Non Hodgkin Lymphoma Clinical Trial

Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

Summary

This phase II Pediatric MATCH trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back (recurrent) or do not respond to treatment (refractory) and have spread to other places in the body (advanced). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Full Description

PRIMARY OBJECTIVE:

I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with ensartinib with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations.

SECONDARY OBJECTIVES:

I. To estimate the progression free survival in pediatric patients treated with ensartinib with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations.

II. To obtain information about the tolerability of ensartinib in children with relapsed or refractory cancer.

III. To provide preliminary estimates of the pharmacokinetics of ensartinib in children with relapsed or refractory cancer.

EXPLORATORY OBJECTIVES:

I. To evaluate other biomarkers as predictors of response to ensartinib and specifically, whether tumors that harbor different missense mutations or fusions (including the crizotinib resistant F1174L ALK variant) will demonstrate differential response to ensartinib treatment.

II. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA).

OUTLINE:

Patients receive ensartinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621F based on the presence of an actionable mutation
Patients must have a body surface area >= 0.5 m^2 at enrollment

Patients must have radiographically measurable disease at the time of study enrollment. Patients with neuroblastoma who do not have measurable disease but have iobenguane (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on a standard magnetic resonance imaging (MRI) or computed tomography (CT)

Note: The following do not qualify as measurable disease:

Malignant fluid collections (e.g., ascites, pleural effusions)
Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
Previously radiated lesions that have not demonstrated clear progression post radiation
Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age

Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score

Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately

Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil counts [ANC] counts): >= 7 days after the last dose of agent
Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator
Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)

Stem cell Infusions (with or without total body irradiation [TBI]):

Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
Autologous stem cell infusion including boost infusion: >= 42 days
Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)

Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial none marrow (BM) radiation

Note: Radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy
Patients must not have received prior exposure to ensartinib; prior treatment with other ALK inhibitors is permitted given that at least 5 half-lives or 21 days have elapsed since therapy discontinuation, whichever is greater

For patients with solid tumors without known bone marrow involvement:

Peripheral absolute neutrophil count (ANC) >= 1000/mm^3
Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity

Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 (within 7 days prior to enrollment) or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment):

Age 1 to < 2 years: maximum serum creatinine 0.6 mg/dL for male and 0.6 mg/dL for female
Age 2 to < 6 years: maximum serum creatinine 0.8 mg/dL for male and 0.8 mg/dL for female
Age 6 to < 10 years: maximum serum creatinine 1 mg/dL for male and 1 mg/dL for female
Age 10 to < 13 years: maximum serum creatinine 1.2 mg/dL for male and 1.2 mg/dL for female
Age 13 to < 16 years: maximum serum creatinine 1.5 mg/dL for male and 1.4 mg/dL for female
Age >= 16 years: maximum serum creatinine 1.7 mg/dL for male and 1.4 mg/dL for female
Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (within 7 days prior to enrollment) (for the purpose of this study, the ULN for SGPT is 45 U/L)
Serum albumin >= 2 g/dL (within 7 days prior to enrollment)
Patients must be able to swallow intact capsules
All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines

Exclusion Criteria:

Pregnant or breast-feeding women will not be entered on this study because there is currently no available information regarding human fetal or teratogenic toxicities; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study treatment and for one week after the last dose of ensartinib

Concomitant medications

Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Investigational drugs: patients who are currently receiving another investigational drug are not eligible
Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible
Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial

CYP3A4 agents: patients who are currently receiving drugs that are strong inducers or strong inhibitors of CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study

Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
Patients who have an uncontrolled infection are not eligible
Patients who have received a prior solid organ transplantation are not eligible
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

98

Study ID:

NCT03213652

Recruitment Status:

Suspended

Sponsor:

National Cancer Institute (NCI)

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There are 119 Locations for this study

See Locations Near You

Children's Hospital of Alabama
Birmingham Alabama, 35233, United States
Providence Alaska Medical Center
Anchorage Alaska, 99508, United States
Banner Children's at Desert
Mesa Arizona, 85202, United States
Banner University Medical Center - Tucson
Tucson Arizona, 85719, United States
Arkansas Children's Hospital
Little Rock Arkansas, 72202, United States
Kaiser Permanente Downey Medical Center
Downey California, 90242, United States
Loma Linda University Medical Center
Loma Linda California, 92354, United States
Miller Children's and Women's Hospital Long Beach
Long Beach California, 90806, United States
Children's Hospital Los Angeles
Los Angeles California, 90027, United States
Valley Children's Hospital
Madera California, 93636, United States
UCSF Benioff Children's Hospital Oakland
Oakland California, 94609, United States
Kaiser Permanente-Oakland
Oakland California, 94611, United States
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
UCSF Medical Center-Mission Bay
San Francisco California, 94158, United States
Children's Hospital Colorado
Aurora Colorado, 80045, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver Colorado, 80218, United States
Yale University
New Haven Connecticut, 06520, United States
Alfred I duPont Hospital for Children
Wilmington Delaware, 19803, United States
Children's National Medical Center
Washington District of Columbia, 20010, United States
University of Florida Health Science Center - Gainesville
Gainesville Florida, 32610, United States
Nemours Children's Clinic-Jacksonville
Jacksonville Florida, 32207, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami Florida, 33136, United States
Nicklaus Children's Hospital
Miami Florida, 33155, United States
AdventHealth Orlando
Orlando Florida, 32803, United States
Arnold Palmer Hospital for Children
Orlando Florida, 32806, United States
Nemours Children's Hospital
Orlando Florida, 32827, United States
Nemours Children's Clinic - Pensacola
Pensacola Florida, 32504, United States
Johns Hopkins All Children's Hospital
Saint Petersburg Florida, 33701, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa Florida, 33607, United States
Children's Healthcare of Atlanta - Egleston
Atlanta Georgia, 30322, United States
Saint Luke's Cancer Institute - Boise
Boise Idaho, 83712, United States
Lurie Children's Hospital-Chicago
Chicago Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Saint Jude Midwest Affiliate
Peoria Illinois, 61637, United States
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States
Riley Hospital for Children
Indianapolis Indiana, 46202, United States
Blank Children's Hospital
Des Moines Iowa, 50309, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
Norton Children's Hospital
Louisville Kentucky, 40202, United States
Children's Hospital New Orleans
New Orleans Louisiana, 70118, United States
Ochsner Medical Center Jefferson
New Orleans Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor Maine, 04401, United States
University of Maryland/Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Sinai Hospital of Baltimore
Baltimore Maryland, 21215, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
C S Mott Children's Hospital
Ann Arbor Michigan, 48109, United States
Michigan State University Clinical Center
East Lansing Michigan, 48824, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis Minnesota, 55404, United States
University of Minnesota/Masonic Cancer Center
Minneapolis Minnesota, 55455, United States
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Children's Mercy Hospitals and Clinics
Kansas City Missouri, 64108, United States
Cardinal Glennon Children's Medical Center
Saint Louis Missouri, 63104, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Children's Hospital and Medical Center of Omaha
Omaha Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas Nevada, 89135, United States
Summerlin Hospital Medical Center
Las Vegas Nevada, 89144, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
Saint Peter's University Hospital
New Brunswick New Jersey, 08901, United States
Albany Medical Center
Albany New York, 12208, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park New York, 11040, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
NYP/Weill Cornell Medical Center
New York New York, 10065, United States
University of Rochester
Rochester New York, 14642, United States
State University of New York Upstate Medical University
Syracuse New York, 13210, United States
New York Medical College
Valhalla New York, 10595, United States
Mission Hospital
Asheville North Carolina, 28801, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte North Carolina, 28203, United States
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Wake Forest Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States
Rainbow Babies and Childrens Hospital
Cleveland Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Nationwide Children's Hospital
Columbus Ohio, 43205, United States
Dayton Children's Hospital
Dayton Ohio, 45404, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo Ohio, 43606, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Legacy Emanuel Children's Hospital
Portland Oregon, 97227, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh Pennsylvania, 15224, United States
Prisma Health Richland Hospital
Columbia South Carolina, 29203, United States
BI-LO Charities Children's Cancer Center
Greenville South Carolina, 29605, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States
East Tennessee Childrens Hospital
Knoxville Tennessee, 37916, United States
Saint Jude Children's Research Hospital
Memphis Tennessee, 38105, United States
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States
Dell Children's Medical Center of Central Texas
Austin Texas, 78723, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States
Cook Children's Medical Center
Fort Worth Texas, 76104, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston Texas, 77030, United States
M D Anderson Cancer Center
Houston Texas, 77030, United States
Children's Hospital of San Antonio
San Antonio Texas, 78207, United States
Methodist Children's Hospital of South Texas
San Antonio Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Primary Children's Hospital
Salt Lake City Utah, 84113, United States
University of Vermont and State Agricultural College
Burlington Vermont, 05405, United States
Children's Hospital of The King's Daughters
Norfolk Virginia, 23507, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States
Seattle Children's Hospital
Seattle Washington, 98105, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane Washington, 99204, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States
West Virginia University Healthcare
Morgantown West Virginia, 26506, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States
Children's Hospital of Wisconsin
Milwaukee Wisconsin, 53226, United States
San Jorge Children's Hospital
San Juan , 00912, Puerto Rico
University Pediatric Hospital
San Juan , 00926, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

98

Study ID:

NCT03213652

Recruitment Status:

Suspended

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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