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1B8 vs MabThera® in patients with Diffuse large B-cell lymphoma
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19 February 2018 - 11:11am
by CIM
19 July 2023 - 3:32pm
by Gladys
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Revision of 19 July 2023 - 3:32pm:
1B8 vs MabThera® in patients with Diffuse large B-cell 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:
Pharmacokinetics and safety of 1B8 vs MabThera evaluation, both in combination with CHOP chemotherapy in newly diagnosed patients diffuse large B-cell lymphoma, CD 20+. Phase I.
Secondary indentifying numbers:
Not applicable
Issuing authority of the secondary identifying numbers:
Not applicable
Primary sponsor:
Center of Molecular Immunology (CIM)
Secondary sponsor:
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:
Center for State Control of Drugs, Medical Devices and Equipment (CECMED)
Authorization date :
19/08/2016
Reference number:
B-17-058-L01
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Elias, INOR Calixto, HHA
Last name:
Gracia Medina, INOR Hernandez Cruz, HHA
Medical Specialty :
MD. Second degree specialist in Oncology, INOR MD. Second degree specialist in Hematology, HHA
Affiliation:
Havana, National Institute of Oncology and Radiobiology (INOR) Havana, “Hermanos Ameijeiras” Hospital (HHA)
Postal address:
29 esq F, Vedado, Plaza de la Revolucion, INOR San Lazaro No. 701 esq. Belascoain. Centro Habana, HHA
City:
Havana, INOR Havana, HHA
Country:
Cuba, INOR Cuba, HHA
Zip Code:
10400, INOR 10300, HHA
Telephone:
+53-78369209
+53-78761459
Email address:
oncmedica@inor.sld.cu
hemat@hha.sld.cu
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, Hematology and Immunology Institute, Yamile Quintero Sierra, MD, first degree specialist in Hematology
Research ethics committees:
National Institute of Oncology and Radiobiology, May 26, 2016.
Hermanos Ameijeiras Hospital, May 10, 2016.
Hematology and Immunology Institute, May 20, 2016.
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Recruiting
Date of first enrollment:
26/04/2017
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:
Diffuse large B-cell lymphoma, newly diagnosed
Health condition(s) code:
Lymphoma, Large B-Cell, Diffuse
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Hemic and Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms
Intervention(s):
Group A (Experimental): 1B8 (Rituximab biosimilar) 375 mg/m2 every 21 days (Intravenous infusions) + CHOP scheme for 6 to 8 cycles. Group B (Control) MabThera (RITUXAN) 375mg / m2 every 21 days (Intravenous infusions) + CHOP scheme for 6 to 8 cycles. CHOP scheme: Doxorubicin (50 mg/m2 day 1); Vincristine (1.4 mg/m2 day 1); Cyclophosphamide (750 mg/m2 day 1); Prednisolone (100 mg days 1 to 5). It is will administered every 21 days, depending on the patient's clinical condition and response to treatment, up to a maximum of 6-8 cycles, considering a maximum cumulative dose of doxorubicin of 450 mg / m2.
Intervention code:
Rituximab
Antibodies, Monoclonal, Murine-Derived
Antibodies, Monoclonal
Biosimilar Pharmaceuticals
Administration, Intravenous
Doxorubicin
Vincristine
Cyclophosphamide
Prednisone
Intervention keyword:
1B8 RITUXAN MabThera® Rituximab biosimilar CHOP scheme
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):
- Pharmacokinetic Serum concentration (Cp). Measurement time: before each cycle of treatment and 3 months after the last cycle Maximum concentration (AUC). Measurement time: before each cycle of treatment and 3 months after the last cycle Half-life (t ½). Measurement time: before each cycle of treatment and 3 months after the last cycle Plasma clearance (CL). Measurement time: before each cycle of treatment and 3 months after the last cycle - Pharmacodynamic - B cells depletion (Absolute counts of CD19+ in peripheral blood). Measurement time: before each cycle of treatment and 3 months after the last cycle
Key secondary outcomes:
Effect: Clinical Response (standardized criteria for NHL: complete remission, unconfirmed complete response, partial remission, stable disease or progressive disease). Measurement time: 4 weeks after the last cycle of treatment Safety: Adverse events (AEs). Measurement time: 10 months - Occurrence of an AE in the subject (yes / no) - Description of AE (Name of adverse event) - Duration of AE (difference between the start dates and completion of the event) - Intensity AE (Mild, Moderate, Severe, Life-threatening or disabling, produces death) - Gravity AE (Severe / serious, severe / not serious) - Attitude to study treatment (unchanged, dose modification, temporary interruption or discontinuation of study treatment) - Result of the AE (recovered, improved, persists or sequels) - Causal relationship (1 Definitive, 2. Very Probable, 3. Probable, 4. Possible 5. Not related 6. Unknown) Immunogenicity: HACA Response (according OD title). Measurement time: before each cycle of treatment, 4 weeks post the last cycle of treatment and 3 months after the last cycle
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:
70 years
Inclusion criteria:
1. Patients that fulfill diagnosis criteria 2. Eligible for scheme CHOP 3. Age greater than or equal to 18 years and not older than 70 years, of any gender. 4. ECOG performance status less than or equal to 2 5. Express written request of the patient 6. Measurable disease at diagnosis 7. Requirements of the clinical laboratory (Hb≥ 100 g/L, ALC ≥ 3 x 109 cells/L, ANC ≥ 1,5x109 /L, Platelets ≥100 x 109/L, Transaminases ≤ 2.5 time upper limit of normal, Creatinine and bilirubin ≤ 1.5 upper limit of normal)
Exclusion criteria:
1. LNH evidence of spread of the central nervous system or primary CNS involvement 2. Extranodal NHL, intravascular or plasmablastic 3. Uncontrolled hypertension 4. History of Demyelinating disease or inflammatory of the CNS or peripheral 5. Pregnancy or breastfeeding. 6. Human Immunodeficiency Virus (HIV) seropositivity 7. History of other cancer, except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix. 8. Acute allergy or history of severe allergic reactions or autoimmune disease or primary immunodeficiencies 9. On any other experimental product. 10. History of allergy to active substances, excipients and murine proteins similar to the experimental product or any of the drugs chemotherapy regimen that will receive to the patient 11. Decompensated related chronic disease, they are including but not limited to: active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, aortic stenosis, endocarditis and psychiatric diseases that may limit adherence to the requirements of the assay 12. Left Ventricular Ejection Fraction less than 50% 13. Known seropositive for hepatitis B or C virus
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:
Active
Study design:
Parallel
Phase:
1
Target sample size:
20
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:
Ivis
Last Name:
Mendoza Hernandez
Specialty:
Degree in Pharmaceutical Sciences. Master in Clinical Pharmacology
Affiliation:
National Coordinator Center for Clinical Trials
Postal Address:
5ta A e/ 60 y 62, Playa
City:
Havana
Country:
Cuba
Zip Code:
11300
Telephone:
+537-216-4227 +537-2164 228
Email :
ivis@cencec.sld.cu
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:
Yanelda
Last Name:
Garcia Vega
Specialty:
Degree in Biochemistry. Master of Science in Clinical Laboratory
Affiliation:
Center of Molecular Immunology
Postal Address:
216 Esquina 15, Atabey, Playa
City:
Havana
Country:
Cuba
Zip Code:
16040
Telephone:
+537 2717933 Ext 3449
Email :
yaneldag@cim.sld.cu
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:
RPCEC00000216
Date of Registration in Primary Registry:
01/09/2016
Record Verification Date:
2018/02/19
Next update date:
2019/02/19
Link to the spanish version:
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