NCT00856245

Brief Summary

Researchers hope to learn if adding rituximab with high doses of chemotherapy and stem cell transplantation will help patients get rid of their lymphoma cells from the bone marrow and stem cell collections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_2

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

May 30, 2017

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

6.4 years

First QC Date

March 3, 2009

Results QC Date

January 23, 2017

Last Update Submit

April 19, 2017

Conditions

Non-Hodgkins Lymphoma

Keywords

non-Hodgkinslymphomastem cell transplant

Outcome Measures

Primary Outcomes (1)

  • Rate of PCR Negativity

    Number of participants that are tumor free by PCR (Polymerase Chain Reaction) analysis post-transplant.

    up to 7 days

Secondary Outcomes (1)

  • Progression Free Survival (PFS) and Overall Survival (OS)

    up to 60 months

Study Arms (1)

Rituximab

OTHER

Patients will be treated IV with rituximab at the rate of 50 milligrams per hour (mg/hour) for 1 hour. If patient tolerates the infusion, the rate is increased by increments of 50 mg/hour every 30 minutes to a maximum of 400 mg/hour. If patient has a severe reaction, the infusion is stopped temporarily and the infusion rate is decreased by 50%. Subsequent infusions are started at the rate of 100 mg/hour, increased by 100 mg/hour every 30 minutes to a maximum of 400 mg/hour if tolerated. Vital signs are monitored every 15 minutes for 2 hours and every 30 minutes thereafter.

Drug: Rituximab

Interventions

RituximabDRUG

375 MG/M2 (milligram per meter squared) given IV (intravenously) weekly x 4-8 doses.

Also known as: Rituxan
Rituximab

Eligibility Criteria

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

You may qualify if:

  • Patients with biopsy-proven refractory CD20+ (cluster of differentiation antigen 20) Follicular lymphoma or transplant eligible mantle cell lymphoma in CR1 (complete remission 1) or later.
  • Patients must be transplant eligible per KUCC BMT SOP (Kansas University Cancer Center Bone Marrow Transplant Standard Operation Procedures) with chemo-sensitive/marrow negative disease.
  • Patients planning to harvest and hold may also be included as long as above criteria are met.

You may not qualify if:

  • Pregnancy
  • Zubrod performance status greater than 2
  • Life expectancy is severely limited by concomitant illness.
  • Uncontrolled arrhythmias or symptomatic cardiac disease precluding transplantation
  • Symptomatic pulmonary disease precluding transplantation
  • Serum creatinine greater than 1.8 mg/dL
  • Serum bilirubin greater than 2 X upper limit of normal, SGPT (serum glutamate pyruvate transaminase) greater than 3 times upper limit of normal
  • Evidence of chronic active hepatitis or cirrhosis
  • Unable to sign informed consent.
  • Allergy to Rituximab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Medical Center, Westwood Campus

Kansas City, Kansas, 66205, United States

Location

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

Results Point of Contact

Title
Siddhartha Ganguly, MD
Organization
University of Kansas Cancer Center
sganguly@kumc.edu
(913) 588-6030

Study Officials

  • Siddhartha Ganguly, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 5, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

May 30, 2017

Results First Posted

May 30, 2017

Record last verified: 2017-04

Locations

US(2)