Know Cancer

forgot password

Phase II Trial of Rituximab and 2-Chlorodeoxyadenosine (2-CDA) in Newly Diagnosed Mantle Cell Lymphoma (MCL)

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

Phase II Trial of Rituximab and 2-Chlorodeoxyadenosine (2-CDA) in Newly Diagnosed Mantle Cell Lymphoma (MCL)


- Determine whether rituximab and cladribine will increase the complete remission rate
and the unconfirmed complete remission rate in patients with mantle cell lymphoma.

- Determine the time to progression in patients treated with this regimen.

- Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

An initial cohort of 6 patients at Mayo Clinic receives rituximab IV over 4-8 hours on day 1
and cladribine IV over 2 hours on days 4-8. If 2 or more patients experience unacceptable
toxicity during the first course, the study is discontinued; otherwise, the study is opened
for enrollment at all NCCTG sites. (The phase II study is open for enrollment as of

Treatment repeats every 28 days for a total of 2-6 courses in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months
for 1 year, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 31 patients will be accrued for this study within 21 months.

Inclusion Criteria


- Histologically confirmed mantle cell lymphoma*

- Measurable or assessable disease defined as at least one of the following:

- Lymph node or tumor mass that is 2.0 cm or more in at least one dimension by CT
scan, MRI, or plain radiograph imaging OR greater than 1.5 cm in at least one
dimension by physical exam

- Splenic enlargement, if the spleen is palpable, at least 3 cm below the left
costal margin

- Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral
blood, liver, lungs, or bowel by lymphoma without a discrete mass would
constitute assessable, but not measurable, disease

- No known CNS involvement NOTE: *If tumor tissue is unavailable for biopsy, blood or
bone marrow specimens may be used to establish patient eligibility provided fusion
signals indicate the presence of t(11;14)(q13;q32) by fluorescence in situ
hybridization using CCND1/IGH AND mantle cell lymphoma involvement is determined by



- 18 and over

Performance status

- ECOG 0-3

Life expectancy

- At least 12 weeks


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Total or direct bilirubin no greater than upper limit of normal (ULN) (with or
without secondary liver involvement)

- SGOT no greater than 3 times ULN (5 times ULN if there is liver involvement)


- Creatinine no greater than 2.0 mg/dL


- No myocardial infarction within the past 6 months

- No uncontrolled high blood pressure

- No unstable angina

- No serious uncontrolled cardiac arrhythmia

- No active congestive heart failure


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 30 days after study

- HIV negative

- No other malignancy within the past 5 years except carcinoma in situ of the cervix,
resected basal cell or squamous cell skin cancer, or prostate cancer that is in
remission after a radical retropubic prostatectomy or radiotherapy

- No medical or psychiatric condition that makes the patient a poor risk for this study

- No active or uncontrolled infection

- No known hypersensitivity to rituximab or its components or to murine proteins


Biologic therapy

- No prior biologic therapy for mantle cell lymphoma


- No prior chemotherapy for mantle cell lymphoma

Endocrine therapy

- No prior endocrine therapy for mantle cell lymphoma


- No prior radiotherapy


- Prior splenectomy allowed (for diagnosis, cytopenia, or symptomatic splenomegaly)

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete remission (CR) and complete remission unconfirmed (CRu) rate at the close of study therapy assessment (after 2, 4, or 6 courses)

Safety Issue:


Principal Investigator

David J. Inwards, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

February 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage I mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell