Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)

To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL

Study Overview

• Status: Completed
• Conditions: Relapsed or Refractory Mantle Cell Lymphoma (MCL)
• Intervention / Treatment: Drug: gemcitabine; Drug: mitoxantrone; Drug: rituximab

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Stage III or IV, histologically confirmed relapsed or refractory MCL as reviewed by the SI
• Is CD20 positive (by immunohistochemistry or FACS)
• Is Cyclin D positive (by immunohistochemistry or FACS)
• Has received prior chemotherapy (required minimum of 1 prior therapies)
• Has received prior treatment with Rituxan
• Has an ECOG Performance Status (PS) 0-2
• Is greater than or equal to 18 years of age
• Has appropriate laboratory values (please refer to protocol for specific laboratory values)
• If a history of cardiac disease is indicated, patient has an LVEF greater than or equal to 50% (MUGA)
• Has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential)
• If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 2 months thereafter
• Has signed a Patient Informed Consent Form
• Has signed a Patient Authorization Form

Exclusion Criteria:

• Has other lymphomas not classified as MCL
• Has had prior treatment with Gemzar and/or Novantrone
• A history of known hypersensitivity to Gemzar, Novantrone, Rituxan, or any component of these drugs
• Has a history of hypersensitivity to murine-cell derived therapeutics
• Has a LVEF indicative of a cardiac condition (LVEF < 50%)
• Is receiving concurrent immunotherapy
• Has evidence of CNS involvement
• Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
• Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
• Is a pregnant or nursing woman
• Is unable to comply with requirements of study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental arm; Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and rituximab.

Drug: gemcitabine; 900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar-->Novantrone-->Rituxan.; Other Names: Gemzar; Drug: mitoxantrone; Novantrone 10 mg/m2on Day 1. The order of administration will be: Gemzar-->Novantrone-->Rituxan.; Other Names: Novantrone; Drug: rituximab; Rituxan 375 mg/m2 on Day 1. The order of administration will be: Gemzar-->Novantrone-->Rituxan.; Other Names: Rituxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (CR + PR)	Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response	The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.	From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.
Overall Survival (OS) Rate at 1 Year	OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.	1 year.
Progression-free Survival Rate at 1 Year.	PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.	1 year.

Collaborators and Investigators

• Sponsor: US Oncology Research
• Collaborators: Eli Lilly and Company
• Investigators: Principal Investigator: Lawrence Garbo, MD, US Oncology Research

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: April 4, 2008
• First Submitted That Met QC Criteria: April 9, 2008
• First Posted (Estimate): April 10, 2008

Study Record Updates

• Last Update Posted (Estimate): November 3, 2016
• Last Update Submitted That Met QC Criteria: September 15, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Mantle-Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Antiviral Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Gemcitabine; Rituximab; Mitoxantrone
• Other Study ID Numbers: 04-026