Non-Hodgkin's LymphomaPhase 1/2NCT00384553
Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma
A Phase 1/2 study testing Rituximab, DHAP and TEC in people with Non-Hodgkin's Lymphoma, run by University of Magdeburg at 1 site in Germany.
Trial summary
This study investigates toxicity and efficacy of 2 x R-DHAP followed by High dose chemotherapy R-TEC and autologous stem cell transplantation in patients with relapsed or refractory aggressive Non- Hodgkins's Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Rituximab, DHAP and TEC
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2004to Jun 2010
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first relapse or primary refractory disease of aggressive Non-Hodgkin's lymphoma stage I-IV
- pretreatment with systemic therapy
- 18-65 years of age
- Performance status:ECOG 0-2
- Granulocyte count >1.5/µm3, Platelet count >100/µm3
- Creatinine -Clearance ≥ 1 ml/sec
Show all 10Show fewer
- GPT/GOT ≤ 1.5 x normal (except tumour related)
- Bilirubine < 22 µmol/l
- no participation in another study 3 month before and during this study
- informed consent
Who cannot join
- Second neoplasia in history or existing except basalioma or squamous epithelium carcinoma of the skin or removed cervical intraepithelial neoplasia
- CNS- involvement by lymphoma
- respiratory Partial- or global insufficiency
- cardiac insufficiency (NYHA-Stage 3-4, EF < 30 %)
- severe neurological or psychiatric disease
- pregnancy
- HIV positivity ,active virus hepatitis, bacterial infection
- No follow up procedures ensured
Trial locations and contacts
1 site in 1 country.
Michael Koenigsmann, PD Dr. med contact
Germany1 site, 1 recruiting
- Recruiting
University of Magdeburg
Magdeburg, 39120
Michael Koenigsmann, PD Dr. med.
About this study
This study investigates toxicity and efficacy of 2 x R-DHAP followed by High dose chemotherapy R-TEC and autologous stem cell transplantation in patients with relapsed or refractory aggressive Non- Hodgkins's Lymphoma.
Read the detailed description
Initial Cytoreduction is performed with DHAP- protocol using dexamethasone, cytarabine and cisplatin followed by high dose chemotherapy with treosulfan, etoposide and cisplatin (TEC) an autologous peripheral blood stem cell transplantation(aPBSCT). In case of only partial remission a second identical high dose chemotherapy and aPBSCT follows. Patients with primary refractory disease or early relapse within 6 months should receive a allogenous stem cell transplantation. For Patients with CD 20 positive B-cell lymphoma the chemotherapy regiments DHAP and TEC are combined with rituximab.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Rituximab, DHAP, TEC, autologous stem cell transplantation
- 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.
RituximabDrug
DHAPDrug
TECDrug
autologous stem cell transplantationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Secondary outcomes (4)
remission rate
remission duration
overall survival
relapse free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startJun 2004
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Investigators
- Michael Koenigsmann, PD Dr. med., Principal investigator, University of Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384553
- Sponsor's protocol ID
- OSHO #071
- Status last verified
- Oct 2006
- First submitted
- 5 Oct 2006
- Last updated
- 6 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma
- ClinicalTrials.gov ID
- NCT00384553
- Acronym / sponsor ID
- OSHO #071
- Conditions
- Non-Hodgkin's Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- Jun 2004
- Study completion
- Jun 2010
- First posted
- 6 Oct 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.
This study investigates toxicity and efficacy of 2 x R-DHAP followed by High dose chemotherapy R-TEC and autologous stem cell transplantation in patients with relapsed or refractory aggressive Non- Hodgkins's Lymphoma.
Detailed description
Initial Cytoreduction is performed with DHAP- protocol using dexamethasone, cytarabine and cisplatin followed by high dose chemotherapy with treosulfan, etoposide and cisplatin (TEC) an autologous peripheral blood stem cell transplantation(aPBSCT). In case of only partial remission a second identical high dose chemotherapy and aPBSCT follows. Patients with primary refractory disease or early relapse within 6 months should receive a allogenous stem cell transplantation. For Patients with CD 20 positive B-cell lymphoma the chemotherapy regiments DHAP and TEC are combined with rituximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- first relapse or primary refractory disease of aggressive Non-Hodgkin's lymphoma stage I-IV
- pretreatment with systemic therapy
- 18-65 years of age
- Performance status:ECOG 0-2
- Granulocyte count >1.5/µm3, Platelet count >100/µm3
Key exclusion criteria (8 listed)
- Second neoplasia in history or existing except basalioma or squamous epithelium carcinoma of the skin or removed cervical intraepithelial neoplasia
- CNS- involvement by lymphoma
- respiratory Partial- or global insufficiency
- cardiac insufficiency (NYHA-Stage 3-4, EF < 30 %)
- severe neurological or psychiatric disease
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 |
|---|---|---|
| Rituximab | Drug | – |
| DHAP | Drug | – |
| TEC | Drug | – |
| autologous stem cell transplantation | Drug | – |
Primary outcome
Toxicity
4 secondary outcomes
remission rate
remission duration
overall survival
relapse free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2006.
Related trials for Non-Hodgkin's Lymphoma
RecruitingPhase 1/2
A Study to Evaluate Safety and Clinical Activity of GSK5926371 in Adult Participants With Relapsed or Refractory B-NHL
Lymphoma, Non-Hodgkin
RecruitingPhase 1
Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell Lymphoma
Recurrent Anaplastic Large Cell Lymphoma, Recurrent Enteropathy-Associated T-Cell Lymphoma
Active, not recruitingObservational study
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia
RecruitingObservational study
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Hematologic Malignancy, Leukemia
Active, not recruitingPhase 1/2
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
Anaplastic Large Cell Lymphoma, Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
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.
Michael Koenigsmann, PD Dr. med contact
Michael Koenigsmann, PD Dr. med. principal investigator
University of Magdeburg
1 site 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 Rituximab, DHAP and TEC in people with Non-Hodgkin's Lymphoma, run by University of Magdeburg 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 10 inclusion and 8 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 6 Oct 2006. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Koenigsmann, PD Dr. med (+4939113281), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity. 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 6 Oct 2006.