NCT00384553

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

October 6, 2006

Status Verified

October 1, 2006

First QC Date

October 5, 2006

Last Update Submit

October 5, 2006

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Toxicity

Secondary Outcomes (4)

  • remission rate

  • remission duration

  • overall survival

  • relapse free survival

Interventions

RituximabDRUG
DHAPDRUG
TECDRUG
autologous stem cell transplantationDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • first relapse or primary refractory disease of aggressive Non-Hodgkin's lymphoma stage I-IV
  • pretreatment with systemic therapy
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Magdeburg

Magdeburg, 39120, Germany

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Michael Koenigsmann, PD Dr. med.

    University of Magdeburg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Koenigsmann, PD Dr. med

CONTACT

+4939113281

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2006

First Posted

October 6, 2006

Study Start

June 1, 2004

Study Completion

June 1, 2010

Last Updated

October 6, 2006

Record last verified: 2006-10

Locations

DE(1)