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A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Phase 2
18 Years
Open (Enrolling)
Recurrent Mantle Cell Lymphoma

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Trial Information

A Phase II Study of CCI-779 in Combination With Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma


I. Determine the overall response rate in patients with relapsed or refractory mantle cell
lymphoma treated with CCI-779 and rituximab.

II. Determine the tolerability of this regimen in these patients. III. Determine adverse
events in patients treated with this regimen.


I. Determine the time to disease progression and overall survival of patients treated with
this regimen.

II. Determine the time to response and duration of response in patients treated with this

OUTLINE: Patients are stratified according to prior response to rituximab (sensitive
[partial response (PR) or complete response (CR) that lasted ≥ 6 months after the last
treatment with rituximab alone or in combination with chemotherapy] vs refractory [stable or
progressive disease OR a PR or CR that lasted < 6 months after the last treatment with
rituximab alone or in combination with chemotherapy]).

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive
rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9,
and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity. After completion of course 3, patients undergo
reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional
courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease
continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or
stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2
additional courses of treatment.

After completion of study treatment, patients are followed every 3 months for 1 year, every
4 months for 1 year, every 6 months for 1 year, and then annually for 2 years.

Inclusion Criteria:

- Histologically confirmed* mantle cell lymphoma (MCL)

- Relapsed, refractory, or stable disease after prior treatment

- Tumor must be cyclin D-1 by immunohistochemistry OR 11;14 translocation by
fluorescent in situ hybridization or cytogenetics

- Measurable disease, defined as ≥ 1 of the following:

- Unidimensionally measurable lymph node or tumor mass ≥ 2 cm by CT scan or MRI

- Splenic enlargement if spleen is palpable ≥ 3 cm below the left costal margin

- Malignant lymphocytosis if absolute lymphocytic count ≥ 5,000 AND lymphocytes
confirmed to be monoclonal by flow cytometry

- No known CNS involvement (e.g., parenchymal mass or leptomeningeal involvement)

- Performance status - ECOG 0-2

- At least 3 months

- No other concurrent treatment for MCL

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 75,000/mm^3

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Direct bilirubin < 1.5 times ULN

- AST ≤ 3 times ULN (5 times ULN if liver involvement by MCL is present)

- Creatinine ≤ 2 times ULN

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment

- Cholesterol ≤ 350 mg/dL

- Fasting triglycerides < 400 mg/dL

- No known HIV positivity

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- No other uncontrolled illness

- No other active malignancy requiring treatment OR that would preclude assessment of
response to study drugs

- Prior biologic response modifiers allowed

- Prior immunotherapy allowed

- Prior high-dose therapy with stem cell support (i.e., stem cell transplantation)

- No concurrent prophylactic growth factor to support neutrophils

- Prior chemotherapy allowed

- No other concurrent chemotherapy

- No concurrent corticosteroids to induce an antitumor response

- Concurrent corticosteroids (≤ 10 mg/day of prednisone or equivalent) for
adrenal insufficiency or acute allergic reactions allowed

- Prior radiotherapy allowed

- No prior treatment with a mTOR inhibitor

- No other concurrent investigational or commercial agents or therapies for MCL

- No other concurrent immunosuppressive therapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete, partial, and unconfirmed) during the first 24 weeks of treatment as defined by the International Workshop criteria

Outcome Time Frame:

Not Provided

Safety Issue:


Principal Investigator

Stephen Ansell

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

Related Keywords:

  • Recurrent Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell



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