Prospective Trial on Immunochemotherapy Plus Autologous Stem Cell Transplantation (SCT) and Allogenic SCT in Primary Mantle-Cell-Lymphoma
NCT ID: NCT00946374
Last Updated: 2009-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2004-07-31
2011-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Sequential Chemo-Radioimmunotherapy Followed by Autologous Transplantation for Patients With Untreated Advanced Stage Mantle Cell Lymphoma
NCT01484093
Induction Chemotherapy (R-CHOP Vs. R-FC) Followed by Interferon Maintenance Versus Rituximab Maintenance in MCL
NCT00209209
CD34+ Selected ASCT for Aggressive Lymphomas
NCT02646098
Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma
NCT00433537
Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Leukemia
NCT00003874
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immunochemotherapy
R-CHOP: Rituximab 375 mg/m²,intravenous ( iv ), day 0 ; Cyclophosphamide 750 mg/m²,iv, day1; Vincristine 1,4 mg/m² but at the maximum 2 mg,iv,d1; Doxorubicin 50 mg/m², iv, d1; Prednisone 100 mg, peroral ( po ), day 1 to day 5
High-dose BEAM plus autologous SCT
High-dose BEAM: Carmustine 300mg/m², iv, day -7; Cytarabine 2 x 200 mg/m², iv, day -6 to day -3; Etoposide 2 x 100 mg/m², iv, day -6 to day -3; Melphalan 140 mg/m², iv, day -2 followed by Autologous stem cell transplantation ( \> 2,5 x 10e6 CD34 positive autologous stem cells, iv, day 0
HLA-identical allogenic SCT
Fludarabine 30 mg/m², iv, day -4 to day -2; Cyclosporin A 2 x 3mg/kg, iv, day -1 to day 0 plus total body irradiation with 2 Gy, day 0 followed by allogenic stem cell transplantation immediately after Radiation.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age 18 to 55 years
3. Confirmed CD20-expression on lymphocytes
4. Effective methods of contraception and negative pregnancy test
5. Sufficient compliance
6. Written patient´s informed consent
Exclusion Criteria
2. Congestive Cardiomyopathy
3. Chronic pulmonary disease including hypoxemia
4. Severe hypertension, not condensable with drugs
5. Severe diabetes mellitus not condensable with drugs
6. Renal Insufficiency ( serum creatinin \> 2,0 mg/dl, other than Lymphoma related)
7. Liver impairment ( Transaminases value more than 3 x upper normal value or Bilirubin \> 2,0 mg/dl, other than Lymphoma related)
8. HIV-Infection
9. Active Hepatitis B-Infection if continuous virostatic treatment is not possible
10. Active Hepatitis C-Infection
11. Clinical signs of cerebrovascular insufficiency or cerebral damages
12. Pregnancy, lactation or inadequate contraception in women of childbearing age
13. Severe psychiatric disorders
14. Transplantation in the past
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heidelberg University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University of Heidelberg
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anthony D. Ho, Ph.D., Prof.
Role: PRINCIPAL_INVESTIGATOR
Director of Department
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital
Heidelberg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Markus Munder, MD
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Homepage University hospital Heidelberg, Germany
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BfArM: A-7140-00-37/4021157
Identifier Type: -
Identifier Source: secondary_id
L-149/2003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.