Chronic Lymphocytic LeukemiaPhase 2NCT00337519
Allogeneic Stem Cell Transplantation in Chronic Lymphocytic Leukemia
A Phase 2 study testing allogeneic stem cell transplantation and Alemtuzumab in people with Chronic Lymphocytic Leukemia, run by Charite University, Berlin, Germany at 3 sites in Germany.
Trial summary
Patients with advanced chronic lymphocytic leukemia (CLL) have a poor long-term prognosis. Allogeneic stem cell transplantation (SCT) in patients with CLL has only rarely been performed in the past because the clinical outcome after myeloablative conditioning was poor, mainly due to the high treatment-related… Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- allogeneic stem cell transplantation and Alemtuzumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 3 sitesGermany
- Study dates
- Jan 2003to Apr 2009
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- written informed consent
- sufficient organ function
- availability of an HLA-compatible donor (related or unrelated)
- age < 65 years
- karnofsky index > = 70%
- B-CLL requiring treatment after failure of at least one prior cytostatic treatment
Who cannot join
- positive HIV-serology
- pregnancy
- intolerance to study drugs
- second neoplasia
- serious infections
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Klinikum Chemnitz gGmbH
Chemnitz, Chemnitz, 09113
Uniklinikum Carl Gustav Carus
Dresden, 01307
Deutsche Klinik für Diagnostik GmbH
Wiesbaden, 65191
About this study
Official title: Chemo-Immunotherapy With Allogeneic Blood Stem Cell Transplantation in Patients With Chronic Lymphocytic Leukemia (Study #02)
Patients with advanced chronic lymphocytic leukemia (CLL) have a poor long-term prognosis. Allogeneic stem cell transplantation (SCT) in patients with CLL has only rarely been performed in the past because the clinical outcome after myeloablative conditioning was poor, mainly due to the high treatment-related mortality. However long-term disease-free survival after allogeneic SCT has been reported. Recently it has been demonstrated by our group and others that non-relapse mortality can be reduced significantly with the use of reduced-intensity conditioning regimens. Yet, graft versus host disease (GVHD) remains an important problem in this setting.
Alemtuzumab is an effective drug for the treatment of patients with advanced CLL and has been successfully applied for GVHD-prophylaxis in the setting of myeloablative and reduced-intensity conditioning regimens. The goal of the present study is to evaluate the role of alemtuzumab as part of a fludarabine-based reduced intensity conditioning regimen for allogeneic SCT in patients with advanced CLL.
Read the detailed description
Patients with relapsed or refractory CLL who are eligible for the study receive a cytoreductive therapy until SCT. Irrespective to the formal response, patients proceed to allogeneic SCT after fludarabine-based reduced-intensity conditioning. The use of granulocyte colony-stimulating factor (G-CSF)-mobilized peripheral blood stem cells > 3 x 10E6 CD34 cells/kg is recommended, but bone marrow > 1 x 10E8 MNC/kg is accepted. GVHD-prophylaxis is based on cyclosporine A adapted to blood levels (150 to 200 ng/mL) over a period of three months. In Phase I of the study, alemtuzumab has been applied as part of the conditioning regimen until day 5. In Phase II, alemtuzumab is given as cytoreductive pre-treatment with the last application of alemtuzumab scheduled for day 14 and after Amendment II in September 2006 scheduled for day 28. Furthermore methotrexate is given on days 1, 3, 6. and 11 at a projected cumulative dose of 45 mg/m2. Subsequent immunosuppressive therapy depends on the occurrence of GvHD, the development of chimerism, and residual disease. Patients with relapsing or residual disease (minimal residual disease excluded) who do not suffer from GvHD should receive donor lymphocytes in increasing dosages. The initial dose is 1 x 105/kg T-cells in unrelated donors and 1 x 106/kg in matched related donors. If no GvHD develops within 6-8 weeks, the next higher dosage is applied.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- allogeneic stem cell transplantation, Alemtuzumab
- Keywords
- chronic lymphocytic leukemia, reduced intensity conditioning, alemtuzumab, allogeneic stem cell transplantation
- 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.
