COVID-19 - APPOINTMENTS AND PROCEDURES

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Pediatric Open Studies

Registry

COG-APEC14B1
Project: EveryChild - A Registry, Eligibility Screening, Biology and Outcome Study
https://clinicaltrials.gov/ct2/show/NCT02402244

CNS

COG-ACNS1422
A Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients
https://clinicaltrials.gov/ct2/show/NCT02724579

National Children’s Hospital-Head Start IV
Newly Diagnosed Children (Less Than 10 Years Old) With Medulloblastoma And Other Central Nervous System Embryonal Tumors. Clinical And Molecular Risk-Tailored Intensive And Compressed Induction Chemotherapy Followed By Consolidation With Randomization To Either Single-Cycle Or To Three Tandem Cycles Of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue
https://clinicaltrials.gov/ct2/show/NCT02875314

COG-ACNS1721
A Phase 2 Study of Veliparib (ABT-888, IND # 139199) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients with Newly Diagnosed High-Grade Glioma (HGG) without H3 K27M or BRAFV600E https://clinicaltrials.gov/ct2/show/NCT03581292

COG-ACNS1723
A Phase 2 Study of Dabrafenib (NSC# 763760) with Trametinib (NSC# 763093) after Local Irradiation in Newly-Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG) (IND# 145355)
https://clinicaltrials.gov/ct2/show/NCT03919071

COG-ACNS1831
A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)
http://clinicaltrials.gov/ct2/show/NCT03871257

COG-ACNS1833
A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
https://clinicaltrials.gov/ct2/show/NCT04166409

Germ Cell

COG-A031102
A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors 
https://clinicaltrials.gov/ct2/show/NCT02375204

COG-AGCT1531
A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
https://clinicaltrials.gov/ct2/show/NCT03067181

Leukemia

COG-AALL1521
A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With  De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway–Mutant Acute Lymphoblastic Leukemia
https://clinicaltrials.gov/ct2/show/NCT02723994

COG-AALL1631
International Phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones
https://clinicaltrials.gov/ct2/show/NCT03007147

COG-AAML1531
Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome
https://clinicaltrials.gov/ct2/show/NCT02521493

COG-AALL1732
A Phase 3 Randomized Trial of Inotuzumab Ozogamicin for Newly Diagnosed High-Risk B-ALL; Risk Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy
https://clinicaltrials.gov/ct2/show/NCT03959085

COG-ADVL1822
A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination with Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) with FLT3-ITD Mutations
https://clinicaltrials.gov/ct2/show/NCT03793478

COG-AAML1831
A phase 3 randomized trial for patients with de novo AML comparing standard therapy including gemtuzumab oz ogamicin GO to CPX-351 with GO, and the addition of the FLT3 inhibitor gilteritinib for patients with FLT3 mutations
https://clinicaltrials.gov/ct2/show/NCT04293562

COG-AALL1621
A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)
https://clinicaltrials.gov/ct2/show/NCT02981628

COG-AAML1921
A Phase I/II Study of Bosutinib in Pediatric Patients with Newly Diagnosed Chronic Phase or Resistant / Intolerant Ph+ Chronic Myeloid Leukemia
https://clinicaltrials.gov/ct2/show/NCT04258943

COG-AALL1821
A Phase 2 Study of Blinatumomab (NSC# 765986, IND# 125462) in Combination with Nivolumab (NSC# 748726, IND# 125462), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged 1-30 Years with First Relapse
https://clinicaltrials.gov/ct2/show/NCT04546399

Liver

COG-AHEP1531
Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) 
hhttps://clinicaltrials.gov/ct2/show/NCT03533582

Lymphoma

COG-ACCL1333
A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention versus No Systemic Anticoagulant Prophylaxis during Induction Chemotherapy in Children with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma (T or B cell) treated with Pegylated (PEG) L-asparaginase
hhttps://clinicaltrials.gov/ct2/show/NCT03533582

SWOG-S1826
A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma
https://clinicaltrials.gov/ct2/show/NCT03907488

Multiple

COG-APEC1621
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Master Version Control Document
https://clinicaltrials.gov/ct2/show/NCT03233204

Neuroblastoma

COG-ANBL1232
Utilizing Response and Biology Based Risk Factors to Guide Therapy in Patients with Non-High Risk Neuroblastoma
https://clinicaltrials.gov/ct2/show/NCT02176967

COG-ANBL1531
A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379)
https://clinicaltrials.gov/ct2/show/NCT03126916

Rhabdomyosarcoma

COG-ARST1431
A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)
https://clinicaltrials.gov/ct2/show/NCT02567435

Solid Tumors

COG-ADVL1711
A Phase 1/2 Study of Lenvatinib in combination with Everolimus in Recurrent and Refractory Pediatric Solid Tumors, including CNS tumors
https://clinicaltrials.gov/ct2/show/NCT03245151

Stem Cell Transplant

NMDP-10-CBA
A Phase I/II Study of MK-3475 (Pembrolizumab) in Children with advanced melanoma or a PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma (KEYNOTE-051)
https://www.clinicaltrials.gov/ct2/show/NCT01351545

NMDP-RESEARCH DATABASE
Phase 2 Trial of XL184 (Cabozantinib) an Oral Small-Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors
https://www.clinicaltrials.gov/ct2/show/NCT00495300

NMDP-SAMPLE REPOSITORY
A Phase 2, multicenter, open-label study to assess safety and preliminary activity of eribulin mesylate in pediatric subjects with relapsed/refractory rhabdomyosarcoma (RMS), non-rhabdomyosarcoma soft tissue sarcoma (NRSTS) and Ewing sarcoma (EWS)
https://www.clinicaltrials.gov/ct2/show/NCT00495300

NMDP-17-SIBS
Identifying Predictors of Poor Health-R elated Quality-of-Life among Pediatric Hematopoietic Stem Cell Donor
https://www.clinicaltrials.gov/ct2/show/NCT03718546

PBMTC-ONC1701
A phase II pilot trial to estimate survival after a non-total body irradiation (TBI) based conditioning regimen in patients diagnosed with B-acute lymphoblastic leukemia (ALL) who are pre-allogeneic hematopoietic cell transplantation (HCT) next-generation-sequence (NGS) minimal residual disease (MRD) negative.
https://clinicaltrials.gov/ct2/show/NCT0350961