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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00384553

Enrollment

Registered

2006-10-06

Start date

2004-06-30

Completion date

2010-06-30

Last updated

2006-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma

Brief summary

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.

Detailed 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.

Interventions

DRUGRituximab

DRUGDHAP

DRUGTEC

DRUGautologous stem cell transplantation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Toxicity	—

Secondary

Measure	Time frame
remission rate	—
remission duration	—
overall survival	—
relapse free survival	—

Countries

Germany

Contacts

Primary ContactMichael Koenigsmann, PD Dr. med

+4939113281

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026