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Peripheral T-cell LymphomaPhase 1NCT02809573

Clinical Trial of Chidamide Combined With CHOP in Peripheral T-cell Lymphoma Patients

A Phase 1 study testing Chidamide, cyclophosphamide and adriacin in people with Peripheral T-cell Lymphoma, run by Chipscreen Biosciences, Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this dose-escalation study is to assess the safety and tolerability of treatment with Chidamide in a range of doses combined with CHOP in fixed dose in patients with newly diagnosed peripheral T-cell lymphoma. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Peripheral T-cell Lymphoma
What is being tested?
Chidamide, cyclophosphamide and adriacin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
11 Aug 2016to 8 Jan 2019
Phase
Phase 1
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

  • Male and female aged 18-65 years old;
  • Histopathologically confirmed Peripheral T -cell Lymphoma (PTCL) including:
  • PTCL-unspecified;
  • Angioimmunoblastic T-cell lymphoma;
  • Anaplastic large cell lymphoma, ALK positive or negative;
  • Subcutaneous panniculitis T-cell lymphoma;
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  • Cutaneous / T-cell lymphoma;
  • Other T-cell lymphoma that investigators consider to be appropriate to be enrolled;
  • Patients have not received anti-tumor therapy;
  • In any Ann Arbor disease stage;
  • ECOG performance status 0-1;
  • Patients without bone marrow involvement. The absolute number of neutrophile is no less then 2.0 * 10^9/L, platelet no less then 100 * 10^9/L. And the concentration of hemoglobin is no less than 110 g/L;
  • Life expectancy is no less than 6 months;
  • Patients who have signed the Informed Consent Form.

Who cannot join

  • Patients who have central nervous system or meninges involvements;
  • Patients have been treated by radiotherapy, chemotherapy or immunotherapy for PTCL;
  • Patients have uncontrollable or significant cardiovascular disease including:
  • history of myocardial infarction;
  • uncontrollable angina within the 6 months before screening, or taking anti-angina drugs at the time of screening;
  • history of congestive heart failure, or the left ventricular ejection fraction (LVEF) is < 50% at the time of screening;
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  • clinically significant ventricular arrhythmia such as ventricular tachycardia, ventricular fibrillation or torsades de pointes;
  • History of supraventricular arrhythmia or nodal arrhythmia that could not been controlled by drug or need a pacemaker;
  • History of cardiomyopathy;
  • History of clinically significant QTc interval prolongation, or QTc interval > 450 ms at screening;
  • Coronary disease which is with symptoms and needs drug therapy;
  • Patients have undergone organ transplantation;
  • Patients with thromboembolic disease, hematencephalon or cerebral infraction within 4 weeks before screening, or patients who are under anticoagulant therapy;
  • Patients with clinically significant abnormalities in gastrointestinal tract, such as dysphagia, chronic diarrhea and intestinal obstruction which may affect the uptake,transformation and absorption of the drug;
  • Patients with active infections, including active bacterial,viral,fungoid, mycobacterium, parasite infections (but not including hyponychium fungoid infection), or infections which need not be treated by intravenous antibody therapies, or antiviral therapies, or any serious infection need to be treated by hospitalization;
  • Patients who have been conducted the surgery on a major organ in less than 6 weeks;
  • Hepatic function: Serum total bilirubin > 1.5 fold of normal range; ALT/AST > 2.5 folds of normal range or 5 folds for liver metastasis; Renal function: Serum creatine > 1.5 folds of normal range;
  • Patients with other malignancies in the past or now (except basal cell carcinoma, squamous-cell carcinoma or carcinoma in situs of cervix that has been adequately treated),unless the malignancy has been radically treated and there has been no evidence of recurrence for 5 years;
  • Pregnant or lactating women and patients in childbearing age who will not carry out birth control;
  • Patients with mental disorders, which may affect understanding and execution of informed consent or the compliance of the study;
  • Drug abuse or long term alcoholism that could affect the evaluation for the study results;
  • Patients considered by investigators not suitable for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

Official title: An Open-label, Multi-center, Phase Ib Clinical Trial of Chidamide Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphoma Patients

The purpose of this dose-escalation study is to assess the safety and tolerability of treatment with Chidamide in a range of doses combined with CHOP in fixed dose in patients with newly diagnosed peripheral T-cell lymphoma.

