NCT00101010|CompletedPhase 2Results

Rituximab and Combination Chemotherapy in Treating Older Patients With Diffuse Large B-Cell Lymphoma

A Phase II Study Of Rituximab-CHOP With Pegylated Liposomal Doxorubicin In Patients Older Than 60 Years Of Age With Untreated Aggressive B-Cell Non-Hodgkin's Lymphoma

M.D. Anderson Cancer Center ClinicalTrials.gov

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6 other identifiers

CDR0000407533MDA-CCOP-2004-0305NCI-64852004-0305NCI-2009-000642U10CA045809

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2005

StartedSep 2005

CompletionSep 2014

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating older patients with diffuse large B-cell lymphoma.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline

Completed

Started Sep 2005

Longer than P75 for phase_2 lymphoma

Geographic Reach

1 country

7 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

9 years study duration

First Submitted

Initial submission to the registry

January 7, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2005

Completed

8 months until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed

9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed

6.1 years until next milestone

Results Posted

Study results publicly available

October 19, 2020

Completed

Last Updated

October 19, 2020

Status Verified

September 1, 2020

Enrollment Period

9 years

First QC Date

January 7, 2005

Results QC Date

September 1, 2020

Last Update Submit

September 22, 2020

Conditions

Lymphoma

Keywords

contiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphoma

Outcome Measures

Primary Outcomes (2)

Disease Response (Complete, Complete Unconfirmed, and Partial Responses) After 4 Courses
Response was defined as participants with a complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on International Workshop Criteria (IWG) for Tumor Response Criteria assessed with CT \& FDG-PET scans at 4 cycles (12 weeks). CR defined as disappearance of all target and non-target lesions in liver \& spleen, \& all lymph node masses regressed to normal size. PR defined as ≥50% reduction in sum of product of diameters (SPD) for measured lymph nodes, splenic \& liver lesions separately compared to baseline SPD. CRu does not qualify for CR above, due to a residual nodal mass or an indeterminate bone marrow.
Evaluation after 12 weeks (4 cycles of 21 days)
Number of Participants Experienced Grade 3 or Higher Cardiac Toxicity After Treatment: Cardiac Toxicity as Measured by Left Ventricular Ejection Fraction (LVEF) on Echocardiogram (ECHO) After 8 Courses
Ejection fraction ( EF) refers to the amount, or percentage, of blood that is pumped (or ejected) out of the ventricles with each contraction. Cardiology evaluation performed before second dose of pegylated liposomal doxorubicin or before entry onto trial, re-evaluation by cardiologist obtained in asymptomatic patients after chemotherapy cycle 4 and again after completion of therapy, and more often if symptomatic. Severe cardiac toxicity considered to be both Grade 3 and 4, and are graded according to NCI common toxicity criteria, CTCAE version 3.0.
Up to 24 weeks (8 cycles of 21 days)

Secondary Outcomes (2)

Survival Rate
Up to 5 years
Disease-free Survival
Up to 5 years or until disease progression

Study Arms (1)

Rituximab - Combination Chemotherapy

EXPERIMENTAL

Rituximab 375 mg/m\^2 intravenous (IV), Cyclophosphamide IV over 1-1½ hours, Pegylated doxorubicin HCl liposome 40 mg/m\^2 IV over 1 hour, Vincristine 2 mg IV, day 1, \& oral Prednisone 40 mg/m\^2 days 1 - 5; Filgrastim (G-CSF) 5 mcg/kg subcutaneously (SC) once daily beginning day 6 continuing until blood counts recover OR Pegfilgrastim 6 mg SC once on day 6 (24 hours after chemotherapy). Treatment repeats every 21 days for up to 8 courses.

Biological: FilgrastimBiological: PegfilgrastimBiological: RituximabDrug: CyclophosphamideDrug: Pegylated liposomal doxorubicin hydrochlorideDrug: PrednisoneDrug: Vincristine Sulfate