LymphomaPhase 2NCT00727207
Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
A Phase 2 study testing everolimus in people with Lymphoma, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- everolimus
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Sep 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, D-81675
About this study
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
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.
Read the 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.
- Conditions
- Lymphoma
- Being tested
- everolimus
- 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
- Medical subject headings
- Lymphoma, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Secondary outcomes (4)
Toxicity and feasibility
Efficacy
Comparison of duration of remission after first- vs second-line chemotherapy
Rate of objective remission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2011
- Study completionSep 2014 (estimated)
Why it stopped: Lack of participations (8 of 25)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulrich Keller, MD, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727207
- Sponsor's protocol ID
- CDR0000597004
- Other IDs
- KRDI-TUM-CRAD001C2428, EUDRACT: 2007-005116-12, EU-20855
- Status last verified
- Dec 2012
- First submitted
- 31 Jul 2008
- Last updated
- 17 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00727207
- Acronym / sponsor ID
- CDR0000597004
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participations (8 of 25)
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Sep 2014 (estimated)
- First posted
- 1 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| everolimus | Drug | – |
Primary outcome
Progression-free survival
4 secondary outcomes
Toxicity and feasibility
Efficacy
Comparison of duration of remission after first- vs second-line chemotherapy
Rate of objective remission
Results and safety
The study was stopped early (reason given: Lack of participations (8 of 25)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Keller, MD principal investigator
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing everolimus in people with Lymphoma, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of participations (8 of 25)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2012.