Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 61 of 315 for:    BENDAMUSTINE

A Phase II Study for Patients With Indolent Non-follicular Non-Hodgkin's Lymphoma (IIL INFL09)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929265
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

Brief Summary:
This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).

Condition or disease Intervention/treatment Phase
Indolent Non-follicular Non-Hodgkin's Lymphoma Drug: Bendamustine Phase 2

Detailed Description:

This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).

The study includes and induction phase and a consolidation phase.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Bendamustine in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-follicular Non-Hodgkin's Lymphoma
Study Start Date : January 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Rituximab - Bendamustine (RB)

1 arm: Rituximab - Bendamustine (RB)

1 arm for all patients

Drug: Bendamustine

INDUCTION PHASE

Rituximab - Bendamustine (RB): cycles 1 to 4 (0, 4, 8, 12 week):

Rituximab: 375 mg/sqm iv, day 1*

Bendamustine: 90 mg/sqm iv, days 1-2 or days 2-3 according to istitutional/patient/physician choice

Repeat cycles every 28 days for a total of 4 cycles

*In cycle 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8.

CONSOLIDATION PHASE

Rituximab - Bendamustine (RB): cycles 5 to 6 (16, 20 week):

Rituximab: 375 mg/sqm iv day 1

Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to istitutional/patient/physician choice

Rituximab two monthly doses

Rituximab: 375 mg/sqm iv week 24 and 28

Other Name: RIBOMUSTIN




Primary Outcome Measures :
  1. Complete remission rate (CR) [ Time Frame: 5 months ]
    Evaluated at the end of treatment


Secondary Outcome Measures :
  1. Safety analysis [ Time Frame: 5 months ]
    Evaluated during and at the end of treatment. Percentage of patients with adverse, hematological and non-hematological toxic events

  2. Overall response rate (ORR) [ Time Frame: 5 months ]
    Evaluated at the end of treatment. Complete plus partial remission.

  3. Overall survival (OS) [ Time Frame: at 2 years ]
    Dead for any causes after diagnosis. Evaluated by means of Kaplan-Meier method.

  4. Progression free survival (PFS) [ Time Frame: at 2 years ]
    Progression, relapse or dead for any causes after diagnosis. Evaluated by means of Kaplan-Meier method.

  5. Disease free survival (PFS) [ Time Frame: at 2 years ]
    Relapse or dead for any causes from the end of treatment, for patients in CR after B+R. Evaluated by means of Kaplan-Meier method.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form
  2. Histological (bone marrow or lymph nodes biopsy) proven diagnosis of B-cell CD20- positive non-follicular NHL according to REAL/WHO Classification:

    i. small lymphocytic lymphoma-SLL (bone marrow or lymph nodes biopsy ii. lymphoplasmacytic/citoid lymphoma/ Waldenstrom macroglobulinemia(bone marrow or lymph nodes biopsy) iii. nodal marginal zone lymphoma (lymph nodes biopsy)

  3. Untreated patients
  4. Stage III or IV or stage II with more than three involved sites
  5. Presence of at least one of the following criteria for the definition of active disease:

    1. Systemic symptoms
    2. Hemoglobin less than 10 g/dL (due to lymphoma)
    3. Platelets less than 100 x 10 9/L (due to lymphoma)
    4. Diffuse bone marrow infiltrate
    5. Lymphocyte doubling time less than 12 months (in leukemic cases)
    6. Bulky disease (>7 cm)
  6. Aged 18 - 75 Life expectancy >6 months
  7. ECOG performance status 0-2
  8. LVEF ≥45% or FS ≥37%
  9. ANC ≥1 x 10 9/l and Platelets count ≥75 x 10 9/l, unless due to bone marrow involvement by follicular lymphoma
  10. Creatinine up to 1.5 x ULN
  11. Conjugated bilirubin up to 2 x ULN
  12. Alkaline phosphatase and transaminases up to 2 x ULN
  13. Written informed content

Exclusion Criteria:

  1. Patients with diagnosis of marginal zone lymphoma of splenic or MALT origin
  2. Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL)
  3. Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy
  4. History of other malignancies within 3 years prior to study entry except for: adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage, localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent
  5. Medical condition requiring long term use (>1 months) of systemic corticosteroids
  6. Active bacterial, viral, or fungal infection requiring systemic therapy
  7. Concurrent medical condition which might exclude administration of therapy
  8. Cardiac insufficiency (NYHA grade III/IV)
  9. Myocardial infarction within 6 months of entry on study
  10. Severe chronic obstructive pulmonary disease with hypoxemia
  11. Severe diabetes mellitus difficult to control with adequate insulin therapy
  12. Hypertension that is difficult to control
  13. Impaired renal function with creatinine clearance <30 ml/min
  14. HIV positivity
  15. HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive(these patientes need to receive prophylaxis with Lamivudine)
  16. HCV positivity with the exception of patients with HCV RNA negative.
  17. CNS involvement by lymphoma
  18. Participation at the same time in another study in with investiogational drugs are used
  19. Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
  20. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
  21. Women in pregnancy or breastfeeding

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): NCT01929265


Locations
Layout table for location information
Italy
SC Ematologia - AO SS. Antonio e Biagio e C. Arrigo
Alessandria, AL, Italy, 15121
SC Ematologia Spedali Civili
Brescia, BS, Italy
Divisione di Ematologia e Trapianti, Ospedale San Maurizio
Bolzano, BZ, Italy
Divisione di Ematologia, Centro Trapianto di Cellule Staminali
San Giovanni Rotondo, Foggia, Italy
Divisione Ematologia I , Ospedale San Martino
Genova, GE, Italy
S.C. Ematologia Azienda Ospedaliera Papardo
Messina, ME, Italy
Divisione di Oncologia Medica ed Ematologia, Istituto Clinico Humanitas
Rozzano, Milano, Italy
Divisione di Ematologia Ospedale Niguarda
Milano, MI, Italy
Centro Oncologico Modenese
Modena, MO, Italy
Ematologia Azienda Ospedaliero Universitaria Paolo Giaccone
Palermo, PA, Italy
Div. Oncologia Medica - CRO, Centro di Riferimento Oncologico
Aviano, PN, Italy
UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, Italy
Oncoematologia Istituto Pascale
Napoli, Italy
S.C.D.U Ematologia Azienda Ospedaliero Universitaria Maggiore
Novara, Italy
UO Ematologia Università - Policlinico San Matteo
Pavia, Italy
Ematologia Ospedale Santo Spirito
Pescara, Italy
UOA Ematologia, Ospedale Civile Ospedale G. da Saliceto
Piacenza, Italy
Div. Ematologia AO Bianchi Melacrino Morelli
Reggio Calabria, Italy
Ematologia, Azienda Ospedaliera Arcispedale "S.Maria Nuova"
Reggio Emilia, Italy
Ematologia, Università "La Sapienza"
Roma, Italy
Clinica Ematologia Policlino Le Scotte
Siena, Italy
Struttura Complessa di Onco-Ematologia Azienda Ospedaliera S.Maria
Terni, Italy
SC Ematologia - Città della Salute e della Scienza
Torino, Italy
SC Ematologia U - Città della Salute e della Scienza
Torino, Italy
Clinica Ematologica e Unità di Terapie Cellulari 'Carlo Melzi' AOU S. Maria della Misericordia
Udine, Italy
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Investigators
Layout table for investigator information
Principal Investigator: Luca Baldini, Prof. UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Layout table for additonal information
Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT01929265     History of Changes
Other Study ID Numbers: IIL INFL09
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: March 2017
Keywords provided by Fondazione Italiana Linfomi ONLUS:
INFL
Indolent non-follicular
untreated INFL
Additional relevant MeSH terms:
Layout table for MeSH terms
Bendamustine Hydrochloride
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action