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Phase II Trial on Efficacy of mTOR Inhibitor RAD001 as Maintenance Therapy for Patients Above 60 Years in Mantle Cell Lymphoma After First and Second Line Chemotherapy


Phase 2
40 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

Phase II Trial on Efficacy of mTOR Inhibitor RAD001 as Maintenance Therapy for Patients Above 60 Years in Mantle Cell Lymphoma After First and Second Line Chemotherapy


OBJECTIVES:

Primary

- Determine the progression-free survival of older patients with mantle cell lymphoma
receiving everolimus and who were previously treated with first- or second-line
chemotherapy.

Secondary

- Determine the toxicity and feasibility of treatment with this drug.

- Determine the efficacy of this drug in these patients.

- Compare the duration of remission after first- vs second-line chemotherapy.

- Determine the rate of objective remission.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily in the absence of disease progression or
unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of mantle cell lymphoma

- Stable disease after first- or second-line chemotherapy

- No uncontrolled cerebral or leptomeningeal disease

PATIENT CHARACTERISTICS:

- WHO performance status 0-2

- Life expectancy ≥ 3 months

- Age ≥ 60 years or patients ≥ 40 and < 60 years who are not suitable for high-dose
chemotherapy followed by autologous stem cell transplantation or allogeneic stem cell
transplantation

- ANC ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin > 9 g/dL

- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

- SGPT and SGOT ≤ 3 times ULN

- Bilirubin ≤ 1.5 times ULN

- No other malignancies within the past 3 years except treated cervical carcinoma or
basal cell cancer

- No other serious or non-controlled illnesses (e.g., diabetes mellitus, uncontrolled
hypertension, serious infections, serious malnutrition, unstable angina pectoris,
weak heart, myocardial infarction within the past 6 months, chronic liver illness,
active ulceration in the gastrointestinal tract, psychiatric illness)

- No known HIV infection

- No gastrointestinal disturbances that could influence the absorption of everolimus
and cause short-intestine syndrome (e.g., atrophic gastritis)

- No coagulation or bleeding diatheses

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Patients must have complied with their previous drug prescription

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- See Patient Characteristics

- Recovered from all prior therapy

- At least 2 weeks since prior surgery, radiotherapy, or systemic antitumor therapy

- More than 4 weeks since prior experimental medication

- No chronic therapy with systemic steroids or other immunosuppressants except
rituximab

- No prior organ transplantation

- No therapy with vitamin K antagonist, except low-dose coumarin

- No prior mTOR inhibitors

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Ulrich Keller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Technische Universität München

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CDR0000597004

NCT ID:

NCT00727207

Start Date:

May 2008

Completion Date:

September 2014

Related Keywords:

  • Lymphoma
  • recurrent mantle cell 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, Mantle-Cell

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