PEG-ASP Etoposide and Gemcitabine for Natural Killer/T Lymphoma

  • STATUS
    Recruiting
  • End date
    Dec 29, 2021
  • participants needed
    35
  • sponsor
    Sun Yat-sen University
Updated on 29 January 2021

Summary

Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the efficacy and safety of pegylated aspargase(PEG-ASP)combined with etoposide and gemcitabine (PEG) treatment in this population.

Description

Treatment PEG dosages were as follows: days 1 and 8,30min intravenous infusion of 1000mg/m2 gemcitabine;day1,4h intravenous infusion of 100mg/m2 etoposide,day1-3,deep intramuscular injection of 2500unit/m2 PEG-ASP at three different sites.The regimen was repeated every 3 weeks.Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got complete remission ,partial regression or stable disease.Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved-field radiation (IFRT) dose was 50-56 Gy.Stage IIIE/IVE patients were given for a maximum of six cycles.Refractory/relapsed patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Autologous haematopoietic stem cell transplantation (AHSCT) was recommended after achieving CR for advanced stage and refractory/relapsed patients

Details
Condition Treatment Refusal
Treatment etoposide, Gemcitabine, Pegaspargase, Involved-field radiotherapy
Clinical Study IdentifierNCT02705508
SponsorSun Yat-sen University
Last Modified on29 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have Treatment Refusal?
Do you have any of these conditions: Do you have Treatment Refusal??
Do you have any of these conditions: Do you have Treatment Refusal??
Do you have any of these conditions: Do you have Treatment Refusal??
pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification
age18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
at least one measurable lesion
adequate haematologic function (haemoglobin > 9.0 g/l, absolute neutrophil count > 1500/ml, platelets > 75,000/l)
adequate hepatic function (total serum bilirubin 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase 2.5 times the upper limit of normal)
adequate renal function (serum creatinine 1.5 mg/dl, creatinine clearance 50 ml/min)
normal coagulation function and electrocardiogram results
Prior chemotherapy and radiotherapy should have been completed >4 weeks 10.earlier,willingness to provide written informed consent

Exclusion Criteria

\-
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note