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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

Must not have

Patients who are unable to swallow pills

Patients with moderate to severe lung disease including those requiring O2 supplementation, unable to walk 50 feet without stopping to rest, and moderate to severe obstructive or restrictive disease of the lung

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1- and 2-year progression-free survival

Awards & highlights

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow pills.

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I have severe lung disease and need oxygen or can't walk 50 feet without resting.

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My condition worsened after taking Zydelig.

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I have inflammatory bowel disease.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have active or untreated brain lymphoma.

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I am not taking any strong medications that could interfere with the trial drugs.

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I haven't had chemotherapy or radiotherapy in the last 2 weeks.

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I have liver disease, cirrhosis, or a hepatitis B/C infection.

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I am not pregnant, nursing, nor planning to become pregnant or nurse during the study.

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I have been diagnosed with diffuse large B-cell lymphoma from the start.

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I am HIV positive.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1- and 2-year progression-free survival for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Discontinuation rate due to Zydelig-related adverse events at 1 year

Secondary study objectives

Progression-free survival at 1 and 2 years after autologous stem cell transplantation.

Side effects data

From 2019 Phase 3 trial • 416 Patients • NCT01569295

62%

Neutropenia

43%

Diarrhoea

38%

Pyrexia

29%

Nausea

26%

Anaemia

25%

Cough

22%

Fatigue

22%

Febrile neutropenia

20%

Thrombocytopenia

18%

Pneumonia

18%

Upper respiratory tract infection

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%

Abdominal pain

10%

Bronchitis

10%

Hypokalaemia

10%

Headache

10%

Dyspnoea

Sinusitis

Aspartate aminotransferase increased

Night sweats

Insomnia

Leukopenia

Oedema peripheral

Nasopharyngitis

Back pain

Pruritus

Productive cough

Dyspepsia

Hypotension

Hypogammaglobulinaemia

Lower respiratory tract infection

Hypertension

Sepsis

Herpes zoster

Oropharyngeal pain

Urinary tract infection

Respiratory tract infection

Anxiety

Colitis

Cellulitis

Septic shock

Myelodysplastic syndrome

Pneumonitis

Pancreatitis

Neutropenic sepsis

Device related infection

Escherichia sepsis

Gastroenteritis

Influenza

Ophthalmic herpes zoster

Pneumocystis jirovecii pneumonia

Pneumonia pseudomonal

Hyponatraemia

Tumour lysis syndrome

Basal cell carcinoma

Prostate cancer

Squamous cell carcinoma of skin

Renal colic

Hypoxia

Pleural effusion

Pulmonary embolism

Respiratory failure

Stevens-Johnson syndrome

Hepatocellular injury

Hypersensitivity

Cytomegalovirus infection

Urosepsis

Malignant melanoma

100%

80%

60%

40%

20%

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.

0 / 18Eligibility criteria met