NCT00005601|CompletedPhase 2

Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

A Phase II Trial of Cisplatinum, Cytosine Arabinoside, Dexamethasone (DHAP) With Rituxan in Patients With Relapsed CD20+ B-Cell Non-Hodgkin's Lymphoma

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

NCCTG-N9981NCI-2012-02326CDR0000067714

Study Type

interventional

Target

Locations

2 countries

Sites

Timeline

RegisteredJan 2003

StartedOct 2000

CompletionFeb 2008

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining combination chemotherapy with monoclonal antibody therapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab in treating patients who have relapsed non-Hodgkin's lymphoma.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline

Completed

Started Oct 2000

Typical duration for phase_2 lymphoma

Geographic Reach

2 countries

21 active sites

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

7.3 years study duration

First Submitted

Initial submission to the registry

May 2, 2000

Completed

5 months until next milestone

Study Start

First participant enrolled

October 1, 2000

Completed

2.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed

4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed

Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

2.7 years

First QC Date

May 2, 2000

Last Update Submit

December 5, 2016

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult Burkitt lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

response
Up to 5 years

Secondary Outcomes (3)

percentage of patients able to proceed to transplant after two courses of this treatment regimen
Up to 5 years
duration of response
Up to 5 years
overall survival
Up to 5 years

Study Arms (1)

rituximab+dexamethasone+cisplatin+cytarabine+sargramostim

EXPERIMENTAL

Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Biological: rituximabDrug: cisplatinDrug: cytarabineDrug: dexamethasoneDrug: sargramostim