Lymphoma, Non-HodgkinPhase 2NCT01148173
High-dose Chemotherapy and Stem Cell Transplantation for Central Nervous System (CNS) Relapse of Aggressive Lymphomas
A Phase 2 study testing Combined systemic and intrathecal chemotherapy followed by HD-ASCT in people with Lymphoma, Non-Hodgkin, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Central nervous system (CNS) relapses of aggressive lymphomas are a rare but devastating complication. There is no therapy standard, conventional approaches are palliative. This study investigates an intensive chemotherapy with CNS penetrating drugs followed by high-dose chemotherapy and autologous stem cell… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- Combined systemic and intrathecal chemotherapy followed by HD-ASCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Oct 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- highly-malignant non-Hodgkins-Lymphoma, mantle-cell lymphoma or follicular lymphoma 3°
- CNS relapse (meningeal or/and intraparenchymal) with or without systemic lymphoma manifestations
- ECOG performance score ≤2
- no active infection
- negative HIV-serology
- adequate renal function (creatinine clearance > 50 ml/min)
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- adequate bone marrow function (granulocytes >1500/μl, platelets > 80000/μl)
- normal bilirubin, AST < 3 x UNL
- negative pregnancy test
Who cannot join
- newly diagnosed NHL with primary CNS involvement
- indolent NHL, lymphoblastic NHL or Burkitt lymphoma
- preceding CNS irradiation
- pretreatment of CNS relapse other than corticosteroids
- immunosuppression, concomitant immunosuppressive therapy, status after organ transplantation or allogenous stem cell transplantation
- second cancer other than basalioma or cervical carcinoma in situ within the last 5 years
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- unfit to receive an intensive chemotherapy
- pregnancy or breastfeeding
- known intolerance to MTX, ifosfamide, Depocyte, cytarabine, thiotepa, carmustine or etoposide
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité Universitätsmedizin
Berlin, State of Berlin, 12200
Lars Fischer, MD, +49308445 ext. 4096, lars.fischer@charite.de
Agnieszka Korfel, MD, +49308445 ext. 4096, agnieszka.korfel@charite.de
About this study
Official title: Combined Systemic and Intrathecal Chemotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Transplantation for CNS Relapse of Aggressive Lymphomas
Central nervous system (CNS) relapses of aggressive lymphomas are a rare but devastating complication. There is no therapy standard, conventional approaches are palliative. This study investigates an intensive chemotherapy with CNS penetrating drugs followed by high-dose chemotherapy and autologous stem cell transplantation as a potentially curative approach.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- Combined systemic and intrathecal chemotherapy followed by HD-ASCT
- Keywords
- CNS relapse, aggressive lymphoma, HD-ASCT
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined systemic and intrathecal chemotherapy followed by HD-ASCTDrug
Also called MTX, Holoxan, Depocyt, Tepadina
Methotrexate Ifosfamide Cytarabine Thiotepa Liposomal cytarabine (intrathecal) Carmustine Etoposide Autologous stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| Systemic and intrathecal chemotherapy | Experimental | Not described Receives: Drug: Combined systemic and intrathecal chemotherapy followed by HD-ASCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure
Measured: 2 years
Secondary outcomes (3)
Overall survival
Measured: 2 years
Remission rate
Measured: 3 months
Toxicity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startOct 2007
- Primary completionOct 2011 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Non-HodgkinStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Agnieszka Korfel, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148173
- Sponsor's protocol ID
- NHL-ZNS-Rezidiv
- Status last verified
- Nov 2007
- First submitted
- 21 Jun 2010
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Korfel A, Elter T, Thiel E, Hanel M, Mohle R, Schroers R, Reiser M, Dreyling M, Eucker J, Scholz C, Metzner B, Roth A, Birkmann J, Schlegel U, Martus P, Illerhaus G, Fischer L. Phase II study of central nervous system (CNS)-directed chemotherapy including high-dose chemotherapy with autologous stem cell transplantation for CNS relapse of aggressive lymphomas. Haematologica. 2013 Mar;98(3):364-70. doi: 10.3324/haematol.2012.077917. Epub 2012 Dec 14.
PubMed 23242601
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Systemic and Intrathecal Chemotherapy Followed by High-dose Chemotherapy and Autologous Stem Cell Transplantation for CNS Relapse of Aggressive Lymphomas
- ClinicalTrials.gov ID
- NCT01148173
- Acronym / sponsor ID
- NHL-ZNS-Rezidiv
- Conditions
- Lymphoma, Non-Hodgkin
- Keywords
- CNS relapse, aggressive lymphoma, HD-ASCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 22 Jun 2010 (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.
Central nervous system (CNS) relapses of aggressive lymphomas are a rare but devastating complication. There is no therapy standard, conventional approaches are palliative. This study investigates an intensive chemotherapy with CNS penetrating drugs followed by high-dose chemotherapy and autologous stem cell transplantation as a potentially curative approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic and intrathecal chemotherapy | Experimental | Drug: Combined systemic and intrathecal chemotherapy followed by HD-ASCT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- highly-malignant non-Hodgkins-Lymphoma, mantle-cell lymphoma or follicular lymphoma 3°
- CNS relapse (meningeal or/and intraparenchymal) with or without systemic lymphoma manifestations
- ECOG performance score ≤2
- no active infection
- negative HIV-serology
Key exclusion criteria (9 listed)
- newly diagnosed NHL with primary CNS involvement
- indolent NHL, lymphoblastic NHL or Burkitt lymphoma
- preceding CNS irradiation
- pretreatment of CNS relapse other than corticosteroids
- immunosuppression, concomitant immunosuppressive therapy, status after organ transplantation or allogenous stem cell transplantation
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 |
|---|---|---|
| Combined systemic and intrathecal chemotherapy followed by HD-ASCTAlso: MTX, Holoxan, Depocyt, TepadinaMethotrexate Ifosfamide Cytarabine Thiotepa Liposomal cytarabine (intrathecal) Carmustine Etoposide Autologous stem cell transplantation | Drug | Systemic and intrathecal chemotherapy |
Primary outcome
Time to treatment failure
Time frame: 2 years
3 secondary outcomes
Overall survival
Time frame: 2 years
Remission rate
Time frame: 3 months
Toxicity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
- Derived from this study: PubMed 23242601Korfel A, Elter T, Thiel E, Hanel M, Mohle R, Schroers R, Reiser M, Dreyling M, Eucker J, Scholz C, Metzner B, Roth A, Birkmann J, Schlegel U, Martus P, Illerhaus G, Fischer L. Phase II study of central nervous system (CNS)-directed chemotherapy including high-dose chemotherapy with autologous stem cell transplantation for CNS relapse of aggressive lymphomas. Haematologica. 2013 Mar;98(3):364-70. doi: 10.3324/haematol.2012.077917. Epub 2012 Dec 14.
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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.
Agnieszka Korfel, MD principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combined systemic and intrathecal chemotherapy followed by HD-ASCT in people with Lymphoma, Non-Hodgkin, run by Charite University, Berlin, Germany 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 9 inclusion and 9 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 22 Jun 2010. 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 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?
Contact Lars Fischer, MD (+ 49 30 8445 ext. 4096, lars.fischer@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment failure (time frame: 2 years). 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 NCT01148173, 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 22 Jun 2010.