Pediatric Hodgkin Lymphoma Treatment Trial With Low Cumulative Doses of Chemotherapy Agents and Reduced Radiation. (LHGALOP2017)

March 18, 2024 updated by: Pedro Zubizarreta, Hospital JP Garrahan

Non Randomized, Multicenter, Prospective Pediatric Hodgkin Lymphoma Treatment Trial Stratified According to Initial Risk Factors and Response to Chemotherapy, Reduced Cumulative Doses of Antineoplastic Agents and Radiotherapy.

This trial proposes a therapy for pediatric Hodgkin lymphoma with the objective of achieving high levels of long lasting complete remission with less risk of late effects.

Patients of both genders, between 2 and 18 years, with newly diagnosed classical Hodgkin lymphoma are admitted.

Initial staging provides stratification in three groups: low, intermediate and high risk. An initial set of two chemotherapy courses is administered to all cases after which a new disease assessment is performed. According to disease response a final therapy group is assigned. Rapid early responders benefit from less chemotherapy. At the end of chemotherapy, radiotherapy is delivered only to patients who do not achieve a complete response. Thus therapy is tailored to initial extension and disease responsiveness. Complete responders at the end of chemotherapy do not receive radiotherapy. Those who are in partial remission receive low dose (30Gy) involved node radiotherapy. Stable or progressive disease at any moment is assumed as a trial failure and new therapeutic strategies are offered to patients off protocol.

Chemotherapy is based upon regimes with well known effectiveness in Hodgkin lymphoma. (i.e. ABVD: doxorubicin, bleomycin, vinblastine and dacarbazine and ESHAP: Etoposide, methyl prednisolone, citarabine and cisplatin). The schedules are delivered with low cumulative drug doses and avoiding the use of toxic alkylating agents. Risks of secondary leukemia and infertility are thus minimized. Doxorubicin and bleomycin do not achieve cumulative doses that may expose to significant risk of heart or lung damage. Radiotherapy reduction avoids late radiation sequels.

This clinical study proposes a therapeutic approach based on chemotherapy that do not sum up high cumulative toxic doses. Therapy is tailored according to initial risk assessment and disease responsiveness. Those who achieve a complete response to chemotherapy do not receive additional radiotherapy, thus avoiding further late effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial proposes a therapy for pediatric Hodgkin lymphoma with the objective of achieving high levels of long lasting complete remission with less risk of late effects.

Patients of both genders, between 2 and 18 years, with newly diagnosed classical Hodgkin lymphoma are admitted. An open surgical biopsy with histopatological diagnosis is preferred.

Initial staging provides stratification in three groups: low, intermediate and high risk. An initial set of two chemotherapy courses is administered to all cases after which an early disease response assessment is performed. According to disease response a final therapy group is assigned (7 arms).

Imaging with PET-CT and Deauville Score is preferred for initial and further disease assessment. Complete response is defined by volume reduction and metabolic remission. In case PET-CT is not available, CT and ultrasound with volume reduction standards to assess response may be used.

Rapid early responders who achieve complete remission (CR) benefit from less chemotherapy. Those who are in partial remission at the end of chemotherapy (late disease assessment) receive low dose (30Gy) involved node radiotherapy. At the end of chemotherapy, radiotherapy is delivered only to patients who do not achieve a CR. Thus, therapy is tailored according to initial extension and disease responsiveness. Complete responders at the end of chemotherapy do not receive radiotherapy. To avoid radiotherapy in the majority of cases constitutes a principal goal of this trial. Stable or progressive disease at any moment is assumed as a trial failure and new therapeutic strategies are offered to these patients off protocol.

Chemotherapy is based upon regimes with well known effectiveness in Hodgkin lymphoma. (i.e. ABVD: doxorubicin, bleomycin, vinblastine and dacarbazine and ESHAP: Etoposide, methyl prednisolone, citarabine and cisplatin).

Low risk arms (Arms A, B and B2) receive no more than 4 cycles of ABVD. Intermediate risk Arm C, 5 cycles of ABVD and Arm D 4 cycles of ABVD and 2 courses of ESHAP. High risk Arm E receives 3 cycles of ABVD and 3 Cycles of ESHAP, Arm F receives 4 courses of ABVD and 4 courses of ESHAP. The schedules are delivered projecting low cumulative drug doses and avoiding the use of toxic alkylating agents. Risks of secondary leukemia and infertility are thus minimized. Doxorubicin and bleomycin do not achieve cumulative doses that may expose to significant risk of heart or lung damage. Radiotherapy reduction avoids late radiation sequels.

Cardiac, lung , thyroid and any other toxic effects are prospectively assessed at onset and regularly during and after therapy.

The main event-free and overall survival proportions end points will be analyzed annually during the following 10 years after the last patient registration.

This clinical study proposes a therapeutic approach based on chemotherapy that do not sum up high cumulative toxic doses. Therapy is tailored according to initial risk assessment and disease responsiveness. Those who achieve a complete response after chemotherapy do not receive additional radiotherapy, thus avoiding further late effects.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
    • CF
      • Buenos Aires, CF, Argentina, C1245AAL
        • Recruiting
        • Hospital JP Garrahan
        • Sub-Investigator:
          • Elizabeth Alfaro, MD
        • Sub-Investigator:
          • Myriam Guitter, MD
        • Sub-Investigator:
          • Cristian Sanchez La Rosa, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • María S Felice, MD
        • Sub-Investigator:
          • Magdalena Schelotto, MD
        • Principal Investigator:
          • Pedro A Zubizarreta, MD
        • Sub-Investigator:
          • Luisina Peruzzo, MD
        • Sub-Investigator:
          • Carla Pennella, MD
        • Sub-Investigator:
          • Carolina Romero, MD

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.

Eligibility Criteria

Ages Eligible for Study

7 months to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histopathological diagnosis of classical Hodgkin lymphoma.
  • Normal renal, hepatic, pulmonary and metabolic function standards.
  • Informed consent signed by patient and/or legal caretakers.

Exclusion Criteria:

  • Lymphocyte predominant nodular Hodgkin lymphoma
  • Any form of immunodeficiency before diagnosis. (primary immunodeficiencies, trasplant recipients or immunosuppressive therapies of any kind including corticoid therapies during 28 days before diagnosis).
  • Pregnancy and breastfeeding period.
  • Sexually active female patients who do not accept an effective contraceptive method during therapy.
  • Positive HIV serology.
  • Penfigus or hepatic ductopenia.
  • Hodgkin lymphoma as a secondary malignant disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A

Low risk with complete early response after two cycles of ABVD chemotherapy schedule. Only one more ABVD course is delivered.

No radiotherapy if CR at the end of chemotherapy.
Radiation: No radiotherapy if CR at the end of chemotherapy.
Adapted chemotherapy without radiotherapy
Drug: Low risk with complete early response after two cycles of ABVD chemotherapy schedule. Only one more ABVD course is delivered.
Low risk with complete early response after two cycles of ABVD chemotherapy schedule. Only one more ABVD course is delivered.
Experimental: Group B

Low risk with partial remission at early response assessment after two cycles of ABVD chemotherpay schedule. Two ABVD courses are delivered.

No radiotherapy if CR at the end of chemotherapy
Radiation: No radiotherapy if CR at the end of chemotherapy.
Adapted chemotherapy without radiotherapy
Drug: Low risk with partial remission at early response assessment after two cycles of ABVD chemotherpay schedule. Two ABVD courses are delivered.
Low risk with partial remission at early response assessment after two cycles of ABVD chemotherpay schedule. Two ABVD courses are delivered.
Experimental: Group B2

Low risk with partial remisssion after 4 cycles of ABVD chemotherapy schedule. Two ESHAP courses are delivered.

No radiotherapy if CR at the end of chemotherapy. IN 30Gy RT in case of PR at the end of chemotherapy
Radiation: No radiotherapy if CR at the end of chemotherapy.
Adapted chemotherapy without radiotherapy
Drug: Low risk with partial remisssion after 4 cycles of ABVD chemotherapy schedule. Two ESHAP courses are delivered.
Low risk with partial remission at early response assessment after two cycles of ABVD chemotherpay schedule. Two ABVD courses are delivered.
Radiation: IN 30Gy RT in case of PR at the end of chemotherapy
Low risk with partial remisssion after 4 cycles of ABVD and 2 ESHAP courses: IN 30Gy RT
Experimental: Group C

Intermediate risk with complete early response after two cycles of ABVD chemotherapy schedule. Three more ABVD courses are delivered.

No radiotherapy if CR at the end of chemotherapy.
Radiation: No radiotherapy if CR at the end of chemotherapy.
Adapted chemotherapy without radiotherapy
Drug: Intermediate risk with complete early response after two cycles of ABVD chemotherapy schedule. Three more ABVD courses are delivered.
Intermediate risk with complete early response after two cycles of ABVD chemotherapy schedule. Three more ABVD courses are delivered.
Experimental: Group D

Intermediate risk with partial remission after two cycles of ABVD chemotherapy schedule. Four more chemotherapy courses are delivered alternating ESHAP and ABVD.

No radiotherapy if CR at the end of chemotherapy. IN 30Gy RT in case of PR at the end of chemotherapy
Radiation: No radiotherapy if CR at the end of chemotherapy.
Adapted chemotherapy without radiotherapy
Radiation: IN 30Gy RT in case of PR at the end of chemotherapy
Low risk with partial remisssion after 4 cycles of ABVD and 2 ESHAP courses: IN 30Gy RT
Drug: Intermediate risk with partial remission after two cycles of ABVD chemotherapy schedule. Four more chemotherapy courses are delivered alternating ESHAP and ABVD.
Intermediate risk with partial remission after two cycles of ABVD chemotherapy schedule. Four more chemotherapy courses are delivered alternating ESHAP and ABVD.
Experimental: Group E

High risk with complete early response after 1 ABVD and 1 ESHAP courses. Four more chemotherapy courses are delivered alternating ESHAP and ABVD.

No radiotherapy if CR at the end of chemotherapy
Radiation: No radiotherapy if CR at the end of chemotherapy.
Adapted chemotherapy without radiotherapy
Drug: High risk with complete early response after 1 ABVD and 1 ESHAP courses. Four more chemotherapy courses are delivered alternating ESHAP and ABVD.
High risk with complete early response after 1 ABVD and 1 ESHAP courses. Four more chemotherapy courses are delivered alternating ESHAP and ABVD.
Experimental: Group F

High risk with partial remission after 1 ABVD and 1 ESHAP courses. Six more chemotherapy courses are delivered alternating ESHAP and ABVD.

No radiotherapy if CR at the end of chemotherapy. IN 30Gy RT in case of PR at the end of chemotherapy
Radiation: No radiotherapy if CR at the end of chemotherapy.
Adapted chemotherapy without radiotherapy
Radiation: IN 30Gy RT in case of PR at the end of chemotherapy
Low risk with partial remisssion after 4 cycles of ABVD and 2 ESHAP courses: IN 30Gy RT
Drug: High risk with partial remission after 1 ABVD and 1 ESHAP courses. Six more chemotherapy courses are delivered alternating ESHAP and ABVD.
High risk with partial remission after 1 ABVD and 1 ESHAP courses. Six more chemotherapy courses are delivered alternating ESHAP and ABVD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free Survival
Time Frame: 3-10 years
Event free survival probability (event= relapse or death)
3-10 years
Overall Survival
Time Frame: 3-10 years
Overall survival probability (event= death)
3-10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute, chronic or late toxic events
Time Frame: 0-10 years
Number of patientsexperiencing treatment-related adverse effects and mortality according to CTCAE v4.0
0-10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital JP Garrahan

Collaborators

Hospital Pereyra Rosell, Montevideo, Uruguay

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

October 6, 2017

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2032

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 991 Hodgkin Lymphoma GALOP2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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