Diffuse, Large B-Cell, Lymphoma Clinical Trial
Official title:
Multicenter Randomized Phase II Study of Treatment With R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI.
Verified date | September 2018 |
Source | Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting
for between 30% and 50% of the patients. Although it is considered a curable disease, still
at least 40 % of the patients will fail first line chemotherapy. The International Prognostic
Index (IPI) score and the age adjusted IPI (aIPI) has been used since they were published to
identify patients with different outcome.
There is not standard therapy for young patients with DLBCL and unfavourable IPI score. The
survival of these patients remains poor, with EFS around 40%.
The combination of RCHOP with new drugs is an attractive approach to treat these patients.
The goal is to evaluate the proportion of patients with Event-Free Survival (EFS) after 2
years, with a diagnosis of DLBCL with an aIPI > 1 or an aIPI =1 with increased levels of
beta-2-microglobulin (above the Upper Limits of Normal.)
Status | Completed |
Enrollment | 121 |
Est. completion date | August 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients diagnosed with primary diffuse DLBCL who have never received treatment for this condition. - Age between 18 and 70 years. - Age-adjusted IPI (aIPI) higher than 1, or equal 1 with high levels of beta-2-microglobulin (above UNL) - Cluster of Differentiation 20 (CD20) positive b lymphocytes. - Eastern Cooperative Oncology Group (ECOG) 0-3. - More than 12 weeks of life expectancy. - Signed Informed Consent. - Nor pregnant women nor breast-feeding women without heterosexual activity during the entire study. Women with heterosexual activity only if they are willing to use two methods of contraceptive. The two contraceptive methods can be, two barrier method or a barrier method combinated with an hormonal contraceptive method to prevent pregnancy, used during the entire study and until 3 months after the study completion. Exclusion Criteria: - Pregnant women or in breast-feeding period, or adults in childbearing period not using an effective contraception method. - Patients with Central Nervous System (CNS) lymphoma. - Severely impaired renal function (creatinine> 2.5 UNL) or hepatic function impairment (bilirubin or Alanine Amino Transaminase (ALT) / Aspartate Aminotransferase (AST) > 3 UNL), unless it is suspected to be due to the disease. - Human immunodeficiency virus (HIV) positive patients - Patient previously treated for the DLBCL - Positive determination of chronic hepatitis B (defined as positive serology for HBsAg). It will be allowed to enroll patients with hidden or previous hepatitis B (defined as positive antibodies against the core of the hepatitis B virus [HBcAb] and HBsAg negative) if undetectable Hepatitis B Virus (HBV) DNA. - Positive results for hepatitis C (antibody serology for hepatitis C virus ((HCV)). Patients with HCV positive may only participate if the Polymerase Chain Reaction (PCR) result is negative for HCV RNA. - History of cardiovascular disease with ventricular ejection fraction < 50%. - Patients with severe psychiatric conditions that may interfere with their ability to understand the study (including alcoholism or drug addiction). - Patients with known hypersensitivity to murine proteins or any other components of the study drugs. - Transformed follicular lymphoma. - History of other neoplastic malignancy with < 5 year of complete response (except for Squamous Cell Carcinoma of the Skin or cervical Carcinoma in situ). - Presence of uncontrolled conditions: cardiac, respiratory, neurologic, metabolic etc., not related to lymphoma. - Uncontrolled hypertension (diastolic blood pressure over 110 mmHg). |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Fundación Alcorcón | Alcorcón | Madrid |
Spain | Institut Català d'Oncologia, Hospital Germans Trias i Pujol | Badalona | Barcelona |
Spain | Hospital Clinic i Provincial de Barcelona | Barcelona | |
Spain | Hospital Universitari de Girona Doctor Josep Trueta | Girona | |
Spain | Hospital de Jerez | Jerez de la Frontera | Cádiz |
Spain | Institut Català d'Oncologia, Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona |
Spain | Centro Integral Oncológico Clara Campal | Madrid | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Universitario Infanta Leonor | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
Spain | Hospital Universitario Central de Asturias | Oviedo | Asturias |
Spain | Hospital Son Llàtzer | Palma | Islas Baleares |
Spain | Hospital Universitario de Salamanca | Salamanca | |
Spain | Hospital Universitario de Canarias | Santa Cruz de Tenerife | |
Spain | Hospital Universitario Marqués de Valdecilla | Santander | Cantabria |
Spain | Hospital Universitario Virgen del Rocío | Sevilla | |
Spain | Hospital Universitari i Politècnic La Fe | Valencia | |
Spain | Hospital Universitario Doctor Peset | Valencia | |
Spain | Complejo Hospitalario Universitario de Vigo | Vigo | Pontevedra |
Spain | Hospital Clínico Universitario Lozano Blesa | Zaragoza | Aragón |
