Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00930514
Other study ID # BP22333
Secondary ID 2008-008490-60
Status Completed
Phase Phase 1
First received June 16, 2009
Last updated November 1, 2016
Start date September 2009
Est. completion date July 2013

Study information

Verified date November 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Ecuador: Public Health Ministry
Study type Interventional

Clinical Trial Summary

This 2 stage study will compare the pharmacokinetics and safety profile of subcutaneous and intravenous rituximab in participants with follicular lymphoma. In the first stage, participants who have achieved at least a partial response after induction treatment with intravenous rituximab will be randomized to one of 3 treatment cohorts, to receive rituximab 375 milligram per square meter (mg/m^2) intravenously, 375 mg/m^2 subcutaneously or 625 mg/m^2 subcutaneously, and pharmacokinetics evaluated on an ongoing basis. Upon selection of the subcutaneous dose (800 mg/m^2) which results in rituximab trough plasma concentration (C trough) values comparable to those achieved with the intravenous formulation, participants in the second stage of the study will be randomized to receive either the subcutaneous or intravenous formulation to demonstrate comparability of the C trough levels with both routes of administration. Maintenance therapy will continue every 2 or 3 months with the subcutaneous formulation.


Recruitment information / eligibility

Status Completed
Enrollment 281
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- CD20-positive follicular non-Hodgkin's lymphoma (NHL)

- Documented partial or complete response a the end of induction treatment with rituximab

- Must have completed induction treatment, and received at least 1 dose of intravenous rituximab maintenance treatment

- Eastern Cooperative Oncology Group (ECOG) performance status of less than and equal to (<=) 2

- Life expectancy of greater than and equal to (>=) 6 months

Exclusion Criteria:

- Histological evidence of transformation of NHL, or types of NHL other than follicular lymphoma

- Presence or history of central nervous system disease

- History of malignancy other than follicular NHL

- Recent major surgery (within 4 weeks prior to screening), excluding lymph node biopsy

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Rituximab
Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months.
Rituximab
Rituximab subcutaneous injection at 800 mg/m^2 dose level, administered every 2 or 3 months.
Rituximab
Rituximab subcutaneous injection 625 mg/m^2 administered every 2 or 3 months.
Rituximab
Rituximab intravenous infusion 375 milligram per square meter (mg/m^2) administered every 2 or 3 months.
Rituximab
Rituximab subcutaneous injection 375 mg/m^2 administered every 2 or 3 months.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Australia,  Brazil,  Canada,  Czech Republic,  Denmark,  Ecuador,  Finland,  France,  Israel,  Italy,  Korea, Republic of,  Mexico,  Norway,  Peru,  Poland,  Russian Federation,  Slovakia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Minimum Observed Plasma Trough Concentration (C trough) Up to 29 months No
Secondary Area Under the Curve From Time Zero to end of Dosing Interval (AUCtau) Up to 29 months No
Secondary Maximum Observed Plasma Concentration (Cmax) Up to 29 months No
Secondary Time to Reach Maximum Observed Plasma Concentration (Tmax) Up to 29 months No
Secondary Plasma Decay Half-Life (t1/2) Up to 29 months No
Secondary Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) Up to 29 months No
See also
  Status Clinical Trial Phase
Completed NCT01950273 - Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma Phase 1
Completed NCT02472756 - Open, Noninterventional Trial of MabThera in Combination With Chemotherapy (CVP, CHOP or FCM) in Patients With Relapsed/Refractory Follicular Lymphoma N/A
Withdrawn NCT00319332 - A Comparative Study Of Iodine I 131 Tositumomab Therapeutic Regimen Versus Ibritumomab Tiuxetan Therapeutic Regimen Phase 3
Completed NCT00193492 - A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma Phase 2
Withdrawn NCT00092274 - Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma Phase 1/Phase 2
Completed NCT03087929 - Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon N/A
Terminated NCT02413489 - An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma Phase 2
Completed NCT00915096 - Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma
Recruiting NCT05849857 - Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries Phase 2
Recruiting NCT05410418 - Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma Phase 2
Terminated NCT01609036 - An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Lymphoma N/A
Completed NCT01234766 - Bendamustine and Rituximab Followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma Phase 2
Completed NCT00849147 - Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603) Phase 2
Terminated NCT00384111 - Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular Non Hodgkin's Lymphoma (NHL) Phase 3
Completed NCT03682796 - Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma Phase 1
Recruiting NCT04982471 - Connect® Lymphoma Disease Registry: A US-Based Prospective Observational Cohort Study
Active, not recruiting NCT02996773 - Haploidentical BMT With Post-Transplant Cyclophosphamide and Bendamustine Phase 1
Terminated NCT00562965 - Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL) Phase 3
Active, not recruiting NCT00317096 - FCM Versus R-FCM Followed by R-Maintenance or Observation Only Phase 3
Not yet recruiting NCT06213636 - Fourth-gen CAR T Cells Targeting CD19/CD22 for Highly Resistant B-cell Lymphoma/Leukemia (PMBCL/CNS-BCL). Phase 1/Phase 2