Systemic Anaplastic Large-Cell LymphomaPhase 4NCT02487316
A Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
A Phase 4 study testing crizotinib in people with Systemic Anaplastic Large-Cell Lymphoma, run by Jun Zhu at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of crizotinib combined with CHOP chemotherapy for patients with ALK(+) Systemic Anaplastic Large Cell Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Anaplastic Large-Cell Lymphoma
- What is being tested?
- crizotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Dec 2017
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy without therapy
- ECOG 0-2
- more than 1 measurable lesions with major axis >1.5cm and minor axis>1.0cm
- estimated survival >/3months
- Age 18-65 years
- Women of childbearing age should have a negative pregnancy test; men and women who need to agree to use effective contraception during the period of treatment and the following 1 years
- Signature of informed consent
Who cannot join
- Age <\ 18years
- without ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy
- without measurable lesions
- being treated by other drugs in other clinical trials
- Pregnant or lactating women, who are not willing to take contraceptive measures during the study period, or are not willing to use effective contraceptive measures during the period of treatment and the following 1 years
- Hepatic insufficiency: serum total bilirubin, ALT more than 2 times higher than normal
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- Renal insufficiency: more than 2 times higher than that of normal serum creatinine
- Blood screening period: WBC < 1 * 109/L * 109/L; platelet < 25; Hb < 60g/L
- HIV test positive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Prospective Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
The purpose of this study is to determine the efficacy and safety of crizotinib combined with CHOP chemotherapy for patients with ALK(+) Systemic Anaplastic Large Cell Lymphoma.
Read the detailed description
ALK(+) Systemic Anaplastic Large Cell Lymphoma patients are treated with crizotinib when they receive CHOP chemotherapy. crizotinib 250mg twice a day is administrated from day 1 of chemotherapy to 18 weeks. standard CHOP chemotherapy (cyclophosphamide, 750mg per square meter of body-surface area,d1, vincristine, 1.4mg per square meter of body-surface area, maximal dose is 2mg d1, doxorubicin, 50mg per square meter of body-surface area d1, plus prednison, 100 mg d1-5) every 3 weeks for up to six cycles.
- Conditions
- Systemic Anaplastic Large-Cell Lymphoma
- Being tested
- crizotinib
- Keywords
- Anaplastic Large Cell Lymphoma, anaplastic lymphoma kinase rearrangement, crizotinib, CHOP chemotherapy
- Medical subject headings
- Lymphoma, Large-Cell, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crizotinibDrug
Also called CHOP chemotherapy
crizotinib 250mg, oral, bid from day 1 to 18 weeks. cyclophosphamide, 750mg/m2,d1, vincristine, 1.4mg/m2, maximal dose is 2mg d1, doxorubicin, 50mg/m2d1, prednison, 100 mg d1-5) every 3 weeks for up to six cycles.
| Study group | Role | What they receive |
|---|---|---|
| crizotinib combined with chemotherapy | Experimental | crizotinib 250mg, bid from day 1 to 18 weeks. cyclophosphamide, 750mg/m2,d1, vincristine, 1.4mg/m2, maximal dose is 2mg d1, doxorubicin, 50mg/m2d1, prednison, 100 mg d1-5) every 3 weeks for up to six cycles. Receives: Drug: crizotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
Measured: 2 years
Secondary outcomes (5)
disease-free survival
Measured: 2 years
overall survival
Measured: 2 years
objective response rate
Measured: 2 years
incidence of >/Grade 3 non-hematology toxicity adverse events
Measured: 2 years
QOL assessment
using a battery of cognitive and quality-of-life (QoL) measures
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Anaplastic Large-Cell LymphomaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Zhu
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Peking University People's Hospital, Peking University Third Hospital, Peking Union Medical College Hospital, Beijing Hospital, Chinese PLA General Hospital, First Hospitals affiliated to the China PLA General Hospital, Air Force General Hospital of the PLA, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Anhui Provincial Hospital, Zhejiang University
- Responsible party
- Sponsor-investigator, Jun Zhu, Peking University
- Investigators
- Jun Zhu, MD, Study chair, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487316
- Sponsor's protocol ID
- PKU-2015052005
- Status last verified
- Dec 2016
- First submitted
- 30 Jun 2015
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Boi M, Zucca E, Inghirami G, Bertoni F. Advances in understanding the pathogenesis of systemic anaplastic large cell lymphomas. Br J Haematol. 2015 Mar;168(6):771-83. doi: 10.1111/bjh.13265. Epub 2015 Jan 6.
