Dear Cam,
Your firewall is rejecting my reply to you so I am posting to you on
the list.
I am so sorry that your counts have gone so low. Platelet counts of
7000-10,000 are very low. Unfortunately, most doctors do not recommend
anything other than platelet transfusions for low platelet counts. For
low
neutrophil count, however, you can discuss a white cell booster called
Neupogen with your doctor, that will boost the white cells and allow
you to
stay on Gleevec. Our doctor uses that for patients with low
neutrophils.
Sprycel also lowers counts but one of my friends who had very low
counts
on Gleevec went to the new drug from Novartis, AMN107 and her platelet
count
is better than it has been in years after an initial drop. This is
only one
patient experience so do not go too much by it.
AMN107 is more powerful than Gleevec and is the other new drug with
Sprycel. Sprycel will lower counts, so will AMN but responses of
individuals to different drugs is different so you can always discuss
these options with your doctor.
I think you will qualify for the trial on the Gleevec intolerant arm
since
your platelet counts are so low. There is an AMN107 trial recruiting
at
Edmonton, Alberta. I have given the trial protocol, below. Is
Edmonton far
from you? And would it be a lot of expense doing a trial there? You
would
probably have to stay there for a while.
I am glad you have a sibling donor as a backup but it can be a good
idea to try the new drugs, please discuss with your doctor and you
should take more than one medical opinion before deciding on
transplant.
Best Wishes,
Anjana
caregiver to Roy
Expanded Access Program of AMN107 in Imatinib-Resistant or Intolerant
Adult
Patients With Chronic Myeloid Leukemia
This study is currently recruiting patients.
Verified by Novartis November 2006
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00302016
Purpose
This study will further evaluate if AMN107 is safe in adults with
chronic
myeloid leukemia who are resistant or intolerant to imatinib and to
provide
patients access to this new drug until the drug becomes commercially
available.
Condition Intervention Phase
Chronic Myeloid Leukemia
Drug: AMN107
Phase III
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult
Chronic; Leukemia, Childhood
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled,
Single
Group Assignment, Safety Study
Official Title: An Open-Label, Multicenter, Expanded Access Study of
Oral
AMN107 in Adult Patients With Imatinib-Resistant or Intolerant Chronic
Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase.
Further study details as provided by Novartis:
Primary Outcomes: Evaluate safety profile; Provide patients with
expanded
access
Secondary Outcomes: No secondary outcomes/objectives planned
Expected Total Enrollment: 2000
Study start: January 2006
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for
Study:
Both
Criteria
Inclusion criteria
a.. Imatinib-resistant or -intolerant Philadelphia
chromosome-positive
chronic myeloid leukemia in blast crisis, accelerated phase, or chronic
phase
b.. Chronic myeloid leukemia patients who have been treated with an
investigational tyrosine kinase inhibitor
c.. Laboratory values within normal limits
Exclusion criteria
a.. Impaired cardiac function
b.. Acute or chronic liver or renal disease considered unrelated to
tumor
c.. Other concurrent severe and/or uncontrolled medical conditions
(e.g.,
uncontrolled diabetes, active or uncontrolled infection) that could
cause
unacceptable safety risks or compromise compliance with the protocol
d.. Patients who are currently receiving treatment with any of the
medications that have the potential to prolong the QT interval or to
inhibit
the metabolism of AMN107 (CYP3A4/5 inhibitors)
e.. Patients with a history of another malignancy that is currently
clinically significant or currently requires active intervention.
