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

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-ADVL1521
A Phase 2 Study of the MEK Inhibitor Trametinib in Children with Relapsed or Refractory Juvenile  Myelomonocytic Leukemia
https://clinicaltrials.gov/ct2/show/NCT03190915

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-AALL1731
A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down Syndrome B Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy) https://clinicaltrials.gov/ct2/show/NCT03914625

COG-AALL1931
An Open-Label, Multicenter Study of RC-P in Patients with Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) Following Hypersensitivity to E. coli-deriv ed Asparaginases https://clinicaltrials.gov/ct2/show/NCT04145531

Liver

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

Multiple

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

COG-AINV18P1
A Phase 1 Study of Palbociclib (IND#141416), a CDK 4/6 Inhibitor, in Combination with Chemotherapy in Children with Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)
https://clinicaltrials.gov/ct2/show/NCT03792256

COG-AGCT1532
A randomized phase 3 trial of accelerated versus standard BEP chemotherapy for patients with Intermediate and poor-risk metastatic germ cell tumors
https://clinicaltrials.gov/ct2/show/NCT02582697

Neuroblastoma

COG-ANBL00B1

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-ADVL1622
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://clinicaltrials.gov/ct2/show/NCT02867592

COG-ADVL1722
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://clinicaltrials.gov/ct2/show/NCT03441360

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