Phase II of High-dose Therapy in Elderly Patients With Relapsed Aggressive NHL or Resistant to First Line Therapy

April 24, 2018 updated by: Fondazione Italiana Linfomi ONLUS

A Phase II Prospective Study of High-dose Myeloablative Therapy, With Stem Cell Devices Support in Elderly Patients (≥65 and ≤ 75 Years) With Relapsed Aggressive Non-Hodgkin Lymphoma or Resistant to First Line Therapy

A phase II prospective, non-randomized study. The study aim is to evaluate the feasibility and activity of high-dose therapy with stem cell in elderly patients with aggressive lymphoma relapsed FIT or resistant to first line therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study aim is to evaluate the toxicity and activity of a therapeutic approach to high doses with support of peripheral blood stem cells (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to therapy first line in terms of event free survival (EFS) and treatment related mortality (TRM)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rimini, Italy, 47923
        • Recruiting
        • Ospedale Degli Infermi
        • Principal Investigator:
          • Anna Lia Molinari, MD
        • Contact:
    • AL
      • Alessandria, AL, Italy, 15121
        • Recruiting
        • A.O. SS.Antonio e Biagio e C. Arrigo
        • Contact:
    • AN
      • Ancona, AN, Italy, 60126
        • Recruiting
        • Ospedali Riuniti
        • Contact:
    • BR
      • Brindisi, BR, Italy, 72100
        • Active, not recruiting
        • Ospedale Perrino
    • BS
    • CT
      • Catania, CT, Italy, 95123
        • Active, not recruiting
        • Policlinico Vittorio Emanuele
    • FG
      • San Giovanni Rotondo, FG, Italy, 71013
        • Active, not recruiting
        • Casa Sollievo Della Sofferenza
    • Forlì-Cesena
      • Meldola, Forlì-Cesena, Italy, 47014
    • GE
      • Genova, GE, Italy, 16132
        • Active, not recruiting
        • IRCCS San Martino - IST
    • MC
      • Civitanova Marche, MC, Italy, 62012
        • Active, not recruiting
        • ASUR Marche, Area Vasta 3
    • ME
      • Messina, ME, Italy, 98158
        • Recruiting
        • AO Riuniti Papardo Piemonte
        • Principal Investigator:
          • Donato Mannina, MD
        • Contact:
    • MI
    • Milano
      • Rozzano, Milano, Italy, 20089
    • PC
      • Piacenza, PC, Italy, 29100
        • Recruiting
        • Ospedale Civile "Guglielmo da Saliceto"
        • Contact:
        • Principal Investigator:
          • Danilele Vallisa, MD
    • PN
      • Aviano, PN, Italy, 33081
        • Recruiting
        • Centro di Riferimento Oncologico
        • Contact:
        • Principal Investigator:
          • Mariagrazia Michieli, MD
    • PR
      • Parma, PR, Italy, 43126
        • Recruiting
        • Azienda Ospaliero Universitaria di Parma
        • Contact:
          • Francesca Re, MD
          • Phone Number: 0521-033306
          • Email: fre@ao.pr.it
        • Principal Investigator:
          • Francesca Re, Prof.
    • PZ
      • Potenza, PZ, Italy, 85100
        • Active, not recruiting
        • Ospedale San Carlo
    • RA
      • Ravenna, RA, Italy, 48100
        • Recruiting
        • AUSL di Ravenna
        • Principal Investigator:
          • Monica Tani, MD
        • Contact:
    • RC
      • Reggio Calabria, RC, Italy, 89125
        • Active, not recruiting
        • A.O. Bianchi - Melacrino - Morelli
    • RE
      • Reggio Emilia, RE, Italy, 43123
    • RM
      • Roma, RM, Italy, 00189
        • Recruiting
        • Policlinico Sant'Andrea
        • Principal Investigator:
          • Maria Christina Cox, MD
        • Contact:
    • SA
      • Nocera Inferiore, SA, Italy, 84014
        • Active, not recruiting
        • Ospedale Nocera- Pagani
      • Salerno, SA, Italy, 84131
        • Active, not recruiting
        • AOU San Giovanni e Ruggi
    • TO
      • Torino, TO, Italy, 10126
        • Recruiting
        • AOU Città della Salute e della Scienza
        • Principal Investigator:
          • Federica Cavallo, MD
        • Contact:
      • Torino, TO, Italy, 10128
        • Active, not recruiting
        • Ospedale Mauriziano
    • TR
      • Terni, TR, Italy, 05100
        • Active, not recruiting
        • AO Santa Maria
    • VC
      • Vercelli, VC, Italy, 13100
        • Active, not recruiting
        • Ospedale S.Andrea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of NHL
  • relapse and refractory pts
  • age ≥ 65 and ≤75
  • ECOG performance status <2
  • FIT patients (Instrumental Activity of Daily Living (IADL)=8, Activity of Daily Living (ADL)=6, Cumulative Illness Rating Scale (CIRS) =0 SCORE=3-4, <5 SCORE=2 )
  • evaluable disease
  • no RT since 3 week
  • absolute neutrophil count >= 1500/mm3 and platelets >= 100.000/106L
  • Creatinin <= 1.5 mg/dL and clearance >40 ml/min/24 h
  • bilirubins < =2 mg/dL
  • forced expiratory volume >50% - arterial pressure O2 >70 mmHg
  • no other neoplastic disease
  • Life expectancy> 3 months
  • signed informed consent