Other protocol-defined inclusion/exclusion criteria may apply
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier
NCT00302016
Novartis 1 800 340 6843
Alabama
University of South Alabama Cancer Research Institute, Mobile,
Alabama, 36693, United States; Recruiting
Jennifer Hartley 251-665-8020 [EMAIL PROTECTED]
Hung T. Khong, M.D., Principal Investigator
Arizona
Arizona Cancer Center, Tucson, Arizona, 85724, United States;
Recruiting
Joanne Kennedy 520-626-6787 [EMAIL PROTECTED]
Michael Carroll, M.D., Principal Investigator
California
City of Hope National Medical Center, Duarte, California,
91010,
United States; Recruiting
Lupe Duarte 626-256-4673 Ext. 63968 [EMAIL PROTECTED]
Ravi Bhatia, M.D., Principal Investigator
Stanford University, Palo Alto, California, 94304, United
States;
Recruiting
Andrea Linder 650-725-4047 [EMAIL PROTECTED]
Jason R. Gotlib, M.D., Principal Investigator
Colorado
University of Colorado, Aurora, Colorado, 80010, United
States;
Recruiting
Anclaire Spaulding 720-848-0667 [EMAIL PROTECTED]
Brian Abbott, M.D., Principal Investigator
Rocky Mountain Cancer Center, Denver, Colorado, 80218, United
States; Recruiting
Juli Murphy 303-285-5087 [EMAIL PROTECTED]
Jeffrey Matous, M.D., Principal Investigator
District of Columbia
Georgetown University Medical Center-Lombardi Cancer Center,
Washington, District of Columbia, 20007-2113, United States;
Recruiting
Amanda Begley 202-687-6185 [EMAIL PROTECTED]
Ekatherine Asatiani, M.D., Principal Investigator
Washington Cancer Institute, Washington, District of Columbia,
20010, United States; Recruiting
Jennifer Benz 202-877-3061 [EMAIL PROTECTED]
Joseph Catlett, M.D., Principal Investigator
Florida
Advanced Medical Specialties, Miami, Florida, 33176, United
States;
Not yet recruiting
Elizabeth Groh 305-595-6864 [EMAIL PROTECTED]
Sara Garrido, M.D., Principal Investigator
Florida Hospital Cancer Institute, Orlando, Florida, 32804,
United
States; Recruiting
Karen Marchman 407-303-2090 [EMAIL PROTECTED]
Rebecca L. Moroose, M.D., Principal Investigator
Hematology Oncology Assoc., Pensacola, Florida, 32501, United
States; Recruiting
Sharon Barrett 850-444-4785 [EMAIL PROTECTED]
Allen J. Patton, M.D., Principal Investigator
Osler Medical Inc./Osler Clinical Research, Melbourne, Florida,
32901, United States; Recruiting
Wendy Beckner 321-725-5050 Ext. 628 [EMAIL PROTECTED]
Stephen Yandel, M.D., Principal Investigator
Florida Oncology Associates, Palatka, Florida, 32177, United
States; Not yet recruiting
Medhi Moezi, M.D., Principal Investigator
MD Anderson Cancer Center, Orlando, Florida, 32806, United
States;
Not yet recruiting
Julio Hajdenberg, M.D., Principal Investigator
Georgia
Medical College of Georgia, Augusta, Georgia, 30912, United
States;
Recruiting
Elizabeth Rohde 706-721-6858 [EMAIL PROTECTED]
Anand Jillella, M.D., Principal Investigator
Emory University Cancer Institute, Atlanta, Georgia, 30322,
United
States; Recruiting
Emily Grant 404-778-5982 [EMAIL PROTECTED]
Jean Khoury, M.D., Principal Investigator
Illinois
University of Chicago Hospital, Chicago, Illinois, 60637,
United
States; Recruiting
Karen Chuang 773-834-2119
Richard Larson, M.D., Principal Investigator
University of Illinois at Chicago, Chicago, Illinois, 60612,
United
States; Recruiting
Jennifer Windhorst 312-355-1470 [EMAIL PROTECTED]
