Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT Number 2009-011789-26 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is a phase II non-comparative study aimed to determine the feasibility and toxicity of the R-CHOP regimen in combination with intrathecal liposomal cytarabine and systemic intermediate-dose methotrexate followed by loco-regional radiotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CHOP, Depocyte, Methotrexate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate | Drug | Weeks 1-15:
Weeks 18-22: • Methotrexate 1.5 g/m2 q14 Days x 2 From Week 24: • Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Assessment | Number of patients who withdrew the treatment due to adverse event | From treatment start until the last drug administration, up to week 22 for the 'R-CHOP, Depocyte, Methotrexate' Group, up to 15 weeks (Weeks 1-15) for the 'R-CHOP + Lyposomal Cytarabine' Group, and from week 18-22 for the 'HD-MTX' Group |
| Measure | Description | Time Frame |
|---|---|---|
| 5 Year Cumulative Incidence of Progressions | Percentage of patients with disease progression after achieving a remission | From the first documented response to relapse until 5 years from study entry |
| 5 Years Progression Free Survival (PFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emanuele Zucca, MD | IOSI | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O. SS. Antonio e Biagio e Cesare Arrigo | Alessandria | Italy | ||||
| Spedali Civili |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38181782 | Derived | Conconi A, Chiappella A, Ferreri AJM, Stathis A, Botto B, Sassone M, Gaidano G, Balzarotti M, Merli F, Tucci A, Vanazzi A, Tani M, Bruna R, Orsucci L, Cabras MG, Celli M, Annibali O, Liberati AM, Zanni M, Ghiggi C, Pisani F, Pinotti G, Dore F, Esposito F, Pirosa MC, Cesaretti M, Bonomini L, Vitolo U, Zucca E. IELSG30 phase 2 trial: intravenous and intrathecal CNS prophylaxis in primary testicular diffuse large B-cell lymphoma. Blood Adv. 2024 Mar 26;8(6):1541-1549. doi: 10.1182/bloodadvances.2023011251. |
Not provided
Not provided
Not provided
Recruitment lasted from 27 September 2009 to 13 July 2017
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | R-CHOP, Depocyte, Methotrexate | Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15:
Weeks 18-22: • Methotrexate 1.5 g/m2 q14 Days x 2 From Week 24: • Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2010 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Percentage of patients free from disease progression after 5 years from study entry
| From study entry until 5 years after |
| 5 Years Overall Survival (OS) | Percentage of patients alive after 5 years from study entry | From study entry until 5 years after |
| Brescia |
| Italy |
| Ematologia Ospedale Businco | Cagliari | Italy |
| S. Martino Hospital | Genova | Italy |
| European Institute of Oncology | Milan | Italy |
| San Raffaele H Scientific Institute | Milan | Italy |
| Policlinico | Modena | Italy |
| A.O. San Gerardo | Monza | Italy |
| AOU Maggiore della Carità | Novara | Italy |
| S. Matteo | Pavia | Italy |
| Ospedale Civile | Piacenza | Italy |
| U.O. Ematologia AUSL Ravenna | Ravenna | Italy |
| Arcispedale Santa Maria Nuova | Reggio Emilia | Italy |
| IFO Regina Elena | Roma | Italy |
| Policlinico Universitario Campus Biomedico | Roma | Italy |
| Università La Sapienza | Rome | Italy |
| Humanitas | Rozzano | Italy |
| Azienda Ospedaliero-Universitaria | Sassari | Italy |
| A.O. S. Maria | Terni | Italy |
| A.O.U. San Giovanni Battista-Molinette, S.C. Ematologia 2 | Torino | 10134 | Italy |
| Ospedale di Circolo Fondazione Macchi | Varese | Italy |
| IOSI | Bellinzona | 6500 | Switzerland |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | R-CHOP, Depocyte, Methotrexate | Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, liposomal cytarabine, methotrexate: Weeks 1-15:
Weeks 18-22: • Methotrexate 1.5 g/m2 q14 Days x 2 From Week 24: • Scrotal prophylactic radiotherapy or involved field radiotherapy(but can be planned concomitantly to R-CHOP in pts with bilateral disease) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Ann Arbor stage | Ann Arbor staging is the staging system for lymphomas. The stage depends on the place where the malignant tissue is located.
