Neoplasms

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Lymphoma

Lymphoproliferative Disorders

Lymphatic Diseases

Hemic and Lymphatic Diseases

Immunoproliferative Disorders

Immune System Diseases

Lymphoma, Follicular

Intervention(s):

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.

Intervention code:

Rituximab

Drug Therapy

Antineoplastic Combined Chemotherapy Protocols

Infusions, Intravenous

Intervention keyword:

CIMAbior

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Parallel

Phase:

Target sample size:

Recruitment for 2 years

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Yaimarelis

Last Name:

Saumell Napoles

Specialty:

Bachelor in Pharmacy

Affiliation:

Center of Molecular Immunology

Postal Address:

Street 216 & 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53 72717933 ext 3491, +53 7214 3144

Email :

yaimarelis@cim.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Yaimarelis

Last Name:

Saumell Napoles

Specialty:

Bachelor in Pharmacy

Affiliation:

Center of Molecular Immunology

Postal Address:

Street 216 & 15, Atabey, Playa,

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53 7271 7933 ext 3491, +53 72143144

Email :

yaimarelis@cim.sld.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000251

Date of Registration in Primary Registry:

05/09/2017

Record Verification Date:

2017/09/05

Next update date:

2018/09/05

Link to the spanish version:

Click here [3]