Ronald Hoffman, M.D., Principal Investigator
Loyola University Medical Center, Maywood, Illinois, 60153,
United
States; Not yet recruiting
Eliza Germano 708-327-3317 [EMAIL PROTECTED]
Scott Smith, M.D., Principal Investigator
Rush University Medical Center, Chicago, Illinois, 60612,
United
States; Not yet recruiting
Teresa O'Brien 312-942-5689
Jamile M. Shammo, M.D., Principal Investigator
Stroger Cook County Hospital, Chicago, Illinois, 60612, United
States; Not yet recruiting
Ahmed Jajeh, M.D., Principal Investigator
Indiana
St. Francis Hospital & Health Centers, Beech Grove, Indiana,
46107,
United States; Recruiting
Elissa Knezevich 317-782-7896 [EMAIL PROTECTED]
Jean Lonergan 317 782 7298 [EMAIL PROTECTED]
Luke Akard, M.D., Principal Investigator
Iowa
University of Iowa Hospitals & Clinics, Iowa City, Iowa, 52242,
United States; Recruiting
Karen Parrott 319-384-9101 [EMAIL PROTECTED]
Roger Gingrich, M.D., Principal Investigator
Kansas
Cancer Center of Kansas, Wichita, Kansas, 67214, United
States; Not
yet recruiting
Bradley Deutsch 315-613-4237
[EMAIL PROTECTED]
Shaker Dakhil, M.D., Principal Investigator
Kentucky
Louisville Oncology Research, Louisville, Kentucky, 40202,
United
States; Recruiting
Juli Brown 502-899-3366 Ext. 175 [EMAIL PROTECTED]
Muneeb Choudry, M.D., Principal Investigator
Louisiana
LSU Health Sciences Center, Shreveport, Louisiana, 71103,
United
States; Recruiting
Julie Laprease 318-813-1498 [EMAIL PROTECTED]
Jonathon Glass, M.D., Principal Investigator
Maryland
St. Agnes Hospital, Baltimore, Maryland, 21229, United States;
Recruiting
Elizabeth Chandler 410-368-2966 [EMAIL PROTECTED]
Carole Miller, M.D., Principal Investigator
Michigan
University of Michigan, Ann Arbor, Michigan, 48109, United
States;
Recruiting
Tina Pelton 734-936-3879 [EMAIL PROTECTED]
Henry Erba, M.D., Principal Investigator
Wayne State University, Detroit, Michigan, 48201, United
States;
Recruiting
Sonica Rehan 313-576-8736 [EMAIL PROTECTED]
Charles Schiffer, M.D., Principal Investigator
St. John Hospital and Medical Center, Grosse Pointe, Michigan,
48236, United States; Not yet recruiting
Muhammad Shurafa, M.D., Principal Investigator
Minnesota
Mayo Clinic Hospital, Rochester, Minnesota, 55905, United
States;
Recruiting
Colleen Irlbeck 507-538-0107 [EMAIL PROTECTED]
Mark Litzow, MD, Principal Investigator
St. Mary's Duluth Clinic, Duluth, Minnesota, 55806, United
States;
Not yet recruiting
Anne Forsman 218-786-3868 [EMAIL PROTECTED]
James Krook, M.D., Principal Investigator
Nebraska
Nebraska Methodist Cancer Center, Omaha, Nebraska, 68114,
United
States; Recruiting
Beth Ricklefs 402-354-5831 [EMAIL PROTECTED]
Stefano Tarantolo, M.D., Principal Investigator
Southeast Nebraska Cancer Center, Lincoln, Nebraska, 68510,
United
States; Not yet recruiting
Tracy Christianson 402-327-7363 [EMAIL PROTECTED]
Wallace (Cary) Peterson, M.D., Principal Investigator
Nevada
Nevada Cancer Institute, Las Vegas, Nevada, 89135, United
States;
Recruiting
Carol Varela 702-822-5433 [EMAIL PROTECTED]
Bryan Y. Wong, M.D., Principal Investigator
New Jersey
Hackensack University Medical Center, Hackensack, New Jersey,
07601,
United States; Recruiting
Linda Butryn 201-996-5896 [EMAIL PROTECTED]
Stuart Goldberg, M.D., Principal Investigator
New Mexico
University of New Mexico Health Sciences Center, Albuquerque,
