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Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, December 2009
First Received: May 12, 2009   Last Updated: December 3, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: Cephalon
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00901927
  Purpose

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.


Condition Intervention Phase
Follicular Lymphoma
Drug: Bendamustine
Drug: Mitoxantrone
Drug: Rituximab
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Complete response (CR) rate [ Time Frame: At 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 37
Study Start Date: May 2009
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
BMR: Experimental
BMR = Bendamustine, Mitoxantrone, and Rituximab
Drug: Bendamustine
Starting dose 90 mg/m^2 by vein over 30-60 minutes on Days 1 and 2 of each cycle.
Drug: Mitoxantrone
10 mg/m^2 by vein over 15 minutes on Day 2 of each cycle.
Drug: Rituximab
375 mg/m^2 by vein over several hours on Day 1 of each cycle.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

2) Able to adhere to the study visit schedule and other protocol requirements.

3) Untreated grade 1, 2, or 3a follicular non-Hodgkin's lymphoma.

4) At least one measurable lesion according to the International Working Group Criteria for Response, of greater that 1.5cm.

5) ECOG performance status of < 2 at study entry.

6) 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 ULN or </= 5 x ULN if hepatic metastases are present.

7) 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.

8) Have a high risk FLIPI score, as defined by a FLIPI score >/= 3.

9) Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 to 14 days prior to study entry.

10) An ejection fraction of >/= 50% as documented by a cardiac function study.

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  2. Pregnant or breast feeding females.
  3. 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.
  4. Use of any prior chemotherapy for follicular lymphoma.
  5. Known hypersensitivity to Bendamustine, mitoxantrone, or mannitol.
  6. A history of congestive heart failure.
  7. Any prior use of bendamustine or mitoxantrone.
  8. Concurrent use of other anti-cancer agents or experimental treatments.
  9. Known positive for HIV or infectious hepatitis type B or C.
  10. Creatinine clearance less than 40 ml/min.
  11. A known history of hepatic insufficiency (patients with a history of fulminate hepatic failure, hepatic encephalopathy, cirrhosis, and autoimmune hepatitis).
  12. Any history of grade 3b follicular lymphoma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901927

Contacts
Contact: Nathan Fowler, MD 713-792-2860

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Nathan Fowler, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cephalon
Investigators
Study Chair: Nathan Fowler, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UT MD Anderson Cancer Center ( Nathan Fowler, MD / Assistant Professor )
Study ID Numbers: 2008-0204
Study First Received: May 12, 2009
Last Updated: December 3, 2009
ClinicalTrials.gov Identifier: NCT00901927     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Lymphoma
Non-Hodgkin's Lymphoma
Untreated High Risk Follicular Lymphoma
Bendamustine hydrochloride
Bendamustine HCI
Bendamustine
CEP-18083
SDX-105
Treanda
Mitoxantrone
Novantrone
Rituximab
Rituxan

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Analgesics
Alkylating Agents
Bendamustine
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Rituximab
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Mitoxantrone
Peripheral Nervous System Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoproliferative Disorders
Central Nervous System Agents
Nitrogen Mustard Compounds

ClinicalTrials.gov processed this record on February 08, 2010