Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell

NCT00656084 | Completed Phase 2 Results

• 1 other identifier: 04-026
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Duration of Response

  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

  1 year.

• Progression-free Survival Rate at 1 Year.

  1 year.

Study Arms (1)

Experimental arm

EXPERIMENTAL

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; Drug: mitoxantrone; Drug: rituximab

Interventions

gemcitabine DRUG

900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.

Also known as: Gemzar

Experimental arm

mitoxantrone DRUG

Novantrone 10 mg/m2on Day 1. The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.

Also known as: Novantrone

Experimental arm

rituximab DRUG

Rituxan 375 mg/m2 on Day 1. The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.

Also known as: Rituxan

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Oncology Research: lead
• Eli Lilly and Company: collaborator

MeSH Terms

Conditions

Recurrence; Lymphoma, Mantle-Cell

Interventions

Gemcitabine; Mitoxantrone; Rituximab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Quinones; Polycyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Lawrence E. Garbo
• Organization: New York Oncology Hematology

Lawrence.Garbo@usoncology.com

(518) 489-0044

Study Officials

• Lawrence Garbo, MD

  US Oncology Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: December 1, 2004
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2008
• Last Updated: November 3, 2016
• Results First Posted: November 3, 2016

Record last verified: 2016-09