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

Diffuse Large B Cell Lymphoma Clinical Trial

— IVAM  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03383406
• Other study ID #: AsanMC_LMP2017-001
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: October 30, 2017
• Last updated: December 22, 2017
• Start date: December 1, 2016
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy
Every cycle(4weeks) Subject will receive Ifosfamide 1.5 g/m2 over 2 hours for Day1~Day5 by Intravenous infusion, Etoposide 150 mg/m2 over 3 hours on Day1~Day3 by Intravenous infusion, Cytarabine 100 mg/m2 over 1 hour on Day1~Day3 by Intravenous infusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess overall survival	CT, PET-CT	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
Primary	Response	CT, PET-CT(positron emission computed tomography )	2 to 3 weeks after completion of the 2nd cycle of treatment (each cycle is 28 days)
Secondary	Assess response rate	CT, PET-CT	4 to 5 weeks after completion of the 4th cycle of treatment(each cycle is 28 days)
Secondary	Assess response rate	CT, PET-CT	6 to 8 weeks after completion of the 6th cycle of treatment(each cycle is 28 days)
Secondary	Assess response rate	CT, PET-CT	After completion of the treatment, up to 24weeks
Secondary	Assess response rate	CT, PET-CT	After 1year completion of the treatment up to 1year
Secondary	Assess response rate	CT, PET-CT	Afer 2years completion of the treatment up to 3years