Stage II indicates a worse outcome. | Count of Participants | Participants |
| |||||||||||||||||
| Bilateral testicular location | Count of Participants | Participants |
| ||||||||||||||||||
| B symptoms | B symptoms include fever, night sweats and weight loss of ≥10% of body weight over 6 months. Presence of B symptoms indicates a worse outcome. | Count of Participants | Participants |
| |||||||||||||||||
| Serum lactate dehydrogenase (LDH) | Count of Participants | Participants |
| ||||||||||||||||||
| Serum Beta2-microglobulin | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events Assessment | Number of patients who withdrew the treatment due to adverse event | Weeks 1 -15 All patients treated with 6 cycles of R-CHOP (CHOP21) on days 0/1 to 5, to be repeated every 21 days Intratecal (IT) Chemotherapy: liposomal cytarabine on day 0 of cycles 2, 3, 4 and 5 of R-CHOP Weeks 18 - 22 High Dose (HD) Methotrexate (MTX) Days 0 - 4 of two 14 days cycles From Week 25 Scrotal prophylactic radio therapy (RT) to the contralateral testis. | Posted | Count of Participants | Participants | From treatment start until the last drug administration, up to week 22 for the 'R-CHOP, Depocyte, Methotrexate' Group, up to 15 weeks (Weeks 1-15) for the 'R-CHOP + Lyposomal Cytarabine' Group, and from week 18-22 for the 'HD-MTX' Group |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | 5 Year Cumulative Incidence of Progressions | Percentage of patients with disease progression after achieving a remission | Posted | Number | 95% Confidence Interval | percentage of participants | From the first documented response to relapse until 5 years from study entry |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 5 Years Progression Free Survival (PFS) | Percentage of patients free from disease progression after 5 years from study entry | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry until 5 years after |
|
| |||||||||||||||||||||||||||||||||
| Secondary | 5 Years Overall Survival (OS) | Percentage of patients alive after 5 years from study entry | Posted | Number | 95% Confidence Interval | percentage of participants | From study entry until 5 years after |
|
|
All cause mortality was assessed through 5 years after study entry. All AEs were collected from the date of informed consent signature until 30 days after the end of treatment (week 26) for the "R-CHOP, Depocyte, Methotrexate" group; from the date of informed consent signature up to week 17 for the 'R-CHOP + Lyposomal Cytarabine' Group; from week 18 until 30 days after the end of treatment (week 26) for the 'HD-MTX' Group
SAE suspected to be related to the study treatment that occurred after the defined reporting period and up to 8 years from treatment start had also to be reported to the Sponsor.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Population | All patients who have received at least one dose of treatment will be considered as Safety Population | 12 | 54 | 19 | 54 | 47 | 54 |
| EG001 | R-CHOP + Lyposomal Cytarabine | Subjects treated with R-CHOP (CHOP21). | 0 | 54 | 17 | 54 | 47 | 54 |
| EG002 | HD-MTX | Subjects treated with HD-MTX. | 0 | 48 | 3 | 48 | 17 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase of neutrophilis | Investigations | MedDRA 5.1 | Systematic Assessment |
| |
| Prostatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 5.1 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Cardiac general pericardial effusion | Cardiac disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| CNS cerebrovascular ischemia | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Mucositis | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Injection site reaction/extravasation changes | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Acute urinary retention | Renal and urinary disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Diarreha | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Flue-like Syndrome | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Mucositis | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 5.1 | Systematic Assessment |
| |
| Sensitive/Peripheral Neuropathy | Nervous system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Transaminases increase | Hepatobiliary disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Trombocytopenia | Blood and lymphatic system disorders | MedDRA 5.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 5.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scientific and Medical Director | International Extranodal Lymphoma Study Group (IELSG) | +41 58 666 | 7321 | ielsg@ior.usi.ch |
| Jan 3, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011239 | Prednisolone |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
Not provided
Not provided
| >=65 years |
|
|
| Stage II |
|
|
| No Presence of B symptoms |
|
|
|
| Not recorded |
|
|
|
|