Immunocytoma/Morbus WaldenströmPhase 2PERLLNCT00927797
Interventional Study on Pentostatin, Cyclophosphamide and Rituximab in Indolent B-Cell Non-Hodgkin-Lymphoma (B-NHL)
A Phase 2 study testing Cyclophosphamide, Pentostatin, Rituximab in people with Immunocytoma/Morbus Waldenström and B-Cell Non-Hodgkin's Lymphoma, run by Heidelberg University.
Trial summary
The combination of Fludarabine and Cyclophosphamide have yielded overall response rates of over 80% in previously untreated patients with indolent Non-Hodgkin-Lymphoma. However, hematotoxicity rates were high with Grade 3 and 4 toxicities of over 50%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunocytoma/Morbus Waldenström, B-Cell Non-Hodgkin's Lymphoma, B-Cell Chronic Lymphocytic Leukemia
- What is being tested?
- Cyclophosphamide, Pentostatin, Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Jan 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed first diagnosis of or relapsed CD20-positive Immunocytoma, B-CLL or other indolent B-NHL
- therapy-requiring CLL defined as: Binet stage C or Binet B combined with occurence of B-symptoms, rapidly progressing disease, risk of organ compression by lymphoma mass
- therapy-requiring Immunocytoma as defined by the Consensus Panel Recommendations from the Second International Workshop on Waldenström´s Macroglobulinemia, 2003)
- age > 18 years
- anticipated life expectancy > 6 months
- ECOG 0-3
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- no significant comorbidities
- signed informed consent
- efficient method of contraception during time of therapy (men and women)
Who cannot join
- age < 18 years
- CD20 negativity
- significant comorbidities interfering with therapy as required by the protocol
- history of HIV infection or active hepatitis
About this study
Official title: Phase II Study to Evaluate the Safety and Efficacy of the Treatment With Pentostatin, Cyclophosphamide and Rituximab Followed by Rituximab Maintenance in Previously Untreated and Relapsed Patients With Immunocytoma/Morbus Waldenström, B-CLL and Other Indolent B-Cell Lymphomas
The combination of Fludarabine and Cyclophosphamide have yielded overall response rates of over 80% in previously untreated patients with indolent Non-Hodgkin-Lymphoma. However, hematotoxicity rates were high with Grade 3 and 4 toxicities of over 50%. Several studies have indicated that the treatment with Pentostatin and Cyclophosphamide causes lower hematotoxicity rates than the combination of Fludarabine and Cyclophosphamide. To evaluate the efficacy and safety of treatment with Pentostatin/Cyclophosphamide immuno-chemotherapy for patients with newly diagnosed or relapsed Immunocytoma/Morbus Waldenström, B-cell chronic lymphocytic leukemia (B-CLL) and other indolent CD20-positive B-NHL, an open, non-randomized, multi-center prospective phase II-study to evaluate the efficacy and safety of treatment with immuno-chemotherapy is conducted. Treatment consists of 6 courses of Pentostatin (4mg/m² on day 1), Cyclophosphamide (600mg/m² on day 1) and Rituximab (375mg/m² on day 0) administered every three weeks. Patients achieving complete or partial remission undergo maintenance therapy consisting of 8 courses of Rituximab (375mg/m²) administered every three months over a period of 2 years.
