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Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma

This study is not yet open for participant recruitment.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma
Official Title  Phase I/II Study of Lenalidomide (Revlimid), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R2CHOP) Chemoimmunotherapy in Patients With Newly Diagnosed Diffuse Large Cell and Follicular Grade IIIA/B B Cell Lymphoma
Brief Summary

RATIONALE: Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with rituximab and combination chemotherapy may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with rituximab and combination chemotherapy and to see how well they work in treating patients with newly diagnosed stage II, stage III, or stage IV diffuse large cell or follicular B-cell lymphoma.

Detailed Description

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of lenalidomide when given in combination with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone in patients with newly diagnosed stage II-IV diffuse large cell or grade 3 follicular B-cell lymphoma. (Phase I)
  • To assess the efficacy of this regimen, in terms of event-free survival and response rate, in these patients. (Phase II)
  • To assess the safety of this regimen in these patients. (Phase II)

Secondary

  • To assess the host immune function at baseline and after treatment and correlate these parameters with tumor response and event-free survival.

OUTLINE: This is a multicenter, phase I dose-escalation study of lenalidomide followed by a phase II study.

  • Phase I: Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1, oral prednisone on days 1-5, and oral lenalidomide on days 1-10. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Phase II: Patients receive lenalidomide at the maximum tolerated dose determined in phase I and rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, prednisone, and pegfilgrastim as in phase I.

Blood is collected at baseline, before course 3, and after completion of study treatment for translational research studies. Research studies include immune function and cytokine analysis, T- and B- quantitative lymphocyte analysis, and single nucleotide polymorphism analysis.

After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure  Toxicity as assessed by NCI CTCAE v3.0 (Phase I) [ Designated as safety issue: Yes ]
Event-free survival at 12 months (Phase II) [ Designated as safety issue: No ]
Secondary Outcome Measure  Overall response rate [ Designated as safety issue: No ]
Overall complete response rate [ Designated as safety issue: No ]
Event-free survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Duration of response [ Designated as safety issue: No ]
Immune function before and after treatment as assessed by T-, B-, and NK-cell quantification [ Designated as safety issue: No ]
Correlation of immune function with clinical outcomes [ Designated as safety issue: No ]
Condition  Lymphoma
Intervention  Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: lenalidomide
Drug: pegfilgrastim
Drug: prednisone
Drug: rituximab
Drug: vincristine
Procedure: laboratory biomarker analysis
Procedure: polymorphism analysis
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Not yet recruiting
Enrollment  47
Start Date  June 2008
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Histologically confirmed diffuse large cell or grade 3A/B follicular lymphoma

    • Newly diagnosed disease
    • Stage II, III, or IV disease
  • Measurable disease, defined as ≥ 1 lesion ≥ 1.5 cm in one diameter, as detected by CT scan or PET-CT scan
  • CD20-positive disease
  • No post-transplant lymphoproliferative disorder (PTLD)
  • No CNS lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal
  • Alkaline phosphatase ≤ 3 times ULN (5 times ULN if direct liver involvement by lymphoma)
  • AST ≤ 3 times ULN (5 times ULN if direct liver involvement by lymphoma)
  • Creatinine ≤ 2 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile female patients must use effective double-method contraception for ≥ 28 days before, during, and for ≥ 28 days after completion of study therapy
  • Fertile male patients must use effective contraception during and for ≥ 28 days after completion of study therapy, even if they have had a successful vasectomy
  • No blood, sperm, or semen donation during and for ≥ 28 days after completion of study therapy
  • Willing to return to enrolling institution for follow-up
  • Willing to provide blood samples for translational research purposes
  • No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would preclude study entry or significantly interfere with the proper assessment of safety and toxicity of the prescribed study regimen
  • No known HIV positivity
  • Not immunocompromised
  • No concurrent uncontrolled illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situation that would preclude compliance with study requirements
  • No other active malignancy, except localized nonmelanotic skin cancer or any cancer that, in the judgment of the investigator, has been treated with curative intent and will not interfere with the study treatment plan and response assessment
  • No myocardial infarction within the past 6 months
  • No congestive heart failure requiring ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Ejection fraction ≥ 45% by MUGA or ECHO
  • No history of life threatening or recurrent thrombosis/embolism (unless on anticoagulation therapy during study treatment)

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy to ≥ 25% of the bone marrow
  • No concurrent erythroid-stimulating agents (e.g., Procrit, Aranesp)
  • No other concurrent treatment for lymphoma
  • No concurrent radiotherapy, chemotherapy, or immunotherapy for another active malignancy
  • Able to receive concurrent prophylactic anticoagulation therapy (e.g., low-dose aspirin [81 mg] daily or an alternative prophylaxis [e.g., warfarin or low molecular weight heparin])
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00670358
Organization ID CDR0000594812
Secondary IDs †† MAYO-MC078E, CELGENE-RV-NHL-PI-0325
Study Sponsor  Mayo Clinic
Collaborators †† National Cancer Institute (NCI)
Investigators 
Principal Investigator:     Thomas E. Witzig, MD     Mayo Clinic    
Investigator:     Craig B. Reeder, MD     Mayo Clinic Scottsdale    
Information Provided By National Cancer Institute (NCI)
Verification Date May 2008
First Received Date  April 30, 2008
Last Updated Date May 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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