Back to results

Dose-Dense Therapy in Aggressive Lymphoma

Primary Purpose

Lymphoma

Status

No longer available

Phase

Locations

Study Type

Expanded Access

Intervention

CEOP/IMVP-Dexa chemotherapy

About this trial

This is an expanded access trial for Lymphoma focused on measuring lymphoma, aggressive, chemotherapy, dose-dense

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

18 and 70 years of age
Centrally reviewed, histologically proven diffuse large B-cell, anaplastic large-cell, or peripheral T-cell unspecified
Measurable disease
All stages

Exclusion Criteria:

Lymphoblastic or Burkitt histology
CNS-disease
HIV-positive
pregnant or lactating women
Pretreatment
Other malignancy
Concomitant diseases that forbid chemotherapy

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00517894

First Posted

August 15, 2007

Last Updated

August 15, 2007

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

1. Study Identification

Unique Protocol Identification Number

NCT00517894

Brief Title

Dose-Dense Therapy in Aggressive Lymphoma

Official Title

Phase 3 Study of Dose-Dense Therapy Versus CHOP in Aggressive Non-Hodgkin's Lymphoma

Study Type

Expanded Access

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

No longer available

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

4. Oversight

5. Study Description

Brief Summary

To investigate if a dose-dense chemotherapy with weekly chemotherapy compared to standard treatment every 3 weeks results in better survival in aggressive non-Hodgkin's lymphoma.

Detailed Description

Patients are randomized to receive dose-dense CEOP/IMVP-Dexa chemotherapy or standard 3-weekly CHOP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

lymphoma, aggressive, chemotherapy, dose-dense

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

CEOP/IMVP-Dexa chemotherapy

Intervention Description

Cyclophosphamide 750 mg/m2 i.v. d 1, epirubicin 70 mg/m2 i.v d 1, vincristine 1.4 mg/m2 i.v. d 1+8, prednisolone 100 mg p.o. d 1-5, ifosfamide 2000 mg/m2 i.v. d 15-17, etoposide 100 mg/m2 i.v. d 15-17, dexamethasone 40 mg p.o. or i.v. d 15-19, methotrexate 800 mg/m2 i.v. d 22. Mesna was given with ifosfamide, calcium-folinate rescue after methotrexate. Filgrastim was given on days 2-7, 9-12, 18-21, 23-28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Eligibility Criteria

Inclusion Criteria: 18 and 70 years of age Centrally reviewed, histologically proven diffuse large B-cell, anaplastic large-cell, or peripheral T-cell unspecified Measurable disease All stages Exclusion Criteria: Lymphoblastic or Burkitt histology CNS-disease HIV-positive pregnant or lactating women Pretreatment Other malignancy Concomitant diseases that forbid chemotherapy

12. IPD Sharing Statement

Citations:

PubMed Identifier

19693500

Citation

Fridrik MA, Hausmaninger H, Lang A, Drach J, Krieger O, Geissler D, Michlmayr G, Ulsperger E, Chott A, Oberaigner W, Greil R. Dose-dense therapy improves survival in aggressive non-Hodgkin's lymphoma. Ann Hematol. 2010 Mar;89(3):273-82. doi: 10.1007/s00277-009-0811-x. Epub 2009 Aug 20.

Results Reference

derived

Learn more about this trial

Dose-Dense Therapy in Aggressive Lymphoma

We'll reach out to this number within 24 hrs