Exclusion Criteria:

  • HBV+ - HCV+ - HIV+
  • NSC involvement - medullar infiltration > 20%
  • other chemotherapy or radiotherapy
  • cardiac disease
  • alteration of liver and kidney function
  • infections
  • demented patient
  • no compliance and depressed pts
  • Frail and Unfit pts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: R-DHAP/R-ICE
High-dose myeloablative therapy (R-DHAP or R-ICE) and conditioning therapy (BEAM or FEAM) in elderly patients with relapsed NHL or resistant to firs line therapy
Drug: R-DHAP/R-ICE

R-DHAP/R-ICE 3 cycles every 21 days:

  1. R-DHAP

    • Rituximab 375 mg/m2, e.v. day 1
    • Desamethasone 40 mg days 1-4
    • cis-Platino100 mg/m2, day 2 (if ≥70 years 75 mg/m2)
    • Aracytin 2000 mg/m2, e.v. day 3 (if ≥70 years 1500 mg/m2)

  2. R-ICE

    • Rituximab 375 mg/m2, e.v. day 1
    • Etoposide 100 mg/mq, e.v. days 1,2,3 (if ≥70 years 75 mg/mq)
    • Ifosfamide with Mesna equidone 5000 mg/mq, day 2 (if ≥70 years 3750 mg/mq)
    • Carboplatino AUC=5, e.v. (max 800 mg/mq), day 2 (if ≥70 years AUC=4)

Conditioning BEAM or FEAM

Other Names:
  • R-DHAP or R-ICE and BEAM or FEAM

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Event free survival EFS
Time Frame: 36 months
Evaluate the toxicity and activity of a therapeutic approach to high doses with stem cell support device (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to 1st line therapy in terms of EFS.
36 months
Treatment related mortality TRM
Time Frame: 100 days from the high doses
Evaluate the toxicity and activity of a therapeutic approach to high doses with stem cell support device (PBSC) in patients aged ≥ 65 and ≤75 years, chemosensitive relapsed or refractory to 1st line therapy in terms of TRM.
100 days from the high doses

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Remission (CR) rate
Time Frame: 48 months (at the end of therapy)
48 months (at the end of therapy)
Overall Survival (OS)
Time Frame: 48 months (at the end of therapy)
48 months (at the end of therapy)
Adverse events incidence evaluation (grade III or IV)
Time Frame: 48 months (at the end of therapy)
Number of participants with adverse events (grade III or IV)
48 months (at the end of therapy)
Quality of Life (QoL)
Time Frame: 54 months
Evaluate the quality of life (QoL) before, after therapy rescue and after six months of high-dose therapy through the quality of life questionnaire of European Organization for Research and Treatment of Cancer (EORTC QLQ-C30)
54 months
Immunologic evaluation
Time Frame: 54 months
Rating basic immunology and 6 months after therapy high doses (lymphocyte subpopulations and Ig subclasses)
54 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Italiana Linfomi ONLUS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luca Castagna, MD, IRCCS Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FIL_RecAnz

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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