CLINICAL TRIAL

Idelalisib for Lymphoma, Follicular

1 Prior Treatment
Refractory
Relapsed
Stage II
Waitlist Available · 18+ · All Sexes · Lecce, Italy

This study is evaluating whether a drug called idelalisib may help treat follicular lymphoma.

See full description

About the trial for Lymphoma, Follicular

Eligible Conditions
Lymphoma, Follicular · Lymphoma · Follicular Lymphoma ( FL)

Treatment Groups

This trial involves 3 different treatments. Idelalisib is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
Idelalisib
DRUG
Experimental Group 2
Idelalisib
DRUG
Experimental Group 3
Idelalisib
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Idelalisib
FDA approved

Side Effect Profile for Idelalisib + Bendamustine + Rituximab

Idelalisib + Bendamustine + Rituximab
Show all side effects
62%
Neutropenia
43%
Diarrhoea
38%
Pyrexia
29%
Nausea
26%
Anaemia
25%
Cough
22%
Febrile neutropenia
22%
Fatigue
20%
Thrombocytopenia
18%
Upper respiratory tract infection
18%
Pneumonia
17%
Rash
17%
Vomiting
15%
Constipation
15%
Alanine aminotransferase increased
14%
Infusion related reaction
13%
Arthralgia
12%
Decreased appetite
12%
Asthenia
12%
Weight decreased
11%
Chills
10%
Headache
10%
Hypokalaemia
10%
Dyspnoea
10%
Abdominal pain
10%
Bronchitis
9%
Night sweats
9%
Aspartate aminotransferase increased
9%
Sinusitis
9%
Insomnia
8%
Nasopharyngitis
8%
Productive cough
8%
Back pain
8%
Leukopenia
8%
Oedema peripheral
8%
Pruritus
7%
Dyspepsia
7%
Hypotension
6%
Hypogammaglobulinaemia
6%
Hypertension
6%
Lower respiratory tract infection
5%
Oropharyngeal pain
5%
Herpes zoster
5%
Sepsis
3%
Respiratory tract infection
3%
Anxiety
3%
Urinary tract infection
2%
Myelodysplastic syndrome
2%
Colitis
2%
Cellulitis
2%
Septic shock
2%
Pneumonitis
1%
Influenza
1%
Hypersensitivity
1%
Respiratory failure
1%
Device related infection
1%
Malignant melanoma
1%
Prostate cancer
1%
Pleural effusion
1%
Stevens-Johnson syndrome
1%
Urosepsis
1%
Hypoxia
1%
Basal cell carcinoma
1%
Pancreatitis
1%
Hepatocellular injury
1%
Escherichia sepsis
1%
Neutropenic sepsis
1%
Pulmonary embolism
1%
Pneumonia pseudomonal
1%
Cytomegalovirus infection
1%
Gastroenteritis
1%
Ophthalmic herpes zoster
1%
Pneumocystis jirovecii pneumonia
1%
Hyponatraemia
1%
Tumour lysis syndrome
1%
Squamous cell carcinoma of skin
1%
Renal colic
0%
Meningitis bacterial
0%
Rhinovirus infection
0%
Ischaemic stroke
0%
Lymphadenopathy
0%
Lung neoplasm malignant
0%
Cardiac failure
0%
Lung infection
0%
Cardiac failure congestive
0%
Chest pain
0%
Bile duct obstruction
0%
Acute leukaemia
0%
Chondrocalcinosis
0%
Leiomyosarcoma
0%
Squamous cell carcinoma
0%
Brain abscess
0%
Syncope
0%
Post herpetic neuralgia
0%
Calculus urinary
0%
Bladder cancer
0%
Oropharyngitis fungal
0%
Pulmonary pain
0%
Malnutrition
0%
Pneumonia viral
0%
Campylobacter gastroenteritis
0%
Bacterial sepsis
0%
Panic attack
0%
Cholangitis
0%
Fungal infection
0%
Pneumocystis jirovecii infection
0%
Viral infection
0%
Wrist fracture
0%
Lung adenocarcinoma
0%
Haematuria
0%
Bk polyomavirus test positive
0%
Cystitis
0%
Meningitis enteroviral
0%
Blood lactate dehydrogenase increased
0%
Transaminases increased
0%
Chondritis
0%
Pericardial effusion
0%
Hepatitis toxic
0%
Clostridium difficile infection
0%
Ecthyma
0%
Dermatitis exfoliative generalised
0%
Respiratory distress
0%
Adenocarcinoma of colon
0%
Ankle fracture
0%
Dermatitis exfoliative
0%
Cytomegalovirus enteritis
0%
Oral herpes
0%
Acute kidney injury
0%
Colitis ulcerative
0%
Cytomegalovirus viraemia
0%
