Brief Summary

A phase II trial to evaluate the efficacy and safety of combination bendamustine and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. It is hypothesized that the BR combination will produce at least a 70% overall response rate.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Nov 2008

Longer than P75 for phase_2

Geographic Reach

1 country

33 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

4.8 years study duration

Study Start

First participant enrolled

November 1, 2008

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed

Last Updated

April 19, 2016

Status Verified

May 1, 2012

Enrollment Period

4.8 years

First QC Date

January 26, 2009

Last Update Submit

April 18, 2016

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

LymphomaB-Cell

Outcome Measures

Primary Outcomes (1)

Best Overall Response Rate (ORR) of bendamustine in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma
1 year for 1st assessment and then 2.5 years for final assessment

Secondary Outcomes (5)

Duration of Response (DOR)
1 year for 1st assessment and then 2.5 years for final assessment
Time to Progression (TTP)
1 year for 1st assessment and then 2.5 years for final assessment
Progression-Free Survival (PFS)
1 year for 1st assessment and then 2.5 years for final assessment
Safety Profile of Study Treatment
1 year for 1st assessment and then 2.5 years for final assessment
Overall Survival (OS)
1 year for 1st assessment and then 2.5 years for final assessment

Study Arms (1)

Bendamustine with rituximab

EXPERIMENTAL

All patients received combination bendamustine with rituximab

Drug: bendamustineDrug: rituximab

Interventions

bendamustineDRUG

120 mg/m2 IV, Days 1, 2 of Cycles 1-6

Also known as: Treanda

Bendamustine with rituximab

rituximabDRUG

375 mg/m2 IV, Day 1 of Cycles 1-6

Also known as: Rituxan

Bendamustine with rituximab

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically confirmed CD20-positive, diffuse large B-cell lymphoma
Measurable disease with at least one bidimensional lymph node or tumor mass \> 1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by PET or CT
Relapsed or refractory after at least one prior therapeutic treatment for diffuse large B-cell lymphoma. Relapsed is defined as patients who initially responded and then progressed. Refractory is defined as patients, whom in the judgment of the Investigator, received adequate prior treatment and did not respond during treatment or progressed within 60 days of last treatment. Relapse following an autologous stem cell transplant allowed.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2
Patient must understand and voluntarily sign IRB-approved informed consent
Life expectancy ≥ three (3) months
Age ≥ 18 years old
Laboratory parameters:
Absolute neutrophil count ≥ 1,000 cells/mm(3)
Platelet count ≥ 75,000 cells/mm(3)
Hemoglobin ≥ 8 g/dL
Creatinine ≤ 2.0 mg/dL or Creatinine Clearance ≥ 50 mL/min (calculated or 24-hr urine sample)
AST/SGOT 2.0 x ULN (≤ 5.0 x ULN if secondary to liver metastases)
ALT/SGPT 2.0 x ULN (≤ 5.0 x ULN if secondary to liver metastases)
Total bilirubin ≤ 2.0 x ULN

You may not qualify if:

Patients with active/symptomatic central nervous system (CNS) involvement based on clinical evaluation. Previously treated CNS involvement that has remained asymptomatic for ≥ 90 days allowed if no CNS involvement shown by lumbar puncture, PET, CT or MRI.
Prior treatment with bendamustine
Known sensitivity to bendamustine or any component of bendamustine
Known anaphylaxis or immunoglobulin E (IgE) mediated hypersensitivity to murine proteins or sensitivity to rituximab or any component of rituximab
Eligible for stem cell transplant (patients who refuse procedure will not be excluded)
Prior allogeneic stem cell transplant within 6 months of Cycle 1, Day 1
Major surgery, not related to debulking procedures, within 21 days of Cycle 1, Day 1. Patients undergoing debulking procedures and minor surgery are allowed after a recovery period, in the judgment of the Investigator.
Chemotherapy, immunotherapy, or irradiation within 28 days of Cycle 1, Day 1 (within 6 weeks for nitrosoureas or mitomycin). Patients on high dose corticosteroids must have tapered to a stable dose equivalent to Prednisone ≤ 15 mg per day within 28 days of Cycle 1, Day 1.
Prior radioimmunotherapy (i.e. Zevalin®) within 10 weeks of Cycle 1, Day 1
Prior use of investigational anti-cancer agents within 28 days of Cycle 1, Day 1
Unresolved toxicities ≥ grade 2 from previous therapy
Pregnant or lactating females. Females of childbearing potential (FCBP) and non-vasectomized men must agree to use effective methods of birth control during and 28 days following treatment period. FCBP must have a negative pregnancy test.
HIV-related lymphoma
Known active HIV or HCV infection, or known seropositivity for HIV, or current or chronic HBV or HCV infection. HBV test required at screening or within 6 months of screening and must indicate negative result. Patients with seropositivity presumed to be due to prior vaccination against Hepatitis B or resolved infection are not excluded (see HBV reactivation guidelines included in rituximab prescribing information).
Concurrent active or history of other malignancies, except nonmelanoma skin cancer or carcinoma in situ of cervix or breast. Patients with previous malignancies are eligible provided they have been disease free for ≥ 1 year.
+4 more criteria

Contact the study team to confirm eligibility.