A Phase II Trial of Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy for Refractory or Relapsed Diffuse Large B Cell Lymphoma

• Status: Enrolling by invitation
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A phase II trial of ifosfamide, etoposide, cytarabine, and methotrexate (IVAM) chemotherapy for refractory or relapsed diffuse large B cell lymphoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Cytarabine; Etoposide; Ifosfamide; Methotrexate

Criteria

Inclusion Criteria:

• Written informed consent

• Histologically confirmed adult patients diagnosed with DLBCL refractory or relapsed.

• Large scale B cell lymphoma not received ASCT(autologous stem-cell transplantation ) after primary chemotherapy

• At least one measurable lesion

• ≥1 cm in greatest transverse diameter by spiral CT

• ≥2 cm in greatest transverse diameter by conventional CT

• ≥1 cm in visible skin lesion

• ≥2 cm in digital exploration

• Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.

• Age 19~59yrs

• MUGA(multiple gated acquisition scan ): Non-Clinical significant and 2D-Echo( Cardiac Index ≥ 50 % )

• Adequate renal function: serum creatinine level < 2.0 mg/dL(177μmol/L) Adequate liver functions: Transaminase (AST/ALT) < 3 X upper limit of normal value (or < 5 x ULN in the presence of DLBCL involvement of the liver), bilirubin < 2 X upper normal value (or < 5 x upper limit of normal in the presence of DLBCL involvement of the liver)

• Adequate hematological function: hemoglobin ≥ 9.0 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL,

• A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are < 1 years after the onset of menopause.

Exclusion Criteria:

• Pre-treatment for ASCT

• Central nervous system (CNS) involvement by lymphoma

• Prior history of malignancies other than lymphoma (except for treated Non Melanoma Skin Cancer, early gastric cancer or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 5 years

• Pregnant or lactating woman, Childbearing potential not employing adequate contraception

• Active uncontrolled infections(Bacterial, Viral, Fungus)

• Other serious illness or medical conditions

• Other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.