New
Mexico, 87131, United States; Recruiting
Rachel Taylor 505-925-4524 [EMAIL PROTECTED]
Ed Libby, M.D., Principal Investigator
Cancer Institute of New Mexico, Santa Fe, New Mexico, 87505,
United
States; Recruiting
Patrick Judson, M.D., Principal Investigator
New York
Mount Sinai Medical Center, New York, New York, 10029, United
States; Recruiting
Ravina Dial [EMAIL PROTECTED]
Janice Gabrilove, M.D., Principal Investigator
Memorial Sloan Kettering Cancer Center, New York, New York,
10017,
United States; Recruiting
Andrew Hoffman 646-227-2177 [EMAIL PROTECTED]
Joseph G. Jurcic, M.D., Principal Investigator
University of Rochester Medical Center, Rochester, New York,
14642,
United States; Recruiting
Patti Messina [EMAIL PROTECTED]
Jane L. Liesveld, M.D., Principal Investigator
Weill Cornell Medical Center, New York, New York, 10021,
United
States; Recruiting
Katherine Vandris 212-746-1204 [EMAIL PROTECTED]
Richard Silver, M.D., Principal Investigator
Roswell Park Cancer Institute, Buffalo, New York, 14263,
United
States; Recruiting
Sheila Tighe 716-845-8360 [EMAIL PROTECTED]
Meir Wetzler, M.D., Principal Investigator
Winthrop Hematology/Oncology, Mineola, New York, 11501, United
States; Not yet recruiting
Harry Staszewski, M.D., Principal Investigator
North Carolina
Wake Forest University, Winston Salem, North Carolina, 27157,
United States; Recruiting
Jennifer McLean 336-713-3539 [EMAIL PROTECTED]
Bayard Powell, M.D., Principal Investigator
Duke University, Durham, North Carolina, 27710, United States;
Recruiting
Patti Davis 919-668-1026 [EMAIL PROTECTED]
David Rizzieri, M.D., Principal Investigator
Oklahoma
Cancer Care Associates, Tulsa, Oklahoma, 74136, United States;
Recruiting
Kathy Shroff 918-499-2000 [EMAIL PROTECTED]
Alan Keller, M.D., Principal Investigator
Cancer Care Associates, Oklahoma City, Oklahoma, 74112, United
States; Recruiting
Christina Caldwell 405-945-9613
[EMAIL PROTECTED]
Romeo Mandanas, M.D., Principal Investigator
Oregon
Oregon Health Sciences University, Portland, Oregon, 97239,
United
States; Recruiting
Gwen Kurilik [EMAIL PROTECTED]
Michael Deininger, M.D., Principal Investigator
Pennsylvania
Western Pennsylvania Cancer Institute, Pittsburgh, Pennsylvania,
15224, United States; Recruiting
Diane Blackwell 412-578-4392 [EMAIL PROTECTED]
James Rossetti, M.D., Principal Investigator
South Carolina
MUSC Hollings Cancer Center, Charleston, South Carolina, 25187,
United States; Recruiting
Jennifer Fulton 843-792-2708 [EMAIL PROTECTED]
Debra Frei-Lahr, M.D., Principal Investigator
Charleston Hematology Oncology, Charleston, South Carolina,
29403,
United States; Recruiting
Deborah McNeal 843-266-2540 [EMAIL PROTECTED]
George F. Geils, M.D., Principal Investigator
Cancer Center of the Carolinas, Greenville, South Carolina,
29615,
United States; Recruiting
Dina Norris 864-241-6251 [EMAIL PROTECTED]
Joe Stephenson, M.D., Principal Investigator
Three Medical Park, Columbia, South Carolina, 29203, United
States;
Not yet recruiting
Francisco Gonzalez, M.D., Principal Investigator
Tennessee
Vanderbilt University Medical Center, Nashville, Tennessee,
37232,
United States; Recruiting
Jill Janssen 615-343-7893 [EMAIL PROTECTED]
Madan Jagasia, M.D., Principal Investigator
The Jones Clinic, Germantown, Tennessee, 38138, United States;
Recruiting
