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A Phase 2 Study of Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone (LR-CD) for Untreated Low Grade Non-Hodgkin Lymphoma Requiring Therapy


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

Thank you

Trial Information

A Phase 2 Study of Lenalidomide, Rituximab, Cyclophosphamide and Dexamethasone (LR-CD) for Untreated Low Grade Non-Hodgkin Lymphoma Requiring Therapy


OBJECTIVES:

Primary

- To assess tumor response to lenalidomide, rituximab, cyclophosphamide, and
dexamethasone in patients with symptomatic previously untreated low-grade non-Hodgkin
lymphoma.

Secondary

- To describe the adverse event profile of this regimen.

- To evaluate overall survival, progression-free survival, duration of response, and time
to treatment failure associated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral lenalidomide once daily on days 1-21, rituximab IV on day 1, oral
cyclophosphamide once daily on days 1, 8, and 15, and oral dexamethasone once daily on days
1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of
disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed symptomatic non-Hodgkin lymphoma by biopsy within the past 6
months

- Any of the following subtypes allowed:

- Grade 1 or 2 lymphoma

- Small lymphocytic lymphoma

- Marginal zone lymphoma

- Lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia [WM])

- Previously untreated disease that, in the investigator's opinion, requires treatment

- Measurable disease by CT or MRI scans with lymph nodes ≥ 2.0 cm in ≥ 1 dimension

- WM patients without lymphadenopathy must meet the following criteria:

- More than 10% lymphocytes, lymphoplasmacytic cells, or plasma cells on a
bone marrow aspirate/biopsy

- Quantitative Immunoglobulin M ≥ 400 mg/dL NOTE: A new classification scheme
for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of
"indolent" or "aggressive" lymphoma will replace the former terminology of
"low", "intermediate", or "high" grade lymphoma. However, this protocol
uses the former terminology.

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- ANC ≥ 1,400/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 2.0 mg/dL

- Total or direct bilirubin ≤ 1.5 mg/dL

- AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if hepatic metastases
are present)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective double-method contraception at least 28 days
prior to, during, and for 28 days after completion of study therapy

- Able to take acetylsalicylic acid (ASA) 325 mg/day as prophylactic anticoagulation
(patients intolerant to ASA may use warfarin or low molecular weight heparin)

- No known hypersensitivity to thalidomide

- No development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs

- No uncontrolled intercurrent illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure requiring use of ongoing maintenance
therapy for life-threatening ventricular arrhythmias

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situations that would limit compliance with study
requirements

- No myocardial infarction within the past 6 months

- No other active malignancy requiring treatment, except for localized nonmelanomatous
skin cancer or any cancer that, in the judgement of the investigator, has been
treated with curative intent and will not interfere with the study treatment plan and
response assessment

- No co-morbid systemic illnesses or other severe concurrent disease which, in the
judgement of the investigator, would make the patient inappropriate for entry into
the study or would interfere significantly with the proper assessment of safety and
toxicity of study treatment

- No known positivity for HIV or infectious hepatitis A, B, or C

- No serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the patient from signing the informed consent

- Willing to return to Mayo Clinic enrolling institution for follow up

- Registered into the RevAssist® program and willing and able to comply with the
requirements of RevAssist®

PRIOR CONCURRENT THERAPY:

- No prior lenalidomide

- No prior irradiation to ≥ 25% of the bone marrow

- More than 28 days since prior experimental drug or therapy

- No concurrent radiotherapy, chemotherapy, or immunotherapy

- No other concurrent anticancer agents or treatments, including thalidomide or
investigational agents

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of confirmed complete responses

Safety Issue:

No

Principal Investigator

Craig B Reeder, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

MC0882

NCT ID:

NCT00784927

Start Date:

November 2008

Completion Date:

Related Keywords:

  • Lymphoma
  • stage I grade 1 follicular lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage I small lymphocytic lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage IV small lymphocytic lymphoma
  • Waldenstrom macroglobulinemia
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • stage I marginal zone lymphoma
  • contiguous stage II marginal zone lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • stage III marginal zone lymphoma
  • stage IV marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

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