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

Primary Purpose

Diffuse Large B Cell Lymphoma

Status

Enrolling by invitation

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Outcomes

Primary Outcome Measures

Response

CT, PET-CT(positron emission computed tomography )

Secondary Outcome Measures

Assess response rate

CT, PET-CT

Assess response rate

CT, PET-CT

Assess response rate

CT, PET-CT

Assess response rate

CT, PET-CT

Assess response rate

CT, PET-CT

Full Information

NCT ID

NCT03383406

First Posted

October 30, 2017

Last Updated

December 22, 2017

Sponsor

Asan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03383406

Brief Title

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

Acronym

IVAM

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

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Enrolling by invitation

Study Start Date

December 1, 2016 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diffuse Large B Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

IVAM

Intervention Description

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.

Primary Outcome Measure Information:

Title

Response

Description

CT, PET-CT(positron emission computed tomography )

Time Frame

2 to 3 weeks after completion of the 2nd cycle of treatment (each cycle is 28 days)

Secondary Outcome Measure Information:

Title

Assess response rate

Description

CT, PET-CT

Time Frame

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

Title

Assess response rate

Description

CT, PET-CT

Time Frame

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

Title

Assess response rate

Description

CT, PET-CT

Time Frame

After completion of the treatment, up to 24weeks

Title

Assess response rate

Description

CT, PET-CT

Time Frame

After 1year completion of the treatment up to 1year

Title

Assess response rate

Description

CT, PET-CT

Time Frame

Afer 2years completion of the treatment up to 3years

Other Pre-specified Outcome Measures:

Title

Assess overall survival

Description

CT, PET-CT

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

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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