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Mantle Cell LymphomaPhase 1/2NCT01170052

Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-Hodgkin's Lymphoma (NHL)

A Phase 1/2 study testing Temsirolimus and Bendamustine in people with Mantle Cell Lymphoma, run by Charite University, Berlin, Germany at 3 sites in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to assess the safety, tolerability and activity of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma who are not eligible for high dose chemotherapy and autologous/allogeneic stem cell transplantation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Temsirolimus and Bendamustine
Type of treatment
Injection or infusion
How many people
20 participants
Where
3 sitesGermany
Study dates
May 2010to Apr 2014
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older
  • Mantle Cell Lymphoma according to REAL/WHO classification
  • First or second relapse or alternatively progression during therapy. Previous use of Bendamustine is permitted, if the patient has reached at least partial remission and progression occured more than 6 months after therapy. Previous high dose chemotherapy with auto-SCT is permitted, if the patient has reached at least partial remission and progression occured more than 12 months after therapy.
  • Patients must not be eligible for high dose chemotherapy with auto-SCT or allo-SCT.
  • Adequate bone marrow function (hemoglobin > 9g/dl, platelet count >100/nL, absolute neutrophil count >1,5 /nL)
  • WHO/ECOG Performance Status 0-2
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  • Measurable disease (two perpendicular diameters by either physical or radiological examination)
  • Life expectancy ≥ 3 weeks
  • Written informed consent

Who cannot join

  • Prior treatment with any m-TOR Inhibitor
  • Unstable or severe uncontrolled medical condition (e.g. severe congestive heart failure, myocardial infarction within the past 6 months, severe, uncontrolled arterial hypertension, renal insufficiency requiring hemodialysis, severe pulmonary disease, severe diabetes)
  • Abnormal liver function: transaminases or total bilirubin > 2 x upper limit of normal (ULN)
  • Abnormal renal function: serum creatinine > 2 x upper limit of normal
  • Previous malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix.
  • Concurrent treatment with strong inhibitors of CYP3A4 and/or inducers of CYP3A4
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  • Pregnant or breastfeeding women (negative pregnancy test not older than 7 days is required for women of fertile age). Men and women of child-bearing potential must agree to use adequate contraception (i.e. failure rate < 1% p.a. )
  • Major surgery within 4 weeks before study entry; minor procedures (e.g. Implantation i.v. port catheter, Lymphnode biopsy) within 1 week before study entry
  • Previous therapy with any investigational agents within 28 days before study entry
  • Concomitant immunotherapy (e.g. Rituximab) or Chemotherapy other than Bendamustine. Use of systemic steroids should be documented and the Principal Investigator be informed.
  • Central nervous system (CNS) lymphomatous involvement
  • HIV positivity
  • Current or chronic hepatitis B or hepatitis C infection
  • Severe psychiatric illness or Individuals that are placed in an institution due to a magisterial or judiciary command.
  • Inability to comply with study requirements

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Dept. of Hematology and Oncology, Charité, Campus Charité Mitte

    Berlin, State of Berlin, 10117

  • Dept. of Hematology and Oncology, Charité, Campus Benjamin Franklin

    Berlin, State of Berlin, 12203

  • Dept. of Hematology and Oncology, Charité, Campus Virchow Klinikum Charité

    Berlin, State of Berlin, 13353

Other trials in Germany

About this study

Official title: Phase I/II Study With Bendamustine and Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Non-hodgkin's Lymphoma (NHL) Not Eligible for High Dose Chemotherapy and Autologous/Allogeneic Stem Cell Transplantation

The purpose of this study is to assess the safety, tolerability and activity of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma who are not eligible for high dose chemotherapy and autologous/allogeneic stem cell transplantation.

Being tested
Temsirolimus, Bendamustine
Keywords
Relapsed Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma, Non-Hodgkins Lymphoma, Temsirolimus, Bendamustine, Phase 1/2
Medical subject headings
Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TemsirolimusDrug

    Also called Torisel®

    Temsirolimus 75mg i.v. day 1, 8, 15, 21 for a 28 day cycle with a maximum of 6 Cycles.

  • BendamustineDrug

    Bendamustin 90mg/m2 i.v. day 2 and 3 for a 28 day cycle with a maximum of 6 Cycles.

  • TemsirolimusDrug

    Consolidation Therapy for Patients reached CR or PR with Temsirolimus 75mg weekly until progression.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Dose-finding

    Is the combination of temsirolimus alongside with bendamustine at the suggested dose feasible or are dose reductions necessary. Number of dose reductions or delays of therapy due to hematologic toxicities (CTCAE) or other adverse events according to protocoll.

    Measured: 6 months

  2. Phase II: Response Rate (Overall response rate, complete and partial response)

    What is the response rate of a therapy with temsirolimus and bendamustine.

    Measured: 6 months

Secondary outcomes (2)

  1. Progression free survival

    This is defined as the period of time between the admission into the clinical trial and the progression of the lymphoma or death of any kind.

    Measured: 2 years

  2. Safety and Tolerability of Temsirolimus and Bendamustine Combination Therapy

    Detection of overall toxicity, serious adverse events (SAE), suspected unexpected serious adverse reactions (SUSAR) during treatment with temsirolimus and bendamustine.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionApr 2012 (estimated)
  4. Study completionApr 2014 (estimated)

Why it stopped: insufficient enrollment

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01170052
Sponsor's protocol ID
EudraCT-No.: 2009-014844-13
Status last verified
Jun 2010
First submitted
14 Jul 2010
Last updated
16 Mar 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Temsirolimus and Bendamustine in people with Mantle Cell Lymphoma, run by Charite University, Berlin, Germany at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 16 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 withdrawn before enrolling participants, so there are no results.

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?

Phase I: Dose-finding (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01170052.

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 16 Mar 2011.

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