Lead Sponsor | Collaborator |
---|---|
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea | Janssen-Cilag, S.A. |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Biological project | To explore the mutational profile in a selection of these cases by massive sequencing. To analyze the impact of the molecular classification of DLBCL based on immunohistochemistry (IHC) (as Hans algorithms, Choi and Meyer) in the prospective series of the patients of this clinical trial. To explore the effect of the expression of genes, Micro-Ribonucleic Acid (miRNAs) and proteins of interest. Refine the IHC analysis with automatic quantification methods of protein expression. To explore the effect of frequent cytogenetic alterations in DLBCL. |
During recruitment period, after patient randomization. | |
Primary | Proportion of patients with Event-Free Survival at 2 years. | To evaluate the proportion of patients with event-free survival at 2 years in patients diagnosed of DLBCL with aIPI > 1 or aIPI=1 with elevated levels of beta 2-microglobulin (above UNL). UNL= Upper Normal Limit. |
During treatment period, there will be assessments every 2 cycles. After end of treatment every 3 month the first year, every 6 months the second year and annually from 3rd to 5th year | |
Secondary | Event-Free survival at 2 years in the different subtypes of DLBCL | Event-free survival at 2 years in the different subtypes of DLBCL subgroups: Germinal center B-cell-like (GCB)/non-GCB. | Once the treatment is started, there will be weekly safety visits, visits before each treatment cycle, at day 60 after the sixth cycle and then follow-up visits every three months during the first 2 years and every 6 months until the 5th year | |
Secondary | Overall survival at 2 years | Overall survival at 2 years in patients diagnosed of DLBCL with aIPI > 1 or aIPI=1 with elevated levels of beta 2-microglobulin (above UNL) | Once the treatment is started, there will be weekly safety visits, visits before each treatment cycle, at day 60 after the sixth cycle and then follow-up visits every three months during the first 2 years and every 6 months until the 5th year. | |
Secondary | Overall response rate and complete remissions | Overall response rate and complete remissions in patients diagnosed of DLBCL with aIPI > 1 or aIPI=1 with elevated levels of beta 2-microglobulin (above UNL). | Once the treatment is started, there will be weekly safety visits, visits before each treatment cycle, at day 60 after the sixth cycle and then follow-up visits every three months during the first 2 years and every 6 months until the 5th year. | |
Secondary | Toxicity according to the CTC criteria | Toxicity according to the Common Toxicity Criteria (CTC) (version 3.0) of the National Cancer Institute (NCI). | Once the treatment is started, there will be weekly safety visits, visits before each treatment cycle, at day 60 after the sixth cycle and then follow-up visits every three months during the first 2 years and every 6 months until the 5th year. | |
Secondary | To evaluate the predictive value for EFS of interim PET/CT evaluation | To evaluate the predictive value for EFS of interim PET/CT evaluation after 2 and 4 cycles of chemotherapy. The PET Network group of Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea (GELTAMO), will conduct this blind central review in real-time (qualitative and quantitative, prospective central review of the PET scans performed) |
Before treatment, after second cycle, after fourth cycle and after treatment completion. | |
Secondary | To identify clinical and biological prognostic factors for response and survival. | To identify clinical and biological prognostic factors for response and survival. | Once the treatment is started, there will be weekly safety visits, a visit before each treatment cycle, a visit at day 60 after the sixth cycle and then follow-up visits every three months the first 2 years and every 6 months until the 5th year. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02871869 -
Cinobufacini Tablets Combined With Chemotherapeutic Protocol in Treatment of Diffuse Large B Cell Lymphoma
|
Phase 2/Phase 3 | |
Terminated |
NCT02374424 -
Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients
|
Phase 2 | |
Completed |
NCT02391116 -
Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)
|
Phase 2 | |
Terminated |
NCT04236141 -
A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Bendamustine and Rituximab Compared With Bendamustine and Rituximab Alone in Chinese Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL).
|
Phase 3 | |
Completed |
NCT00599170 -
Rituximab Plus CHOP With Sargramostim in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
|
Phase 2 | |
Completed |
NCT02867566 -
A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients
|
Phase 3 | |
Terminated |
NCT02855359 -
Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma
|
Phase 2 | |
Completed |
NCT02216890 -
Safety Study of SGN-CD70A in Cancer Patients
|
Phase 1 | |
Active, not recruiting |
NCT01181271 -
Tandem Auto-Allo Transplant for Lymphoma
|
Phase 2 |