Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia

NCT ID: NCT02303821

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-16
• Study Completion Date: 2024-06-28

Brief Summary

The purpose of Phase 1b of this study is to:

• Asses the safety, tolerability and activity of carfilzomib, alone and in combination with induction chemotherapy, in children with relapsed or refractory acute lymphoblastic leukemia (ALL).
• Determine the maximum tolerated dose (MTD) and to recommend a phase 2 dose of carfilzomib in combination with induction chemotherapy.

The purpose of Phase 2 of this study is to compare the rate of complete remission (CR) of carfilzomib in combination with vincristine, dexamethasone, PEG asparaginase, daunorubicin (VXLD) at the end of induction therapy to an appropriate external control.

Conditions

Acute Lymphoblastic Leukemia (ALL)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1b: Dose Escalation 1

Subjects will receive carfilzomib in combination with induction chemotherapy, comprising an R3 backbone of dexamethasone, mitoxantrone, PEG asparaginase, and vincristine.

Subjects will have a 1 week carfilzomib single agent Lead in Window prior to the Induction Cycle.

Subjects will receive a 4 week cycle of induction chemotherapy and have the option to receive a 4 week cycle of consolidation chemotherapy (Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine), if stable disease or better response is achieved at the end of the Induction Cycle.

Group Type: EXPERIMENTAL

Carfilzomib

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Mitoxantrone

Intervention Type: DRUG

PEG-asparaginase

Intervention Type: DRUG

Vincristine

Intervention Type: DRUG

Intrathecal (IT) Methotrexate

Intervention Type: DRUG

Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)

Intervention Type: DRUG

6-Mercaptopurine

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Cytarabine

Intervention Type: DRUG

Phase 1b: Dose Escalation 2

Subjects will receive carfilzomib in combination with induction chemotherapy, comprising a VXLD backbone of vincristine, dexamethasone, PEG asparaginase, and daunorubicin.

Subjects will receive a 4 week cycle of carfilzomib and induction chemotherapy and then have the option to receive a 4 week cycle of consolidation chemotherapy (Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine), if stable disease or better response is achieved at the end of the Induction Cycle.

Group Type: EXPERIMENTAL

Carfilzomib

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

PEG-asparaginase

Intervention Type: DRUG

Vincristine

Intervention Type: DRUG

Intrathecal (IT) Methotrexate

Intervention Type: DRUG

Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)

Intervention Type: DRUG

6-Mercaptopurine

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Cytarabine

Intervention Type: DRUG

Daunorubicin

Intervention Type: DRUG

Phase 2: Aged ≥ 12 months at screening

All subjects aged ≥ 12 months at screening.

Subjects will receive the recommended phase 2 dose (RP2D) of carfilzomib determined in Phase 1b.

Subjects will receive a 4 week cycle of carfilzomib and induction chemotherapy comprising of a VXLD backbone of vincristine, dexamethasone, PEG asparaginase and daunorubicin. Subjects will then have the option to receive a 4 week cycle of carfilzomib in combination with consolidation chemotherapy Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine) if subjects showed no disease progression at the end of the Induction Cycle.

Group Type: EXPERIMENTAL

Carfilzomib

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

PEG-asparaginase

Intervention Type: DRUG

Vincristine

Intervention Type: DRUG

Intrathecal (IT) Methotrexate

Intervention Type: DRUG

Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)

Intervention Type: DRUG

6-Mercaptopurine

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Cytarabine

Intervention Type: DRUG

Daunorubicin

Intervention Type: DRUG

Phase 2: Aged < 12 months at screening

All subjects aged < 12 months at screening.

Subjects will receive the recommended phase 2 dose (RP2D) of carfilzomib determined in Phase 1b.

Subjects will receive a modified 5 week cycle (based on Interfant-06) of carfilzomib and induction chemotherapy comprising of a VXLD backbone of vincristine, dexamethasone, PEG asparaginase and daunorubicin. Subjects will then have the option to receive a 5 week cycle (modified based on Interfant-06) of carfilzomib in combination with consolidation chemotherapy Children's Oncology Group (COG) modified Berlin Frankfurt Münster (BFM) chemotherapy backbone (6 mercaptopurine, cyclophosphamide, cytarabine, PEG asparaginase, vincristine), if subjects showed no disease progression at the end of the Induction Cycle.

Group Type: EXPERIMENTAL

Carfilzomib

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

PEG-asparaginase

Intervention Type: DRUG

Vincristine

Intervention Type: DRUG

Intrathecal (IT) Methotrexate

Intervention Type: DRUG

Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)

Intervention Type: DRUG

6-Mercaptopurine

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Cytarabine

Intervention Type: DRUG

Daunorubicin

Intervention Type: DRUG

Interventions

Carfilzomib

Intervention Type: DRUG

Dexamethasone

Intervention Type: DRUG

Mitoxantrone

Intervention Type: DRUG

PEG-asparaginase

Intervention Type: DRUG

Vincristine

Intervention Type: DRUG

Intrathecal (IT) Methotrexate

Intervention Type: DRUG

Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)

Intervention Type: DRUG

6-Mercaptopurine

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Cytarabine

Intervention Type: DRUG

Daunorubicin

Intervention Type: DRUG

Other Intervention Names

PR-171; PR171; Kyprolis® (carfilzomib) for Injection

Eligibility Criteria

Inclusion Criteria

1. Age 21 years or younger at the time of initial ALL diagnosis and age > 1 year at the time of study treatment initiation.

2. Subjects must have a diagnosis of relapsed or refractory ALL with ≥ 5% blasts in the bone marrow (M2 or M3 disease), with or without extramedullary disease.

-To be eligible, subjects must have had 1 or more prior therapeutic attempts, defined as:

• Early first relapse (< 36 months from original diagnosis) after achieving a CR (B-ALL) or first relapse any time following the original diagnosis after achieving a CR (T-ALL)
• First refractory bone marrow relapse occurring any time after original diagnosis after achieving a CR (ie, ≥1 failed attempt to induce a second remission) OR
• Relapse after achieving a CR following the first or subsequent relapse (i.e., ≥ 2 relapses) OR
• Failing to achieve a CR from original diagnosis after at least 1 induction attempt

3. Subjects must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment before enrollment.

4. Subjects must have a serum creatinine level that is ≤ 1.5 × institutional upper limit of normal (ULN) according to age. If serum creatinine level is > 1.5 × ULN, the subject must have a calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m2.

5. Adequate liver function, defined as both of the following:

• Total bilirubin ≤ 1.5 × institutional ULN except in the presence of Gilbert Syndrome
• Alanine aminotransferase (ALT) ≤ 5 × institutional ULN

6. Performance status: Karnofsky or Lansky scores ≥ 50 for subjects > 16 years old or ≤ 16 years old, respectively.

1. Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated, except for standard of care local testing as permitted per protocol.

2. Age greater than or equal to 1 month to less than 21 years. Subjects greater than or equal to 18 years must have had their original diagnosis at less than 18 years of age.

3. Subjects must be diagnosed with relapsed or refractory relapsed ALL.

4. Subjects must have a documented first remission, less than 5% blasts in the bone marrow (M1 bone marrow) and no evidence of extramedullary disease.

5. T-cell ALL with bone marrow relapse (defined as greater than or equal to 5% leukemia blasts in bone marrow) or refractory relapse with or without extramedullary disease.

OR B-cell ALL bone marrow relapse or refractory relapse (defined as greater than or equal to 5% leukemia blasts in bone marrow) after having received a targeted B-cell immune therapy (eg, blinatumomab, inotuzumab or a CAR-T therapy) with or without extramedullary disease..

6. Adequate liver function: bilirubin less than or equal to 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) less than or equal to 5 x ULN.

7. Adequate renal function: serum creatinine less than or equal to 1.5 x ULN or glomerular filtration rate (GFR) greater than or equal to 70 mL/min/1.73 m^2; or for children less than 2 years of age, greater than or equal to 50 mL/min/1.73 m^2.

8. Adequate cardiac function: shortening fraction greater than or equal to 30% or ejection fraction greater than or equal to 50%.

9. Karnofsky (subjects greater than or equal to 16 years of age) or Lansky (subjects 12 months to less than 16 years of age) performance status greater than or equal to 50%.

10. Subjects must have fully recovered from the acute toxic effects of all previous chemotherapy, immunotherapy, or radiotherapy treatment before enrollment (for example: recovery from gastrointestinal toxicity may occur more rapidly than less reversible organ toxicities such as sinusoidal obstruction syndrome or non-infectious pneumonitis, for serious prior toxicities recommended discussion with Amgen medical monitor).

11. Life expectancy of greater than 6 weeks per investigator's judgement at time of screening.

Exclusion Criteria

1. Known allergy to any of the drugs used in the study (Subjects who have had a previous allergy to PEG-asparaginase and if able, may receive Erwinia asparaginase at the investigator's discretion)

2. Known allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib)

3. Left ventricular fractional shortening < 30%

4. History of ≥ Grade 2 pancreatitis

5. Active graft-versus-host disease requiring systemic treatment

6. Positive culture for or other clinical evidence of infection with bacteria or fungus within 14 days of the initiation of study treatment

7. Down Syndrome

8. Prior therapy restrictions:

• Subjects must have completed therapy with granulocyte-colony stimulating factor (G-CSF) or other myeloid growth factors at least 7 days before study treatment initiation, or at least 14 days before study treatment initiation, if pegylated myeloid growth factors were administered.
• Subjects must have completed any type of active immunotherapy (e.g., tumor vaccines) at least 42 days before study treatment initiation.
• Subjects must have received the last dose of a non-monoclonal antibody biologic agent at least 7 days before study treatment initiation.
• At least 3 antibody half-lives must have elapsed since the last dose of monoclonal antibody (e.g., 66 days for rituximab and 69 days for epratuzumab) before subjects may initiate study treatment.
• Subjects must not have received other antineoplastic agents with therapeutic intent, excluding hydroxyurea and antimetabolites administered as part of maintenance chemotherapy, within 7 days prior to study treatment initiation.

9. Hepatitis B infection with positive hepatitis B DNA

1. Prior treatment with carfilzomib.

2. Intolerance, hypersensitivity, or inability to receive any of the chemotherapy components of the VXLD regimen. An exception is allowed for allergy to asparaginase products if Erwinia asparaginase is unable to be administered,

3. Autologous HSCT within 6 weeks prior to start of study treatment.

4. Allogeneic HSCT within 3 months prior to start of study treatment.

5. Active GVHD requiring systemic immune suppression.

6. Less than 30 days from discontinuation of immune suppressive therapy administered for the treatment of acute or chronic GVHD.

7. Isolated extramedullary relapse.

8. Positive bacterial or fungal infection within 14 days of enrollment (except for documented line infection, line has been removed, and blood culture after line removal is negative for 5 days prior to first dose of induction therapy). Antibiotics may be administered for prophylaxis as per institutional standards up to and after enrollment.

9. Subjects with less than 3 antibody half-lives since the last dose of monoclonal antibody (eg, 66 days for rituximab, 69 days for epratuzumab, inotuzumab for 36 days), prior to first dose of investigational product must be discussed with the Amgen medical monitor and may be allowed to enroll based on extent of disease or evidence of rapidly rising peripheral or bone marrow blast counts.

10. Cell-based immunotherapy (eg, donor leucocyte infusion, CAR-T cells, tumor vaccines) within 42 days prior to first dose of investigational product. If the Amgen medical monitor agrees, an exception may be granted to the 42-day requirement for subjects with rapidly rising peripheral or bone marrow blast counts.

11. Down's syndrome.

12. Presence of another active cancer.

13. History of grade greater than or equal to 2 pancreatitis within 6 months to screening.

14. Unresolved toxicities from prior anticancer therapy, defined as not having resolved to CTCAE version 4.03 grade 1 or to levels dictated in the eligibility criteria apart from alopecia or toxicities from prior anticancer therapy that are considered irreversible and do not trigger another exclusion criterion (defined as having been present and stable for greater than 4 weeks).

15. Antitumor therapy (chemotherapy, investigational agents, molecular-targeted therapy) within 7 days of day 1 of induction. Exception: hydroxyurea to control peripheral blood leukemic cell counts is allowed until start of investigational product.

16. Active viral infection, including but not limited to cytomegalovirus (CMV), Hepatitis B infection with positive serum hepatitis surface antigen or hepatitis B DNA, HIV, Hepatitis C with detectable hepatitis C RNA. Subjects who have previously received a stem cell transplant must be screened for CMV infection, unless both subject and donor are known to be CMV negative.

17. Currently receiving treatment in another investigational device or product study, or less than 14 days since ending treatment on another investigational device or product study.

18. Uncontrolled arrhythmias or screening ECG with corrected QT interval (QTc) of greater than 470 msec.

19. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

20. Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after the last dose of any study treatment or for 12 months after last dose of cyclophosphamide if administered during optional consolidation cycle.

21. Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 6 months after the last dose of any study treatment or for 12 months after last dose of cyclophosphamide if administered during optional consolidation cycle.

22. Female subjects of childbearing potential with a positive pregnancy test assessed at Screening by a serum or urine pregnancy test.

23. Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use a condom with spermicide during treatment and for an additional 6 months after the last dose of any study treatment, even if they have undergone a successful vasectomy.

24. Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom with spermicide during treatment, for duration of pregnancy, and for an additional 6 months after the last dose of any study treatment.

25. Male subjects unwilling to abstain from donating semen or sperm during treatment and for an additional 6 months after the last dose of any study treatment.

26. Known allergy to captisol (a cyclodextrin derivative used to solubilize carfilzomib; for a complete listing of Captisol-enabled drugs, see the Ligand Pharmaceuticals, Inc. website).

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) - Study Design & Execution Collaborator

UNKNOWN

Sponsor Role: collaborator

Innovative Therapies For Children with Cancer Consortium

OTHER

Sponsor Role: collaborator

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

University of California San Francisco Benioff Childrens Hospital Oakland

Oakland, California, United States

Childrens Hospital of Orange County

Orange, California, United States

Childrens Hospital Colorado

Aurora, Colorado, United States

Childrens Healthcare of Atlanta, Egleston

Atlanta, Georgia, United States

Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States

The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

Baltimore, Maryland, United States

Childrens Hospital and Clinics of Minnesota

Minneapolis, Minnesota, United States

Childrens Mercy Hospital

Kansas City, Missouri, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Childrens Hospital of New York Presbyterian

New York, New York, United States

Levine Childrens Hospital at Carolinas Medical Center d/b/a Atrium Health

Charlotte, North Carolina, United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Nationwide Childrens Hospital

Columbus, Ohio, United States

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Saint Judes Childrens Research Hospital

Memphis, Tennessee, United States

Childrens Medical Center

Dallas, Texas, United States

Texas Childrens Hospital West Tower

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

University of Utah Medical Center Primary Childrens Medical Center

Salt Lake City, Utah, United States

West Virginia University Medicine Childrens

Morgantown, West Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Hospital Aleman

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Sydney Childrens Hospital

Randwick, New South Wales, Australia

The Childrens Hospital at Westmead

Westmead, New South Wales, Australia

Queensland Childrens Hospital

South Brisbane, Queensland, Australia

The Royal Childrens Hospital

Parkville, Victoria, Australia

Perth Childrens Hospital

Nedlands, Western Australia, Australia

St Anna Kinderspital

Vienna, , Austria

Hospital São Rafael - IDOR

Salvador, Estado de Bahia, Brazil

Hospital da Crianca de Brasília

Brasília, Federal District, Brazil

Liga Paranaense do Combate ao Cancer - Hospital Erasto Gaertner

Curitba, Paraná, Brazil

Hospital Pequeno Principe

Curitiba, Paraná, Brazil

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital da Crianca Santo Antonio Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Fundacao Pio 12 Hospital de Amor de Barretos

Barretos, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Itaci Instituto de Tratamento do Cancer Infantil

São Paulo, São Paulo, Brazil

Beneficencia Portuguesa de Sao Paulo

São Paulo, , Brazil

University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL EAD

Sofia, , Bulgaria

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Hospital Luis Calvo Mackenna

Santiago, , Chile

Hospital Roberto del Rio

Santiago, , Chile

Sociedad de Oncologia y Hematologia del Cesar

Valledupar, Cesar Department, Colombia

Clinica Imbanaco S.A.S

Cali, Valle del Cauca Department, Colombia

Fakultni nemocnice Brno

Brno, , Czechia

University Hospital Rigshospitalet

København Ø, , Denmark

Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

Bordeaux, , France

Centre Hospitalier Regional Universitaire de Lille

Lille, , France

Hopital Armand Trousseau

Paris, , France

Hopital Robert Debre

Paris, , France

Centre Hospitalier Universitaire de Toulouse - Hopital des enfants

Toulouse, , France

Centre Hospitalier Universitaire de Nancy - Hopital Enfants de Brabois

Vandœuvre-lès-Nancy, , France

Agia Sofia Children Hospital

Athens, , Greece

Agia Sofia Children Hospital

Goudi, , Greece

General Children Hospital Panagioti and Aglaias Kyriakou

Goudi, , Greece

General University Hospital of Patras Panagia i Voithia

Pátrai, , Greece

Ippokrateio General Hospital of Thessaloniki

Thessaloniki, , Greece

Hong Kong Childrens Hospital

Kowloon Bay, , Hong Kong

Sheba Medical Center

Tel Litwinsky, , Israel

Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

Bari, , Italy

Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico

Catania, , Italy

IRCCS Istituto Giannina Gaslini

Genova, , Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza (MB), , Italy

Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon

Napoli, , Italy

Azienda Ospedaliera di Padova

Padua, , Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

IRCCS Ospedale Pediatrico Bambino Gesu

Roma, , Italy

Azienda Ospedaliera Citta della Salute e della Scienza Torino Ospedale Infantile Regina Margherita

Torino, , Italy

BRCR Global Mexico

Guadalajara, Jalisco, Mexico

BRCR Global Mexico

Mexico City, Mexico City, Mexico

Instituto Nacional de Pediatria

Mexico City, Mexico City, Mexico

BRCR Global Mexico

Puebla City, , Mexico

Prinses Maxima Centrum voor Kinderoncologie

Utrecht, , Netherlands

Oslo Universitetssykehus Rikshospitalet

Oslo, , Norway

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, , Poland

CSK Uniwersytetu Medycznego w Lodzi Uniwersyteckie Centrum Pediatrii im Marii Konopnickiej

Lodz, , Poland

Uniwersytecki szpital dzieciecy

Lublin, , Poland

Uck wum dzieciecy szpital kliniczny im jozefa polikarpa brudzinskiego

Warsaw, , Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, , Poland

SPSK nr 1 im Prof Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach

Zabrze, , Poland

Centro Hospitalar Universitario de Coimbra

Coimbra, , Portugal

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE

Lisbon, , Portugal

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Porto, , Portugal

Institutul Clinic Fundeni

Bucharest, , Romania

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Cluj-Napoca, , Romania

Spitalul Clinic de Urgenta pentru Copii Louis Turcanu Timisoara

Timișoara, , Romania

FSBI N N Blokhin Russian Oncology Research Center Ministry of Health of Russian Federation

Moscow, , Russia

FSBI FSCC of pediatric hematology, oncology and immunology n a Dmitry Rogachev

Moscow, , Russia

SBEI of HPE Saint Petersburg State Medical University na academic I P Pavlov of MoH of RF

Saint Petersburg, , Russia

King Fahad Medical City

Riyadh, , Saudi Arabia

National University Hospital

Singapore, , Singapore

KK Womens and Childrens Hospital

Singapore, , Singapore

Chris Hani Baragwanath Hospital

Johannesburg, , South Africa

Seoul National University Hospital

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Pusan National University Yangsan Hospital

Yangsan-si, Gyeongsangnam-do, , South Korea

Hospital Sant Joan de Deu

Esplugues de Llobregat, Catalonia, Spain

Hospital Universitario Infantil Niño Jesus

Madrid, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Karolinska Universitetssjukhuset Solna

Solna, , Sweden

National Taiwan University Hospital

Taipei, , Taiwan

Mackay Memorial Hospital Taipei Branch

Taipei, , Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Phramongkutklao Hospital

Bangkok, , Thailand

Ramathibodi Hospital

Bangkok, , Thailand

Siriraj Hospital

Bangkok, , Thailand

Acibadem Adana Hastanesi

Adana, , Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi Hastanesi

Ankara, , Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, , Turkey (Türkiye)

Medical Park Antalya Hastanesi

Antalya, , Turkey (Türkiye)

Bursa Uludag Universitesi Tip Fakultesi

Bursa, , Turkey (Türkiye)

Medical Park Bahcelievler Hastanesi

Istanbul, , Turkey (Türkiye)

Medipol Mega Universite Hastanesi

Istanbul, , Turkey (Türkiye)

Ege Universitesi Tip Fakultesi

Izmir, , Turkey (Türkiye)

Erciyes Universitesi Tip Fakultesi Mustafa Eraslan ve Fevzi Mercan Cocuk Hastanesi

Kayseri, , Turkey (Türkiye)

The Royal Marsden NHS Foundation Trust

Sutton, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Brazil; Bulgaria; Canada; Chile; Colombia; Czechia; Denmark; France; Greece; Hong Kong; Israel; Italy; Mexico; Netherlands; Norway; Poland; Portugal; Romania; Russia; Saudi Arabia; Singapore; South Africa; South Korea; Spain; Sweden; Taiwan; Thailand; Turkey (Türkiye); United Kingdom

References

Burke MJ, Ziegler DS, Bautista F, Attarbaschi A, Gore L, Locatelli F, M O'Brien M, Pauly M, Kormany WN, Tian S, Morris CL, Baruchel A. Phase 1b study of carfilzomib with induction chemotherapy in pediatric relapsed/refractory acute lymphoblastic leukemia. Pediatr Blood Cancer. 2022 Dec;69(12):e29999. doi: 10.1002/pbc.29999. Epub 2022 Oct 10.

Reference Type: DERIVED

PMID: 36215217 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

2014-001633-84

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CFZ008

Identifier Type: -

Identifier Source: org_study_id