AzTrials
AzTrials

Follicular LymphomaPhase 1/2BERTNCT01078142

Temsirolimus, Bendamustine and Rituximab for Relapsed Follicular Lymphoma or Mantle Cell Lymphoma

A Phase 1/2 study testing Temsirolimus, Rituximab, Bendamustin in people with Follicular Lymphoma and Mantle Cell Lymphoma, run by Georg Hess, MD at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multicenter, open label, single arm, phase I/II study. There will be no placebo usage within this trial. Phase I: Primary: To establish a maximum tolerated dose of the addition of Temsirolimus to a regimen of Bendamustine and Rituximab (BERT) in patients with relapsed follicular lymphoma and mantle cell… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma, Mantle Cell Lymphoma
What is being tested?
Temsirolimus, Rituximab, Bendamustin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteGermany
Study dates
2 Feb 2010to 8 Sep 2017
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

  • Histologically proven diagnosis of follicular non-Hodgkin's lymphoma grades l, II or IIIA or mantle cell lymphoma (including Cyclin D1 expression) according to the World Health Organization classification
  • Documented relapse or progression following at least one but not more than 3 antineoplastic treatments
  • At least 1 measurable tumor mass (>1.5 cm x >1.0 cm) or bone marrow infiltration
  • Subjects 18 years or older
  • Status post. high dose therapy or no transplantation option available or patient refuses an aggressive treatment strategy
  • Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Show all 12Show fewer
  • Adequate bone marrow reserve: Platelets of at least 75000/µl, absolute neutrophil count at least 1500/µl. In case of extensive bone marrow infiltration and lower platelet or absolute neutrophil counts, patients can not be included in the phase I part of the trial. In the phase II proportion of the trial patients may be included with a platelet count of more or equal to 50000/µl on the discretion of the investigator, if thrombocytopenia is associated with massive bone marrow infiltration.
  • Adequate hepatic and renal function
  • Alanine aminotransferase <2.5 x upper limit of normal (ULN); Aspartate aminotransferase <2.5 x ULN, Total bilirubin <1.5 x ULN
  • Measured or calculated creatinine clearance >50 mL/min
  • Eastern Cooperative Oncology Group [ECOG] performance Status 0-2
  • Female subject must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum ß-hCG pregnancy test at screening

Who cannot join

  • Lymphoma other than MCL or FL
  • Active central nervous System lymphoma. Brain MRI is required only if clinically indicated
  • Pregnancy or breast feeding women
  • Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure (NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled hyperlipoproteinemia)
  • Active uncontrolled infections including HIV-positivity, active Hep B or C
  • Mental status precluding patient's compliance
Show all 15Show fewer
  • Comedication with strong CYP 3A4/5-inhibitors or -inducers (Appendix 22.7)
  • Prior treatment with Temsirolimus
  • Known CD20 negativity
  • Patients refractory to Bendamustine in a prior treatment line, defined as relapse within 1 year after initiation of first cycle. Exception: termination of treatment prior to third scheduled cycle for reasons other than toxicity.
  • Status post allogeneic transplantation
  • Peripheral neuropathy or neuropathic pain of Grade 2 or worse
  • Diagnosed or treated for a malignancy other than NHL except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, DCIS of the breast, or other solid tumors curatively treated with no evidence of disease for >5 years
  • Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is not excluded.
  • Known intolerance to sirolimus or derivates, or Bendamustine or Rituximab.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Universitätsmedizin Mainz

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

About this study

Official title: A Phase I/II Trial to Evaluate the Safety, Feasibility and Efficacy of the Addition of Temsirolimus to a Regimen of Bendamustine and Rituximab for the Treatment of Patients With Follicular Lymphoma or Mantle Cell Lymphoma in First to Third Relapse

This is a multicenter, open label, single arm, phase I/II study. There will be no placebo usage within this trial.

Phase I:

Primary: To establish a maximum tolerated dose of the addition of Temsirolimus to a regimen of Bendamustine and Rituximab (BERT) in patients with relapsed follicular lymphoma and mantle cell lymphoma.

Phase II:

Primary: To evaluate the ORR in patients with MCL or FL treated with the established BERT dose Secondary: To determine the complete remission rate, progression free survival rate and overall survival rate and to investigate safety and tolerability of BERT.

Read the detailed description

The first part of the study is a phase I study in which the maximum tolerated dose of the combination of Temsirolimus, Bendamustine and Rituximab will be established. In the phase I part of the trial 3 patients will be included in each dose level. After inclusion of 3 patients, each patient has to receive at least 2 complete cycles without DLT until the enrolment into the next cohort can be initiated. In case of one DLT, 3 additional patients will be added to the specific dose level. If a second DLT appears, the last dose level without DLT will be considered the standard dose for the phase II trial. If the third dose level is achieved without any DLT, there will be no further dose escalation.

In the phase II proportion of the trial, after establishment of a maximum tolerated dose, the efficacy of the combination regimens in two different patient cohorts will be evaluated. In the one cohort, 30 patients with relapsed mantle cell lymphoma will be treated; the second cohort will be composed of 30 patients with relapsed follicular lymphoma.

Being tested
Temsirolimus, Rituximab, Bendamustin
Keywords
temsirolimus, bendamustine, rituximab, mantle cell lymphoma, follicular lymphoma
Medical subject headings
Lymphoma, Follicular, Lymphoma, Mantle-Cell

What participants receive

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

  • Temsirolimus, Rituximab, BendamustinDrug

    Also called Mabthera, Rituxan, Torisel, Bendamustin, Ribomustin, Trenda

    Phase I:

    Temsirolimus 25 - 50 - 75mg, day 1,8,15 Bendamustin 90/m2, day 1,2 Rituximab 375/m2, day 1 Phase II at established dose, repeat day 28-42 (max)

Study groups in NCT01078142
Study groupRoleWhat they receive
Single armExperimentalBendamustin, Rituximab, Temsirolimus
Receives: Drug: Temsirolimus, Rituximab, Bendamustin

What is being measured

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

  1. Phase I: MTD / Phase II: ORR

    phase II: ORR is evaluated approx. 6 weeks after end of treatment

    Measured: Phase I: 2 months (start cycle 3), Phase II: 6 months

Secondary outcomes (1)

  1. Progression free survival

    for part II only

    Measured: at 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 posted2 Mar 2010 (estimated)
  2. Study start2 Feb 2010
  3. Primary completion8 Sep 2017
  4. Study completion8 Sep 2017

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01078142
Sponsor's protocol ID
341
Acronym
BERT
Status last verified
May 2017
First submitted
18 Feb 2010
Last updated
11 Sep 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Temsirolimus, Rituximab, Bendamustin in people with Follicular Lymphoma and Mantle Cell Lymphoma, run by Georg Hess, MD 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?

The sponsor lists 12 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: finished, as of the sponsor's last update on 11 Sep 2017. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: MTD / Phase II: ORR (time frame: Phase I: 2 months (start cycle 3), Phase II: 6 months). 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 NCT01078142.

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 11 Sep 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in