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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04161885
Other study ID # M19-063
Secondary ID 2019-002621-30
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date February 26, 2020
Est. completion date November 30, 2026

Study information

Verified date February 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 465
Est. completion date November 30, 2026
Est. primary completion date November 30, 2026
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Participants must be at least 18 years old for Part 1 and, at least 12 years old for Part 2. - Participant must be diagnosed with Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria (2017) and either be planning for allogeneic stem cell transplantation or have received allogeneic stem cell transplantation within the past 60 days. - Blast percentage in bone marrow before transplant must be < 10%. - Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must be < 5% after transplant. - Participant meet adequate renal, hepatic and hematologic criteria as described in the protocol. - Participants >= 17 years old must have a Karnofsky Performance Scale (KPS) score > 50 and participants between 12 to 16 years old must have a Lansky Play Performance Scale score > 40. Exclusion Criteria: - History of disease progression during prior treatment with venetoclax. - History of any other malignancy within 2 years prior to study entry, except for: Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent; Myelodysplastic Syndrome, Myeloproliferative neoplasm (only allowed if it transformed to AML and AML should be the indication for marrow transplantation). - Participant has known infection with HIV or history of being positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. - Presence of clinical or laboratory symptoms/signs of extramedullary myeloid malignancy.

Study Design


Intervention

Drug:
Venetoclax
Tablet; Oral
Azacitidine
Subcutaneous (SC) or intravenous (IV) injection
Other:
Best Supportive Care (BSC)
BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.

Locations

Country Name City State
Australia Royal Adelaide Hospital /ID# 215678 Adelaide South Australia
Australia The Kinghorn Cancer Centre /ID# 214660 Darlinghurst New South Wales
Australia Alfred Health /ID# 240931 Melbourne Victoria
Australia Peter MacCallum Cancer Ctr /ID# 214653 Melbourne Victoria
Brazil Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 215145 Jaú Sao Paulo
Brazil Hospital de Clinicas de Porto Alegre /ID# 215042 Porto Alegre Rio Grande Do Sul
Brazil Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 239516 Sao Paulo
Brazil Hospital Nove de Julho /ID# 242359 São Paulo Sao Paulo
Canada CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591 Montreal Quebec
Canada Royal Victoria Hospital / McGill University Health Centre /ID# 215253 Montreal Quebec
Canada Saskatoon Cancer Centre /ID# 238821 Saskatoon Saskatchewan
Canada Princess Margaret Cancer Centre /ID# 215344 Toronto Ontario
Canada Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363 Vancouver British Columbia
China Aerospace Center Hospital /ID# 217018 Beijing Beijing
China Chinese PLA General Hospital /ID# 216287 Beijing Beijing
China Peking University People's Hospital /ID# 215551 Beijing Beijing
China Xiangya Hospital Central South University /ID# 219025 Changsha Hunan
China Fujian Medical University Union Hospital /ID# 215555 Fuzhou Fujian
China Guangdong Provincial People's Hospital /ID# 218666 Guangzhou Guangdong
China Nanfang Hospital of Southern Medical University /ID# 215553 Guangzhou Guangdong
China Zhujiang Hospital of Southern Medical University /ID# 216333 Guangzhou Guangdong
China The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550 Hangzhou Zhejiang
China The First Affiliated Hospital of Nanchang University /ID# 239168 Nanchang Jiangxi
China Zhongda Hospital Southeast University /ID# 218926 Nanjing Jiangsu
China Shanghai Changhai Hospital /ID# 216334 Shanghai Shanghai
China Shenzhen Second People's Hospital /ID# 239401 Shenzhen Guangdong
China The First Affiliated Hospital of Soochow University /ID# 216605 Suzhou Jiangsu
China Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546 Tianjin Tianjin
China Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552 Wuhan Hubei
China Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 238373 Wuhan Hubei
China Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 216282 Xi'an Shanxi
China The Affiliated Hospital of Xuzhou Medical University /ID# 239098 Xuzhou Jiangsu
China Henan Cancer Hospital /ID# 215554 Zhengzhou Henan
Czechia Fakultni Nemocnice Brno /ID# 214811 Brno
Czechia Fakultni nemocnice Hradec Kralove /ID# 214814 Hradec Kralove
Czechia Fakultni Nemocnice Ostrava /ID# 239922 Ostrava
Czechia Ustav hematologie a krevni transfuze /ID# 215133 Praha
France CHU de Besancon - Jean Minjoz /ID# 241171 Besancon Doubs
France CHRU Lille - Hopital Claude Huriez /ID# 217916 Lille Nord
France CHU de Nantes, Hotel Dieu -HME /ID# 214060 Nantes Pays-de-la-Loire
France CHU de Nice - Hôpital Archet 1 /ID# 214056 Nice Alpes-Maritimes
France AP-HP - Hopital Saint-Antoine /ID# 216957 Paris
France AP-HP - Hopital Saint-Louis /ID# 214054 Paris
France Hopital Pitie Salpetriere /ID# 241072 Paris
France CHU Bordeaux - Hopital Haut Leveque /ID# 214055 Pessac Gironde
Germany Klinikum Augsburg /ID# 239583 Augsburg
Germany Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214244 Dresden
Germany Universitaetsklinikum Halle (Saale) /ID# 239585 Halle (Saale)
Germany Medizinische Hochschule Hannover /ID# 214243 Hannover
Germany Universitaetsklinik Heidelberg /ID# 216623 Heidelberg Baden-Wuerttemberg
Germany Universitaetsklinikum Leipzig /ID# 245892 Leipzig Sachsen
Germany Universitaetsklinikum Muenster /ID# 215213 Muenster Nordrhein-Westfalen
Germany Universitaetsklinikum Wuerzburg /ID# 215212 Wuerzburg
Greece General Hospital of Athens Evangelismos /ID# 238810 Athens Attiki
Greece University General Hospital Attikon /ID# 238812 Athens Attiki
Greece University General Hospital of Patras /ID# 238811 RION Patras Achaia
Hungary Debreceni Egyetem Klinikai Kozpont /ID# 241123 Debrecen Hajdu-Bihar
Israel Rabin Medical Center /ID# 214509 Haifa H_efa
Israel Rambam Health Care Campus /ID# 214507 Haifa H_efa
Israel Hadassah Medical Center-Hebrew University /ID# 218697 Jerusalem Yerushalayim
Israel Schneider Children's Medical Center /ID# 224326 Petah Tikva HaMerkaz
Israel Sheba Medical Center /ID# 239571 Ramat Gan Tel-Aviv
Israel The Chaim Sheba Medical Center /ID# 214305 Ramat Gan Tel-Aviv
Israel Tel Aviv Sourasky Medical Center /ID# 214508 Tel Aviv Tel-Aviv
Italy ASST Spedali civili di Brescia /ID# 215997 Brescia
Italy IEO -Istituto Europeo di Oncologia /ID# 242579 Milan Milano
Italy Ospedale San Raffaele IRCCS /ID# 214311 Milan Milano
Italy Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 254964 Rome Roma
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910 Rome Lazio
Italy A.O.U. Citta della Salute e della Scienza di Torino /ID# 216148 Turin Torino
Japan Anjou Kousei Hospital /ID# 215857 Anjo-shi Aichi
Japan Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939 Bunkyo-ku Tokyo
Japan National Cancer Center Hospital /ID# 242639 Chuo-ku Tokyo
Japan Kyushu University Hospital /ID# 215285 Fukuoka-shi Fukuoka
Japan Fukushima Medical University Hospital /ID# 252293 Fukushima-shi Fukushima
Japan Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 217522 Hiroshima-shi Hiroshima
Japan Tokai University Hospital /ID# 250086 Isehara-shi Kanagawa
Japan Imamura General Hospital /ID# 215688 Kagoshima-shi Kagoshima
Japan Kanazawa University Hospital /ID# 242955 Kanazawa-shi Ishikawa
Japan Kobe City Medical Center General Hospital /ID# 215388 Kobe-shi Hyogo
Japan Kyoto University Hospital /ID# 243209 Kyoto-shi Kyoto
Japan Toranomon Hospital /ID# 215311 Minato-ku Tokyo
Japan Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 215679 Nagoya-shi Aichi
Japan Hyogo Medical University Hospital /ID# 215389 Nishinomiya-shi Hyogo
Japan Okayama University Hospital /ID# 214842 Okayama-shi Okayama
Japan Osaka Metropolitan University Hospital /ID# 215227 Osaka-shi Osaka
Japan Kindai University Hospital /ID# 214917 Osakasayama-shi Osaka
Japan Jichi Medical University Saitama Medical Center /ID# 216092 Saitama-shi Saitama
Japan Hokkaido University Hospital /ID# 215937 Sapporo-shi Hokkaido
Japan Tohoku University Hospital /ID# 214670 Sendai-shi Miyagi
Japan National Center for Child Health and Development /ID# 242479 Setagaya-ku Tokyo
Japan Jichi Medical University Hospital /ID# 216091 Shimotsuke-shi Tochigi
Japan Keio University Hospital /ID# 243549 Shinjuku-ku Tokyo
Japan Yamagata University Hospital /ID# 253304 Yamagata-shi Yamagata
Japan Kanagawa Cancer Center /ID# 215029 Yokohama-shi Kanagawa
Japan University of Fukui Hospital /ID# 253383 Yoshida-gun Fukui
Korea, Republic of Asan Medical Center /ID# 214893 Seoul
Korea, Republic of Samsung Medical Center /ID# 239087 Seoul
Korea, Republic of Seoul National University Hospital /ID# 214891 Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214892 Seoul
Spain Hospital Clinic de Barcelona /ID# 215108 Barcelona
Spain Hospital Santa Creu i Sant Pau /ID# 240397 Barcelona
Spain Hospital General Universitario Gregorio Maranon /ID# 215107 Madrid
Spain Hospital Universitario La Paz /ID# 218103 Madrid
Spain Hospital Universitario Ramon y Cajal /ID# 218102 Madrid
Spain Hospital Universitario Virgen del Rocio /ID# 215463 Sevilla
Spain Hospital Clinico Universitario de Valencia /ID# 215106 Valencia
Switzerland Universitätsspital Basel /ID# 215892 Basel Basel-Stadt
Switzerland Universitatsspital Zurich /ID# 215891 Zurich Zuerich
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197 Kaohsiung
Taiwan China Medical University Hospital /ID# 215198 Taichung
Taiwan Taichung Veterans General Hospital /ID# 239288 Taichung
Taiwan Taipei Veterans General Hosp /ID# 239289 Taipei
Taiwan National Taiwan University Hospital /ID# 215245 Taipei City
Taiwan Linkou Chang Gung Memorial Hospital /ID# 215319 Taoyuan City
United Kingdom University Hospitals Birmingham NHS Foundation Trust /ID# 215120 Birmingham
United Kingdom NHS Greater Glasgow and Clyde /ID# 215663 Glasgow Scotland
United Kingdom Imperial College Healthcare NHS Trust /ID# 215665 London
United Kingdom King's College Hospital NHS Foundation Trust /ID# 215338 London
United Kingdom The Royal Marsden NHS Foundation Trust /ID# 215124 London
United Kingdom University College London Hospitals NHS Foundation Trust /ID# 215662 London
United Kingdom The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 248359 Newcastle upon Tyne
United States UCHSC Anschultz Cancer Pavilion /ID# 215618 Aurora Colorado
United States University of Maryland Med Ctr /ID# 213855 Baltimore Maryland
United States Massachusetts General Hospital /ID# 215765 Boston Massachusetts
United States Montefiore Medical Center - Moses Campus /ID# 241669 Bronx New York
United States Roswell Park Comprehensive Cancer Center /ID# 217857 Buffalo New York
United States University of North Carolina /ID# 215814 Chapel Hill North Carolina
United States Ann & Robert H Lurie Children's Hospital of Chicago /ID# 215840 Chicago Illinois
United States The University of Chicago Medical Center /ID# 215616 Chicago Illinois
United States UC Health - Cincinnati /ID# 239263 Cincinnati Ohio
United States University Hospitals - Seidman Cancer Center /ID# 239260 Cleveland Ohio
United States Texas Oncology - Medical City Dallas /ID# 216720 Dallas Texas
United States Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735 Dallas Texas
United States Colorado Blood Cancer Institute /ID# 215980 Denver Colorado
United States Karmanos Cancer Institute - Dresner Clinic /ID# 214581 Detroit Michigan
United States City of Hope /ID# 213681 Duarte California
United States The John Theurer Cancer /ID# 215251 Hackensack New Jersey
United States Penn State Hershey Medical Ctr /ID# 217120 Hershey Pennsylvania
United States Indiana Blood & Marrow Transpl /ID# 215842 Indianapolis Indiana
United States University of Mississippi Medical Center /ID# 239343 Jackson Mississippi
United States Mayo Clinic /ID# 239710 Jacksonville Florida
United States University of Arkansas for Medical Sciences /ID# 239804 Little Rock Arkansas
United States Univ of Wisconsin Hosp/Clinics /ID# 216096 Madison Wisconsin
United States Loyola University Medical Ctr /ID# 215617 Maywood Illinois
United States Masonic Cancer Center /ID# 239492 Minneapolis Minnesota
United States TriStar Centennial Medical Center /ID# 218750 Nashville Tennessee
United States Ochsner Clinic Foundation-New Orleans /ID# 213834 New Orleans Louisiana
United States Columbia University Medical Center /ID# 240875 New York New York
United States Memorial Sloan Kettering Cancer Center-Koch Center /ID# 240680 New York New York
United States Weill Cornell Medical College /ID# 214887 New York New York
United States University of Oklahoma, Stephenson Cancer Center /ID# 215611 Oklahoma City Oklahoma
United States AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985 Orlando Florida
United States Children's Hospital of Philadelphia - Main /ID# 215410 Philadelphia Pennsylvania
United States Perelman Center for Advanced Medicine - /ID# 214518 Philadelphia Pennsylvania
United States Allegheny General Hospital /ID# 216756 Pittsburgh Pennsylvania
United States UPMC Hillman Cancer Ctr /ID# 213715 Pittsburgh Pennsylvania
United States Oregon Health & Science University /ID# 215874 Portland Oregon
United States Virginia Commonwealth University Medical Center Main Hospital /ID# 239203 Richmond Virginia
United States Mayo Clinic - Rochester /ID# 214685 Rochester Minnesota
United States Texas Transplant Institute /ID# 214691 San Antonio Texas
United States Arizona Oncology - Scottsdale - Cancer Transplant Institute /ID# 239711 Scottsdale Arizona
United States Fred Hutchinson Cancer Research Center /ID# 214436 Seattle Washington
United States University of Arizona Cancer Center - Tucson /ID# 242507 Tucson Arizona
United States Wake Forest Univ HS /ID# 239210 Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  China,  Czechia,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1) DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax and AZA as described in the protocol and evaluated by the Investigator and the sponsor. Up to the first treatment cycle (28 days)
Primary Overall Survival (OS) (Part 2) OS is defined as the number of days from the date of randomization to the date of death from any cause. Up to 45 months after the first participant is randomized
Secondary Morphologic Relapse-Free Survival (RFS) (Part 2) Morphologic relapse from AML defined as bone marrow blasts of >= 5% or reappearance of blasts in the peripheral blood not attributable to any other cause (e.g., bone marrow regeneration) in at least 2 peripheral blood samples at least one week apart or development of extramedullary disease after achieving a complete remission (CR) or complete remission with incomplete count recovery (CRi); or the date of death from any cause, whichever comes first as determined by Independent Review Committee (IRC). Up to 39 months after the first participant is randomized
Secondary Composite Relapse-Free Survival (RFS) (Part 2) Morphologic relapse from AML, non-morphologic relapse from AML, which is defined as increase in disease burden determined by standard methods with reappearance or acquisition of new findings with or without change in anti-leukemic treatment per investigator decision due to cytogenetic abnormalities or change in molecular marker or measurable residual disease by multiparameter flow with sensitivity to at least 10^-3; or the date of death from any cause, whichever comes first as determined by IRC. Up to 39 months after the first participant is randomized
Secondary Graft-versus-Host Disease (GvHD)-free, Relapse Free Survival (GRFS) (Part 2) GRFS is defined as number of days from the date of randomization to occurrence of disease relapse OR incidence of GvHD OR death from any cause. Up to 39 months after the first participant is randomized
Secondary Graft-versus-Host Disease (GvHD) Rate (Part 2) GvHD rate is defined as grade 2 or higher for acute graft-versus-host disease (aGvHD) and moderate/severe for chronic graft-versus-host disease (cGvHD) assessed by investigator. Up to 39 months after the first participant is randomized
Secondary Change from Baseline in Physical Functioning as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) (Part 2) The EORTC-QLQ-C30 is a 30-item patient-reported questionnaire composed of both multi-item and single scales including 5 functional scales (physical, role, emotional, social, and cognitive), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participantts rate items on a 4-point scale ranging from 1 to 4 (1 = Not at All, 2 = A Little, 3 = Quite a Bit, and 4 = Very Much). Up to 39 months after the first participant is randomized
Secondary Change From Randomization in Fatigue in Adult Participants (Part 2) Fatigue is measured as Patient Reported Outcome (PRO) using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a. Up to 39 months after the first participant is randomized
Secondary Measurable Residual Disease (MRD) Response Rate in Participants With MRD >= 10^-3 at Randomization (Part 2) MRD conversion rate is defined as percentage of participants who convert to MRD < 10^-3 after initiation of treatment. Up to 39 months after the first participant is randomized
Secondary Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2) Time to deterioration defined as number of days from randomization to either deterioration of >= 5 points based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3 or death due to any cause. Up to 39 months after the first participant is randomized
Secondary Change in Patient Reported Signs, Symptoms and Impact of Acute Myeloid Leukemia (AML) as Measured by the European Quality-of-Life-5 Dimensional-5-Level (EQ-5D-5L) The EQ-5D-5L is a generic preference instrument that has been validated in numerous population and has 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. These dimensions are measured on a 5-point scale: with higher scores representing better functioning/quality of life and greater symptom burden. Up to 39 months after the first participant is randomized
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