Pediatric Open Studies

General Biology

COG-APEC14B1
Project: Every child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
COG-APAL2020SC
Pediatric Acute Leukemia (PedAL2020SC) screening trial – developing new therapies for relapsed leukemias
TSLP
TSLP in Pediatric B-ALL

Registry

COG-APEC14B1
Project: Every child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study
COG-ALTE07C1
Neuropsychological, Social, Emotional and Behavioral outcomes in children with cancer

Long Term Follow-Up

COG-ALTE05N1
Umbrella Long-Term Follow-Up Protocol

Medication

COG-ACCL2121
A Multicenter Study to Assess Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of HTX-019 as a Single-Dose or 3-Day Regimen for Prevention of Nausea and Vomiting in Pediatric Subjects Receiving Emetogenic Chemotherapy
COG-ACCL2031
A phase 3 randomized placebo-controlled trial evaluating Memantine (IND # 149832) for neurocognitive protection in children undergoing cranial radiotherapy as part of treatment for primary central nervous system tumors

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
Albert Kheradpour, MD
COG-ACNS1821
A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and HighGrade Glioma (HGG) https://www.clinicaltrials.gov/ct2/show/NCT05099003
Albert Kheradpour, MD
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
Albert Kheradpour, MD
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
Albert Kheradpour, MD
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
Albert Kheradpour, MD
COG-ACNS1931
A Phase 3 Study of Selumetinib (NSC# 748727) or Selumetinib in Combination with Vinblastine for Non-NF1, Non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations
https://www.clinicaltrials.gov/ct2/show/NCT04576117
Albert Kheradpour, MD
COG-ACNS2021
A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor
https://www.clinicaltrials.gov/ct2/show/NCT04684368
Albert Kheradpour, MD
COG-ACNS2031
A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children with Average-Risk Medulloblastoma and Reduced Therapy in Children with Medulloblastoma with Low-Risk Features.
 
HEAD START 4
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 either Single Cycle or Randomization to either Single-Cycle or to Three Tandem Cycles of Marrow-Ablative Chemotherapy with) for neurocognitive protection in children undergoing cranial radiotherapy as part of treatment for primary central nervous system tumors – request Autologous Hematopoietic Progenitor Cell Rescue
 

Germ Cell

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 *limited strata available*
https://clinicaltrials.gov/ct2/show/NCT03067181
Albert Kheradpour, MD
COG-AGCT1532
A Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-Risk Metastatic Germ Cell Tumors
 

Hepatoblastoma

COG-AHEP1531
Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) *limited strata available*

Kidney

COG-AREN03B2
Renal Tumors Classification, Biology & Banking Study *LOH testing is NOT provided through study*
COG-AREN1721
A Randomized Phase 2 Trial of AXITINIB/Nivolumab Combination Therapy vs Single Agent AXITINIB or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups
COG-AREN1921
Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)

Solid Tumors

COG-APEC1621 MATCH
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Master Version Control Protocol
COG-APEC1621 A
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) – Phase 2 sub protocol of LOXO-101 (Larotrectinib) in patients with tumors harboring actionable NTRK fusions *limited strata available*
COG-APEC1621 F
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) – Phase 2 sub protocol of Ensartinib in patients with tumors harboring ALK or ROS1 genomic alterations
COG-APEC1621 K
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 3 Sub protocol of AG-120 (Ivosidenib) in Patients with Tumors Harboring 1DH1 Mutations *limited strata available*
COG-APEC1621 M
NCI-COG Pediatric MATCH (molecular analysis for therapy Choice) - Phase 3 sub protocol of Tipifarnib in patients with Tumors Harboring HRAS genomic alterations
COG-APEC1621 N
NCI-COG Pediatric MATCH (molecular analysis for therapy choice)- Phase 2 sub protocol of Loxo-292 in patients with tumors harboring RET gene alterations

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
Albert Kheradpour, MD
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
Albert Kheradpour, MD
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 *limited strata available*
https://clinicaltrials.gov/ct2/show/NCT03959085
Albert Kheradpour, MD
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
Albert Kheradpour, MD
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
Albert Kheradpour, MD
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
Albert Kheradpour, MD
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
Albert Kheradpour, MD
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 *limited strata available*
https://clinicaltrials.gov/ct2/show/NCT04546399
Albert Kheradpour, MD
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-Lymphobl) *limited strata available*
https://clinicaltrials.gov/ct2/show/NCT03914625
Albert Kheradpour, MD

Lymphoma

COG-AHOD2131
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immune Oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
 
COG-ANHL1931
A Randomized Phase 3 Trial of Nivolumab (NSC# 748726) in Combination with Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
https://www.clinicaltrials.gov/ct2/show/NCT04759586
Albert Kheradpour, MD
COG-ANHL2121
Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis
 
SWOG-E4412
A Phase I Study with an Expansion Cohort/Randomized Phase II Study of the Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma
 
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
Albert Kheradpour, MD

Neuroblastoma

 
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) *limited strata available*
https://clinicaltrials.gov/ct2/show/NCT03126916
Albert Kheradpour, MD
COG-ANBL00B1
Neuroblastoma Biology Studies
https://www.clinicaltrials.gov/ct2/show/NCT00904241
Albert Kheradpour, MD

Osteosarcoma

COG-AOST2031
A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma
COG-AOST2032
A feasibility and randomized phase 2/3 study of the VEFGR2/MET inhibitor Cabozantinib in combination with Cytotoxic chemotherapy for newly diagnosed osteosarcoma

Rhabdomyosarcoma

COG-ARST1921
A Safety, Pharmacokinetic and Efficacy Study of a y-Secretase Inhibitor, Nirogacestat (PF-03084014; IND# 146375), in Children and Adolescents with Progressive, Surgically Unresectable Desmoid Tumors
https://www.clinicaltrials.gov/ct2/show/NCT04195399
Albert Kheradpour, MD
COG-ARST2031
A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High-Risk Rhabdomyosarcoma (HR-RMS)
 
COG-ARST2032
A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma
 

Stem Cell Transplant

COG-ASCT2031
A Multi-Center Phase 3 Randomized Trial of Matched Unrelated Donor (MUD) Virus HLA-Haploidentical Related (Haplo) Myeloablative Hematopoietic Cell Transplantation for Children, Adolescents and young Adults (AYA) with Acute Leukemia or Myelodysplastic Syndrome (MDS
 
NMDP-10-CBA
A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications
https://www.clinicaltrials.gov/ct2/show/NCT01351545
Albert Kheradpour, MD
NMDP-RESEARCH DATABASE
Protocol for A Research Database for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
https://www.clinicaltrials.gov/ct2/show/NCT02401009
Albert Kheradpour, MD
NMDP-SAMPLE REPOSITORY
Protocol for A Research Sample Repository for Hematopoietic Cell Transplantation, Other Cellular Therapies and Marrow Toxic Injuries
https://www.clinicaltrials.gov/ct2/show/NCT01166009
Albert Kheradpour, MD
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
Albert Kheradpour, MD
PTCTC-ONC1701 (EndRAD)
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
https://clinicaltrials.gov/ct2/show/NCT0350961
Albert Kheradpour, MD