Peripheral T-cell LymphomaPhase 2NCT02445404
Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated PTCL
A Phase 2 study testing CHOP and fractionated ICED in people with Peripheral T-cell Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study is a Randomized Phase II Study to Compare Efficacy of CHOP versus Fractionated ICED in Transplant-eligible Patients with Previously Untreated Peripheral T-cell Lymphoma. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Peripheral T-cell Lymphoma
- What is being tested?
- CHOP and fractionated ICED
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Sep 2015to 30 Jun 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-65 years
- Informed consent
- Subject able to adhere to the study visit schedule and other protocol requirements.
- Histologically proven Peripheral T-cell Lymphoma,No prior chemotherapy for the treatment of Peripheral T-cell Lymphoma It includes the following subtypes.
- PTCL, not otherwise specified
- Angioimmunoblastic T-cell lymphoma
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- Anaplastic large cell lymphoma, ALK-negative type
- Enteropathy-associated T-cell lymphoma
- Hepato-splenic T-cell lymphoma
- Subcutaneous panniculitis-like T-cell lymphoma
- Primary cutaneous gamma-delta T-cell lymphoma
- Primary cutaneous CD8+ aggressive epidermotropic lymphoma
- Other non classifiable T-cell Lymphoma
- Performance status (ECOG) 0,1 or 2
- A negative pregnancy test prior to treatment must be available both for pre-menopausal women
- Female of childbearing potential (FCBP) must: contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on IP; and for 3 months following the last dose of IP.Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 3 months following IP discontinuation.
- life expectancy≥90day(3months)
Who cannot join
- Other serious medical illnesses or psychiatric disorders
- Any state that the confusion in the interpretation of test result.
- Other type lymphoma ex) B-cell lymphoma
- Other type T-cell lymphoma
- Adult T-Cell Leukemia/Lymphoma
- NK/T-cell Lymphoma, Nasal Type
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- ALK-Positive Anaplastic Large-Cell Lymphoma
- Cutaneous Tcell lymphoma
- primary cutaneous CD30+ lympho- proliferative disorder
- primary cutaneous Anaplastic T cell lymphoma
- Previously treated for PTCL(Except for a short period before randomization of corticosteroids (a period of not more than 8 days)
- Previous radiation therapy
- CNS involvement.
- If the contraindication to chemoherapy
- Subject has known historical or active infection with HIV.
- BM function: ANC < 1.5 × 109/L; Platelet count <100,000/mm2 (100 × 109/L), SGOT/AST or SGPT/ALT ≥ 3.0 x ULN, Bilirubin> 2 x upper normal value
- serum creatinine level > 2.0 x ULN
- Any other malignancies within the past 3 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
- MUGA scan <45%
- Those who administered doxorubicin exceeding 200 mg / m2
- Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Breast-feeding or pregnant female
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul, Korea, Republic of, 135-710
Won Seog Kim, M.D, Ph. D, 234106548 ext. 82, wskimsmc@skku.edu
Seok Jin Kim, M.D,Ph. D, 234101766 ext. 82, kstwoh@skku.edu
About this study
Official title: Randomized Phase II Study to Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated Peripheral T-cell Lymphoma
This study is a Randomized Phase II Study to Compare Efficacy of CHOP versus Fractionated ICED in Transplant-eligible Patients with Previously Untreated Peripheral T-cell Lymphoma.
Read the detailed description
It recommends that the CHOP regimen in the primary T-cell lymphoma therapies currently used but did not get satisfactory effect of therapy (progression-free survival 40%), primarily to consider the clinical trial at NCCN guideline.But why the CHOP regimen is widely used because physicians are accustomed to use. Fractionated ICED therapy is a therapy by adjusting the Original ICE regimen.This is how the capacity of Ifosfamide divided into three days. (Fractionated ifosfamide).Original ICE therapy has been widely used as a salvage therapy of patients with relapsed or refractory lymphoma for a long time, it has been recommended as part of primary therapy of T-cell lymphoma.But Fractionated ICED is added to dexamethasone therapy in order to improve the effectiveness as a primary therapy.The recurrent lymphoma in 75 patients with treatment after Fractionated ICE when the self-stem cell transplantation, showed a more than 40% progression-free survival.Thus treatment of Fractionated ICED targeting previously untreated patients, and if a combination of high-dose dexamethasone to expect to be able to induce a progression-free survival of 60% or more.
