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

• ClinicalTrials.gov Identifier: NCT02303821
• Recruitment Status: Recruiting
• First Posted: December 1, 2014
• Last Update Posted: May 10, 2021
• Sponsor: Amgen
• Collaborators: Therapeutic Advances in Childhood Leukemia & Lymphoma (TACL) - Study Design & Execution Collaborator; Innovative Therapies For Children with Cancer Consortium
• Information provided by (Responsible Party): Amgen

Study Description

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 response (CR) of carfilzomib in combination with vincristine, dexamethasone, PEG asparaginase, daunorubicin (VXLD) at the end of induction therapy to an appropriate external control.

Condition or disease	Intervention/treatment	Phase
Acute Lymphoblastic Leukemia (ALL)	Drug: Carfilzomib; Drug: Dexamethasone; Drug: Mitoxantrone; Drug: PEG-asparaginase; Drug: Vincristine; Drug: Intrathecal (IT) Methotrexate; Drug: Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate); Drug: 6-Mercaptopurine; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Daunorubicin	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 118 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 1b/2 Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia
• Actual Study Start Date: February 16, 2015
• Estimated Primary Completion Date: January 22, 2024
• Estimated Study Completion Date: January 22, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Carfilzomib; Other Names: PR-171; PR171; Kyprolis® (carfilzomib) for Injection; Drug: Dexamethasone; Drug: Mitoxantrone; Drug: PEG-asparaginase; Drug: Vincristine; Drug: Intrathecal (IT) Methotrexate; Drug: Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate); Drug: 6-Mercaptopurine; Drug: Cyclophosphamide; Drug: Cytarabine
Experimental: 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.	Drug: Carfilzomib; Other Names: PR-171; PR171; Kyprolis® (carfilzomib) for Injection; Drug: Dexamethasone; Drug: PEG-asparaginase; Drug: Vincristine; Drug: Intrathecal (IT) Methotrexate; Drug: Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate); Drug: 6-Mercaptopurine; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Daunorubicin
Experimental: 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.	Drug: Carfilzomib; Other Names: PR-171; PR171; Kyprolis® (carfilzomib) for Injection; Drug: Dexamethasone; Drug: PEG-asparaginase; Drug: Vincristine; Drug: Intrathecal (IT) Methotrexate; Drug: Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate); Drug: 6-Mercaptopurine; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Daunorubicin
Experimental: 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.	Drug: Carfilzomib; Other Names: PR-171; PR171; Kyprolis® (carfilzomib) for Injection; Drug: Dexamethasone; Drug: PEG-asparaginase; Drug: Vincristine; Drug: Intrathecal (IT) Methotrexate; Drug: Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate); Drug: 6-Mercaptopurine; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Daunorubicin

Outcome Measures

Primary Outcome Measures :

1. Phase 1b: Number of Subjects who Experience One or More Adverse Events (AE) [ Time Frame: 36 months ]
2. Phase 1b: Number of Subjects who Experience One or More Serious Adverse Events (SAEs) [ Time Frame: 36 months ]
3. Phase 1b: Number of Subjects who Experienced a Clinically Significant Change from Baseline in Key Laboratory Analytes [ Time Frame: 36 months ]
   Changes from baseline in key laboratory analytes.
4. Phase 1b: Number of Subjects who Experience a Clinically Significant Change from Baseline in Vital Signs [ Time Frame: 36 months ]
   Changes from baseline in vital signs
5. Phase 1b: Number of Subjects who Experience a Clinically Significant Change from Baseline in Physical Findings [ Time Frame: 36 months ]
   Changes from baseline in physical findings
6. Phase 1b: Time to Toxicity [ Time Frame: 36 months ]
   Time to toxicity will be evaluated to differentiate single-agent carfilzomib from carfilzomib in combination with induction chemotherapy
7. Phase 1b: Maximum Tolerated Dose (MTD) [ Time Frame: 36 months ]
   Maximum tolerated dose (MTD) of carfilzomib in combination with induction chemotherapy. Determination of the MTD as the dose that has the highest posterior probability of having a dose-limiting toxicity (DLT) rate within the target toxicity interval (20%-33%), while the posterior probability of excessive/unacceptable toxicity (>33%-100%) is less than 40%.
8. Phase 2: Complete Response (CR) Rate After Induction Therapy in Subjects Aged ≥ 12 Months at Screening [ Time Frame: From Day 29 up to a maximum of Day 45 ]
   CR will be assessed in all subjects who do not show disease progression during induction therapy (Day 1 to Day 28) between Day 29 and Day 45, or start of alternative therapy, whichever comes first. Subjects can receive alternative therapy after completing induction therapy on Day 28.
9. Phase 2: Complete Response (CR) Rate After Induction Therapy in Subjects Aged < 12 Months at Screening [ Time Frame: From Day 36 up to a maximum of Day 50 ]
   CR will be assessed in all subjects who do not show disease progression during induction therapy (Modified based on Interfant-06: Day 1 to Day 35) between Day 36 and Day 50, or start of alternative therapy, whichever comes first. Subjects can receive alternative therapy after completing induction therapy on Day 35.

Secondary Outcome Measures :

1. Phase 1b: Maximum plasma concentration (Cmax) [ Time Frame: 36 months ]
   Maximum plasma concentration (Cmax), alone and in combination with induction chemotherapy, will be derived from levels of carfilzomib assayed in Pharmacokinetic (PK) samples. Estimates for Cmax will be tabulated and summarized (i.e., mean, standard deviation).
2. Phase 1b: Total Plasma Exposure - Area Under the Curve (AUC) [ Time Frame: 36 months ]
   Total Plasma Exposure - Area Under the Curve (AUC), alone and in combination with induction chemotherapy, will be derived from levels of carfilzomib assayed in Pharmacokinetic (PK) samples. Estimates for AUC will be tabulated and summarized (i.e., mean, standard deviation).
3. Phase 1b: Number of Subjects who Experience Complete Response (CR) or Complete Response with Incomplete Hematological Recovery (CRi) [ Time Frame: 36 months ]
4. Phase 1b: Minimal Residual Disease (MRD) Status [ Time Frame: 36 months ]
   Proportion of subjects who achieve MRD status < 10-3 and < 10-4 lymphoblasts at the end of the Induction Cycle as assessed by quantitative immunoglobulin/T-cell receptor (Ig/TcR) polymerase chain reaction (PCR)
5. Phase 2: Number of Subjects who Experience a Treatment-emergent Adverse Event (TEAE) [ Time Frame: 29 months ]
6. Phase 2: Number of Subjects who Experience a Treatment-related Adverse Event [ Time Frame: 29 months ]
7. Phase 2: Number of Subjects who Experience a Severe Adverse Event [ Time Frame: 29 months ]
8. Phase 2: Number of Subjects who Experience a Laboratory Abnormality [ Time Frame: 29 months ]
9. Phase 2: Number of Subjects who Experience Complete Response (CR), Complete Response with Incomplete Recovery of Platelets (CRp), or Complete Response with Incomplete Hematological Recovery (CRi) [ Time Frame: 29 months ]
10. Phase 2: Event Free Survival (EFS) [ Time Frame: 29 months ]
    EFS, defined as time from initiation of therapy until treatment failure (defined as failure to reach at least a CRi after consolidation or after induction in subjects that do not receive consolidation), relapse, or death from any cause.
11. Phase 2: Overall Survival (OS) [ Time Frame: 29 months ]
    OS defined as time from initiation of therapy until death from any cause.
12. Phase 2: Duration of Response (DOR) [ Time Frame: 29 months ]
    DOR, defined as time from earliest of CR, CRp, CRh, or CRi to relapse or death from any cause.
13. Phase 2: Minimal Residual Disease (MRD) Status in all Subjects [ Time Frame: 29 months ]
    Proportion of subjects who achieve MRD status < 10-4 lymphoblasts at the end of the Induction Cycle as assessed by quantitative immunoglobulin/T-cell receptor (Ig/TcR) polymerase chain reaction (PCR)
14. Minimal Residual Disease (MRD) Status in Subjects with Complete Response (CR), CR with Incomplete Recovery of Platelets (CRp), CR with Partial Hematological Recovery (CRh) or CR with Incomplete Hematological Recovery (CRi) [ Time Frame: 29 months ]
    Proportion of subjects who achieve MRD status < 10-3 and < 10-4 lymphoblasts at the end of the Induction Cycle as assessed by quantitative immunoglobulin/T-cell receptor (Ig/TcR) polymerase chain reaction (PCR).
15. Number of Subjects who Experience a Stem Cell Transplant or Chimeric Antigen Receptor T Cell Therapy (CAR-T) [ Time Frame: 29 months ]
16. Phase 2: Number of Subjects who Experience a Clinically Significant Change from Baseline in Laboratory Analytes [ Time Frame: 29 months ]
17. Number of Subjects who Experience Complete Response (CR), CR with Incomplete Recovery of Platelets (CRp), or CR with Incomplete Hematological Recovery (CRi) After Consolidation Therapy in Subjects Aged ≥ 12 Months at Screening [ Time Frame: Day 29 and 45 ]
18. Number of Subjects who Experience Complete Response (CR), CR with Incomplete Recovery of Platelets (CRp), or CR with Incomplete Hematological Recovery (CRi) After Consolidation Therapy in Subjects Aged ≥ 12 Months at Screening [ Time Frame: Day 36 to 50 ]
19. Phase 2: Maximum Plasma Concentration (Cmax) [ Time Frame: 29 months ]
20. Phase 2: Area Under the Concentration-time Curve (AUC) [ Time Frame: 29 months ]
21. Phase 2: Half-life (t1/2) of Carfilzomib [ Time Frame: 29 months ]

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Phase 1b Key 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.

Phase 2 Inclusion Criteria:

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.
2. Age ≥ 1 month to < 21 years. Subjects ≥ 18 years must have had their original diagnosis at < 18 years of age.
3. Subjects must be diagnosed with relapsed or refractory relapsed ALL.
4. Subjects must have a documented first remission, ≤ 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 ≥ 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 ≥ 5% leukemia blasts in bone marrow) after having received a targeted B-cell immune therapy as treatment for a prior relapse (eg, blinatumomab, inotuzumab or a CAR-T therapy) with or without extramedullary disease. Subjects that received blinatumomab for treatment of MRD positive disease during first remission or for primary induction failure to achieve a first remission do not qualify.

6. Adequate liver function: bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 5 x ULN.
7. Adequate renal function: serum creatinine ≤ 1.5 x ULN or glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m^2; or for children < 2 years of age ≥ 50 mL/min/1.73 m^2.
8. Adequate cardiac function: shortening fraction ≥ 30% or ejection fraction ≥ 50%.
9. Karnofsky (subjects ≥ 16 years of age) or Lansky (subjects 12 months to < 16 years of age) performance status ≥ 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 > 6 weeks per investigator's judgement at time of screening.

Phase 1b Key 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

Phase 2 Exclusion Criteria:

1. Prior treatment with carfilzomib.
2. Prior treatment with a proteasome inhibitor (other than carfilzomib) within < 3 months of enrollment or to which a subject did not respond (response is defined as bone marrow with < 5% blasts).
3. Treatment with a chemotherapy regimen including a vinca alkaloid, steroid, L-asparaginase, and anthracycline combination with or without other chemotherapy agents within 2 months of enrollment (eg VXLD, VPLD, R3).
4. 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,
5. Autologous HSCT within 6 weeks prior to start of study treatment.
6. Allogeneic HSCT within 3 months prior to start of study treatment.
7. Active GVHD requiring systemic immune suppression.
8. < 30 days from discontinuation of immune suppressive therapy administered for the treatment of acute or chronic GVHD.
9. Isolated extramedullary relapse.
10. 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.
11. < 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.
12. 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.
13. Down's syndrome.
14. Presence of another active cancer.
15. History of grade ≥ 2 pancreatitis within 6 months to screening.
16. 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 > 4 weeks).
17. 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.
18. Active viral infection, including but not limited to 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.
19. Currently receiving treatment in another investigational device or product study, or < 14 days since ending treatment on another investigational device or product study.
20. Uncontrolled arrhythmias or screening ECG with corrected QT interval (QTc) of > 470 msec.
21. 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.
22. 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.
23. 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.
24. Female subjects of childbearing potential with a positive pregnancy test assessed at Screening by a serum or urine pregnancy test.
25. 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.
26. 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.
27. 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.

