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

NCT03383406 | Unknown Phase 2 DMC

• 1 other identifier: AsanMC_LMP2017-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assess response rate

  4 to 5 weeks after completion of the 4th cycle of treatment(each cycle is 28 days)

• Assess response rate

  6 to 8 weeks after completion of the 6th cycle of treatment(each cycle is 28 days)

• Assess response rate

  After completion of the treatment, up to 24weeks

• Assess response rate

  After 1year completion of the treatment up to 1year

• Assess response rate

  Afer 2years completion of the treatment up to 3years

Other Outcomes (1)

• Assess overall survival

  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

Study Arms (1)

I Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM)

EXPERIMENTAL

Drug: Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy

Interventions

Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy DRUG

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.

Also known as: IVAM

I Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM)

Eligibility Criteria

• Age: 19 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Ifosfamide; Etoposide; Cytarabine; Methotrexate; Drug Therapy

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: December 26, 2017
• Study Start: December 1, 2016
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 26, 2017

Record last verified: 2017-12