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Zydelig Maintenance for Non-Hodgkin's Lymphoma
Phase 2
Waitlist Available
Led By Jean Yared, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >18
ECOG performance status <4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1- and 2-year progression-free survival
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective in treating lymphoma after a stem cell transplant.
Who is the study for?
This trial is for adults over 18 with certain types of B-cell non-Hodgkin's lymphoma who've had a stem cell transplant. They should be stable or improving post-transplant, able to use contraception, and have normal organ function. Excluded are those recently on other treatments, with severe lung disease, active infections, liver issues, or unable to take pills.Check my eligibility
What is being tested?
The study tests Zydelig as a maintenance therapy after autologous stem cell transplantation in patients with indolent or transformed indolent B-cell non-Hodgkins lymphoma. It aims to determine the safety and effectiveness of this drug in preventing cancer recurrence.See study design
What are the potential side effects?
Zydelig may cause side effects like diarrhea, fever, fatigue, coughing, nausea; it can also lead to serious conditions such as liver toxicity, severe skin reactions and intestinal perforation among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
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I am not completely bedridden.
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I am eligible for high dose chemotherapy followed by stem cell transplant.
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My liver and kidney functions are within the normal range required by the trial.
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My cancer is one of the specified types of non-Hodgkin lymphoma.
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I am 30-120 days post stem cell transplant with stable or improving cancer and recovered blood counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1- and 2-year progression-free survival
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1- and 2-year progression-free survival
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Discontinuation rate due to Zydelig-related adverse events at 1 year
Secondary outcome measures
Progression-free survival at 1 and 2 years after autologous stem cell transplantation.
Side effects data
From 2019 Phase 3 trial • 416 Patients • NCT0156929562%
Neutropenia
43%
Diarrhoea
38%
Pyrexia
29%
Nausea
26%
Anaemia
25%
Cough
22%
Fatigue
22%
Febrile neutropenia
20%
Thrombocytopenia
18%
Upper respiratory tract infection
18%
Pneumonia
17%
Vomiting
17%
Rash
15%
Constipation
15%
Alanine aminotransferase increased
14%
Infusion related reaction
13%
Arthralgia
12%
Asthenia
12%
Weight decreased
12%
Decreased appetite
11%
Chills
10%
Bronchitis
10%
Abdominal pain
10%
Hypokalaemia
10%
Headache
10%
Dyspnoea
9%
Aspartate aminotransferase increased
9%
Night sweats
9%
Sinusitis
9%
Insomnia
8%
Nasopharyngitis
8%
Back pain
8%
Pruritus
8%
Leukopenia
8%
Oedema peripheral
8%
Productive cough
7%
Hypotension
7%
Dyspepsia
6%
Hypogammaglobulinaemia
6%
Hypertension
6%
Lower respiratory tract infection
5%
Sepsis
5%
Herpes zoster
5%
Oropharyngeal pain
3%
Urinary tract infection
3%
Respiratory tract infection
3%
Anxiety
2%
Colitis
2%
Cellulitis
2%
Septic shock
2%
Pneumonitis
2%
Myelodysplastic syndrome
1%
Escherichia sepsis
1%
Ophthalmic herpes zoster
1%
Hyponatraemia
1%
Influenza
1%
Basal cell carcinoma
1%
Pancreatitis
1%
Neutropenic sepsis
1%
Device related infection
1%
Gastroenteritis
1%
Pneumonia pseudomonal
1%
Pulmonary embolism
1%
Renal colic
1%
Pneumocystis jirovecii pneumonia
1%
Prostate cancer
1%
Squamous cell carcinoma of skin
1%
Hypoxia
1%
Tumour lysis syndrome
1%
Stevens-Johnson syndrome
1%
Pleural effusion
1%
Respiratory failure
1%
Hepatocellular injury
1%
Hypersensitivity
1%
Cytomegalovirus infection
1%
Urosepsis
1%
Malignant melanoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Idelalisib + Bendamustine + Rituximab
Placebo + Bendamustine + Rituximab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Oral Zydelig 150 mg BIDExperimental Treatment1 Intervention
Zydelig given orally at 150 mg twice daily continuously on 28-day cycles starting 30 to 120 days after autologous stem cell transplantation for patients with indolent or transformed indolent B-cell NHL, for up to 1 year maintenance duration. Dose withhold/modification is allowed according to tolerability/toxicity.
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,622 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,083 Previous Clinical Trials
843,325 Total Patients Enrolled
University of Miami Sylvester Comprehensive Cancer CenterOTHER
9 Previous Clinical Trials
2,585 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.I cannot swallow pills.I have severe lung disease and need oxygen or can't walk 50 feet without resting.My condition worsened after taking Zydelig.I have inflammatory bowel disease.I am not completely bedridden.You have had allergic reactions to similar drugs like Zydelig.Your blood counts have not returned to normal as defined in the study protocol.I am eligible for high dose chemotherapy followed by stem cell transplant.You are expected to live for at least four more months.My liver and kidney functions are within the normal range required by the trial.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My cancer is one of the specified types of non-Hodgkin lymphoma.I have had treatments before my stem cell transplant, but I didn't progress while on Zydelig.I agree to use birth control during and for 30 days after the study.I have active or untreated brain lymphoma.I am not taking any strong medications that could interfere with the trial drugs.I am 30-120 days post stem cell transplant with stable or improving cancer and recovered blood counts.You have had a previous history of PCP pneumonia or CMV infection.I haven't had chemotherapy or radiotherapy in the last 2 weeks.I have liver disease, cirrhosis, or a hepatitis B/C infection.I am not pregnant, nursing, nor planning to become pregnant or nurse during the study.I have been diagnosed with diffuse large B-cell lymphoma from the start.I am HIV positive.
Research Study Groups:
This trial has the following groups:- Group 1: Oral Zydelig 150 mg BID
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has research into Zydelig been conducted previously?
"As of now, a dozen clinical trials are in progress for the drug Zydelig. Two have advanced to Phase 3 and the primary sites for these tests are based in Hualien and Texas. There is also 471 different locations that are running studies on this medication."
Answered by AI
Are any new participants currently being added to this research study?
"This clinical trial regrettably is no longer recruiting. This particular study was launched on October 23, 2017 and the most recent update occurred on April 21, 2022. For those that are seeking other studies related to waldenstrom macroglobulinemia, there exist 1944 trials actively accepting patients while 12 Zydelig based research initiatives require participants."
Answered by AI
Is this medical investigation pioneering a new approach?
"Zydelig has been the focus of research since 2014, when Gilead Sciences sponsored its first trial with 50 participants. After being approved by Phase 2 in that same year, there are now 12 active studies revolving around Zydelig across 161 cities and 30 countries."
Answered by AI
Is Zydelig a reliable and secure option for patients?
"The safety of Zydelig was appraised a 2, as Phase 2 trial data exists to support the drug's security but not its efficacy."
Answered by AI
How many participants are eligible to join this research endeavor?
"At this time, this study is not open for enrollment. The trial was initially announced on October 23rd 2017 and last modified April 21st 2022. If you are looking for alternative studies, there are 1944 other clinical trials recruiting patients with waldenstrom macroglobulinemia and 12 more actively accepting participants that involve Zydelig medication."
Answered by AI
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