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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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 (PET/CT fusion)

- 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])

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Toxicity as assessed by NCI CTCAE v3.0 (Phase I)

Safety Issue:

Yes

Principal Investigator

Grzegorz S. Nowakowski, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

MC078E

NCT ID:

NCT00670358

Start Date:

August 2008

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • Lymphoma
  • Lymphoma, B-Cell

Name

Location

Mayo ClinicRochester, Minnesota  55905
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224