NCT00901927

Brief Summary

The goal of this clinical research study is to learn if the combination of bendamustine hydrochloride, mitoxantrone, and rituximab can help to control follicular lymphoma. The safety of this drug combination will also be studied.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2009

Longer than P75 for phase_2

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

May 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

April 3, 2020

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

6.7 years

First QC Date

May 12, 2009

Results QC Date

March 5, 2020

Last Update Submit

April 1, 2020

Conditions

Follicular Lymphoma

Keywords

LymphomaNon-Hodgkin's LymphomaUntreated High Risk Follicular LymphomaBendamustine hydrochlorideBendamustine HCIBendamustineCEP-18083SDX-105TreandaMitoxantroneNovantroneRituximabRituxan

Outcome Measures

Primary Outcomes (1)

  • Complete Response Rate of the Combination of BMR (Bendamustine + Mitoxantrone + Rituximab)

    To evaluate the complete response rate of the combination of BMR in previously untreated follicular non-Hodgkin's lymphoma. CR defined by International Working Group Criteria for Response for Non-Hodgkin's Lymphoma as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms.

    3 months

Secondary Outcomes (2)

  • Participants With Adverse Events

    3 months

  • Time to Progression (TTP) for Participants Treated With BMR (Bendamustine, Mitoxantrone, and Rituximab)

    5 months

Study Arms (1)

Bendamustine + Mitoxantrone + Rituximab

EXPERIMENTAL

Bendamustine starting dose 90 mg/m\^2 intravenously (IV) over 30-60 minutes on Days 1 and 2 of each 8-day cycle. Mitoxantrone 10 mg/m\^2 IV over 15 minutes on Day 2 of each cycle. Rituximab 375 mg/m\^2 IV over several hours on Day 1 of each cycle.

Drug: BendamustineDrug: MitoxantroneDrug: Rituximab

Interventions

BendamustineDRUG

Starting dose 90 mg/m\^2 by vein over 30-60 minutes on Days 1 and 2 of each cycle.

Also known as: Bendamustine Hydrochloride, Bendamustine HCI, CEP-18083, SDX-105, Treanda
Bendamustine + Mitoxantrone + Rituximab
MitoxantroneDRUG

10 mg/m\^2 by vein over 15 minutes on Day 2 of each cycle.

Also known as: Novantrone
Bendamustine + Mitoxantrone + Rituximab
RituximabDRUG

375 mg/m\^2 by vein over several hours on Day 1 of each cycle.

Also known as: Rituxan
Bendamustine + Mitoxantrone + Rituximab

Eligibility Criteria

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

You may qualify if:

  • Age \>18 years at the time of signing the informed consent form.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Untreated grade 1, 2, or 3a follicular non-Hodgkin's lymphoma.
  • At least one measurable lesion according to the International Working Group Criteria for Response, of greater that 1.5cm.
  • Eastern Cooperative Oncology Group (ECOG) performance status of \< 2 at study entry.
  • Laboratory test results within these ranges: Absolute neutrophil count \>/=1.5 x 10\^9/L; Platelet count \>/=100 x 10\^9/L; Serum creatinine \</= 2.0 mg/dL; Total bilirubin \</= 1.5 mg/dL; AST (SGOT) and ALT (SGPT) \</= 2 x upper limit of normal (ULN) or \</= 5 x ULN if hepatic metastases are present.
  • Disease free of prior malignancies for at least 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast.
  • Have a high risk FLIPI score, as defined by a FLIPI score \>/= 3.
  • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 to 14 days prior to study entry.
  • An ejection fraction of \>/= 50% as documented by a cardiac function study.

You may not qualify if:

  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or breast feeding females.
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Use of any prior chemotherapy for follicular lymphoma.
  • Known hypersensitivity to Bendamustine, mitoxantrone, or mannitol.
  • A history of congestive heart failure.
  • Any prior use of bendamustine or mitoxantrone.
  • Concurrent use of other anti-cancer agents or experimental treatments.
  • Known positive for HIV or infectious hepatitis type B or C.
  • Creatinine clearance less than 40 ml/min.
  • A known history of hepatic insufficiency (patients with a history of fulminate hepatic failure, hepatic encephalopathy, cirrhosis, and autoimmune hepatitis).
  • Any history of grade 3b follicular lymphoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Lymphoma, FollicularLymphomaLymphoma, Non-Hodgkin

Interventions

Bendamustine HydrochlorideMitoxantroneRituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

ButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicQuinonesPolycyclic CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Nathan Fowler/Clinical Professor, Lymphoma-Myeloma
Organization
The University of Texas (UT) MD Anderson Cancer Center
nfowler@mdanderson.org
(832) 671-3018

Study Officials

  • Nathan Fowler, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

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

May 12, 2009

First Posted

May 14, 2009

Study Start

May 1, 2009

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 3, 2020

Results First Posted

April 3, 2020

Record last verified: 2020-04

Locations

US(1)