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Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma

Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Non-Hodgkin's Lymphoma

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Trial Information

Risk Adapted Therapy Optimization for Patients With Relapsed or Refractory Aggressive Non-Hodgkin-Lymphoma

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.

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Principal Investigator

Michael Koenigsmann, PD Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Magdeburg


Germany: Ethics Commission

Study ID:

OSHO #071



Start Date:

June 2004

Completion Date:

June 2010

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin