NCT02099292

Brief Summary

The investigator prospectively evaluated the combination of Rituximab and Dexa-BEAM (dexamethasone, carmustine, etoposide, cytarabine, melphalan) followed by high dose therapy in patients with relapsed/refractory aggressive and indolent lymphoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2001

Longer than P75 for phase_2

Status
completed

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

May 1, 2001

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
8.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
Last Updated

March 28, 2014

Status Verified

March 1, 2014

Enrollment Period

4 years

First QC Date

March 21, 2014

Last Update Submit

March 25, 2014

Conditions

Relapsed Non-Hodgkin-Lymphoma

Keywords

lymphomahigh dose therapyDexaBEAMRituximabrole of alternative salvage treatment - dexaBEAM

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

    PFS at 5 years in patients * completing the entire protocol (PPP) * intention to treat population (IIT)

    five years follow up

Secondary Outcomes (1)

  • Overall Survival

    five years follow up

Other Outcomes (1)

  • Safety

    until day 100 post hig-dose therapy (HDT) with autologous stemcell-transplantation (SCT)

Study Arms (1)

Rituximab and DexaBEAM

EXPERIMENTAL

Rituximab and DexaBEAM

Drug: Rituximab and DexaBEAM

Interventions

Rituximab and DexaBEAMDRUG

combination treatment

Also known as: Rituxan
Rituximab and DexaBEAM

Eligibility Criteria

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

You may qualify if:

  • age between 18 and 65 years
  • Patients with aggressive B-cell-lymphoma:diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or grade IIIB follicular lymphoma (FL) with relapse after complete remission (CR) or failure to achieve CR on treatment.
  • Patients with indolent lymphoma: FL grade I-IIIA, marginal zone lymphoma (MZL) and immunocytoma (IC) if relapsed or failure to achieve at least partial remission (PR) on treatment.
  • CD20 positive
  • previous therapy: at least 3 cycles of anthracycline containing regimens.
  • ECOG (Eastern Cooperative Oncology Group) 0-2
  • measurable disease
  • adequate bone marrow function (absolute neutrophil count \[ANC\] \>1500/µl; platelet count \>100,000/µl), unless there was clear evidence of bone marrow involvement
  • glomerular filtration rate \> 60ml/min
  • ASAT(aspartate transaminase)/ALAT(alanine aminotransferase) \< 2.5-fold upper limit of normal (ULN) unless associated with liver infiltration
  • free from other cancers for at least 5 years, with the exception of basal cell carcinoma and carcinoma in situ of the uterine cervix.
  • given informed consent

You may not qualify if:

  • (central nervous system) CNS-lymphoma
  • HIV
  • Hepatitis B or C
  • pregnancy
  • breast-feeding women
  • high dose therapy or allogeneic transplantation
  • glomerular filtration rate \< 60ml/min
  • ASAT/ALAT \> 2.5-fold upper limit of normal (ULN) unless associated with liver infiltration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms 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

  • Georg Hess, MD

    Johannes Gutenberg University Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head Study Department of the Department of Hem / Onc

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 28, 2014

Study Start

May 1, 2001

Primary Completion

May 1, 2005

Study Completion

March 1, 2014

Last Updated

March 28, 2014

Record last verified: 2014-03