NCT01103388

Brief Summary

The goal of this clinical research is to see if Rituxan (rituximab) therapy given after high dose chemotherapy and transplant of a patients own stem cells will prevent or delay the return of the lymphoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2010

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

2.7 years

First QC Date

April 12, 2010

Last Update Submit

July 27, 2012

Conditions

Non-Hodgkin's Lymphoma

Keywords

RituximabRituxanLymphomaHigh dose chemotherapyAutologous transplantationAutologous stem cell transplantASCT

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Progression Free Survival (PFS)

    2 Years

Study Arms (2)

Rituximab

EXPERIMENTAL
Drug: Rituximab

No Rituximbab

NO INTERVENTION

Interventions

RituximabDRUG

375 mg/m\^2 by vein (IV) in 4 weekly doses (1 cycle) every 6 months for 4 cycles.

Also known as: Rituxan
Rituximab

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diffuse large B cell non-Hodgkin's lymphoma who are 5-6 months status post an autologous stem cell transplant and are in CR. Patients who are positive for t(14;18) by PCR or for BCL-2 by Southern blot are eligible provided there is no other disease present.
  • Absolute neutrophil count (ANC) \> 1500/mm3 independent of growth factor support
  • No evidence of symptomatic cardiac or pulmonary disease
  • Platelet count \> 75,000 mm3
  • Zubrod performance status of 2 or less.
  • Negative pregnancy test in patients of "child bearing potential"

You may not qualify if:

  • Uncontrolled active infection
  • Severe concomitant medical or psychiatric illness
  • Serum bilirubin \> 2.0 mg/dl 4) Transaminases \> 2xULN 5) Serum creatinine \> 2.0 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

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

  • Chitra M. Hosing, MD

    UT MD Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 14, 2010

Study Start

August 1, 2003

Primary Completion

April 1, 2006

Study Completion

April 1, 2010

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(1)