Lucinda Boldien 901-685-5969 [EMAIL PROTECTED]
Michael C. Jones, M.D., Principal Investigator
Texas
UT Southwestern Medical Center, Dallas, Texas, 75390, United
States; Recruiting
Erica Goetz 214-648-7030 [EMAIL PROTECTED]
Robert Collins, M.D., Principal Investigator
Utah
Utah Cancer Specialists, Salt Lake City, Utah, 84106, United
States; Recruiting
Tracy Burback 801-269-0231 [EMAIL PROTECTED]
Graydon Harker, M.D., Principal Investigator
Washington
Swedish Cancer Institute, Seattle, Washington, 98104, United
States; Recruiting
Dione Pedersen 206-386-2444 [EMAIL PROTECTED]
Michael Milder, M.D., Principal Investigator
West Virginia
West Virginia University Hospital, Morgantown, West Virginia,
26506,
United States; Not yet recruiting
Pam Bunner 304-293-5619 [EMAIL PROTECTED]
Solveig Ericson, M.D., Principal Investigator
Australia
St. Leonards, NSW, Australia; Not yet recruiting
Austria
Wien, Austria; Recruiting
Peter Valent, Prof. +43 140 400 6086 [EMAIL PROTECTED]
Innsbruck, Austria; Recruiting
Wels, Austria; Recruiting
Graz, Austria; Recruiting
Linz, Austria; Recruiting
Belgium
Liege, Belgium; Recruiting
Edegem, Belgium; Recruiting
Yvoir, Belgium; Recruiting
Hasselt, Belgium; Recruiting
Brussels, Belgium; Recruiting
Antwerpen, Belgium; Recruiting
La Louviere, Belgium; Recruiting
Roeselar, Belgium; Not yet recruiting
Bruxelles, Belgium; Recruiting
Gent, Belgium; Recruiting
Arlon, Belgium; Recruiting
Brugge, Belgium; Recruiting
Leuven, Belgium; Recruiting
Aalst, Belgium; Recruiting
Brazil
Belo Horizonte, Brazil; Not yet recruiting
Rio de Janeiro, Brazil; Not yet recruiting
Sao Paulo, Brazil; Not yet recruiting
Curitiba, Brazil; Not yet recruiting
Campinas, Brazil; Not yet recruiting
Brasilia-DF, Brazil; Not yet recruiting
Curitaba, Brazil; Not yet recruiting
Ribeirao Preto, Brazil; Not yet recruiting
Porto Alegre-RS, Brazil; Not yet recruiting
Canada
Ottawa, Canada; Recruiting
Vancouver, British Columbia, Canada; Recruiting
Montreal, Quebec, Canada; Not yet recruiting
Toronto, Ontario, Canada; Recruiting
Edmonton, Alberta, Canada; Recruiting
Halifax, Nova Scotia, Canada; Recruiting
Hamilton, Ontario, Canada; Recruiting
Czech Republic
Olomouc, Czech Republic; Recruiting
Praha 2, Czech Republic; Not yet recruiting
Pizen-Lochotin, Czech Republic; Recruiting
Brno, Czech Republic; Not yet recruiting
Hradec Kralove, Czech Republic; Recruiting
Plzen, Czech Republic; Recruiting
Denmark
Copenhagen, Denmark; Recruiting
Vejle, Denmark; Recruiting
France
Limoges, France; Recruiting
Grenoble, France; Recruiting
Dijon, France; Recruiting
Marseille, France; Recruiting
Lille, France; Recruiting
Angers, France; Recruiting
Vandoeuvre, France; Recruiting
Poitiers, France; Recruiting
Nantes, France; Recruiting
Rennes, France; Recruiting
Nice, France; Recruiting
Lyon, France; Recruiting
Bordeaux, France; Recruiting
Toulouse, France; Recruiting
Le Chesnay, France; Recruiting
Creteil, France; Recruiting
Strasbourg, France; Recruiting
Germany
Hamburg, Germany; Recruiting
Munchen, Germany; Recruiting
Dresden, Germany; Recruiting
Mainz, Germany; Recruiting
Heidelberg, Germany; Recruiting
Hannover, Germany; Recruiting
Bremerhaven, Germany; Not yet recruiting
Mannheim, Germany; Recruiting
Frankfurt, Germany; Recruiting
Kiel, Germany; Recruiting
Oldenburg, Germany; Recruiting
Berlin, Germany; Recruiting