PubMed 25559471
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study of Treatment ALK(+) Systemic Anaplastic Large Cell Lymphoma With Crizotinib
- ClinicalTrials.gov ID
- NCT02487316
- Acronym / sponsor ID
- PKU-2015052005
- Conditions
- Systemic Anaplastic Large-Cell Lymphoma
- Keywords
- Anaplastic Large Cell Lymphoma, anaplastic lymphoma kinase rearrangement, crizotinib, CHOP chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jun ZhuUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Peking University People's Hospital, Peking University Third Hospital, Peking Union Medical College Hospital, Beijing Hospital, Chinese PLA General Hospital, First Hospitals affiliated to the China PLA General Hospital, Air Force General Hospital of the PLA, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Anhui Provincial Hospital, Zhejiang University
- Study start
- Jul 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 Jul 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.
The purpose of this study is to determine the efficacy and safety of crizotinib combined with CHOP chemotherapy for patients with ALK(+) Systemic Anaplastic Large Cell Lymphoma.
Detailed description
ALK(+) Systemic Anaplastic Large Cell Lymphoma patients are treated with crizotinib when they receive CHOP chemotherapy. crizotinib 250mg twice a day is administrated from day 1 of chemotherapy to 18 weeks. standard CHOP chemotherapy (cyclophosphamide, 750mg per square meter of body-surface area,d1, vincristine, 1.4mg per square meter of body-surface area, maximal dose is 2mg d1, doxorubicin, 50mg per square meter of body-surface area d1, plus prednison, 100 mg d1-5) every 3 weeks for up to six cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| crizotinib combined with chemotherapy | Experimental | Drug: crizotinibcrizotinib 250mg, bid from day 1 to 18 weeks. cyclophosphamide, 750mg/m2,d1, vincristine, 1.4mg/m2, maximal dose is 2mg d1, doxorubicin, 50mg/m2d1, prednison, 100 mg d1-5) every 3 weeks for up to six cycles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- primary ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy without therapy
- ECOG 0-2
- more than 1 measurable lesions with major axis >1.5cm and minor axis>1.0cm
- estimated survival >/3months
- Age 18-65 years
Key exclusion criteria (9 listed)
- Age <\ 18years
- without ALK(+) systemic anaplastic large cell lymphoma histologically confirmed by biopsy
- without measurable lesions
- being treated by other drugs in other clinical trials
- Pregnant or lactating women, who are not willing to take contraceptive measures during the study period, or are not willing to use effective contraceptive measures during the period of treatment and the following 1 years
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 |
|---|---|---|
| crizotinibAlso: CHOP chemotherapycrizotinib 250mg, oral, bid from day 1 to 18 weeks. cyclophosphamide, 750mg/m2,d1, vincristine, 1.4mg/m2, maximal dose is 2mg d1, doxorubicin, 50mg/m2d1, prednison, 100 mg d1-5) every 3 weeks for up to six cycles. | Drug | crizotinib combined with chemotherapy |
Primary outcome
complete remission rate
Time frame: 2 years
5 secondary outcomes
disease-free survival
Time frame: 2 years
overall survival
Time frame: 2 years
objective response rate
Time frame: 2 years
incidence of >/Grade 3 non-hematology toxicity adverse events
Time frame: 2 years
QOL assessment
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Results publication: PubMed 25559471Boi M, Zucca E, Inghirami G, Bertoni F. Advances in understanding the pathogenesis of systemic anaplastic large cell lymphomas. Br J Haematol. 2015 Mar;168(6):771-83. doi: 10.1111/bjh.13265. Epub 2015 Jan 6.
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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.
Jun Zhu, MD study chair
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing crizotinib in people with Systemic Anaplastic Large-Cell Lymphoma, run by Jun Zhu at 1 site in China.
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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 30 Dec 2016. 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 China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
complete remission rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02487316, which also lists 1 linked publication.
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 30 Dec 2016.