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Bendamustine, Mitoxantrone, and Rituximab (BMR) for Patients With Untreated High Risk Follicular Lymphoma

This study has been terminated.
(Study was closed early due to toxicity)
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00901927
First received: May 12, 2009
Last updated: May 26, 2016
Last verified: May 2016
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]
    Number of patients with complete response (CR) rate defined as percentage of number of complete response in total number of patients treated. The trial will be conducted by the Simon's optimal two-stage design and the CR rate estimated accordingly.


Enrollment: 14
Study Start Date: May 2009
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bendamustine + Mitoxantrone + Rituximab
Bendamustine starting dose 90 mg/m^2 by vein over 30-60 minutes on Days 1 and 2 of each cycle. Mitoxantrone 10 mg/m^2 by vein over 15 minutes on Day 2 of each cycle. Rituximab 375 mg/m^2 by vein over several hours on Day 1 of each cycle.
Drug: Bendamustine
Starting dose 90 mg/m^2 by vein over 30-60 minutes on Days 1 and 2 of each cycle.
Other Names:
  • Bendamustine Hydrochloride
  • Bendamustine HCI
  • CEP-18083
  • SDX-105
  • Treanda
Drug: Mitoxantrone
10 mg/m^2 by vein over 15 minutes on Day 2 of each cycle.
Other Name: Novantrone
Drug: Rituximab
375 mg/m^2 by vein over several hours on Day 1 of each cycle.
Other Name: Rituxan

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >18 years at the time of signing the informed consent form.
  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. Eastern Cooperative Oncology Group (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 upper limit of normal (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 milli-International unit (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901927

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00901927     History of Changes
Other Study ID Numbers: 2008-0204  NCI-2012-01629 
Study First Received: May 12, 2009
Last Updated: May 26, 2016
Health Authority: United States: Food and Drug Administration

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, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Bendamustine Hydrochloride
Mitoxantrone
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016