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Trial record 9 of 430 for:    ifosfamide

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

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ClinicalTrials.gov Identifier: NCT03383406
Recruitment Status : Enrolling by invitation
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Cheolwon Suh, 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

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy for Refractory or Relapsed Diffuse Large B Cell Lymphoma
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025


Arm Intervention/treatment
Experimental: I Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) 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.

Other Name: IVAM




Primary Outcome Measures :
  1. Response [ Time Frame: 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 :
  1. Assess response rate [ Time Frame: 4 to 5 weeks after completion of the 4th cycle of treatment(each cycle is 28 days) ]
    CT, PET-CT

  2. Assess response rate [ Time Frame: 6 to 8 weeks after completion of the 6th cycle of treatment(each cycle is 28 days) ]
    CT, PET-CT

  3. Assess response rate [ Time Frame: After completion of the treatment, up to 24weeks ]
    CT, PET-CT

  4. Assess response rate [ Time Frame: After 1year completion of the treatment up to 1year ]
    CT, PET-CT

  5. Assess response rate [ Time Frame: Afer 2years completion of the treatment up to 3years ]
    CT, PET-CT


Other Outcome Measures:
  1. Assess overall survival [ Time Frame: 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 ]
    CT, PET-CT



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Cheolwon Suh, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03383406     History of Changes
Other Study ID Numbers: AsanMC_LMP2017-001
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ifosfamide
Isophosphamide mustard
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Methotrexate
Cytarabine
Etoposide
Etoposide phosphate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents