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Sponsored by: |
Allos Therapeutics |
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Information provided by: | Allos Therapeutics |
ClinicalTrials.gov Identifier: | NCT00481871 |
This is a Phase 1/2a, non-randomized, open-label, multi-center study designed to determine the Maximum Tolerated Dose (MTD) of Pralatrexate Injection and Gemcitabine with vitamin B12 and folic acid supplementation to patients with relapsed or refractory lymphoproliferative malignancies.
Condition | Intervention | Phase |
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Relapsed or Refractory Lymphoproliferative Malignancies |
Drug: Pralatrexate Injection Drug: Gemcitabine hydrochloride (HCl) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | A Phase 1/2a Open-Label Study of Sequential Pralatrexate and Gemcitabine With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Lymphoproliferative Malignancies |
Estimated Enrollment: | 84 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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PDX/Gem: Experimental
Pralatrexate Injection and Gemcitabine
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Drug: Pralatrexate Injection
Pralatrexate Injection will be administered via IV push and then followed by an infusion of Gemcitabine every other week. One cycle of treatment will be 4 weeks in duration. The total treatment duration will not exceed 12 months from first treatment.
Drug: Gemcitabine hydrochloride (HCl)
Following Pralatrexate Injection administration, Gemcitabine will be administered via IV infusion every other week. One cycle of treatment will be 4 weeks in duration. The total treatment duration will not exceed 12 months from first treatment.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Phase 1, B-cell:
Phase 2a, PTCL:
Phase 2a, B-cell:
Contact: Shannon Wilroy | 303-426-6262 | swilroy@allos.com |
Contact: Michelle Parent | 303-426-6262 | mparent@allos.com |
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Sipra Choudhury 650-736-2563 schoudhury@stanford.edu | |
Principal Investigator: Ranjana Hira Advani, MD | |
University of California at Los Angeles | Recruiting |
Los Angeles, California, United States, 90095-7077 | |
Contact: Donna Fernando 310-794-4376 dfernando@mednet.ucla.edu | |
Principal Investigator: Lauren Pinter-Brown, MD | |
United States, Colorado | |
Rocky Mountain Cancer Center | Recruiting |
Denver, Colorado, United States, 80218 | |
Contact: Karen Morris 303-285-5004 Karen.Morris@USONCOLOGY.com | |
Principal Investigator: Jeffrey Matous, MD | |
United States, Illinois | |
University of Chicago Hospital | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Angela Cisneros 773-834-4075 acisnero@medicine.bsd.uchicago.edu | |
Principal Investigator: Sonali Smith, MD | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115-6013 | |
Contact: Shannon Kerivan 617-632-4591 skerivan@partners.org | |
Principal Investigator: Eric Jacobsen, MD | |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Justina First 314-362-4206 jfirst@im.wustl.edu | |
Principal Investigator: Nancy Bartlett, MD | |
United States, Nebraska | |
University of Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68198 | |
Contact: Maribeth Hohenstein 402-559-9053 mahohens@unmc.edu | |
Principal Investigator: Julie Vose, MD | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10017 | |
Contact: Hanna Weissbrot 646-227-2139 weissbrh@mskcc.org | |
Principal Investigator: Steven Horwitz, MD | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Danielle Wright 212-342-3482 dw2316@columbia.edu | |
Principal Investigator: Owen O'Connor, MD, PhD | |
United States, Texas | |
Cancer Therapy & Research Center | Recruiting |
San Antonio, Texas, United States, 78229-4427 | |
Contact: Tyson DeSutter 210-450-5595 desutter@uthscsa.edu | |
Principal Investigator: Swaminathan Padmanabhan, MD | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Shawn Morgan 713-745-2717 smorgan@MDAnderson.org | |
Principal Investigator: Barbara Pro, MD | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Fereshteh Assadian 206-667-7540 fassadia@fhcrc.org | |
Principal Investigator: Andrei Shustov, MD, Ph.D |
Study Chair: | Steven M. Horwitz, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Allos Therapeutics, Inc. ( Medical Monitor ) |
Study ID Numbers: | PDX-009 |
Study First Received: | June 1, 2007 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00481871 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Lymphoproliferative malignancies Lymphoma Hodgkin's disease Non-Hodgkin's lymphoma PTCL T/NK-cell leukemia/lymphoma T-cell lymphoma/leukemia (HTLV 1+) Angioimmunoblastic T-cell lymphoma Blastic NK lymphoma Anaplastic large cell lymphoma T/NK-cell lymphoma |
Enteropathy-type intestinal lymphoma Hepatosplenic T-cell lymphoma Extranodal peripheral T/NK-cell lymphoma Subcutaneous panniculitis T-cell lymphoma Transformed mycosis fungoides PDX Pralatrexate Gemcitabine Gemzar Vitamin B12 Folic acid |
Antimetabolites Immunologic Factors Aminopterin Sezary Syndrome Mycosis Fungoides Lymphoma, Small Cleaved-cell, Diffuse Leukemia Mycoses Cutaneous T-cell Lymphoma Lymphoma, T-Cell Vitamins Lymphoma, Large-Cell, Anaplastic Micronutrients Lymphoma, Large-cell Gemcitabine |
Hodgkin Disease Lymphoma Lymphoma, Large B-Cell, Diffuse Vitamin B Complex Hematinics Hodgkin Lymphoma, Adult Immunoblastic Lymphadenopathy Hydroxocobalamin Hodgkin's Disease Vitamin B 12 Trace Elements Folic Acid Antagonists Intestinal Diseases Immunosuppressive Agents Antiviral Agents |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Hematologic Agents Physiological Effects of Drugs Aminopterin Vitamins Therapeutic Uses Micronutrients Gemcitabine |
Vitamin B Complex Hematinics Growth Substances Vitamin B 12 Enzyme Inhibitors Folic Acid Antagonists Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Folic Acid Neoplasms Radiation-Sensitizing Agents |