Back to resultsStudy of Forodesine Hydrochloride in Patients With Relapsed/Refractory Precursor T-Lymphoblastic Leukemia/Lymphoma Who Have Failed Two or More Prior Treatment Regimens
Primary Purpose
Leukemia, Lymphoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Forodesine Hydrochloride Sterile Solution, 5 mg/mL
Forodesine Hydrochloride Capsules (100 mg)
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring leukemia, lymphoma
Eligibility Criteria
Inclusion Criteria:
- Patients with an unequivocal histologic diagnosis of precursor T-lymphoblastic leukemia/lymphoma (World Health Organization [WHO] classification).
- Failure to have responded to or relapsed after two or more treatment regimens for their disease, one of which could be HSCT.
- Performance status of 2 by Eastern Cooperative Oncology Group (ECOG) criteria (see Appendix A).
- Eighteen years of age and older.
- Life expectancy of at least three months.
- Adequate liver function (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] ≤3 times upper limit of normal), unless related to the underlying leukemia.
- Negative serum or urine pregnancy test within two to seven days prior to the start of study treatment in females of childbearing potential.
- Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study in such a manner that the risk of pregnancy is minimized. Acceptable contraceptives include intra-uterine devices (IUDs), hormonal contraceptives (oral, depot, patch, or injectable), and double-barrier methods such as condoms or diaphragms with spermicidal gel or foam.
- Signed informed consent form (ICF) prior to start of any study-specific procedures.
- Willing and able to provide authorization for the use and disclosure of personal health information in accordance with Health Insurance Portability and Accountability Act (HIPAA) policy (U.S. patients only).
Exclusion Criteria:
- Patients with known human immunodeficiency virus (HIV) infection or human T lymphotrophic virus 1 (HTLV-1).
- Patients with active hepatitis B or C infection.
- Patients with clinical evidence of active central nervous system (CNS) leukemia.
- Active serious infection not controlled by oral or intravenous antibiotics.
- Patients with a calculated creatinine clearance of <50 mL/min.
- Prior treatment with any investigational antileukemic or chemotherapy agent within seven days prior to study entry or lack of full recovery from side effects due to prior therapy, independent of when that therapy was given.
- Rapidly progressive disease with compromised organ function judged to be life threatening by the Investigator.
- Concurrent treatment with other antileukemia agents (CNS prophylaxis [e.g., intrathecal methotrexate, cytarabine, or hydrocortisone] and corticosteroid use will not be excluded, but must first be approved by the Medical Monitor) (see Sections 9.2.1 and 9.2.2).
- Pregnant and/or lactating female.
- Patients who cannot swallow or who have chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the product.
- Hypersensitive or intolerant to any component of the study drug formulations.
- Patients who have received prior forodesine treatment.
Sites / Locations
- University of Chicago Medical Center
- Louisana State University Health Sciences Center
- New York Medical College Division of Oncology
- Liberty Hematology and Oncology
- University of Texas MD Anderson Cancer Center
Outcomes
Primary Outcome Measures
To determine the rate of complete remission for T lymphoblastic leukemia/lymphoma relapsed or refractory patients. The complete remission rate will be evaluated over the three-month Initial Treatment Period.
Secondary Outcome Measures
To determine the rate of CR achieved based on prior HSCT status
Assess safety and tolerability
Assess survival end points
Evaluate the maintenance and duration of response
Evaluate the proportion of patients able to proceed to HSCT
Evaluate the effects of this forodesine regimen on plasma levels of dGuo
Determine the effects of this forodesine regimen on clinical end points
Explore potential predictive biomarkers
Full Information
NCT ID
NCT00419081
First Posted
January 5, 2007
Last Updated
January 18, 2012
Sponsor
BioCryst Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00419081
Brief Title
Study of Forodesine Hydrochloride in Patients With Relapsed/Refractory Precursor T-Lymphoblastic Leukemia/Lymphoma Who Have Failed Two or More Prior Treatment Regimens
Official Title
A Phase IIb, Multicenter, Open-Label, Nonrandomized, Repeat-Dose Study of Forodesine Hydrochloride in Patients With Relapsed/Refractory Precursor T-Lymphoblastic Leukemia/Lymphoma Who Have Failed Two or More Prior Treatment Regimens.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
Issues with Manufacturing
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioCryst Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether Forodesine Hydrochloride is effective in treating patients with relapsed/refractory precursor T-Lymphoblastic Leukemia/Lymphoma who have failed two or more prior treatment regimens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
leukemia, lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Forodesine Hydrochloride Sterile Solution, 5 mg/mL
Intervention Type
Drug
Intervention Name(s)
Forodesine Hydrochloride Capsules (100 mg)
Primary Outcome Measure Information:
Title
To determine the rate of complete remission for T lymphoblastic leukemia/lymphoma relapsed or refractory patients. The complete remission rate will be evaluated over the three-month Initial Treatment Period.
Secondary Outcome Measure Information:
Title
To determine the rate of CR achieved based on prior HSCT status
Title
Assess safety and tolerability
Title
Assess survival end points
Title
Evaluate the maintenance and duration of response
Title
Evaluate the proportion of patients able to proceed to HSCT
Title
Evaluate the effects of this forodesine regimen on plasma levels of dGuo
Title
Determine the effects of this forodesine regimen on clinical end points
Title
Explore potential predictive biomarkers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with an unequivocal histologic diagnosis of precursor T-lymphoblastic leukemia/lymphoma (World Health Organization [WHO] classification).
Failure to have responded to or relapsed after two or more treatment regimens for their disease, one of which could be HSCT.
Performance status of 2 by Eastern Cooperative Oncology Group (ECOG) criteria (see Appendix A).
Eighteen years of age and older.
Life expectancy of at least three months.
Adequate liver function (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] ≤3 times upper limit of normal), unless related to the underlying leukemia.
Negative serum or urine pregnancy test within two to seven days prior to the start of study treatment in females of childbearing potential.
Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study in such a manner that the risk of pregnancy is minimized. Acceptable contraceptives include intra-uterine devices (IUDs), hormonal contraceptives (oral, depot, patch, or injectable), and double-barrier methods such as condoms or diaphragms with spermicidal gel or foam.
Signed informed consent form (ICF) prior to start of any study-specific procedures.
Willing and able to provide authorization for the use and disclosure of personal health information in accordance with Health Insurance Portability and Accountability Act (HIPAA) policy (U.S. patients only).
Exclusion Criteria:
Patients with known human immunodeficiency virus (HIV) infection or human T lymphotrophic virus 1 (HTLV-1).
Patients with active hepatitis B or C infection.
Patients with clinical evidence of active central nervous system (CNS) leukemia.
Active serious infection not controlled by oral or intravenous antibiotics.
Patients with a calculated creatinine clearance of <50 mL/min.
Prior treatment with any investigational antileukemic or chemotherapy agent within seven days prior to study entry or lack of full recovery from side effects due to prior therapy, independent of when that therapy was given.
Rapidly progressive disease with compromised organ function judged to be life threatening by the Investigator.
Concurrent treatment with other antileukemia agents (CNS prophylaxis [e.g., intrathecal methotrexate, cytarabine, or hydrocortisone] and corticosteroid use will not be excluded, but must first be approved by the Medical Monitor) (see Sections 9.2.1 and 9.2.2).
Pregnant and/or lactating female.
Patients who cannot swallow or who have chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the product.
Hypersensitive or intolerant to any component of the study drug formulations.
Patients who have received prior forodesine treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Auro del Giglio, MD
Organizational Affiliation
Faculdade de Medicina do ABC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Belinda Pinto Simoes, MD
Organizational Affiliation
Hospital das Clinicas de Faculdade de Medicina de Ribeirao Preto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Sergio Chiattone, MD
Organizational Affiliation
Irmandade da Santa Casa de Misercordia de Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carmino Antonio de Souza, MD
Organizational Affiliation
Hospital de Clinicias da UICAMP - Centro de Hematologia e Hemoterapia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Barqueti Jendiroba, MD
Organizational Affiliation
Centro Goiano de Oncologia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ernesto de Meis, MD
Organizational Affiliation
INCA - Instituto Nacional de Cancer
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernando Antonio Sellos Ribeiro, MD
Organizational Affiliation
Instituto Estadual de Hematologia Artur de Siqueira Cavalcanti - HEMORIO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ines Guterres, MD
Organizational Affiliation
Hospital Nossa Senhora de Conceicao
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johnny Francisco Cordeiro Camargo, MD
Organizational Affiliation
Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer - CEPEP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jose Salvador Rodrigues Oliveira, MD
Organizational Affiliation
Hospital Santa Marcelina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucia Mariano da Rocha Silla, MD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mair Pedro de Souza, MD
Organizational Affiliation
Fundacao Hospital Amaral Carvalho
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Aparecida Zanichelli, MD
Organizational Affiliation
Hospital Brigadeiro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Lucia de Martino Lee, MD
Organizational Affiliation
Instituto de Oncologia Pediatrica - GRAACC Grupo de Apoio as Adolescente e a Crianca com Cancer - UNIFESP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ricardo Pasquini, MD
Organizational Affiliation
Hospital de Clinicas da Universidade Federal do Parana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicholas Novitzky, MD
Organizational Affiliation
Division of Haematology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vernon Louw, MD
Organizational Affiliation
Free State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Farhad Ravandi, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Seiter, MD
Organizational Affiliation
New York Medical College, Division of Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Turturro, MD
Organizational Affiliation
Louisana State University Health Sciences Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luis Isola, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wendy Stock, MD
Organizational Affiliation
University of Chicago Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Gonzalez, MD
Organizational Affiliation
Liberty Hematology and Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Foran, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ellen Ritchie, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leonard Heffner, MD
Organizational Affiliation
The Emory Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Madan Jagasia, MD
Organizational Affiliation
The Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katarzyna Jamieson, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary Schiller, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anjali Advani, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kellie Sprague, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tanya Trippett, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Meir Wetzler, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Gaiger, MD
