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| 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 |
| 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 |
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:
Contacts and Locations| Contact: Nathan Fowler, MD | 713-792-2860 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Nathan Fowler, MD | |
| Study Chair: | Nathan Fowler, MD | UT MD Anderson Cancer Center |
More Information
| 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 |
|
Lymphoma Non-Hodgkin's Lymphoma Untreated High Risk Follicular Lymphoma Bendamustine hydrochloride Bendamustine HCI Bendamustine CEP-18083 |
SDX-105 Treanda Mitoxantrone Novantrone Rituximab Rituxan |
|
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 |