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

Therapuetic Areas:Oncology
Age Range:18 - 120
Start Date:August 25, 2008
End Date:May 2019

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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

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.



- 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)


- 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

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.


- 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 (PET/CT fusion)

- CD20-positive disease

- No post-transplant lymphoproliferative disorder (PTLD)

- No CNS lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells


- 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

- 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

- 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

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situation that would preclude compliance with study

- 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)


- 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

- 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])
We found this trial at
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
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Scottsdale, AZ
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
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Jacksonville, FL
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Rochester, Minnesota 55905
Principal Investigator: Grzegorz S. Nowakowski, M.D.
Phone: 855-776-0015
Rochester, MN
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