A Phase II Study to Evaluate Efficacy and Safety of P276-00 in Relapsed and/or Refractory Mantle Cell Lymphoma

Summary

The purpose of this study is to determine whether P276-00 is safe and effective in treatment of Mantle Cell Lymphoma that is recurred after or not responding to at least one previous line of treatment.

Conditions

• Mantle Cell Lymphoma

Interventions

DRUG

P276-00

P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity

Sponsors & Collaborators

• Piramal Enterprises Limited

  lead INDUSTRY

Principal Investigators

• Brad Kahl, MD · Director of the Lymphoma Service and Associate Professor of Medicine, University of Wisconsin- Madison

• Gabrail Nashat, MD · CEO, President, Gabrail Cancer Center

• Martha Glenn, MD · Associate Professor of Medicine, Huntsman Cancer Institute, Salt Lake City

• Andre Goy, MD · Director of Lymphoma and Deputy Director of Cancer Center, Hackensack University Medical Center, Hackensack

• Roger Lyons, MD · President, Cancer Care Centers of South Texas , San Antonio

• Nishitha Reddy, MD · Vanderbilt University Medical Center, Nashville

• Reena Nair, MD · Professor and Medical Oncologist, Tata Memorial Hospital, Mumbai, India

• Anand Pathak, MD · Medical Oncologist, Cancer Care Clinic and Hospital, Nagpur, India

• Vinod Raina, MD · Head Dept of Medical Oncology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India

• N K Warrier, MD · Senior Consultant Oncologist, Malabar Institute of Medical Sciences, Calicut, India

• Cecil Ross, MD · Consultant Oncologist, St. Johns Medical College & Hospital, Bangalore, India

• Kirushna kumar, MD · Consultant Oncologist, Meenakshi mission hospital and research centre, Madurai, India

• S H Advani, MD · Consultant Oncologist, Jaslok Hospital and Research Centre, Mumbai, India

• Patrick Johnston, MD · Associate Professor of Medicine, College of Medicine, Mayo Clinic, Rochester, USA

• Ajay Gopal, MD · Associate Professor of Medicine, Department of Medicine, University of Washington, Seattle, Washington.

• Craig Reeder, MD · Consultant, Division of Hematology/Oncology, Department of Internal Medicine, Mayo Clinic, Arizona

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2011-02-28

Completion

2012-08-31

Countries

• United States
• India

Study Locations