Diffuse Large B Cell LymphomaPhase 2IVAMNCT03383406
A Phase II Trial of Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy for Refractory or Relapsed Diffuse Large B Cell Lymphoma
A Phase 2 study testing Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy in people with Diffuse Large B Cell Lymphoma, run by Asan Medical Center.
Trial summary
A phase II trial of ifosfamide, etoposide, cytarabine, and methotrexate (IVAM) chemotherapy for refractory or relapsed diffuse large B cell lymphoma Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 14Show fewer
- ≥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.
Who cannot join
- 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.
About this study
A phase II trial of ifosfamide, etoposide, cytarabine, and methotrexate (IVAM) chemotherapy for refractory or relapsed diffuse large B cell lymphoma
Read the 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.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) ChemotherapyDrug
Also called IVAM
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.
| Study group | Role | What they receive |
|---|---|---|
| I Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) | Experimental | Not described Receives: Drug: Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
CT, PET-CT(positron emission computed tomography )
Measured: 2 to 3 weeks after completion of the 2nd cycle of treatment (each cycle is 28 days)
Secondary outcomes (5)
Assess response rate
CT, PET-CT
Measured: 4 to 5 weeks after completion of the 4th cycle of treatment(each cycle is 28 days)
Assess response rate
CT, PET-CT
Measured: 6 to 8 weeks after completion of the 6th cycle of treatment(each cycle is 28 days)
Assess response rate
CT, PET-CT
Measured: After completion of the treatment, up to 24weeks
Assess response rate
CT, PET-CT
Measured: After 1year completion of the treatment up to 1year
Assess response rate
CT, PET-CT
Measured: Afer 2years completion of the treatment up to 3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Dec 2016
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheolwon Suh, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383406
- Sponsor's protocol ID
- AsanMC_LMP2017-001
- Acronym
- IVAM
- Status last verified
- Dec 2017
- First submitted
- 30 Oct 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy for Refractory or Relapsed Diffuse Large B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03383406
- Acronym / sponsor ID
- IVAM / AsanMC_LMP2017-001
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) | Experimental | Drug: Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) ChemotherapyAlso: IVAMEvery 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. | Drug | I Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) |
Primary outcome
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 )
5 secondary outcomes
Assess response rate
Time frame: 4 to 5 weeks after completion of the 4th cycle of treatment(each cycle is 28 days)
Assess response rate
Time frame: 6 to 8 weeks after completion of the 6th cycle of treatment(each cycle is 28 days)
Assess response rate
Time frame: After completion of the treatment, up to 24weeks
Assess response rate
Time frame: After 1year completion of the treatment up to 1year
Assess response rate
Time frame: Afer 2years completion of the treatment up to 3years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy in people with Diffuse Large B Cell Lymphoma, run by Asan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response (time frame: 2 to 3 weeks after completion of the 2nd cycle of treatment (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.