Status:
UNKNOWN
A Phase II Trial of Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy for Refractory or Relapsed Diffuse Large B Cell Lymphoma
Lead Sponsor:
Asan Medical Center
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
19-60 years
Phase:
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03383406
Start Date
December 1 2016
End Date
December 31 2025
Last Update
December 26 2017
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