Clinical trial NCT03383406: A Phase II Trial of Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy for Refractory or Relapsed Diffuse Large B Cell Lymphoma
Official title: A Phase II Trial of Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy for Refractory or Relapsed Diffuse Large B Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Response
timeFrame: 2 to 3 weeks after completion of the 2nd cycle of treatment (each cycle is 28 days)
Secondary outcomes:
measure: Assess response rate
timeFrame: 4 to 5 weeks after completion of the 4th cycle of treatment(each cycle is 28 days)
measure: Assess response rate
timeFrame: 6 to 8 weeks after completion of the 6th cycle of treatment(each cycle is 28 days)
measure: Assess response rate
timeFrame: After completion of the treatment, up to 24weeks
measure: Assess response rate
timeFrame: After 1year completion of the treatment up to 1year
measure: Assess response rate
timeFrame: Afer 2years completion of the treatment up to 3years
Other outcomes:
measure: Assess overall survival
timeFrame: The time from the 1st day of treatment to death of any cause or the date of last follow-up, assessed up to 66 months
Locations:
Study officials:
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