- Conditions
- Immunocytoma/Morbus Waldenström, B-Cell Non-Hodgkin's Lymphoma, B-Cell Chronic Lymphocytic Leukemia
- Being tested
- Cyclophosphamide, Pentostatin, Rituximab
- Keywords
- immunochemotherapy, Pentostatin, Cyclophosphamide, Rituximab, Maintenance, indolent B-NHL, B-CLL, B-NHL
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone, Lymphoma, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide, Pentostatin, RituximabDrug
| Study group | Role | What they receive |
|---|---|---|
| Immunochemotherapy, Maintencance | Experimental | Not described Receives: Drug: Cyclophosphamide, Pentostatin, Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: overall response rate
Measured: after 6 months and after 36 months
Secondary outcomes (4)
Toxicity according to WHO-Grading
Measured: throughout the treatment and until 36 months after
Efficacy: complete remission rate
Measured: after 6 months and 36 months
Efficacy: partial remission rate
Measured: after 6 months and 36 months
Efficacy: progression-free survival
Measured: after 6 months and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startFeb 2005
- Primary completionJan 2009 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunocytoma/Morbus WaldenströmStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Diakonie Krankenhaus Schwäbisch Hall, Germany, Klinikum der Universitaet Muenchen, Grosshadern, Klinikum am Plattenwald, Bad Friedrichshall, Germany, Diakonie-Klinikum Stuttgart, Gemeinschaftspraxis Porowski & Koniczek, Heilbronn, Germany, Universitätsmedizin Mannheim
- Investigators
- Anthony D Ho, Ph.D., Prof., Principal investigator, Director of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927797
- Sponsor's protocol ID
- L-278/2004
- Other IDs
- BfArM 4022892
- Acronym
- PERLL
- Status last verified
- Jun 2009
- First submitted
- 23 Jun 2009
- Last updated
- 25 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Safety and Efficacy of the Treatment With Pentostatin, Cyclophosphamide and Rituximab Followed by Rituximab Maintenance in Previously Untreated and Relapsed Patients With Immunocytoma/Morbus Waldenström, B-CLL and Other Indolent B-Cell Lymphomas
- ClinicalTrials.gov ID
- NCT00927797
- Acronym / sponsor ID
- PERLL / L-278/2004
- Conditions
- Immunocytoma/Morbus Waldenström, B-Cell Non-Hodgkin's Lymphoma, B-Cell Chronic Lymphocytic Leukemia
- Keywords
- immunochemotherapy, Pentostatin, Cyclophosphamide, Rituximab, Maintenance, indolent B-NHL, B-CLL, B-NHL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Diakonie Krankenhaus Schwäbisch Hall, Germany, Klinikum der Universitaet Muenchen, Grosshadern, Klinikum am Plattenwald, Bad Friedrichshall, Germany, Diakonie-Klinikum Stuttgart, Gemeinschaftspraxis Porowski & Koniczek, Heilbronn, Germany, Universitätsmedizin Mannheim
- Study start
- Feb 2005
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 25 Jun 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 combination of Fludarabine and Cyclophosphamide have yielded overall response rates of over 80% in previously untreated patients with indolent Non-Hodgkin-Lymphoma. However, hematotoxicity rates were high with Grade 3 and 4 toxicities of over 50%. Several studies have indicated that the treatment with Pentostatin and Cyclophosphamide causes lower hematotoxicity rates than the combination of Fludarabine and Cyclophosphamide. To evaluate the efficacy and safety of treatment with Pentostatin/Cyclophosphamide immuno-chemotherapy for patients with newly diagnosed or relapsed Immunocytoma/Morbus Waldenström, B-cell chronic lymphocytic leukemia (B-CLL) and other indolent CD20-positive B-NHL, an open, non-randomized, multi-center prospective phase II-study to evaluate the efficacy and safety of treatment with immuno-chemotherapy is conducted. Treatment consists of 6 courses of Pentostatin (4mg/m² on day 1), Cyclophosphamide (600mg/m² on day 1) and Rituximab (375mg/m² on day 0) administered every three weeks. Patients achieving complete or partial remission undergo maintenance therapy consisting of 8 courses of Rituximab (375mg/m²) administered every three months over a period of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunochemotherapy, Maintencance | Experimental | Drug: Cyclophosphamide, Pentostatin, Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- confirmed first diagnosis of or relapsed CD20-positive Immunocytoma, B-CLL or other indolent B-NHL
- therapy-requiring CLL defined as: Binet stage C or Binet B combined with occurence of B-symptoms, rapidly progressing disease, risk of organ compression by lymphoma mass
- therapy-requiring Immunocytoma as defined by the Consensus Panel Recommendations from the Second International Workshop on Waldenström´s Macroglobulinemia, 2003)
- age > 18 years
- anticipated life expectancy > 6 months
Key exclusion criteria (4 listed)
- age < 18 years
- CD20 negativity
- significant comorbidities interfering with therapy as required by the protocol
- history of HIV infection or active hepatitis
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 |
|---|---|---|
| Cyclophosphamide, Pentostatin, Rituximab | Drug | Immunochemotherapy, Maintencance |
Primary outcome
Efficacy: overall response rate
Time frame: after 6 months and after 36 months
4 secondary outcomes
Toxicity according to WHO-Grading
Time frame: throughout the treatment and until 36 months after
Efficacy: complete remission rate
Time frame: after 6 months and 36 months
Efficacy: partial remission rate
Time frame: after 6 months and 36 months
Efficacy: progression-free survival
Time frame: after 6 months and 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2009.
- Homepage of the DepartmentLink provided by the sponsor.
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.
Anthony D Ho, Ph.D., Prof. principal investigator
Director of Department
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Pentostatin, Rituximab in people with Immunocytoma/Morbus Waldenström and B-Cell Non-Hodgkin's Lymphoma, run by Heidelberg University.
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 4 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 25 Jun 2009. 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 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?
Efficacy: overall response rate (time frame: after 6 months and after 36 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 25 Jun 2009.