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

Phase 2

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy

• Registration Number: NCT03383406
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2017-10-30
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-22
• Last Update Submitted: 2017-12-22
• Study First Posted: 2017-12-26
• Last Update Posted: 2017-12-26
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
I Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM)	Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy	-

Primary Outcome Measures

Name	Time	Method
Response	2 to 3 weeks after completion of the 2nd cycle of treatment (each cycle is 28 days)	CT, PET-CT(positron emission computed tomography )

Secondary Outcome Measures

Name	Time	Method
Assess response rate	Afer 2years completion of the treatment up to 3years	CT, PET-CT