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

Asan Medical Center

Status and phase

Invitation-only

Phase 2

Conditions

Diffuse Large B Cell Lymphoma

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03383406

AsanMC_LMP2017-001

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

19 to 60 years old

Volunteers

No Healthy Volunteers

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.