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

University of Magdeburg

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: Rituximab

Drug: DHAP

Drug: autologous stem cell transplantation

Drug: TEC

Study type

Interventional

Funder types

Other

Identifiers

NCT00384553

OSHO #071

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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