ACTIVE_NOT_RECRUITING

Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

Conditions

Hodgkin Lymphoma Pediatric Cancer Frontline Therapy Response Adapted Therapy Risk Adapted Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase II study using risk and response-adapted therapy for low, intermediate and high risk classical Hodgkin lymphoma. Chemotherapy regimens will be based on risk group assignment. Low-risk and intermediate- risk patients will be treated with bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine, and prednisone (BEABOVP) chemotherapy. High-risk patients will receive Adcetris® (brentuximab vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) (AEPA) and cyclophosphamide, Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC) (CAPDac) chemotherapy. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an adequate response (AR) after 2 cycles of therapy for all risk groups.

Official Title

Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17

Quick Facts

Study Start:2018-12-12

Study Completion:2028-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03755804

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Histologically confirmed, previously untreated CD30+ classical HL. (Participants are still eligible if they received limited emergent RT or steroid therapy - maximum of 7 days if within the last month or as approved by PI). * Age ≤ 21 years at the time of diagnosis (i.e., participants are eligible until their 22nd birthday) for low-risk and intermediate-risk * Age ≤ 25 years at the time of diagnosis (i.e., participants are eligible until their 26th birthday) for high-risk * All Ann Arbor stages. * Low-Risk: IA, IIA (excluding patients with "E" lesions or mediastinal bulk) * Intermediate-Risk: IA or IIA with "E" lesions or bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph) and IB, IIIA. * High-Risk: IIB, IIIB, IV * Adequate renal function based on GFR ≥ 70 ml/min/1.73m2 OR serum creatinine adjusted for age and gender as follows: Age 1 to \< 2 years: maximum serum creatinine 0.6 mg/dL for males and 0.6 mg/dL for females, Age 2 to \< 6 years: maximum serum creatinine 0.8 mg/dL for males and 0.8 mg/dL for females, Age 6 to \< 10 years: maximum serum creatinine 1 mg/dL for males and 1 mg/dL for females, Age 10 to \< 13 years: maximum serum creatinine 1.2 mg/dL for males and 1.2 mg/dL for females, Age 13 to \< 16 years: maximum serum creatinine 1.5 mg/dL for males and 1.4 mg/dL for females, Age ≥16 years: maximum serum creatinine 1.7 mg/dL for males and 1.4 mg/dL for females * Adequate hepatic function (total bilirubin ≤ 1.5 x ULN for age, and AST/ALT ≤ 2.5 x ULN for age). * Adequate hematologic criteria at baseline, unless secondary to Hodgkin disease diagnosis * Absolute neutrophil count (ANC) ≥1000/µL * Platelets ≥ 75,000/µL * Adequate cardiac function defined as shortening fraction of ≥ 27% by echocardiogram or MUGA, unless decreased function is due to large mediastinal mass or effusion related to HL. * Adequate pulmonary function defined as no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 92% on room air unless secondary to a large mediastinal mass or effusion related to HL. * Female participant who is post-menarchal must have a negative urine or serum pregnancy test. * Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.	* CD30 negative HL. * Has received prior therapy for Hodgkin lymphoma * Inadequate organ function * High-risk participants with a history of ≥ grade 2 peripheral neuropathy or any active neurologic disease that would impede the ability to assess neurologic toxicities. * Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.

Inclusion Criteria

Exclusion Criteria

* Histologically confirmed, previously untreated CD30+ classical HL. (Participants are still eligible if they received limited emergent RT or steroid therapy - maximum of 7 days if within the last month or as approved by PI).
* Age ≤ 21 years at the time of diagnosis (i.e., participants are eligible until their 22nd birthday) for low-risk and intermediate-risk
* Age ≤ 25 years at the time of diagnosis (i.e., participants are eligible until their 26th birthday) for high-risk
* All Ann Arbor stages.
* Low-Risk: IA, IIA (excluding patients with "E" lesions or mediastinal bulk)
* Intermediate-Risk: IA or IIA with "E" lesions or bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph) and IB, IIIA.
* High-Risk: IIB, IIIB, IV
* Adequate renal function based on GFR ≥ 70 ml/min/1.73m2 OR serum creatinine adjusted for age and gender as follows: Age 1 to \< 2 years: maximum serum creatinine 0.6 mg/dL for males and 0.6 mg/dL for females, Age 2 to \< 6 years: maximum serum creatinine 0.8 mg/dL for males and 0.8 mg/dL for females, Age 6 to \< 10 years: maximum serum creatinine 1 mg/dL for males and 1 mg/dL for females, Age 10 to \< 13 years: maximum serum creatinine 1.2 mg/dL for males and 1.2 mg/dL for females, Age 13 to \< 16 years: maximum serum creatinine 1.5 mg/dL for males and 1.4 mg/dL for females, Age ≥16 years: maximum serum creatinine 1.7 mg/dL for males and 1.4 mg/dL for females
* Adequate hepatic function (total bilirubin ≤ 1.5 x ULN for age, and AST/ALT ≤ 2.5 x ULN for age).
* Adequate hematologic criteria at baseline, unless secondary to Hodgkin disease diagnosis
* Absolute neutrophil count (ANC) ≥1000/µL
* Platelets ≥ 75,000/µL
* Adequate cardiac function defined as shortening fraction of ≥ 27% by echocardiogram or MUGA, unless decreased function is due to large mediastinal mass or effusion related to HL.
* Adequate pulmonary function defined as no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 92% on room air unless secondary to a large mediastinal mass or effusion related to HL.
* Female participant who is post-menarchal must have a negative urine or serum pregnancy test.
* Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.

* CD30 negative HL.
* Has received prior therapy for Hodgkin lymphoma
* Inadequate organ function
* High-risk participants with a history of ≥ grade 2 peripheral neuropathy or any active neurologic disease that would impede the ability to assess neurologic toxicities.
* Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.

Contacts and Locations

Principal Investigator

Matthew Ehrhardt, MD, MS

PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Study Locations (Sites)

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, 94304

United States

St. Jude Midwest Affiliate - Peoria

Peoria, Illinois, 61637

United States

St. Jude Affiliate Baton Rouge Clinic (Our Lady of the Lakes Regional Medical Center)

Baton Rouge, Louisiana, 70809

United States

Maine Children's Cancer Program

Scarborough, Maine, 04074

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

St. Jude Affiliate Clinic at Novant Health Hemby Children's Hospital

Charlotte, North Carolina, 28204

United States

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

Matthew Ehrhardt, MD, MS, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-12-12

Study Completion Date2028-07-01

Study Record Updates

Study Start Date2018-12-12

Study Completion Date2028-07-01

Terms related to this study

Keywords Provided by Researchers

Hodgkin Lymphoma
Pediatric Cancer
Frontline Therapy
Response Adapted Therapy
Risk Adapted Therapy

Additional Relevant MeSH Terms

Hodgkin Lymphoma