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

NCT ID: NCT00384553

Last Updated: 2006-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rituximab

Intervention Type DRUG

DHAP

Intervention Type DRUG

TEC

Intervention Type DRUG

autologous stem cell transplantation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Magdeburg

OTHER

Sponsor Role lead

Principal Investigators

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Michael Koenigsmann, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Magdeburg

Locations

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University of Magdeburg

Magdeburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Michael Koenigsmann, PD Dr. med

Role: CONTACT

Phone: +4939113281

Other Identifiers

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OSHO #071

Identifier Type: -

Identifier Source: org_study_id