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Trial on Lenalidomide Given as Maintenance Therapy for Relapsed Diffuse Large B Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00799513
Recruitment Status : Unknown
Verified March 2012 by Andres J. M. Ferreri, IRCCS San Raffaele.
Recruitment status was:  Recruiting
First Posted : December 1, 2008
Last Update Posted : March 22, 2012
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Andres J. M. Ferreri, IRCCS San Raffaele

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: Lenalidomide Phase 2

Detailed Description:

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 or MINE 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 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial to Evaluate the Safety and Activity of Single-agent Lenalidomide Given as Maintenance Therapy After Response to Second-line Therapy in Patients With Relapsed DLBCL, Not Eligible for High-dose Chemotherapy and ASCT
Study Start Date : October 2009
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : November 2013


Arm Intervention/treatment
Experimental: 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.
Drug: 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.
Other Name: Revlimid




Primary Outcome Measures :
  1. 1-year progression-free survival [ Time Frame: 1-year ]

Secondary Outcome Measures :
  1. Median overall survival, response rate, response duration [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 65 years
  • Age < 65 but not eligible to high-dose chemotherapy and autologous stem cell transplantation
  • Biopsy-proven DLBCL relapsed to previous combination chemotherapy regimen ± rituximab
  • PR or CR to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab
  • ECOG performance status score < 4
  • Female of childbearing potential (FCBP) must demonstrate to practice a proper contraception to avoid any pregnancy risk during the study and at least 28 days after the discontinuation of the study
  • Male subjects must agree to practice a proper contraception during any sexual contact with females childbearing potential

Exclusion Criteria:

  • CNS involvement
  • Prior ASCT
  • TTP <6 months after first-line therapy
  • Use of experimental drugs during second-line salvage chemotherapy
  • Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus )
  • Active infectious disease
  • HIV, HBV or HCV- positivity
  • Impaired liver function (Bilirubin >2 x upper normal limit; ALT/AST/GGT > 3 x upper normal limit) at one month from salvage chemotherapy conclusion
  • Impaired renal function (creatinine clearance <50 ml/min) at one month from salvage chemotherapy conclusion
  • Absolute neutrophil count (ANC) <1000/microL
  • Platelet count <75.000 /mm3
  • Hemoglobin <9 g/dL
  • Non-co-operative behaviour or non-compliance
  • Psychiatric diseases or conditions that might impair the ability to give informed consent
  • Pregnant or lactating females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799513


Contacts
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Contact: Andrés J. Ferreri, MD 0039-02-2643 7649 andres.ferreri@hsr.it
Contact: Stefania Trinca 0039-02-2643 4289 stefania.trinca@hsr.it

Locations
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Italy
San Raffaele Scientific Institute Recruiting
Milan, Italy, 20132
Sub-Investigator: Roberto Crocchiolo, MD         
Sub-Investigator: Silvia Govi, MD         
Sponsors and Collaborators
IRCCS San Raffaele
Celgene Corporation
Investigators
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Study Chair: Andrés J. Ferreri, MD San Raffaele Scientific Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andres J. M. Ferreri, Unit Head, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT00799513     History of Changes
Other Study ID Numbers: 2008-003729-18
2008-003729-18 ( EudraCT Number )
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: March 2012
Keywords provided by Andres J. M. Ferreri, IRCCS San Raffaele:
Lenalidomide
revlimid
large B-cell lymphoma
relapse
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lenalidomide
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents