Trial | NCT00384553  Report issue

Official Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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.
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 Started
Jun 30
2004
Study Completion
Jun 30
2010
Last Update
Oct 06
2006
Estimate

Drug Rituximab

Drug DHAP

Drug TEC

Drug autologous stem cell transplantation

Criteria 

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 consent

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 ensured
No Results Posted