Leukemia, Lymphocytic, Chronic, B-CellPhase 1/2NCT00951457
Bendamustine Combined With Alemtuzumab in Pretreated Chronic Lymphocytic Leukemia (CLL)
A Phase 1/2 study testing Bendamustine and Alemtuzumab in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 7 sites in Austria.
Trial summary
The primary objective of this study is to determine the percentage of patients achieving a response, defined as the percentage of patients achieving complete response, partial response and stable disease/ no change upon treatment with the combination therapy according to NCI response criteria (also established… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic, B-Cell
- What is being tested?
- Bendamustine and Alemtuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesAustria
- Study dates
- Mar 2009to 6 Aug 2012
- 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
- Male or female patients with CD23+, CD5+, CD19+ light chain monoclonal B-CLL with treatment indication according to IWCLL criteria (Appendix 4)
- 1st or greater relapse after fludarabine or any other primary treatment regimen OR Refractory to any previous treatment and simultaneous indication for treatment according to IWCLL criteria (Appendix 4)
- Age 18 years and older
- ECOG status 0 - 2
- Life expectancy > 6 months
- Written informed consent given by the patient
- Patient using a reliable means of contraception (e.g. physical barrier, contraceptive pill or patch, spermicide and barrier, or IUD) for the duration of the study. Male patients have to use an adequate contraception method for the duration of study treatment and for 6 months following completion of study treatment. Women of childbearing potential have to use an effective method of contraception for the duration of study participation.
Who cannot join
- HIV positive or positive for Hepatitis B or C
- Active uncontrolled infection
- Pregnant or lactating women
- Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or to the excipients of any of the applied drugs (e.g. Bendamustine hydrochloride or mannitol)
- Previous treatment with bendamustine
- Treatment with an experimental drug within the previous 2 months
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- Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent.
- Transformation to aggressive B-cell malignancy (e.g. large B-cell lymphoma, Richter's syndrome, or prolymphocytic leukemia (PLL)
- Decreased kidney function with creatinine clearance < 30 ml/min
- Patients with severe co-morbidities or major organ dysfunctions (e.g. known severe liver damage, jaundice)
- Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina
- Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent, or patients unable to comply with requirements of study protocol
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Austria7 sites
Landeskrankenhaus Feldkirch
Feldkirch, A-6806
Medizinische Universitaet Innsbruck, Abtlg. f. Haematologie und Onkologie
Innsbruck, Tyrol, A-6020
A.ö. Landeskrankenhaus Leoben
Leoben, A-8700
Krankenhaus der Elisabethinen Linz
Linz, A-4010
Krankenhaus der Stadt Linz
Linz, A-4020
Universitaetsklinik f. Innere Medizin III
Salzburg, A-5020
Klinikum Wels-Grieskirchen GmbH
Wels, A-4600
About this study
Official title: Bendamustine Combined With Alemtuzumab in Pretreated Chronic Lymphocytic Leukemia (CLL) - A Phase I/II Trial With Concomitant Evaluation of Safety and Efficacy
The primary objective of this study is to determine the percentage of patients achieving a response, defined as the percentage of patients achieving complete response, partial response and stable disease/ no change upon treatment with the combination therapy according to NCI response criteria (also established according to IWCLL guidelines) upon treatment with a combination of bendamustine and alemtuzumab.
Read the detailed description
This is a non-randomized, multicenter, open-label, single-arm Phase I/II study to evaluate the safety and efficacy of bendamustine combined with alemtuzumab in patients with pretreated CD20-positive CLL (according to the revised NCI/ IWCLL criteria).
Eligible patients will receive bendamustine as 4 courses of 70 mg/m2 on days 1 and 2 every 28 days and 30 mg alemtuzumab s.c. continuously on days 1, 3 and 5 of every week, for a maximum of 16 weeks. Safety assessments will be conducted weekly; efficacy assessments including imaging will be performed at months 2, 4, 6, 10 and 16. Bone marrow biopsies will be performed upon CR (according to the 2008 IWCLL response criteria) or fixed at 6 and 16 months.
Following recruitment of the first 3 and 7 patients safety evaluations will be performed by a data safety monitoring board. An interim analysis for response and safety as well as maximum tolerated dose levels will occur after the first 7 patients have completed treatment (Gehan timepoint). If the treatment is deemed clinically safe a further 13 patients will be enrolled.
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Being tested
- Bendamustine, Alemtuzumab
- Keywords
- CLL, pretreated, immune therapy, dose escalation, maintenance therapy, Bendamustine, Alemtuzumab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Ribomustin
AlemtuzumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Overall study | Experimental | Dose escalation phase:
Days -3, -2, -1: 3 - 10 - 30 mg Alemtuzumab s.c.
Treatment phase:
Bendamustine 70 mg/m2 i.v. on d1 + d2 repeat every 28 days for 4 cycles
Alemtuzumab 30 mg s.c. 3x per week (days 1, 3, 5) continuously in parallel with chemotherapy cycles for a maximum of 16 weeks Receives: Drug: Bendamustine; Drug: Alemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the percentage of patients achieving a response, defined as the percentage of patients achieving complete response, partial response and stable disease/ no change upon treatment with the combination therapy
Measured: 2 -16 months
Secondary outcomes (7)
To evaluate the efficacy of a bendamustine/ alemtuzumab combination therapy in terms of complete response rates
Measured: 2 - 16 months
To evaluate the achievable cumulative doses of bendamustine and alemtuzumab in terms of maximum tolerated doses while on treatment
Measured: 2 -16 months
To determine response rates in all phases by 4-colour flow cytometric MRD analysis
Measured: 2 -16 months
To identify and characterize potential risk factors via FISH cytogenetics, CD38/ Zap-70 expression and mutational status
Measured: 2 - 6 months
To define clonal evolution by use of longitudinal FISH cytogenetics
Measured: 2 - 6 months
To define T cell subsets including prognostic EM T cells and Treg cells
Measured: 2 - 16 months
To document change upon quality of life by use of a standardized QoL questionnaire
Measured: 2 -16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startMar 2009
- Primary completion6 Aug 2012
- Study completion6 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, Chronic, B-CellStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Sponsor type
- University, hospital or other
- Collaborators
- Mundipharma Pte Ltd.
- Responsible party
- Sponsor
- Investigators
- Richard Greil, Prof.Dr., Study chair, Arbeitsgemeinschaft medikamentoese Tumortherapie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951457
- Sponsor's protocol ID
- AGMT CLL-6 BendAlem
- Status last verified
- Dec 2017
- First submitted
- 3 Aug 2009
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bendamustine Combined With Alemtuzumab in Pretreated Chronic Lymphocytic Leukemia (CLL) - A Phase I/II Trial With Concomitant Evaluation of Safety and Efficacy
- ClinicalTrials.gov ID
- NCT00951457
- Acronym / sponsor ID
- AGMT CLL-6 BendAlem
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Keywords
- CLL, pretreated, immune therapy, dose escalation, maintenance therapy, Bendamustine, Alemtuzumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese TumortherapieUniversity, hospital or other
- Collaborators
- Mundipharma Pte Ltd.
- Study start
- Mar 2009
- Primary completion
- 6 Aug 2012 (actual)
- Study completion
- 6 Aug 2012 (actual)
- First posted
- 4 Aug 2009 (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.
The primary objective of this study is to determine the percentage of patients achieving a response, defined as the percentage of patients achieving complete response, partial response and stable disease/ no change upon treatment with the combination therapy according to NCI response criteria (also established according to IWCLL guidelines) upon treatment with a combination of bendamustine and alemtuzumab.
Detailed description
This is a non-randomized, multicenter, open-label, single-arm Phase I/II study to evaluate the safety and efficacy of bendamustine combined with alemtuzumab in patients with pretreated CD20-positive CLL (according to the revised NCI/ IWCLL criteria).
Eligible patients will receive bendamustine as 4 courses of 70 mg/m2 on days 1 and 2 every 28 days and 30 mg alemtuzumab s.c. continuously on days 1, 3 and 5 of every week, for a maximum of 16 weeks. Safety assessments will be conducted weekly; efficacy assessments including imaging will be performed at months 2, 4, 6, 10 and 16. Bone marrow biopsies will be performed upon CR (according to the 2008 IWCLL response criteria) or fixed at 6 and 16 months.
Following recruitment of the first 3 and 7 patients safety evaluations will be performed by a data safety monitoring board. An interim analysis for response and safety as well as maximum tolerated dose levels will occur after the first 7 patients have completed treatment (Gehan timepoint). If the treatment is deemed clinically safe a further 13 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall study | Experimental | Drug: Bendamustine, Drug: AlemtuzumabDose escalation phase: Days -3, -2, -1: 3 - 10 - 30 mg Alemtuzumab s.c. Treatment phase: Bendamustine 70 mg/m2 i.v. on d1 + d2 repeat every 28 days for 4 cycles Alemtuzumab 30 mg s.c. 3x per week (days 1, 3, 5) continuously in parallel with chemotherapy cycles for a maximum of 16 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients with CD23+, CD5+, CD19+ light chain monoclonal B-CLL with treatment indication according to IWCLL criteria (Appendix 4)
- 1st or greater relapse after fludarabine or any other primary treatment regimen OR Refractory to any previous treatment and simultaneous indication for treatment according to IWCLL criteria (Appendix 4)
- Age 18 years and older
- ECOG status 0 - 2
- Life expectancy > 6 months
Key exclusion criteria (12 listed)
- HIV positive or positive for Hepatitis B or C
- Active uncontrolled infection
- Pregnant or lactating women
- Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or to the excipients of any of the applied drugs (e.g. Bendamustine hydrochloride or mannitol)
- Previous treatment with bendamustine
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 | Drug | Overall study |
| Alemtuzumab | Drug | Overall study |
Primary outcome
To determine the percentage of patients achieving a response, defined as the percentage of patients achieving complete response, partial response and stable disease/ no change upon treatment with the combination therapy
Time frame: 2 -16 months
7 secondary outcomes
To evaluate the efficacy of a bendamustine/ alemtuzumab combination therapy in terms of complete response rates
Time frame: 2 - 16 months
To evaluate the achievable cumulative doses of bendamustine and alemtuzumab in terms of maximum tolerated doses while on treatment
Time frame: 2 -16 months
To determine response rates in all phases by 4-colour flow cytometric MRD analysis
Time frame: 2 -16 months
To identify and characterize potential risk factors via FISH cytogenetics, CD38/ Zap-70 expression and mutational status
Time frame: 2 - 6 months
To define clonal evolution by use of longitudinal FISH cytogenetics
Time frame: 2 - 6 months
To define T cell subsets including prognostic EM T cells and Treg cells
Time frame: 2 - 16 months
To document change upon quality of life by use of a standardized QoL questionnaire
Time frame: 2 -16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
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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.
Richard Greil, Prof.Dr. study chair
Arbeitsgemeinschaft medikamentoese Tumortherapie
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bendamustine and Alemtuzumab in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 7 sites in Austria.
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 7 inclusion and 12 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 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Austria. 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?
To determine the percentage of patients achieving a response, defined as the percentage of patients achieving complete response, partial response and stable disease/ no change upon treatment with the combination therapy (time frame: 2 -16 months). 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 3 Mar 2022.