Trial 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
NCT ID:
NCT00670358
Condition:
Lymphoma
Conditions: Official terms:
Lymphoma
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Liposomal doxorubicin
Vincristine
Lenalidomide
Conditions: Keywords:
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
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
pegfilgrastim
Intervention type:
Biological
Intervention name:
rituximab
Intervention type:
Drug
Intervention name:
cyclophosphamide
Intervention type:
Drug
Intervention name:
doxorubicin hydrochloride
Intervention type:
Drug
Intervention name:
lenalidomide
Intervention type:
Drug
Intervention name:
prednisone
Intervention type:
Drug
Intervention name:
vincristine sulfate
Intervention type:
Genetic
Intervention name:
polymorphism analysis
Intervention type:
Other
Intervention name:
laboratory biomarker analysis
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.
Criteria for 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 (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])
Gender:
All
Minimum age:
18 Years
Maximum age:
120 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259-5499
Country:
United States
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Start date:
August 25, 2008
Completion date:
November 11, 2024
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00670358
