Clinical trial · Interventional
A Phase II Trial of Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy for Refractory or Relapsed Diffuse Large B Cell Lymphoma
NCT03383406CI-TRIAL-00030913IVAMunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A phase II trial of ifosfamide, etoposide, cytarabine, and methotrexate (IVAM) chemotherapy for refractory or relapsed diffuse large B cell lymphoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- I Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM)
- interventionNames
- Drug: Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy
Primary outcomes (1)
- measure
- Response
- timeFrame
- 2 to 3 weeks after completion of the 2nd cycle of treatment (each cycle is 28 days)
- description
- CT, PET-CT(positron emission computed tomography )
Secondary outcomes (5)
- measure
- Assess response rate
- timeFrame
- 4 to 5 weeks after completion of the 4th cycle of treatment(each cycle is 28 days)
- description
- CT, PET-CT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.