Leipzig, Germany; Recruiting
Freiburg, Germany; Recruiting
Stuttgart, Germany; Recruiting
Ulm, Germany; Recruiting
Greifswald, Germany; Not yet recruiting
Chemnitz, Germany; Recruiting
Augsburg, Germany; Recruiting
Tubingen, Germany; Recruiting
Regensburg, Germany; Recruiting
Weiden, Germany; Recruiting
Aschaffenburg, Germany; Recruiting
Braunschweig, Germany; Recruiting
Greece
Athens, Greece; Recruiting
Hong Kong
Pokfulam, Hong Kong; Recruiting
Hungary
Budapest, Hungary; Recruiting
Ireland
Dublin, Ireland; Recruiting
Italy
Roma, Italy; Recruiting
Bologna, Italy; Recruiting
Firenze, Italy; Recruiting
Genova, Italy; Recruiting
Napoli, Italy; Recruiting
Milano, Italy; Recruiting
Pavia, Italy; Not yet recruiting
Via Pansini, Italy; Not yet recruiting
Orbassano, Italy; Recruiting
Cagliari, Italy; Recruiting
San Giovanni Rotundo, Italy; Recruiting
Pescara, Italy; Recruiting
Novara, Italy; Recruiting
Catanzaro, Italy; Recruiting
Siena, Italy; Recruiting
Ancona, Italy; Recruiting
Palermo, Italy; Recruiting
Rionero in Vulture, Italy; Recruiting
Reggio Calabria, Italy; Recruiting
Monza, Italy; Recruiting
Brescia, Italy; Recruiting
Pesaro, Italy; Recruiting
Perugia, Italy; Recruiting
Nuoro, Italy; Recruiting
Korea, Republic of
Jeollanam-do, Korea, Republic of; Recruiting
Seoul, Korea, Republic of; Recruiting
Daegu, Korea, Republic of; Recruiting
Lebanon
Beirut, Lebanon; Recruiting
Malaysia
Kuala Lumpur, Malaysia; Recruiting
Pulau Pinang, Malaysia; Not yet recruiting
Mexico
Mexico D.F., Mexico; Not yet recruiting
Netherlands
Amsterdam, Netherlands; Recruiting
Poland
Gdansk, Poland; Recruiting
Warszawa, Poland; Recruiting
Krakow, Poland; Recruiting
Szczecin, Poland; Recruiting
Russian Federation
Moscow, Russian Federation; Recruiting
Ufa, Russian Federation; Recruiting
Chelyabinsk, Russian Federation; Recruiting
Novosibirsk, Russian Federation; Recruiting
Saint-Petersburg, Russian Federation; Recruiting
Samara, Russian Federation; Recruiting
Singapore
Singapore, Singapore; Recruiting
South Africa
Roodepoort, Gauteng, South Africa; Not yet recruiting
Cape Town, Western Cape, South Africa; Not yet recruiting
Johannesburg, Gauteng, South Africa; Not yet recruiting
Spain
Cataluna, Spain; Recruiting
Baracaldo, Pais Vasco, Spain; Recruiting
Malaga, Spain; Recruiting
Barcelona, Cataluna, Spain; Recruiting
Salamanca, Castilla y Leon, Spain; Recruiting
San Sabastian, Pais Vasco, Spain; Recruiting
Zaragosa, Aragon, Spain; Not yet recruiting
Valencia, Spain; Recruiting
Granada, Andalucia, Spain; Recruiting
Galicia, Spain; Recruiting
Madrid, Spain; Recruiting
Murcia, Spain; Recruiting
Sweden
Linkoping, Sweden; Recruiting
Lund, Sweden; Recruiting
Uppsala, Sweden; Recruiting
Goteborg, Sweden; Recruiting
Switzerland
Bern, Switzerland; Recruiting
Lausanne, Switzerland; Recruiting
Basel, Switzerland; Recruiting
Taiwan
Tainan, Taiwan; Recruiting
Chiayi, Taiwan; Recruiting
Kaohsiung, Taiwan; Not yet recruiting
Thailand
Bangkok, Thailand; Recruiting
Study chairs or principal investigators
Novartis, Study Chair, Novartis
More Information
Study ID Numbers: CAMN107A2109
Last Updated: November 10, 2006
Record first received: March 9, 2006
ClinicalTrials.gov Identifier: NCT00302016
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-12-04
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