Lymphoma, Non-HodgkinPhase 1/2NCT00426855
Bendamustine and Bortezomib Combination Therapy in Indolent Non-Hodgkin's Lymphoma(NHL)
A Phase 1/2 study testing Bendamustine and Bortezomib in people with Lymphoma, Non-Hodgkin, run by Peter Moosmann.
Trial summary
The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Bendamustine and Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jun 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Symptomatic recurrent or refractory indolent NHL or B-CLL
- Adequate organ and bone marrow function
- Karnofsky greater than 50%
Who cannot join
- Candidates for autologous stem cell transplantation
- Secondary high grade lymphoma
- Concurrent severe medical condition
About this study
Official title: Weekly Bendamustine and Bortezomib Combination Therapy in Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or B-CLL: A Single-Center Phase 2 Study
The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable.
Read the detailed description
Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patient population.
Preliminary results from patients with multiple myeloma showed that the combination of bendamustine and bortezomib is efficacious and well tolerated. However, there are so far no data on this combination in patients with NHL or CLL.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Bendamustine, Bortezomib
- Keywords
- Lymphoma, Non-Hodgkin, Low-Grade
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Ribomustin, SDX-105
starting with 60 mg/m^ 2, IV, dose escalation, weekly d1,8,15 q5w
BortezomibDrug
Also called Velcade
weekly 1.5mg/m^2, IV, d1,8,15,22 q5w
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine and Bortezomib | Experimental | Combination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section Receives: Drug: Bendamustine; Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Bendamustine Dosage for Further Studies
Measured: Three weeks after treatment termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionFeb 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Moosmann
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Aarau
- Responsible party
- Sponsor-investigator, Peter Moosmann, Kantonsspital Aarau
- Investigators
- Peter R Moosmann, MD PhD, Principal investigator, Cantonal Hospital of Aarau, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426855
- Sponsor's protocol ID
- ZOHT-01/07
- Status last verified
- Apr 2015
- First submitted
- 24 Jan 2007
- Last updated
- 3 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Moosmann P, Heizmann M, Kotrubczik N, Wernli M, Bargetzi M. Weekly treatment with a combination of bortezomib and bendamustine in relapsed or refractory indolent non-Hodgkin lymphoma. Leuk Lymphoma. 2010 Jan;51(1):149-52. doi: 10.3109/10428190903275602. No abstract available.
PubMed 19860608
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekly Bendamustine and Bortezomib Combination Therapy in Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma or B-CLL: A Single-Center Phase 2 Study
- ClinicalTrials.gov ID
- NCT00426855
- Acronym / sponsor ID
- ZOHT-01/07
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- Lymphoma, Non-Hodgkin, Low-Grade
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Peter MoosmannUniversity, hospital or other
- Collaborators
- Kantonsspital Aarau
- Study start
- Jan 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Jan 2007 (estimated)
- Results
- Posted 3 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the combination of bendamustine and bortezomib in patients with indolent Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia is safe and tolerable.
Detailed description
Bendamustin and bortezomib have been shown to be effective in the treatment of patients with indolent Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL). Both compounds appear not to be cross-resistant with prior therapy. Therefore, it is of interest to combine bendamustine and bortezomib in this patient population.
Preliminary results from patients with multiple myeloma showed that the combination of bendamustine and bortezomib is efficacious and well tolerated. However, there are so far no data on this combination in patients with NHL or CLL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bendamustine and Bortezomib | Experimental | Drug: Bendamustine, Drug: BortezomibCombination Chemotherapy of Bendamustine and Bortezomib as described in the intervention section |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic recurrent or refractory indolent NHL or B-CLL
- Adequate organ and bone marrow function
- Karnofsky greater than 50%
Key exclusion criteria (3 listed)
- Candidates for autologous stem cell transplantation
- Secondary high grade lymphoma
- Concurrent severe medical condition
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 |
|---|---|---|
| BendamustineAlso: Ribomustin, SDX-105starting with 60 mg/m^ 2, IV, dose escalation, weekly d1,8,15 q5w | Drug | Bendamustine and Bortezomib |
| BortezomibAlso: Velcadeweekly 1.5mg/m^2, IV, d1,8,15,22 q5w | Drug | Bendamustine and Bortezomib |
Primary outcome
Optimal Bendamustine Dosage for Further Studies
Time frame: Three weeks after treatment termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19860608Moosmann P, Heizmann M, Kotrubczik N, Wernli M, Bargetzi M. Weekly treatment with a combination of bortezomib and bendamustine in relapsed or refractory indolent non-Hodgkin lymphoma. Leuk Lymphoma. 2010 Jan;51(1):149-52. doi: 10.3109/10428190903275602. No abstract available.
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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.
Peter R Moosmann, MD PhD principal investigator
Cantonal Hospital of Aarau, Switzerland
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bendamustine and Bortezomib in people with Lymphoma, Non-Hodgkin, run by Peter Moosmann.
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 3 inclusion and 3 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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 3 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Optimal Bendamustine Dosage for Further Studies (time frame: Three weeks after treatment termination). 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 NCT00426855, which also lists 1 linked publication.
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 3 Apr 2015.