Contacts and Locations

Contacts

Contact: Amgen Call Center; 866-572-6436; medinfo@amgen.com

Locations

United States, California

Research Site; Completed

Los Angeles, California, United States, 90027

United States, Colorado

Research Site; Recruiting

Aurora, Colorado, United States, 80045

United States, District of Columbia

Research Site; Completed

Washington, District of Columbia, United States, 20010

United States, Florida

Research Site; Completed

Miami, Florida, United States, 33136

Research Site; Completed

Saint Petersburg, Florida, United States, 33701

United States, Georgia

Research Site; Recruiting

Atlanta, Georgia, United States, 30342

United States, Illinois

Research Site; Recruiting

Chicago, Illinois, United States, 60611

United States, Maryland

Research Site; Recruiting

Baltimore, Maryland, United States, 21231

United States, Michigan

Research Site; Completed

Ann Arbor, Michigan, United States, 48109-5718

United States, Minnesota

Research Site; Completed

Minneapolis, Minnesota, United States, 55404

United States, New York

Research Site; Recruiting

New York, New York, United States, 10032

United States, North Carolina

Research Site; Recruiting

Charlotte, North Carolina, United States, 28203

United States, Ohio

Research Site; Recruiting

Cincinnati, Ohio, United States, 45229

Research Site; Recruiting

Columbus, Ohio, United States, 43205

United States, Tennessee

Research Site; Recruiting

Memphis, Tennessee, United States, 38105

United States, Texas

Research Site; Recruiting

Dallas, Texas, United States, 75235

Research Site; Recruiting

Houston, Texas, United States, 77030

United States, Utah

Research Site; Recruiting

Salt Lake City, Utah, United States, 84113

United States, Wisconsin

Research Site; Recruiting

Milwaukee, Wisconsin, United States, 53226

Australia, New South Wales

Research Site; Recruiting

Randwick, New South Wales, Australia, 2031

Australia, Queensland

Research Site; Recruiting

South Brisbane, Queensland, Australia, 4101

Australia, Victoria

Research Site; Recruiting

Parkville, Victoria, Australia, 3052

Austria

Research Site; Recruiting

Wien, Austria, 1090

Canada, Ontario

Research Site; Completed

Toronto, Ontario, Canada, M5G 1X8

Canada, Quebec

Research Site; Recruiting

Montreal, Quebec, Canada, H3T 1C5

Denmark

Research Site; Recruiting

Kobenhavn O, Denmark, 2100

France

Research Site; Recruiting

Bordeaux Cedex, France, 33076

Research Site; Recruiting

Lille, France, 59037

Research Site; Recruiting

Paris, France, 75012

Research Site; Recruiting

Paris, France, 75019

Research Site; Recruiting

Toulouse Cedex 9, France, 31059

Research Site; Recruiting

Vandoeuvre les Nancy, France, 54511

Israel

Research Site; Recruiting

Tel Hashomer, Israel, 5262000

Italy

Research Site; Recruiting

Monza (MB), Italy, 20900

Research Site; Recruiting

Roma, Italy, 00165

Netherlands

Research Site; Completed

Rotterdam, Netherlands, 3015 CN

Spain

Research Site; Recruiting

Madrid, Spain, 28009

Switzerland

Research Site; Completed

Zuerich, Switzerland, 8032

United Kingdom

Research Site; Completed

Birmingham, United Kingdom, B4 6NH

Research Site; Completed

London, United Kingdom, WC1N 3JH

Research Site; Completed

Manchester, United Kingdom, M13 9WL

Research Site; Completed

Newcastle upon Tyne, United Kingdom, NE1 4LP

Research Site; Recruiting

Sutton, United Kingdom, SM2 5PT

Sponsors and Collaborators

Amgen

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

Innovative Therapies For Children with Cancer Consortium

Investigators

• Study Director: MD; Amgen

More Information

Additional Information:

AmgenTrials clinical trials website 

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT02303821
• Other Study ID Numbers: CFZ008; 2014-001633-84 ( EudraCT Number )
• First Posted: December 1, 2014
• Last Update Posted: May 10, 2021
• Last Verified: February 2021

Additional relevant MeSH terms:

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cytarabine; Dexamethasone; Hydrocortisone; Cyclophosphamide; Methotrexate; Vincristine; Daunorubicin; Asparaginase; Mercaptopurine; Mitoxantrone; Pegaspargase; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Myeloablative Agonists; Anti-Inflammatory Agents