Organizational Affiliation
Medical University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Werner Linkersch, MD
Organizational Affiliation
Department of Heamtology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Nachbaur, MD
Organizational Affiliation
Department of Heamatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Agnes Buzin, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephane de Botton, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacques Delaunnay, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Herve Dombret, MD
Organizational Affiliation
Service Clinique des Maladies du Sang
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francoise Huguet-Rigal, MD
Organizational Affiliation
Service d'Hematologie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norbert Ifrah, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnaud Pigneux, MD
Organizational Affiliation
CHU du Hart Leveque
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno Quesnel, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Houmedaly Reman, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xavier Thomas, MD
Organizational Affiliation
Maladies du Sang
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norbert Vey, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis Witz, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Genadi Iosava, MD
Organizational Affiliation
Institute for Heamatology & Transfusiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mamia Zodelava, MD
Organizational Affiliation
Heamatology and Transfusiology Dept
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Reinhard Andreesen, MD
Organizational Affiliation
Universitat Regensburg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walter Aulitzky, MD
Organizational Affiliation
Innere Abt. II
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrich Duehrsen, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerhard Ehninger, MD
Organizational Affiliation
Klinikum Carl Gustav Carus der Technischen Universitat
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnold Ganser, MD
Organizational Affiliation
ABT Hamatologie und Onkologie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
R. Haas, MD
Organizational Affiliation
Universitatsklinik Dusseldorf
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dieter Hoelzer, MD
Organizational Affiliation
Leiterin der Studienzentrale
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
W-D Ludwig, MD
Organizational Affiliation
Charite Universitatsmedizin Berlin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deiter Niederwieser, MD
Organizational Affiliation
Abt. Haematologie / Onkologie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Pfreunschuh, MD
Organizational Affiliation
Medizinische Klinik I
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mathias Schmid, MD
Organizational Affiliation
Innere Medizin III, Hamatologie und Onkologie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norbert Schmitz, MD
Organizational Affiliation
Hamatologsiche Abteilung
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Staib, MD
Organizational Affiliation
Med. Klinik I / Hamatolgie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthias Stelljes, MD
Organizational Affiliation
Innere Medizin A
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michele Baccarani, MD
Organizational Affiliation
Istitutp di Ematologia ed Oncologia Medica
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Renato Bassan, MD
Organizational Affiliation
Dipartimento di Oncoloia ed Ematico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alberto Bosi, MD
Organizational Affiliation
Aziendo Osperdaliero Universitaria Careggi Oncologia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felicetto Ferrara, MD
Organizational Affiliation
Azienda Ospedaliera Antonio Cardarelli
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Foa, MD
Organizational Affiliation
Cattedra di Ematologie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eugenio Gallo, MD
Organizational Affiliation
Divisione di Ematologia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincenzo Liso, MD
Organizational Affiliation
UO Universita degi Studi Policinico Ematologia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Salvatore Mirto, MD
Organizational Affiliation
Azienda Osperdaliera Vincenzo Cervello Divisione
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enrica Morra, MD
Organizational Affiliation
Complessa di Ematologia and Dir Departmento
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enrico Pogliani, MD
Organizational Affiliation
Ematologia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bob Lowenberg, MD
Organizational Affiliation
Eramus University Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jerzy Holowiecki, MD
Organizational Affiliation
Klinika Hematologii I
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wieslaw Jedrzejczak, MD
Organizational Affiliation
Klinika Hematologii i Onkologii
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kazimierz Kuliczkowski, MD
Organizational Affiliation
Department of Heamatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tadeusz Robak, MD
Organizational Affiliation
Klinika Hematologii Akademii Meduycznej Wojewodzki
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aleksander Skotnicki, MD
Organizational Affiliation
Katedra i Klinika Hematologii Collegium Medicum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
K. Abdulkadyrov, MD
Organizational Affiliation
Head of Hematology Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anatoli Golenkov, MD
Organizational Affiliation
Head of Clinical Heam and Immunotherapy Dept.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S. Moiseev, MD
Organizational Affiliation
Faculty Therapy Dept
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Valerie Savchenko, MD
Organizational Affiliation
Dir. Research Institute for BMT and Molecular Hematology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Ribera, MD
Organizational Affiliation
Insitut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Louisana State University Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
New York Medical College Division of Oncology
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Liberty Hematology and Oncology
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Forodesine Hydrochloride in Patients With Relapsed/Refractory Precursor T-Lymphoblastic Leukemia/Lymphoma Who Have Failed Two or More Prior Treatment Regimens
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