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

NCT ID: NCT03383406

Last Updated: 2017-12-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2025-12-31

Brief Summary

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

Detailed Description

Diffuse Large B-Cell lymphoma is currently used as a standard treatment, with a combination of chemotherapy (R-CHOP), which includes Rituximab. However, the survival rate is very poor if the primary treatment is refractory or relapsed within a year or less. The duration of these patients ' lives is around one year and the five-year survival rate is 15-20 %. Thus, a new treatment strategy is needed to improve the survival of the patient with DLBCL, which are either refractory and relapsed.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM)

Group Type: EXPERIMENTAL

Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy

Intervention Type: DRUG

Every cycle(4weeks)

Subject will receive Ifosfamide 1.5 g/m2 over 2 hours for Day1~Day5 by Intravenous infusion, Etoposide 150 mg/m2 over 3 hours on Day1~Day3 by Intravenous infusion, Cytarabine 100 mg/m2 over 1 hour on Day1~Day3 by Intravenous infusion.

Interventions

Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy

Every cycle(4weeks)

Subject will receive Ifosfamide 1.5 g/m2 over 2 hours for Day1~Day5 by Intravenous infusion, Etoposide 150 mg/m2 over 3 hours on Day1~Day3 by Intravenous infusion, Cytarabine 100 mg/m2 over 1 hour on Day1~Day3 by Intravenous infusion.

Intervention Type: DRUG

Other Intervention Names

IVAM

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Cheolwon Suh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AsanMC_LMP2017-001

Identifier Type: -

Identifier Source: org_study_id