- Conditions
- Peripheral T-cell Lymphoma
- Being tested
- CHOP, fractionated ICED
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHOPDrug
Also called cyclophosphamide, cyclophosphamide, vincristine,prednisone
cyclophosphamide, 750mg/m² IV day1 doxorubicin, 50 mg/m² IV day1 vincristine, 1.4 mg/m² (max 2 mg) IV day1 prednisone ,40 mg/m² PO day1~5 every 3 weeks
fractionated ICEDDrug
Also called ifosfamide, carboplatin, etoposide, dexamethasone
ifosfamide, 1.67 g/m² IV day1~3 carboplatin, AUC =5 IV day1 etoposide, 100mg/m² IV day1~3 dexamethasone 40 mg PO or IV day1~4 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| CHOP | Active comparator | cyclophosphamide, 750mg/m² IV day1 doxorubicin, 50 mg/m² IV day1 vincristine, 1.4 mg/m² (max 2 mg) IV day1 prednisone ,40 mg/m² PO day1~5 every 3 weeks Receives: Drug: CHOP; Drug: fractionated ICED |
| Fractionated ICED | Experimental | ifosfamide, 1.67 g/m² IV day1~3 carboplatin, AUC =5 IV day1 etoposide, 100mg/m² IV day1~3 dexamethasone 40 mg PO or IV day1~4 every 3 weeks Receives: Drug: CHOP; Drug: fractionated ICED |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
Time to disease progression is defined as the time from treatment start to the first recording of relapse or disease progression or death of any cause
Measured: 3 years
Secondary outcomes (4)
Overall survival
Duration of survival is defined as the time from treatment start to death of any cause or the date of last follow-up. Subjects who are alive will be censored using the date at which they are last known to be alive
Measured: 3 years
overall response rate
They should be classified as complete remission(CR),Partial remission(PR),Stable disease(SD), or progression disease(PD)according to the Revised Response Criteria for Malignant Lymphoma
Measured: 3 years
Response duration
Measured: 3 years
Toxicity profiles
Toxicity profiles as measured by Adverse Events and Laboratory results.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study start23 Sep 2015
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Samsung 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- Won Seog Kim, MD,Ph.D., Principal investigator, Samsung Medical Center,Seoul,Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445404
- Sponsor's protocol ID
- 2014-12-011
- Status last verified
- Oct 2020
- First submitted
- 12 May 2015
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study to Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT02445404
- Acronym / sponsor ID
- 2014-12-011
- Conditions
- Peripheral T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 23 Sep 2015 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 15 May 2015 (estimated)
- 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.
This study is a Randomized Phase II Study to Compare Efficacy of CHOP versus Fractionated ICED in Transplant-eligible Patients with Previously Untreated Peripheral T-cell Lymphoma.
Detailed description
It recommends that the CHOP regimen in the primary T-cell lymphoma therapies currently used but did not get satisfactory effect of therapy (progression-free survival 40%), primarily to consider the clinical trial at NCCN guideline.But why the CHOP regimen is widely used because physicians are accustomed to use. Fractionated ICED therapy is a therapy by adjusting the Original ICE regimen.This is how the capacity of Ifosfamide divided into three days. (Fractionated ifosfamide).Original ICE therapy has been widely used as a salvage therapy of patients with relapsed or refractory lymphoma for a long time, it has been recommended as part of primary therapy of T-cell lymphoma.But Fractionated ICED is added to dexamethasone therapy in order to improve the effectiveness as a primary therapy.The recurrent lymphoma in 75 patients with treatment after Fractionated ICE when the self-stem cell transplantation, showed a more than 40% progression-free survival.Thus treatment of Fractionated ICED targeting previously untreated patients, and if a combination of high-dose dexamethasone to expect to be able to induce a progression-free survival of 60% or more.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHOP | Active comparator | Drug: CHOP, Drug: fractionated ICEDcyclophosphamide, 750mg/m² IV day1 doxorubicin, 50 mg/m² IV day1 vincristine, 1.4 mg/m² (max 2 mg) IV day1 prednisone ,40 mg/m² PO day1~5 every 3 weeks |
| Fractionated ICED | Experimental | Drug: CHOP, Drug: fractionated ICEDifosfamide, 1.67 g/m² IV day1~3 carboplatin, AUC =5 IV day1 etoposide, 100mg/m² IV day1~3 dexamethasone 40 mg PO or IV day1~4 every 3 weeks |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age 19-65 years
- Informed consent
- Subject able to adhere to the study visit schedule and other protocol requirements.
- Histologically proven Peripheral T-cell Lymphoma,No prior chemotherapy for the treatment of Peripheral T-cell Lymphoma It includes the following subtypes.
- Performance status (ECOG) 0,1 or 2
Key exclusion criteria (22 listed)
- Other serious medical illnesses or psychiatric disorders
- Any state that the confusion in the interpretation of test result.
- Other type lymphoma ex) B-cell lymphoma
- Other type T-cell lymphoma
- Previously treated for PTCL(Except for a short period before randomization of corticosteroids (a period of not more than 8 days)
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 |
|---|---|---|
| CHOPAlso: cyclophosphamide, cyclophosphamide, vincristine,prednisonecyclophosphamide, 750mg/m² IV day1 doxorubicin, 50 mg/m² IV day1 vincristine, 1.4 mg/m² (max 2 mg) IV day1 prednisone ,40 mg/m² PO day1~5 every 3 weeks | Drug | CHOP, Fractionated ICED |
| fractionated ICEDAlso: ifosfamide, carboplatin, etoposide, dexamethasoneifosfamide, 1.67 g/m² IV day1~3 carboplatin, AUC =5 IV day1 etoposide, 100mg/m² IV day1~3 dexamethasone 40 mg PO or IV day1~4 every 3 weeks | Drug | CHOP, Fractionated ICED |
Primary outcome
progression free survival
Time frame: 3 years
Time to disease progression is defined as the time from treatment start to the first recording of relapse or disease progression or death of any cause
4 secondary outcomes
Overall survival
Time frame: 3 years
overall response rate
Time frame: 3 years
Response duration
Time frame: 3 years
Toxicity profiles
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- 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.
Won Seog Kim, MD,Ph.D. principal investigator
Samsung Medical Center,Seoul,Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHOP and fractionated ICED in people with Peripheral T-cell Lymphoma, run by Samsung Medical Center at 1 site in South Korea.
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 17 inclusion and 22 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Won Seog Kim, MD,Ph.D. (234106548 ext. 82, wskimsmc@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 3 years). 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 22 Oct 2020.