allogeneic stem cell transplantationProcedure or surgery
see detailed description
AlemtuzumabDrug
alemtuzumab is given as cytoreductive pre-treatment with the last application of alemtuzumab scheduled for day 14
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | see detailed description Receives: Procedure: allogeneic stem cell transplantation; Drug: Alemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: 400 days
Secondary outcomes (5)
safety according to common toxicity criteria (CTC)
Measured: at discharge and until last follow up
rate of primary and secondary graft failure
Measured: until last follow up
rate of acute and chronic GVHD
Measured: day 100 and last follow up
response rate
Measured: 2 years
chimerism
Measured: day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startJan 2003
- Primary completionApr 2009 (estimated)
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Carl Gustav Carus, Deutsche Klinik fuer Diagnostik
- Investigators
- Johannes Schetelig, MD, Study chair, University Hospital Carl Gustav Carus, Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337519
- Sponsor's protocol ID
- CLL #02
- Other IDs
- DJCLS-R03/01
- Status last verified
- Jan 2009
- First submitted
- 15 Jun 2006
- Last updated
- 29 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemo-Immunotherapy With Allogeneic Blood Stem Cell Transplantation in Patients With Chronic Lymphocytic Leukemia (Study #02)
- ClinicalTrials.gov ID
- NCT00337519
- Acronym / sponsor ID
- CLL #02
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- chronic lymphocytic leukemia, reduced intensity conditioning, alemtuzumab, allogeneic stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University Hospital Carl Gustav Carus, Deutsche Klinik fuer Diagnostik
- Study start
- Jan 2003
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 16 Jun 2006 (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.
Patients with advanced chronic lymphocytic leukemia (CLL) have a poor long-term prognosis. Allogeneic stem cell transplantation (SCT) in patients with CLL has only rarely been performed in the past because the clinical outcome after myeloablative conditioning was poor, mainly due to the high treatment-related mortality. However long-term disease-free survival after allogeneic SCT has been reported. Recently it has been demonstrated by our group and others that non-relapse mortality can be reduced significantly with the use of reduced-intensity conditioning regimens. Yet, graft versus host disease (GVHD) remains an important problem in this setting.
Alemtuzumab is an effective drug for the treatment of patients with advanced CLL and has been successfully applied for GVHD-prophylaxis in the setting of myeloablative and reduced-intensity conditioning regimens. The goal of the present study is to evaluate the role of alemtuzumab as part of a fludarabine-based reduced intensity conditioning regimen for allogeneic SCT in patients with advanced CLL.
Detailed description
Patients with relapsed or refractory CLL who are eligible for the study receive a cytoreductive therapy until SCT. Irrespective to the formal response, patients proceed to allogeneic SCT after fludarabine-based reduced-intensity conditioning. The use of granulocyte colony-stimulating factor (G-CSF)-mobilized peripheral blood stem cells > 3 x 10E6 CD34 cells/kg is recommended, but bone marrow > 1 x 10E8 MNC/kg is accepted. GVHD-prophylaxis is based on cyclosporine A adapted to blood levels (150 to 200 ng/mL) over a period of three months. In Phase I of the study, alemtuzumab has been applied as part of the conditioning regimen until day 5. In Phase II, alemtuzumab is given as cytoreductive pre-treatment with the last application of alemtuzumab scheduled for day 14 and after Amendment II in September 2006 scheduled for day 28. Furthermore methotrexate is given on days 1, 3, 6. and 11 at a projected cumulative dose of 45 mg/m2. Subsequent immunosuppressive therapy depends on the occurrence of GvHD, the development of chimerism, and residual disease. Patients with relapsing or residual disease (minimal residual disease excluded) who do not suffer from GvHD should receive donor lymphocytes in increasing dosages. The initial dose is 1 x 105/kg T-cells in unrelated donors and 1 x 106/kg in matched related donors. If no GvHD develops within 6-8 weeks, the next higher dosage is applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: allogeneic stem cell transplantation, Drug: Alemtuzumabsee detailed description |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- written informed consent
- sufficient organ function
- availability of an HLA-compatible donor (related or unrelated)
- age < 65 years
- karnofsky index > = 70%
Key exclusion criteria (5 listed)
- positive HIV-serology
- pregnancy
- intolerance to study drugs
- second neoplasia
- serious infections
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 |
|---|---|---|
| allogeneic stem cell transplantationsee detailed description | Procedure or surgery | 1 |
| Alemtuzumabalemtuzumab is given as cytoreductive pre-treatment with the last application of alemtuzumab scheduled for day 14 | Drug | 1 |
Primary outcome
Progression-free survival
Time frame: 400 days
5 secondary outcomes
safety according to common toxicity criteria (CTC)
Time frame: at discharge and until last follow up
rate of primary and secondary graft failure
Time frame: until last follow up
rate of acute and chronic GVHD
Time frame: day 100 and last follow up
response rate
Time frame: 2 years
chimerism
Time frame: day 100
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
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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.
Johannes Schetelig, MD study chair
University Hospital Carl Gustav Carus, Dresden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing allogeneic stem cell transplantation and Alemtuzumab in people with Chronic Lymphocytic Leukemia, 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Jan 2009. 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 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?
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 (time frame: 400 days). 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 29 Jan 2009.