Clinical trial · Interventional
Prospective Trial on Immunochemotherapy Plus Autologous Stem Cell Transplantation (SCT) and Allogenic SCT in Primary Mantle-Cell-Lymphoma
A Prospective Phase II Trial on R-CHOP Followed by High-dose BEAM and Autologous SCT and HLA-identical Allogenic SCT After Dose-reduced Conditioning in Patients Age < 55 Years With Primary Mantle-Cell-Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to improve the overall survival of Mantle-Cell-Lymphoma (MCL) by a new concept of treatment with primary curative intention consisting of six courses of immunochemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation (SCT) and HLA-identical allogenic SCT after a dose-reduced conditioning regimen of total body irradiation (TBI) with 2 Gy and Fludarabine in younger patients with primary Mantle-Cell-Lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle-Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-dose BEAM plus autologous SCT | Drug | — | UNRESOLVED |
| HLA-identical allogenic SCT | Other | — | UNRESOLVED |
| Immunochemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Efficacy: ORR, OS, EFS
- timeFrame
- during treatment and on day 720 after allogenic SCT
Secondary outcomes (3)
- measure
- Toxicity according to WHO-Grading
- timeFrame
- During treatment and until follow-up
- measure
- GvL-effect after allogenic SCT
- timeFrame
- Allogenic SCT until day 720 after transplantation
- measure
- Comparison of OS between patients completing the protocol and patients not receiving allogenic SCT
- timeFrame
- First diagnosis of MCL until day 720 after transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. First diagnosis of Mantle-Cell-Lymphoma without any previous therapies except for pre-phase treatment consisting of steroids 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: 1. Manifest cardiac insufficiency, not compensated 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
References
Publications (0)
Data not yet available