Read the detailed description

The purpose of this study is to assess the tolerability and safety include adverse events, vital signs, laboratory tests, etc., of a range of doses of chidamide combined with CHOP in peripheral T-cell lymphoma patients, and to determine the dose limit toxicity and the maximum tolerable dose.

Being tested
Chidamide, cyclophosphamide, adriacin, vincristine, prednisone
Keywords
peripheral T-cell lymphoma, PTCL, chidamide, CHOP, phase Ib
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.

  • ChidamideDrug

    Also called CS055

    In the lead-in period, patients take a single dose of Chidamide tablet on the first day and then off for 3 days before the first cycle begins. In the subsequent treatment cycles, Chidamide tablets are given orally on Day 1,4,8 and 11 of each cycle.

  • cyclophosphamideDrug

    Also called CTX

    On Day 1, cyclophosphamide is given in a 20-minute intravenous (IV) infusion at 750 mg/m^2 in 5 minutes after chidamide administration

  • adriacinDrug

    Also called ADR

    On Day 1, Adriacin is given in a 20-minute IV infusion at 50 mg/m^2 soon after cyclophosphamide administration.

  • vincristineDrug

    Also called VCR

    On Day 1, vincristine is given in IV infusion at 1.4 mg/m^2 after adriacin administration.

  • prednisoneDrug

    Also called PED

    On Day 1 to 5, prednisone is given orally at 100 mg once a day

Study groups in NCT02809573
Study groupRoleWhat they receive
study drugsExperimentalLead-in period is 4 days. Patients take a single dose of Chidamide tablet, then off for 3 days before the first cycle begins. In the subsequent treatment cycles, Chidamide tablets are given orally on Day 1,4,8 and 11 of each cycle. Cyclophosphamide, adriacin and vincristine are given in intravenous infusion on Day 1. On Day 1 to 5, prednisone is given orally. Treatment cycles are repeated every 3 weeks .The combination therapy lasts for at most 6 cycles. Patients enter the single agent therapy if attained complete response after 6-cycle combination therapy. In this stage, patients take chidamide orally on Day 1, 4, 8 and 11 of each cycle.
Receives: Drug: Chidamide; Drug: cyclophosphamide; Drug: adriacin; Drug: vincristine; Drug: prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. dose-limiting toxicity (DLT)

    Measured: Day 1 - 21

Secondary outcomes (9)

  1. Adverse events

    Measured: About 21 weeks

  2. complete response rate

    Measured: About 21 weeks

  3. Duration of response

    Measured: About 21 weeks

  4. Progression free survival

    Measured: About 21 weeks

  5. Objective response rate

    Measured: About 21 weeks

  6. Overall survival

    Measured: About 21 weeks

  7. Area under the concentration versus time curve (AUC)

    Measured: Day 1 of the lead-in period and Day 1 of the combination therapy

  8. Peak plasma concentration (Cmax)

    Measured: Day 1 of the lead-in period and Day 1 of the combination therapy

  9. Time of Cmax (Tmax)

    Measured: Day 1 of the lead-in period and Day 1 of the combination therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2016 (estimated)
  2. Study start11 Aug 2016
  3. Primary completion8 Jan 2019
  4. Study completion8 Jan 2019

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02809573
Sponsor's protocol ID
CDM103
Status last verified
Jul 2019
First submitted
17 Jun 2016
Last updated
24 Jul 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Chidamide, cyclophosphamide and adriacin in people with Peripheral T-cell Lymphoma, run by Chipscreen Biosciences, Ltd. 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 14 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: finished, as of the sponsor's last update on 24 Jul 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

dose-limiting toxicity (DLT) (time frame: Day 1 - 21). 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 NCT02809573.

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 24 Jul 2019.

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