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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Fondazione Italiana Linfomi ONLUS.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT00907348
First received: May 21, 2009
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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).


Condition Intervention Phase
Non Hodgkin Lymphoma
Follicular Lymphoma
Drug: LR-CHOP21
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Fondazione Italiana Linfomi ONLUS:

Primary Outcome Measures:
  • Evaluation of adverse events according with Common Terminology Criteria for Adverse events (CTCAE) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 49
Study Start Date: October 2007
Estimated Study Completion Date: January 2012
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907348

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

No publications provided by Fondazione Italiana Linfomi ONLUS

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier: NCT00907348     History of Changes
Other Study ID Numbers: IIL_REAL07
Study First Received: May 21, 2009
Last Updated: October 12, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione Italiana Linfomi ONLUS:
NHL
Non Hodgkin Lymphoma
Follicular Lymphoma

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014