Prospective Multicenter Dose Finding Phase II Pilot Trial to Evaluate Efficacy and Safety of LR-CHOP21 for Elderly Patients With Untreated Diffuse Large B Cell Lymphoma (REAL07)

October 12, 2011 updated by: Fondazione Italiana Linfomi ONLUS

Prospective Multicenter Dose Finding Phase II Pilot Trial to Evaluate Efficacy and Safety of Treatment With Lenalidomide Plus R-CHOP21 (LR-CHOP21) for Elderly Patients With Untreated Diffuse Large B Cell Lymphoma (DLBCL)

This is a prospective multicenter phase II pilot trial designed with the purpose of dose finding to evaluate the efficacy and safety of treatment with Lenalidomide plus R-CHOP21 (LR-CHOP21) for elderly patients with untreated Diffuse Large B Cell Lymphoma (DLBCL).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

49

Phase

  • 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
      • Alessandria, Italy
        • Divisione di Ematologia Osp. SS. Antonio e Biagio
      • Aviano, Italy
        • Divisione di Oncologia Medica A Centro di Riferimento Oncologico
      • Bari, Italy
        • IRCCS Istituto Tumori Giovanni Paolo II
      • Bari, Italy
        • Cattedra di Ematologia Università Policlinico
      • Bologna, Italy, 40138
        • Istituto di Ematologia "Seragnoli" Polic.S.Orsola-Malpighi
      • Brescia, Italy
        • Divisione di Ematologia Spedali Civili
      • Cagliari, Italy
        • Divisione di Ematologia Osp. Businco
      • Candiolo (TO), Italy
        • Onco-Ematologia I.R.C.C.
      • Genova, Italy, 16132
        • Ematologia 1 Ospedale S. Martino
      • Milano, Italy
        • Divisione di Ematologia Ospedale Niguarda
      • Napoli, Italy
        • UO Ematologia II Facoltà di Medicina e Chirurgia Università Federico II
      • Novara, Italy
        • Divisione di Ematologia Università Avogadro
      • Pavia, Italy
        • UO Ematologia Università - Policlinico San Matteo
      • Roma, Italy
        • Dipartimento di biotecnologie cellulari ed ematologia Ospedale Umberto I - La Sapienza
      • Terni, Italy, 05100
        • Oncoematologia - Univ. Perugia Sede Terni,
      • Torino, Italy, 10126
        • S.C.Ematologia 1 AOU San Giovanni Battista
      • Torino, Italy
        • SC Ematologia 2 ASO San Giovanni Battista
      • Tricase (LE), Italy
        • UO Ematologia Osp. Cardinale Panico

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

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Understand and voluntarily sign an informed consent form
  2. Able to adhere to the study visit schedule and other protocol requirements

  3. Histologic subtypes as follows:

    • CD20 positive Diffuse large B-Cell lymphoma
    • CD20 positive Follicular grade IIIb
  4. Age 60-80
  5. Untreated patients. In patients with bulky mass or systemic symptoms or compressive disease or rapidly progressive adenopathies a pre-study treatment is allowed with steroids and/or a single dose of Vincristine 1.4 mg/mq (max 2) in the seven days prior the start of the study treatment
  6. Measurable and/or evaluable disease
  7. Ann Arbor stage II, III, IV
  8. International Prognostic Index at low-intermediate, intermediate-high, high risk (2/3/4-5)
  9. Adequate haematological counts: ANC > 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement
  10. Conjugated bilirubin up to 2 x UNL
  11. Alkaline phosphatase and transaminases up to 2 x UNL
  12. Creatinine clearance > 50 ml/min
  13. HIV negativity
  14. HCV negativity
  15. HBV negativity or patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
  16. Cardiac ejection fraction (MUGA scan or echocardiography) > 45%
  17. Non peripheral neuropathy or CNS disease. Non testicular Lymphoma
  18. Life expectancy > 6 months
  19. Performance status < 2 according to ECOG scale
  20. Comprehensive geriatric assessment (CGA) as outlined in Appendix 15 showing absence of any impairment in activity of daily living (ADL), of any condition defining a geriatric syndrome, and of any grade 4 comorbidity or of more than three grade 3 comorbidities according to CIRS-G scale
  21. Disease free of prior malignancies for ≥ 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast

  22. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: for at least 28 days before starting study drug;while participating in the study; for at least 28 days after discontinuation from the study

    • The two methods of reliable contraception must include one highly effective method (i.e., intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e., latex condom, diaphragm, cervical cap)
    • FCBP must be referred to a qualified provider of contraceptive methods if needed

Exclusion Criteria:

  1. Lymphoblastic Lymphoma
  2. Burkitt Lymphoma
  3. Non Hodgkin lymphoma CD 20 negative
  4. Mantle Cell Lymphoma
  5. Follicular Non Hodgkin Lymphoma grade I-II-IIIa
  6. Primitive mediastinal diffuse large B cell lymphoma with only mediastinal involvement
  7. International Prognostic Index at low risk (1)
  8. Has known or suspected hypersensitivity or intolerance to Rituximab
  9. History of evolutive malignancy within the last 3 years other than squamous cell and basal cell carcinoma of the skin or carcinoma in situ of the cervix or breast
  10. Extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy before enrollment within 3 years before the start of treatment
  11. Exposure to Rituximab prior to study entry
  12. Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study
  13. CNS disease (meningeal and/or brain involvement by lymphoma) or Testicular involvement
  14. DVT in the last year
  15. History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
  16. Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug
  17. Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 5, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
  18. Creatinine clearance < 50 ml/min
  19. Presence of major neurological disorders
  20. HIV positivity
  21. HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- with HBV-DNA negative
  22. HCV positivity
  23. Active opportunistic infection
  24. Comprehensive geriatric assessment (CGA) as outlined in Appendix 15 showing presence of any impairment in activity of daily living (ADL), of any condition defining a geriatric syndrome, and of any grade 4 comorbidity or of more than three grade 3 comorbidities according to CIRS-G scale
  25. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohorts 1 - 2 - 3 - 4
Chemiotherapy
Drug: LR-CHOP21

FIRST DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1; Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 5 mg/day D1-D14

SECOND DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1;Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 10 mg/day D1-D14

THIRD DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1; Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 15 mg/day D1-D14

FOURTH DOSE LEVEL: Rituximab 375 mg/sqm D 0 or 1; Cyclophosphamide 750 mg/sqm iv D1; Doxorubicin 50 mg/sqm iv D1; Vincristine 1.4 mg/sqm iv D1; Prednisone 40 mg/sqm orally D1, D2, D3, D4, D5; Revlimid 20 mg/day D1-D14 Repeated every 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of adverse events according with Common Terminology Criteria for Adverse events (CTCAE)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate (ORR)
Time Frame: 4 years
4 years

Collaborators and Investigators

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

Sponsor

Fondazione Italiana Linfomi ONLUS

Collaborators

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Investigators

  • Study Director: Umberto Vitolo, MD, Azienda Sanitaria Ospedaliera-Universitaria S. Giovanni Battista - TORINO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

May 21, 2009

First Submitted That Met QC Criteria

May 21, 2009

First Posted (Estimate)

May 22, 2009

Study Record Updates

Last Update Posted (Estimate)

October 13, 2011

Last Update Submitted That Met QC Criteria

October 12, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIL_REAL07

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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