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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003729-18 | EudraCT Number |
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| Name | Class |
|---|---|
| Celgene | INDUSTRY |
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This phase II multi-institutional trial will explore the safety and efficacy of lenalidomide monotherapy given as maintenance therapy following salvage chemo-immunotherapy in patients with relapsed or refractory chemosensitive diffuse large B-cell lymphoma
Patients older than 65 years or younger but not eligible to high-dose chemotherapy and autologous stem cell transplantation with biopsy-proven diffuse large B-cell lymphoma relapsed to previous combination chemotherapy regimen ± rituximab, who achieved at least a partial response to second-line chemotherapy (ICE or DHAP/DHAOx ((D)examethasone (H)igh-dose (A)ra-C - cytarabine (P)latinol (cisplatin)) or MINE (Mesna Ifosfamide Mitoxantrone Etoposide) regimen) + rituximab will receive single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment until progression of disease. Dose reductions of study drug will be made in case of adverse events when reported as correlated and when clinically appropriate.
One-year progression free survival (PFS) will be the primary endpoint and overall survival, response rate and toxicity will be the secondary endpoints. With the null hypothesis (P0) of 1-year PFS of 30%, this study will consider a satisfactory efficacy of lenalidomide worth of further investigation a P1 corresponding to a 1-yr PFS of 50% (that is an absolute increase of 20% in terms of 1-yr progression-free survival). Considering a standard type I error (α) of 0,05 and a power of 80% (Type 2 error of 20%) 47 patients will be necessary for the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomide | Experimental | single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease. |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year Progression-free Survival | It is defined as the number of participants alive after 1 year from enrolment to progression or relapse of lymphoma (if post-induction disease status was PR (Partial Response) or CR (Complete Response), respectively). Patients alive at last follow-up will be censored. | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Secondary measures to describe long term outcome of treatment -Progression free survival It is defined as the number of participants, on a 5 yrs follow up, free from disease progression | 5 years |
| Progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrés J. Ferreri, MD | San Raffaele Scientific Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Scientific Institute | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28219694 | Derived | Ferreri AJ, Sassone M, Zaja F, Re A, Spina M, Rocco AD, Fabbri A, Stelitano C, Frezzato M, Rusconi C, Zambello R, Couto S, Ren Y, Arcari A, Bertoldero G, Nonis A, Scarfo L, Calimeri T, Cecchetti C, Chiozzotto M, Govi S, Ponzoni M. Lenalidomide maintenance in patients with relapsed diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplantation: an open label, single-arm, multicentre phase 2 trial. Lancet Haematol. 2017 Mar;4(3):e137-e146. doi: 10.1016/S2352-3026(17)30016-9. Epub 2017 Feb 17. | |
| 23834234 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lenalidomide | single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease. Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lenalidomide | single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease. Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of 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 |
| 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 | 1-year Progression-free Survival | It is defined as the number of participants alive after 1 year from enrolment to progression or relapse of lymphoma (if post-induction disease status was PR (Partial Response) or CR (Complete Response), respectively). Patients alive at last follow-up will be censored. | Posted | Count of Participants | Participants | 1-year |
|
5 years
Definition per International Conference on Harmonization (ICH)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lenalidomide | single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease. Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | NCI CTCAE V3.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia G3+ | Blood and lymphatic system disorders | NCI CTCAE V3.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | San Raffaele Hospital IRCCS | 0226437649 | ferreri.andres@hsr.it |
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| 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 | Dec 1, 2015 | Jan 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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|
Progression It is defined as the number of participants with disease recurrence observed on a 5 yrs follow up.
| 5 years |
| Duration of Response | Secondary measures to describe long term outcome of treatment
| 5 years |
| Overall Survival | Secondary measures to describe long term outcome of treatment -Overall survival It is defined as the number of participants alive at 5ys from enrolment (death for any cause). Patients alive at last follow-up will be censored. | 5 years |
| Derived |
| Vose JM, Habermann TM, Czuczman MS, Zinzani PL, Reeder CB, Tuscano JM, Lossos IS, Li J, Pietronigro D, Witzig TE. Single-agent lenalidomide is active in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell transplantation. Br J Haematol. 2013 Sep;162(5):639-47. doi: 10.1111/bjh.12449. Epub 2013 Jul 9. |
| Participants |
| No |
|
| 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 | Count of Participants | Participants |
|
| Relapse Status | Count of Participants | Participants |
|
| Previous Lines for Diffuse Large B Cell Lymphoma (DLBCL) treatment | The different treatments for the medical condition used before the trial | Count of Participants | Participants |
|
| Previous ASCT (Autologous Stem-Cell Transplantation) | Count of Participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Score >=1 | Eastern Cooperative Oncology Group is a 0 to 5 scale which define health status 0 is perfectly healthy 5 is death | Count of Participants | Participants |
|
| International Prognostic Index | The International Prognostic Index (IPI) is a clinical tool developed by oncologists to aid in predicting the prognosis of patients with aggressive non-Hodgkin's lymphoma: Low risk (0-1 points) - 5-year survival of 73% Low-intermediate risk (2 points) - 5-year survival of 51% High-intermediate risk (3 points) - 5-year survival of 43% High risk (4-5 points) - 5-year survival of 26% | Count of Participants | Participants |
|
| Advanced stage of disease | Count of Participants | Participants |
|
| Increased LDH (lactate dehydrogenase) serum level | Count of Participants | Participants |
|
| Systemic symptoms (B status) | Count of Participants | Participants |
|
| Extranodal disease | Count of Participants | Participants |
|
| Bone marrow infiltration | Count of Participants | Participants |
|
| Hepatitis viral infection | Count of Participants | Participants |
|
| Salvage chemoimmunotherapy | Count of Participants | Participants |
|
| Response at time of trial registration | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Progression Free Survival | Secondary measures to describe long term outcome of treatment -Progression free survival It is defined as the number of participants, on a 5 yrs follow up, free from disease progression | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Progression | Progression It is defined as the number of participants with disease recurrence observed on a 5 yrs follow up. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Duration of Response | Secondary measures to describe long term outcome of treatment
| Posted | Count of Participants | Participants | 5 years |
|
|
|
| Secondary | Overall Survival | Secondary measures to describe long term outcome of treatment -Overall survival It is defined as the number of participants alive at 5ys from enrolment (death for any cause). Patients alive at last follow-up will be censored. | Posted | Count of Participants | Participants | 5 years |
|
|
|
| 22 |
| 48 |
| 12 |
| 48 |
| 7 |
| 48 |
| diarrhea | Gastrointestinal disorders | NCI CTCAE V3.0 | Systematic Assessment |
|
| melena | Gastrointestinal disorders | NCI CTCAE V3.0 | Systematic Assessment |
|
| stroke | Vascular disorders | NCI CTCAE V3.0 | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | NCI CTCAE V3.0 | Systematic Assessment |
|
| Herpes voster virus | Infections and infestations | NCI CTCAE V3.0 | Systematic Assessment |
|
| intestinal infraction | Gastrointestinal disorders | NCI CTCAE V3.0 | Systematic Assessment |
|
| meningitis | Infections and infestations | NCI CTCAE V3.0 | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |