A Study of Ponatinib With Chemotherapy in Children, Teenagers, and Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Sponsor
Takeda (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04501614
Collaborator
(none)
68
70
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78
1
0

Study Details

Study Description

Brief Summary

This study is about an anticancer drug called ponatinib which is a tyrasine kinase inhibitor given with chemotherapy to children, teenagers, and young adults up to 21 years of age with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia who have relapsed or are resistant to other treatment.

The main aims of this study are to confirm the highest dose of ponatinib tablets and minitablet capsules that can be given to participants with acceptable side effects, and to evaluate if participant's leukemia achieves remission.

Participants will take ponatinib tablets with chemotherapy. For participants who cannot swallow tablets, a minitablet form of the ponatinib will be provided. Participants will take ponatinib for 10 weeks in combination with chemotherapy (reinduction and consolidation blocks) and will be followed up for at least 3 years.

Detailed Description

The drug being tested in this study is called ponatinib. Ponatinib is being tested to treat pediatric population who have Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Ph+ mixed phenotype acute leukemia (Ph+ MPAL), or Philadelphia chromosome-like ALL (US only) who have relapsed or are resistant or intolerant to a prior tyrosine kinase inhibitor (TKI)-containing therapy, or who have the T315I mutation.

The study will enroll approximately 68 participants. Participants will be assigned to a treatment group either in phase 1 or phase 2. Participants unable to swallow the ponatinib tablets will receive the age-appropriate formulation, minitablets:

• Ponatinib + Chemotherapy

All participants will be asked to take ponatinib once daily. In phase 1 ponatinib will be administered in combination with a chemotherapy backbone to determine the recommended phase 2 dose (RP2D) of ponatinib. In both phase 1 and phase 2, treatment consists of two 35-day blocks of therapy (reinduction block and consolidation block). Each block will include 29 days of treatment of daily ponatinib and a chemotherapy backbone regimen followed by a rest period from chemotherapy for a minimum of 6 days consisting of daily ponatinib only.

This is a multi-center trial and will be conducted worldwide. The overall time to participate in this study is 6.5 years. Participants will make multiple visits to the clinic, and may be contacted by telephone in at least 36 months of follow-up after treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pivotal Phase 1/2, Single-Arm, Open-label Study to Evaluate the Safety and Efficacy of Ponatinib With Chemotherapy in Pediatric Patients With Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy, or Who Have the T315I Mutation
Actual Study Start Date :
Feb 24, 2021
Anticipated Primary Completion Date :
Feb 27, 2025
Anticipated Study Completion Date :
Aug 27, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ponatinib

Ponatinib tablet or age appropriate formulation (AAF) in combination with chemotherapy backbone, orally, once daily in both reinduction block and consolidation block (35 days each including 29 days of treatment followed by rest period from chemotherapy for a minimum of 6 days consisting of daily ponatinib only) in Phase 1 to determine RP2D. In Phase 2 participants will receive ponatinib at RP2D in combination with chemotherapy backbone at RP2D determined in Phase 1.

Drug: Ponatinib
Ponatinib tablets.

Drug: Ponatinib AAF
Ponatinib age appropriate formulation (AAF).

Drug: Chemotherapy Agents
Chemotherapy agents for reinduction include vincristine, dexamethasone, polyethylene glycol (PEG)-asparaginase (Erwinia asparaginase when PEG-asparaginase is not available), daunorubicin. Agents for intrathecal (IT) chemotherapy, central nervous system (CNS)-1/2: IT methotrexate chemotherapy, or CNS-3: triple intrathecal (ITT) methotrexate, hydrocortisone, cytarabine. Chemotherapy agents for consolidation include dexamethasone, vincristine, methotrexate, PEG-asparaginase (Erwinia asparaginase when PEG-asparaginase is not available), cyclophosphamide, etoposide, CNS-1/2: IT methotrexate chemotherapy, CNS-3: ITT chemotherapy methotrexate, hydrocortisone, cytarabine. The doses for chemotherapy agents for reinduction will be given as per standard of care.

Outcome Measures

Primary Outcome Measures

  1. Phase 1: Recommended Phase 2 Dose (RP2D) of Ponatinib in Combination With Chemotherapy [Up to Week 4]

    The RP2D is the maximum tolerated dose (MTD) or less.

  2. Phase 2: Complete Remission (CR) Rate at the end of Reinduction Block [Up to Week 4]

    CR rate is defined as percentage of participants with CR at end of reinduction block. CR is defined as no circulating blasts and <5% blasts in the bone marrow (BM); normal maturation of all cellular components in the bone marrow; no extramedullary disease; absolute neutrophil count (ANC) >1000 cells/μl (or >1.0 × 10^9 cells/L); Platelets >100,000/μl (or >100 × 10^9 platelets /L).

Secondary Outcome Measures

  1. Phase 1: CR Rate at the end of Reinduction Block [Up to Week 4]

    CR rate is defined as percentage of participants with CR at end of reinduction block. CR is defined as no circulating blasts and <5% blasts in the BM; normal maturation of all cellular components in the bone marrow; no extramedullary disease; absolute neutrophil count (ANC) >1000 cells/μl (or >1.0 × 10^9 cells/L); Platelets >100,000/μl (or >100 × 10^9 platelets /L).

  2. Phase 1: Presence the Breakpoint Cluster Region- Abelson (BCR-ABL1) Domain Mutation Pre and Post Ponatinib Treatment [Up to Week 8]

  3. Phase 2: Percentage of Participants with Continued CR or who Achieved CR at the End of Consolidation Block [Up to Week 8]

    CR is defined as no circulating blasts and <5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC >1000 cells/μl (or >1.0 × 10^9 cells/L); Platelets >100,000 platelets/μl (or >100 × 10^9 platelets /L).

  4. Phase 2: Percentage of Participants with Negative Minimal Residual Disease (MRD) [Up to Weeks 4 and 8]

    MRD negative rate is the percentage of participants who achieve MRD negative status by evaluation of bone marrow aspirate at <0.01% threshold.

  5. Phase 2: Percentage of Participants who Relapsed or Progressed Following Reinduction and Consolidation [Up to Weeks 4 and 8]

  6. Phase 2: Event-free Survival (EFS) [Up to approximately 36 months]

    EFS is defined as time from date of enrollment until death due to any cause; refractory to treatment (defined as failure to achieve CR by end of the consolidation block) or relapse from CR. CR is defined as no circulating blasts and <5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC >1000 cells/μl (or >1.0 × 10^9 cells/L); Platelets >100,000 platelets/μl (or >100 × 10^9 platelets /L).

  7. Phase 2: Progression-free Survival (PFS) [Up to approximately 36 months]

    PFS is defined as time from date of enrolment until death due to any cause; disease progression (clinical deterioration associated with disease process, including evidence of increasing blasts in the bone marrow and/or evidence of new organ involvement) or relapse from CR. CR is defined as no circulating blasts and <5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC >1000 cells/μl (or >1.0 × 10^9 cells/L); Platelets >100,000 platelets/μl (or >100 × 10^9 platelets /L).

  8. Phase 2: Overall Survival (OS) [Up to approximately 36 months]

    OS is defined as time from first dose of ponatinib until death due to any cause.

  9. Phase 2: Duration of Response (DOR) [Up to approximately 36 months]

    DOR is defined as the interval between the first assessment at which the criteria for CR are met until the time at which relapse from CR occurs. CR is defined as no circulating blasts and <5% blasts in the bone marrow; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC >1000 cells/μl (or >1.0 × 10^9 cells/L); Platelets >100,000 platelets/μl (or >100 × 10^9 platelets /L).

  10. Phase 2: Percentage of Participants who Underwent Hematopoietic Stem Cell Transplantation (HSCT) [Up to approximately 36 months]

  11. Phase 2: Presence of BCR-ABL Domain Mutation Pre and Post Ponatinib Treatment [Up to Week 8]

  12. Phase 1: Cmax: Maximum Observed Plasma Concentration for Ponatinib [Predose and at multiple timepoints (Up to 24 hours) postdose on Days 1 and 22]

  13. Phase 1: Tmax: Time of First Occurrence of Cmax for Ponatinib [Predose and at multiple timepoints (Up to 24 hours) postdose on Days 1 and 22]

  14. Phase 1: AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ponatinib [Predose and at multiple timepoints (Up to 24 hours) postdose on Days 1 and 22]

  15. Phase 1 and 2: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Venous Thrombotic/Embolic Events (VTEs), and Adverse Events of Special Interest (AESIs) [From the first dose of study drug up to 30 days after last dose of study drug (Up to 36 months)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Participants must have a diagnosis of Ph+ ALL, Philadelphia chromosome-positive plus mixed phenotype acute leukemia (Ph+ MPAL), or Ph-like ALL (US only) with:
  1. Involvement of BM with ALL, including one of the following: i. M2 BM (5%-24% lymphoblasts): by morphology with confirmatory testing consisting of at least one of the following: flow cytometry lymphoblasts ≥5%, or BCR-ABL1 fluorescence in situ hybridization, or ≥10-2 leukemic clone identified by immunoglobulin heavy chain-T-cell receptor polymerase chain reaction, OR ii. M3 BM (≥25% lymphoblasts): by morphology, OR iii. Participants with combined BM (as defined above) and extramedullary disease.

  2. Evidence of Ph+ ALL, MPAL, or Ph-like ALL: i. Definite evidence of BCR-ABL1 fusion (Ph) for Ph+ All and MPAL, OR ii. Definite evidence of Ph-like ALL (US only) with targetable kinase-activating lesions involving any of the following kinase genes: ABL1, ABL2, CSF1R, and PDGFRB.

and either (i) or (ii) as follows: (i) For non-US sites: participants who have relapsed (post 0 or 1 HSCT) or are resistant or intolerant to at least one prior therapy that contained a BCR-ABL-targeted tyrosine kinase inhibitor (TKI), or for US sites: participants who have relapsed (post 0 or 1 HSCT) or are resistant or intolerant to at least one prior therapy that contained a second-generation BCR-ABL1-targeted TKI (i.e, dasatinib, nilotinib, and bosutinib) (ii) Have a BCR-ABL1 T315I mutation irrespective of relapse, resistance/intolerance, or transplant status and irrespective of any prior TKI use.

Notes:

A participant will be defined as intolerant if they had a Grade ≥3 nonhematologic toxicity or a Grade 4 hematologic toxicity considered at least possibly related to the last TKI and lasting for >2 weeks, and led to discontinuation of therapy.

Participants with Ph-like ALL (US only): Referring institution's laboratory results will be accepted for study enrollment.

  1. Performance Status: Karnofsky performance status ≥50% for participants >16 years of age or Lansky Play Scale ≥50% for participants ≤16 years of age.

  2. Have recovered to less than Grade 2 National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 5, or to baseline, from any nonhematologic toxicities (except alopecia) due to previous therapy.

  3. Participants must meet the following criteria related to prior therapies:

  • Cytoreduction with hydroxyurea: Hydroxyurea can be initiated and continued for up to 24 hours before the start of protocol therapy.

  • Participants who relapsed while receiving cytotoxic therapy: At least 14 days must have passed since the completion of the last dose of chemotherapy before the first dose of ponatinib can be given except for the following: intrathecal (IT) chemotherapy and/or maintenance therapy such as vincristine, mercaptopurine, methotrexate, or glucocorticoids. There is no waiting period for those relapsing on maintenance-like therapy.

  • HSCT: Participants who have experienced relapse after a HSCT are eligible, provided they have no evidence of acute or chronic graft-versus-host disease (GVHD), are not receiving GVHD prophylaxis or treatment, and are at least 90 days posttransplant at the time of enrollment.

  • Hematopoietic growth factors: Before the first dose of ponatinib, at least 7 days must have passed since completion of therapy with granulocyte colony-stimulating factor or other growth factors, and at least 14 days must have passed since completion of therapy with pegfilgrastim.

  • Biologics and Targeted Therapies: Before the first dose of ponatinib, at least 7 days must have passed since the last dose of a biologic agent. For agents that have known AEs occurring beyond 7 days after administration, this period must be extended beyond the time during which AEs are known to occur. The duration of this interval must be discussed with the sponsor's medical monitor/designee.

  • Monoclonal antibodies: After the last dose of monoclonal antibody, at least 3 half-lives of the administered antibody must have passed before the first dose of ponatinib.

  • Immunotherapy: Before the first dose of ponatinib, at least 30 days must have passed after the completion of any type of immunotherapy (eg, tumor vaccines, chimeric antigen receptor T-cell [CAR-T-cell]).

  • Immunosuppressive therapy: Before the first dose of ponatinib, at least 14 days must have passed after the completion of immunosuppressive therapy (including regimens following stem cell transplant).

  • Radiotherapy: No washout period is necessary for radiation given to any extramedullary site other than central nervous system (CNS); ≥90 days must have passed if participant received prior total body irradiation or craniospinal or cranial radiotherapy.

  • Anthracyclines: Participants must have had a lifetime exposure of <400 mg/m^2 of doxorubicin equivalents of anthracyclines.

    1. Adequate renal function defined as: Estimated glomerular filtration rate (eGFR) using the Schwartz formula, OR radioisotope glomerular filtration rate (GFR)≥70 mL/min/1.73 m^2, OR a normal serum creatinine based on age and sex.

b)Adequate liver function defined as: Direct bilirubin ≤1.5 times the upper limit of normal (ULN) for age AND ALT ≤5 times the ULN for age.

