RituxCIM in relapsed or refractory indolent 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.

Scientific title:

Evaluation of the effect and safety of RituxCIM (biosimilar Rituximab) in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma

Secondary indentifying numbers:

IIC RD-EC 138

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM) Cuban Health Ministry (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:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

11/07/2011

Reference number:

05.006.10.B

Principal investigator

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

First name:

Carlos

Last name:

Hernández Padrón

Medical Specialty :

MD, second degree specialist in Hematology

Affiliation:

Hematology and Immunology Institute

Postal address:

San Francisco y Perla, Altahabana

City:

Havana

País:

Cuba

Zip Code:

10800

Telephone:

+53-76442456

Email address:

chdezp@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:

Havana, Hospital “Hermanos Ameijeiras”, Isbel Moya Pérez, MD, first degree specialist in Hematology

Havana, Center of Medical and Surgical Research, Clara Luna Conde, MD, first degree specialist in Hematology

Havana, National Institute of Oncology and Radiobiology, Elías A. Gracia Medina, MD, first degree specialist in Oncology

Havana, Hospital “Carlos J. Finlay”, Viviana Cristo Pérez, MD, first degree specialist in Hematology

Pinar del Rio, Hospital “Abel Santamaría”, Dayan Marín Hernández, MD, first degree specialist in Hematology

Artemisa, Hospital “Comandante Pinares”, Anadelys Gamez Perez, MD, first degree specialist in Hematology

Cienfuegos, Hospital “Gustavo Aldereguía Lima”, Julio Dámaso Fernández Águila, MD, first degree specialist in Hematology

Villa Clara, Hospital “Arnaldo Milián Castro”, Agnerys López Saucedo, MD, first degree specialist in Hematology

Villa Clara, Hospital Celestino Hernández Robau, Ana de la Torre Santos, MD, first degree specialist in Oncology

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

Santi Spiritus, Hospital “Camilo Cienfuegos”, Michel Rafael Sánchez González, MD, first degree specialist in Hematology

Las Tunas, Hospital “Ernesto Guevara”, Rogelio Pérez Rivero, MD, first degree specialist in Hematology

Research ethics committees:

Hematology and Immunology Institute, July 5, 2010

Hospital “Hermanos Ameijeiras”, January 11, 2010

Center of Medical and Surgical Research, April 28, 2010

National Institute of Oncology and Radiobiology, Abril 19, 2010

Hospital “Carlos J. Finlay”, May 31, 2010

Hospital “Abel Santamaría”, June 16, 2010

Hospital “Comandante Pinares”, June 14, 2012

Hospital “Gustavo Aldereguía Lima”, March 26, 2010

Hospital “Arnaldo Milián Castro”, January 4, 2010

Hospital Celestino Hernández Robau, June 15, 2010

Hospital “Juan Bruno Zayas”, June 11, 2010

Hospital “Camilo Cienfuegos”, July 17, 2013

Hospital “Ernesto Guevara”, June 21, 2013

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

18/10/2011

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:

Relapsed or refractory indolent B-cell non-Hodgkin lymphoma

Intervention(s):

Study group RituxCIM (Rituximab biosimilar): 375mg/m2 weekly, for 4 weeks (intravenous infusion), following the same methodology of administration of the commercial Rituximab.

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):

Overall Response (complete remission (CR), unconfirmed complete response (Rcu) or partial remission (PR)). Measuring Time: at 6 weeks after four doses.

Key secondary outcomes:

Progression-free survival (PFS). Time in months from inclusion date until it objectively documented progressive disease or death. Measuring time: 1 year of follow-up or progression date or death date. Time to progression (TTP).Time in months from clinical response date until it objectively documented progressive disease or death. Measuring time: 1 year of follow-up or progression date or death date. Pharmacokinetics (Plasma concentration, maximal concentration, plasma half-life of a drug (T ½), Clearance). Measuring time: at 1st and 4th dose. Immune Response (Labeling with mAb, B-cell markers, serum immunoglobulin levels, levels of circulating immune complexes, complement hemolytic activity CH50). Measuring time: before each dose of RitxCIM, at 6 weeks after 4 doses. B cells depletion (Absolute counts of B cells in peripheral blood). Measuring time: before each dose of RitxCIM, at 6 weeks after 4 doses. Incidence of Adverse Events (AE) (type (name of AE), Duration (difference between start date and the end date of the AE), Intensity (Mild, Moderate, Severe, which threatens or incapacitates, Death), Gravity (Serious, Not serious), Attitude regarding treatment (No change, Dose modification, temporary interruption of treatment, final interruption of treatment), Outcome (Recovered, Improved, Persists, Sequelae) causality relationship (Final, Very Likely, Likely, Possible, Not related, Unknown)). Measuring time: in every administration until to complete 1 year.

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. Age greater than or equal to 18 years, of any gender. 3. Performance status less than or equal to 2 (ECOG). 4. Able and willing to give written informed consent. 5. Patients could have received any previous specific therapy (Chemotherapy/radiotherapy), provided that such treatment had ended, at least, 4 weeks before being included in the study. 6. Patients comply with the requirements of the clinical laboratory: Hemoglobin≥ 100 g/L ALC ≥ 3 x 10∧9 cells/L ANC ≥ 1,5x10∧9 /L platelets ≥100 x 10∧9/L, TGO/TGP≤ 2.5 time upper normal limits creatinine and bilirubin ≤ 1.5 time upper normal limits.

Exclusion criteria:

1. Presence of brain metastasis. 2. Diagnosis of follicular lymphoma III B (clasiffied by WHO). 3. Patients who have been previously treated with corticosteroids, two weeks before inclusion 4. Uncontrolled hypertension 5. History of demyelinated diseases or inflammatory perfiric or CNS. 6. Pregnancy or breastfeeding. 7. Human Immunodeficiency Virus (HIV) seropositivity 8. History of other cancer, except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix. 9. Acute allergy or history of severe allergic reactions or autoimmune disease. 10. Patients on any other experimental product. 11. Patients who have been previously treated with comercial Rituximab 12. History of allergy to chemical or biologicl compounds similar to the experimental product. 13. Patients who have any decompensated concomitant disease, including but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, aortic stenosis, endocarditis and psychiatric illnesses that may limit adherence to the requirements of the test.

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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

1-2

Target sample size:

114

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:

Patricia

Last Name:

Hernandez Casaña

Specialty:

PhD, Clinical Researcher Promoter

Affiliation:

Center of Molecular Immunology

Postal Address:

216th & 15th Ave., Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600, PO Box 16040

Telephone:

+537-214-3145

Email :

patriciahc@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:

Patricia

Last Name:

Hernandez Casaña

Specialty:

PhD, Clinical Researcher Promoter

Affiliation:

Center of Molecular Immunology

Postal Address:

216th & 15th Ave., Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600, PO Box 16040

Telephone:

+537 214-3145

Email :

patriciahc@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:

RPCEC00000174

Date of Registration in Primary Registry:

05/11/2013

Record Verification Date:

2013/11/05

Next update date:

2014/11/05

Link to the spanish version:

Click here [3]