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Belinostat + Zidovudine for Adult T-Cell Lymphoma
Study Summary
This trial will test a new combination therapy for ATLL consisting of Belinostat and AZT.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 2 trial • 32 Patients • NCT00301756Trial Design
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Who is running the clinical trial?
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- I do not have any other active cancers.I have been diagnosed with aggressive adult T-cell leukemia/lymphoma.My liver issues are not caused by lymphoma.My blood tests show I have ATLL cells.I have been treated with AZT/IFNα for 2 weeks or more and saw improvement in my blood counts.I've been on chemotherapy for at least 2 weeks and my blood counts have partially improved.I am 18 years old or older.I've had high-dose steroids and my blood condition has stabilized or improved.My blood test shows remaining ATLL cells.I have been diagnosed with HTLV-1 infection.My cancer can be measured or evaluated, including at the molecular level.My organs and bone marrow are working well.I can take care of myself but may not be able to do any work.I am not pregnant and agree to use birth control.My cancer is getting worse at the time of joining the study.I am currently taking erythropoietin or G-CSF.I have severe heart disease.My liver is working well.I do not have any uncontrolled illnesses.My leukemia is chronic with favorable features or is a smoldering type.
- Group 1: Belinostat + Zidovudine
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What therapeutic purpose does Belinostat typically serve?
"Belinostat is an appropriate intervention for HIV/AIDS and multiple types of lymphoma as well, including non-Hodgkin's Lymphoma and Follicular lymphoma."
Are there any prior investigations which have utilized Belinostat?
"Currently, 38 clinical investigations into Belinostat are active with 12 of them at Phase 3. With the majority of these trials situated in Buffalo, New york; there is a total of 3435 locations conducting research on this drug."
How might Belinostat endanger the health of individuals?
"While there is some evidence of Belinostat's safety, no clinical data exists that confirms its efficacy; thus it has been given a score of 2."
How many participants have enrolled in this experiment?
"Affirmative. The clinical trial database indicates that this research is actively enrolling participants, which began on December 12th 2016 and was last updated November 10th 2022. Currently, 20 individuals are being sought for the study at one single medical site."
Are any new participants being admitted to this experiment?
"Confirmatively, clinicaltrials.gov illustrates that this medical trial began recruiting on December 12th 2016 and is still ongoing as of November 10th 2022. The study seeks to enrol 20 patients in a single healthcare centre."
What is the primary purpose of this investigation?
"The primary objective of the trial, monitored over a 13 month period, is to quantify the amount of participants that achieve Complete Molecular Response (CMR). Secondary outcomes include One Year Rate of Overall Survival (OS), defined as time from treatment initiation until death or censoring; Rate of Participants Achieving Clinical Response - CR and PR determined by clinical, radiologic, molecular and pathologic criteria; and HTLV-1 pro-viral load measured through serum blood samples."
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