  1. No clinical, radiological or laboratory evidence of pancreatitis, including:

  2. Serum lipase must be <2 times the ULN, and

  3. Serum amylase must be <2 times the ULN.

  4. Adequate cardiac function defined as shortening fraction ≥27% by echocardiogram (ECHO) OR left ventricular ejection fraction of ≥50% by multigated acquisition scan (MUGA).

Exclusion Criteria:
  1. A history or current diagnosis of Burkitt leukemia/lymphoma or mature B-cell leukemia.

  2. A history or current diagnosis of chronic myeloid leukemia (CML).

  3. Diagnosis of ALL, MPAL, or Ph-like ALL (US only) with targetable kinase-activating lesions after treatment with cytotoxic therapy for another cancer.

  4. Diagnosis of another concurrent primary malignancy.

  5. Clinically significant cardiovascular disease, including but not limited to:

  6. Any history of myocardial infarction (MI) or unstable angina.

  7. History of or presence of heart block, and/or clinically significant ventricular or atrial arrhythmias.

  8. Uncontrolled hypertension, defined as persistent elevation of systolic and/or diastolic blood pressures to ≥95th percentile based on age, sex, and height percentiles despite appropriate antihypertensive management.

  9. Current systemic use of drug(s) that are known to have a risk of causing prolonged corrected QT interval (QTc) or torsades de pointes unless drug(s) can be changed to acceptable alternatives (ie, an alternate class of agents that do not affect the cardiac conduction system) or the participants can safely discontinue the drug(s).

  10. Uncontrolled hypertriglyceridemia (triglycerides ≥450 mg/dL).

  11. Current systemic use of any medications or herbal supplements that are known to be strong inhibitors or strong inducers of CYP3A within 7 days before the first dose of study drug.

  12. Previous treatment with ponatinib.

  13. Planned non-protocol chemotherapy, radiation therapy, another investigational agent, or immunotherapy while participant is on study treatment.

  14. Known gastrointestinal disease or gastrointestinal procedure that could interfere with the oral absorption of ponatinib.

  15. Participants with DNA fragility syndromes, such as Fanconi anemia and Bloom syndrome.

  16. Participants with Down syndrome.

  17. Participants with uncontrolled systemic infection, or known laboratory and/or clinical evidence of active infection with HIV, hepatitis B, or hepatitis C.

  18. Participants with pre-existing significant CNS pathology including: history of severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination/movement disorder, or autoimmune disease with CNS involvement are not eligible.

  19. Participants with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible. (Participants with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits and causative factor(s) have resolved).

  20. Uncontrolled seizure disorder. (Participants with seizure disorders that do not require antiepileptic drugs or are well controlled with stable doses of antiepileptic drugs are eligible).

  21. History of severe coagulopathy or cardiovascular or peripheral vascular events.

  22. Treatment with live attenuated vaccinations within 30 days prior to initiation of study treatment regimen.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Phoenix Childrens Hospital Phoenix Arizona United States 85016
2 Arkansas Children's Hospital Little Rock Arkansas United States 72202
3 Children's Hospital Los Angeles Los Angeles California United States 90027
4 Rady Childrens Hospital San Diego - PIN San Diego California United States 92123
5 UCSF Medical Comprehensive Cancer San Francisco California United States 94143
6 Alfred I Dupont Hospital For Children Wilmington Delaware United States 19803
7 Ann and Robert H Lurie Childrens Hospital of Chicago Chicago Illinois United States 60611
8 Riley Hospital For Children Indianapolis Indiana United States 46202
9 Dana Farber Cancer Institute Boston Massachusetts United States 02215
10 Children's Mercy Hospital and Clinica Kansas City Missouri United States 64108
11 Cincinnati Children's Hospital Medical Center - PIN Cincinnati Ohio United States 45229
12 Nationwide Children's Hospital Columbus Ohio United States 43205
13 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
14 St Jude Children's Research Hospital Memphis Tennessee United States 38105
15 Children's Medical Center Research Institute at UT Southwestern Dallas Texas United States 75235
16 Hospital Universitario Austral Pilar Buenos Aires Argentina B1629AHJ
17 Hospital Italiano de Buenos Aires Buenos Aires Argentina C1199ABB
18 Queensland Children's Hospital South Brisbane Queensland Australia 4101
19 Royal Children's Hospital Melbourne - PIN Parkville Victoria Australia 3052
20 Perth Children's Hospital Nedlands Western Australia Australia 6009
21 Rua Ramiro Barcelos, 2350 Curitiba Parana Brazil 81520-060
22 Irmandade Da Santa Casa de Misericordia de Porto Alegre Porto Alegre Rio Grande Du Sul Brazil 90020-090
23 Hospital de Clinicas de Porto Alegre (HCPA) - PPDS Porto Alegre Rio Grande Du Sul Brazil 90035-903
24 Clinica SUPRA Chapecó Santa Catarina Brazil 89801-355
25 Fundacao Pio XII Hospital de Cancer de Barretos Barretos Sao Paulo Brazil 14784-400
26 Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP Ribeirao Preto Brazil 14051-140
27 Graacc Grupo de Apoio Ao Adolescente E A Crianca Com Cancer Sao Paulo Brazil 04039-001
28 Hospital Santa Marcelina Sao Paulo Brazil 08270-070
29 West China Second University Hospital, Sichuan Univesity Chengdu China 610041
30 Children's Hospital of Chongqing Medical University Chongqing China 400014
31 The Affiliated Hospital of Guizhou Medical University Guiyang China 550004
32 The Second Hospital of Anhui Medical University Hefei China 230601
33 Qilu Hospital of Shandong University Jinan China 250012
34 The Affiliated Hospital of Qingdao University Qingdao China 260003
35 Children's Hospital of Shanghai Shanghai China 200040
36 Shanghai Children's Medical Center Shanghai China 200127
37 Children's Hospital of Soochow University Suzhou China 215025
38 Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Tianjin China 300020
39 Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan China 430022
40 Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan China 430030
41 Fakultni nemocnice Brno Brno Czechia 61300
42 Fakultni nemocnice v Motole Praha Czechia 15006
43 Hopital Sud Rennes Ille-et-Vilaine France 35200
44 Assistance Publique Hopitaux de Marseille Marseille France 13385
45 Hopital Robert Debre Paris France 75019
46 Hopital Des Enfants Toulouse France 31059
47 IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN Roma Lazio Italy 165
48 Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN Genova Liguria Italy 16147
49 Fndazione MBBM (MONZA E BRIANZA PER IL BAMBINO E LA SUA MAMMA) - c/o Centro Maria Letizia Verga Monza Lombardia Italy 20900
50 Ospedale Infantile Regina Margherita - INCIPIT - PIN Torino Piemonte Italy 10126
51 Seoul National University Hospital Seoul Korea, Republic of 3080
52 Severance Hospital Yonsei University Health System Seoul Korea, Republic of 3722
53 Asan Medical Center - PPDS Seoul Korea, Republic of 5505
54 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of 6591
55 Hospital Universitario Dr. Jose Eleuterio Gonzalez Monterrey Nuevo Leon Mexico 64460
56 Instituto Nacional de Pediatria Ciudad De Mexico Mexico 4530
57 Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca Guadalajara Mexico 44340
58 Princess Maxima Center for Pediatric Oncology - PIN Utrecht Netherlands 3584 CS
59 Uniwersytecki Szpital Dzieciecy Krakow Poland 30-663
60 SPZOZ Centralny Szpital Kliniczny UM w Lodzi Lodz Poland 92-213
61 SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego Zabrze Poland 41-800
62 Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. Lisbon Lisboa Portugal 1099-023
63 Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS Porto Portugal 4200-072
64 Hospital Universitario Vall d'Hebron - PPDS Barcelona Spain 8035
65 Hospital Infantil Universitario Nino Jesus - PIN Madrid Spain 28009
66 Hospital Universitario Virgen del Rocio - PPDS Sevilla Spain 41013
67 Royal Marsden Hospital - Surrey Surrey Quays Sutton United Kingdom SM2 5PT
68 Birmingham Children's Hospital Birmingham United Kingdom B4 6NH
69 Cambridge University Hospitals NHS Foundation Trust Cambridge United Kingdom CB2 0QQ
70 Royal Hospital for Children (Glasgow) - PPDS - PIN Glasgow United Kingdom G3 8SJ

Sponsors and Collaborators

  • Takeda

Investigators

  • Study Director: Study Director Clinical Science, Takeda

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Takeda
ClinicalTrials.gov Identifier:
NCT04501614
Other Study ID Numbers:
  • Ponatinib-1501
  • 2019-002549-39
  • U1111-1225-0394
First Posted:
Aug 6, 2020
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Takeda
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022