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A Pilot Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Who Are Candidates for Autologous Stem Cell Transplant | Clinical Trials | Clareo Health

TERMINATEDEARLY_PHASE1

A Pilot Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Who Are Candidates for Autologous Stem Cell Transplant

NCT00515138•University of California, San Francisco

View on ClinicalTrials.gov

Summary

This study seeks to determine the maximum tolerated dose of bortezomib in combination with rituximab, ifosfamide, carboplatin, and etoposide for patients with relapsed or primary refractory aggressive B-Cell Non-Hodgkin's lymphoma (diffuse large B-cell, mantle cell, follicular grade III, transformed lymphoma). Subjects will be enrolled in cohorts of 3 at each bortezomib dose level, starting at 1 mg/m(2), and escalating to 1.3, 1.5, and 1.7 mg/m(2). Bortezomib will be given on days 1 (prior to rituximab) and 4, rituximab 375 mg/m(2)/day on days 2, 3, and 4 of a 21-day cycle. They will also receive filgrastim on days 6-13 or pegfilgrastim on day 6.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aggressive B-Cell Lymphoma, CD-20 positive, in first relapse or refractory to first-line chemotherapy
•* Diffuse large B-cell Lymphoma, Mantle cell lymphoma, Follicular lymphoma (Grade III), Transformed Follicular Lymphoma
•* Rituximab is allowed
•* Prior radiation is allowed
•18-70 years of age
•ECOG performance status of 0-2
•HIV seronegative
•Measurable disease on CT scan by international working group response criteria
•No CNS involvement
•Subject is considered to be a candidate for autologous stem cell transplant in the opinion of the treating physician
+2 more criteria

Exclusion Criteria

•Platelet count of \<75 x 10(9)/L
•Absolute neutrophil count of \<1.0 x 10(9)/L
•Calculated or measured creatinine clearance of \<60 mL/minute within 14 days before enrollment
•Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
•Subject has hypersensitivity to bortezomib, boron or mannitol.
•Female subject is pregnant or breast-feeding.
•Subject has been treated with more than one prior chemotherapy regimen.
•Subject has received other investigational drugs with 14 days before enrollment.
•Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Locations (1)

University of California San Francisco

San Francisco, California, United States

Key Dates

Start Date

May 1, 2007

Primary Completion Date

November 1, 2011

Completion Date

November 1, 2011

Last Updated

April 12, 2012

Enrollment

ACTUAL participants

Conditions

Lymphoma, B-Cell

Interventions

Rituximab, Ifosfamide, Carboplatin, Etoposide, Bortezomib

DRUG

Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma

NCT04161248

Lymphoma, B-Cell

View study

RECRUITINGPHASE1

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

NCT06528301

Lymphoma, B-CellLymphoma, Non-Hodgkin (NHL)+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Pilot Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Who Are Candidates for Autologous Stem Cell Transplant

Inclusion Criteria

Exclusion Criteria

Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

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A Phase 1/2 Study of STP938 for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas

Axicabtagene Ciloleucel for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma