Back to resultsEverolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
Primary Purpose
Lymphoma
Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
everolimus
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring 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
Eligibility 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
Sites / Locations
- Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
Toxicity and feasibility
Efficacy
Comparison of duration of remission after first- vs second-line chemotherapy
Rate of objective remission
Full Information
NCT ID
NCT00727207
First Posted
July 31, 2008
Last Updated
December 13, 2012
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT00727207
Brief Title
Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Why Stopped
Lack of participations (8 of 25)
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well everolimus works in treating older patients with mantle cell lymphoma who received previous first-line or second-line chemotherapy.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Non-Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
everolimus
Primary Outcome Measure Information:
Title
Progression-free survival
Secondary Outcome Measure Information:
Title
Toxicity and feasibility
Title
Efficacy
Title
Comparison of duration of remission after first- vs second-line chemotherapy
Title
Rate of objective remission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Keller, MD
Organizational Affiliation
Technical University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-81675
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
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