JCOG2210: High dose therapy with autologous stem cell transplantation versus observation for patients with newly diagnosed peripheral T-cell lymphoma who achieved complete metabolic response after induction therapy, a multicenter, randomized, phase III study

JRCT ID: jRCTs031240169

Registered date:18/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Peripheral T-cell lymphoma with complete metabolic response after induction chemotherapy
• Date of first enrollment: 18/06/2024
• Target sample size: 140
• Study type: Interventional

Intervention(s)

Induction chemotherapy after primary registration
CD30 positive: BV+CHP (Brentuximab Vedotin 1.8 mg/kg day1, Cyclophosphamide 750 mg/m2 day1, Doxorubicin 50 mg/m2 day1, Prednisolone 100 mg/body day1 to 5) is administered 6 courses.
CD30 negative: CHOP (Cyclophosphamide 750 mg/m2 day1, Doxorubicin 50 mg/m2 day1, Vincristine 1.4 mg/m2 day1, Prednisolone100 mg/body day1 to 5) is administered 6 courses.

Treatment after secondary registration
Arm A: Observation alone
Arm B: Autologous peripheral stem cell harvesting (Filgrastim 300 ug/m2 or Lenograstim 5 ug/kg day 1 to 4 or 5, Plerixafor 0.24mg/kg day 4)
LEED with autologous peripheral stem cell transplantation (Melphalan 130 mg/m2 day -1, Cyclophosphamide 60 mg/kg days -4 to -3, Mesna 72mg /kg days -4 to -3, Etoposide 500 mg/m2 days -4 to -2, Dexamethasone 40 mg/body days -4 to -1, Autologous peripheral stem cell transplantation day 0, Filgrastim 300 ug/m2 or Lenograstim 5 ug/kg day 1 to) is administered.

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Overall survival, complete metabolic response rate after induction chemotherapy, adverse events, serious adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

Primary registration criteria
(1) Pathologically proven peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), follicular T-cell lymphoma (FTCL), nodal peripheral T-cell lymphoma with T follicular helper cell phenotype (nPTCL with TFH phenotype), or anaplastic large cell lymphoma ALK-negative type (ALK-negative ALCL).
(2) Confirmed CD30 positive or negative.
(3) Aged 18 to 65 years old at primary registration
(4) ECOG performance status of 0 to 2.
(5) Presence of clear FDG uptake in lesions on FDG-PET/CT.
(6) No prior treatment of chemotherapy, radiotherapy, or antibody therapy for peripheral T-cell lymphoma.
(7) No central nervous system involvement on clinical diagnosis.
(8) Sufficient organ function
(i) Neutrophil >= 1,000/mm3 (>= 500/mm3 in patients with bone marrow invasion of lymphoma)
(ii) Hb >= 8.0 g/dL
(iii) Platelet >= 75,000/mm3 (>= 50,000/mm3 in patients with bone marrow invasion of lymphoma)
(iv) T.Bil <= 2.0mg/dL
(v) AST <= 150U/L.
(vi) ALT <= 150U/L.
(vii) CCr >= 30mL/min
(viii) SpO2 >= 93% (room air).
(9) Sufficient cardiac function.
(i) No ischemic changes, atrial fibrillation, or ventricular arrhythmias requiring treatment on the latest ECG.
(ii) LVEF >= 50% on echocardiography.
(10) Written informed consent.

Secondary registration criteria
(1) Primary registration of this trial.
(2) Following (i) or (ii) is fulfilled.
(i) Completion of 6 courses of CHOP or BV+CHP and complete metabolic response on FDG-PET/CT.
(ii) Completion of 4 or 5 courses of CHOP or BV+CHP due to difficulty in continuation arising from adverse events and complete metabolic response on FDG-PET/CT.
(3) No grade 2 or higher non-hematologic toxicity except for grade 2 or 3 peripheral sensory neuropathy and grade 2 peripheral motor neuropathy.
(4) Sufficient cardiac function
(i) No ischemic changes, atrial fibrillation, or ventricular arrhythmias requiring treatment on the latest ECG.
(ii) LVEF >= 50% on echocardiography.
(5) ECOG performance status of 0 to 2.
(6) Sufficient organ function
(i) Neutrophil >= 1,000/mm3
(ii) Hb >= 8.0 g/dL
(iii) Platelet >= 75,000/mm3
(iv) T.Bil <= 2.0mg/dL
(v) AST <= 100U/L.
(vi) ALT <= 100U/L.
(vii) CCr >= 30mL/min
(viii) SpO2 >= 93% (room air).
(7) Within 22 to 56 days from the start date of the final course of CHOP or BV+CHP.

Exclude criteria

(1) Synchronous or metachronous (within 5 years) malignancies.
(2) Infectious disease requiring systemic treatment.
(3) Female during pregnancy, within 28 days of postparturition, or during lactation. Males with partners planning conception shortly.
(4) Severe psychological disorder difficult to participate in this clinical study.
(5) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
(6) Uncontrollable diabetes mellitus.
(7) Uncontrollable hypertension.
(8) Unstable angina pectoris, or history of myocardial infarction within 6 months.
(9) Uncontrollable valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
(10) Positive HBs antigen or HCV antibody.
(11) Positive HIV antibody.
(12) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema based on chest CT.

Related Information

• Primary Sponsor: ISHITSUKA Kenji
• Source(s) of Monetary Support: National Cancer Center Japan