EUCTR2006-007082-36-GR
Active, not recruiting
Not Applicable
A Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosis
Hellenic Oncology Cooperative Group0 sites55 target enrollmentJuly 18, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hellenic Oncology Cooperative Group
- Enrollment
- 55
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Understand and voluntarily sign an informed consent form.
- •2\.Age \>18 years at the time of signing the informed consent form.
- •3\.Able to adhere to the study visit schedule and other protocol requirements.
- •4\.Confirmed diagnosis of AL amyloidosis
- •5\.Need for treatment in the judgment of their treating physician
- •6\.Evaluable or measurable disease defined by any of the following:
- •I.Measurable serum free light chains \> 10 mg/dL, kappa or lambda, provided ?/? ratio is abnormal (measurable disease) or abnormal ?/? ratio (evaluable)
- •II.monoclonal protein in the serum\>1 g/dL
- •7\.ECOG Performance Status (PS) 0, 1, 2 or 3
- •8\.Laboratory test results within these ranges:
Exclusion Criteria
- •1\.Patients with symptomatic multiple myeloma with asymptomatic biopsy confirmed AL amyloidosis
- •2\.Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •3\.Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
- •4\.Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •5\.Use of any other experimental drug or therapy within 28 days of baseline.
- •6\.Known hypersensitivity to thalidomide.
- •7\.The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •8\.Any prior use of lenalidomide.
- •9\.Concurrent use of other anti\-cancer agents or treatments.
- •10\.Known positive for HIV or infectious hepatitis, type A, B or C.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
Phase I/II Trial of Lenalidomide in Combination with Vorinostat and Dexamethasone as Therapy in Relapsed or Refractory Patients with Peripheral T-Cell Non-Hodgkin’s Lymphoma (PTCL)EUCTR2008-006919-20-ATArbeitsgemeinschaft medikamentöse Tumortherapie gemeinnützige GmbH
Active, not recruiting
Not Applicable
Phase II study of the combination of Lenalidomide and Alemtuzumab as consolidation in patients who responded to a previus chemotherapeutic regimen administered for relapsed or refractory Chronic Lymphocytic Leukemia (CLL) - len-camCLL patientsMedDRA version: 9.1Level: LLTClassification code 10008958Term: Chronic lymphocytic leukaemiaEUCTR2008-001823-71-ITAssociazione Malattie Sangue ONLUS
Terminated
Phase 1
A Phase Ib study of lenalidomide in combination with imatinib for adult patients with chronic myeloid leukaemia in second molecular remissioACTRN12615001169538South Australian Health & Medical Research Institute (SAHMRI)3
Active, not recruiting
Not Applicable
A Phase 1/2 Study of Lenalidomide in combination with Bendamustine (LEBEN) in relapsed and primary refractory Hodgkin Lymphomarelapsed and primary refractory Hodgkin LymphomaMedDRA version: 14.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]EUCTR2011-002810-35-ITISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
Active, not recruiting
Phase 1
PHASE II STUDY OF LENALIDOMIDE IN COMBINATION WITH RITUXIMAB (R) FOR THE TREATMENT OF INDOLENT NON FOLLICULAR NON HODGKIN LYMPHOMA - NDHistological proved diagnosis of B-cell CD20-positive non follicular NHL according to REAL/WHO Classification: a. small lymphocytic lymphoma b. lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia, c. nodal marginal zone lymphoma d. splenic marginal zone lymphomae. e. extranodal non-gastric marginal zone lymphomaMedDRA version: 9.1Level: LLTClassification code 10029463MedDRA version: 9.1Level: LLTClassification code 10003911MedDRA version: 9.1Level: LLTClassification code 10041652MedDRA version: 9.1Level: LLTClassification code 10025345EUCTR2008-001591-80-ITG.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI