EUCTR2013-002388-25-IT
Active, not recruiting
Phase 1
Phase II study to evaluate the safety and the efficacy of rituximab, cyclophosphamide, non-pegylated liposomal doxorubicin, vincristine and prednisolone (R-COMP 14) as front-line therapy for patients with active Waldenstrom Macroglobulinemia
Azienda Ospedaliera Ospedali Riuniti Marche Nord0 sites40 target enrollmentJanuary 30, 2014
DrugsMYOCET
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Azienda Ospedaliera Ospedali Riuniti Marche Nord
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent prior to any study procedures being performed
- •Diagnosis of untreated Waldenstrom Macroglobulinemia
- •Age \>18 and \<80 years.
- •Karnofsky score \= 70% or WHO \=1\.
- •Adequate renal, pulmonary and hepatic function:
- •Serum creatinine \< 2 mg/dl;
- •Sat O2 \= 96%;
- •ALT/AST \= 2\.5 x N.
- •Fertile female must use adequate contraceptive precautions.
- •Patients with active disease.
Exclusion Criteria
- •People unable or unwilling to give informed consent.
- •Age \< 18 or \> 80 years.
- •HIV positivity.
- •HCV positivity with high viral load..
- •HBs Ag positivity.
- •Pregnancy or nursing female
- •Current uncontrolled infection.
- •Patients with a history of other malignancies within 2 years prior to
- •study entry.
- •Treatment with any other IMP, or participating in another clinical trial
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 2
Phase II study to evaluate the safety and the efficacy of CBD (Bortezomib, Cyclophosphamide, Dexamethasone) regimen for the patients with relapsed and/or refractory multiple myelomarelapsed and/or refractory multiple myelomaJPRN-UMIN000003076ara Hospital Kinki University School Of Medicine20
Active, not recruiting
Phase 1
A phase IIb study to determine the safety and efficacy of candidate influenza vaccine (MVA-NP+M1) in combination with licensed inactivated influenza vaccine in adults aged 65 years and aboveInfluenzaMedDRA version: 20.0 Level: LLT Classification code 10016790 Term: Flu System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]EUCTR2017-001103-77-GBVaccitech Limited862
Completed
Not Applicable
Intensive blood glucose control for chronic obstructive pulmonary disease (COPD) patients on acute medical wardsAcute exacerbation of chronic obstructive pulmonary disease (AECOPD)RespiratoryOther chronic obstructive pulmonary diseaseISRCTN42412334St George's, University of London (UK)20
Active, not recruiting
Not Applicable
TRIAL TO ASSESS THE EFFICACY OF LENVATINIB IN METASTATIC NEUROENDOCRINE TUMORS (TALENT STUDY).?EUCTR2015-001467-39-ESGETNE (Grupo Español de Tumores Neuroendocrinos)110
Completed
Phase 2
A clinical trial to study the safety and efficacy of a monoclonal antibody in patients with active psoriasisCTRI/2008/091/000296Biocon Limited