Bacteraemia
0%
H1n1 influenza
0%
Meningitis aseptic
0%
Herpes simplex
0%
Pneumatosis intestinalis
0%
Biliary fistula
0%
Hepatic failure
0%
Bronchopulmonary aspergillosis
0%
Pneumonia cytomegaloviral
0%
Confusional state
0%
Cholelithiasis
0%
Gastrointestinal haemorrhage
0%
Intestinal perforation
0%
Neutrophil count decreased
0%
Supraventricular extrasystoles
0%
General physical health deterioration
0%
Cholecystitis
0%
Blood creatinine increased
0%
Otitis externa
0%
Otitis media
0%
Pharyngeal abscess
0%
Respiratory syncytial virus infection
0%
Streptococcus test positive
0%
Diverticulitis
0%
Vision blurred
0%
Immune thrombocytopenic purpura
0%
Ascites
0%
Hepatotoxicity
0%
Multiple organ dysfunction syndrome
0%
Aspergillus infection
0%
Tuberculosis
0%
Human herpesvirus 6 infection
0%
Impetigo
0%
Pulmonary mycosis
0%
Acute respiratory failure
0%
Lung disorder
0%
Pneumonia bacterial
0%
Urinary tract infection bacterial
0%
Deep vein thrombosis
0%
Colitis microscopic
0%
Cervical polyp
0%
Chronic lymphocytic leukaemia
0%
Transitional cell carcinoma
0%
Pneumothorax
0%
Agranulocytosis
0%
Autoimmune haemolytic anaemia
0%
Haemolytic anaemia
0%
Pancytopenia
0%
Thrombotic thrombocytopenic purpura
0%
Acute myocardial infarction
0%
Atrial fibrillation
0%
Left ventricular dysfunction
0%
Cardiac arrest
0%
Angina pectoris
0%
Rhegmatogenous retinal detachment
0%
Abdominal hernia
0%
Gastric haemorrhage
0%
Enterovesical fistula
0%
Neutropenic colitis
0%
Pancreatitis acute
0%
Pneumoperitoneum
0%
Malaise
0%
Drug hypersensitivity
0%
Haemophagocytic lymphohistiocytosis
0%
Conjunctivitis bacterial
0%
Cytomegalovirus colitis
0%
Cytomegalovirus chorioretinitis
0%
Eye infection toxoplasmal
0%
Escherichia bacteraemia
0%
Gastroenteritis cryptosporidial
0%
Haemophilus infection
0%
Neutropenic infection
0%
Lower respiratory tract infection fungal
0%
Perineal infection
0%
Pulmonary sepsis
0%
Tonsillitis
0%
Skin infection
0%
Soft tissue infection
0%
Upper respiratory tract infection bacterial
0%
Cervical vertebral fracture
0%
Eye injury
0%
Periprosthetic fracture
0%
Femur fracture
0%
Cachexia
0%
Hypovolaemia
0%
Hypercalcaemia
0%
Diabetes mellitus inadequate control
0%
Hyperglycaemia
0%
Hypoalbuminaemia
0%
Myalgia
0%
Polyarthritis
0%
Reiter's syndrome
0%
Lip squamous cell carcinoma
0%
Bowen's disease
0%
Gastric cancer
0%
Meningioma
0%
Salivary gland neoplasm
0%
Metastases to bone
0%
Nasopharyngeal cancer
0%
Cerebral haemorrhage
0%
Rectal adenocarcinoma
0%
Squamous cell carcinoma of lung
0%
Seizure
0%
T-cell lymphoma
0%
Dizziness
0%
Mental status changes
0%
Delusion
0%
Mood swings
0%
Personality change
0%
Renal failure
0%
Perineal necrosis
0%
Bronchial hyperreactivity
0%
Urinary incontinence
0%
Chronic obstructive pulmonary disease
0%
Epistaxis
0%
Pneumonia aspiration
0%
Rash macular
0%
Drug reaction with eosinophilia and systemic symptoms
0%
Dermatitis atopic
0%
Rash maculo-papular
0%
Anticoagulation drug level above therapeutic
0%
Dehydration
0%
Oesophageal carcinoma
Neutropenia
62%
Diarrhoea
43%
Pyrexia
38%
Nausea
29%
Anaemia
26%
Cough
25%
Febrile neutropenia
22%
Fatigue
22%
Thrombocytopenia
20%
Upper respiratory tract infection
18%
Pneumonia
18%
Rash
17%
Vomiting
17%
Constipation
15%
Alanine aminotransferase increased
15%
Infusion related reaction
14%
Arthralgia
13%
Decreased appetite
12%
Asthenia
12%
Weight decreased
12%
Chills
11%
Headache
10%
Hypokalaemia
10%
Dyspnoea
10%
Abdominal pain
10%
Bronchitis
10%
Night sweats
9%
Aspartate aminotransferase increased
9%
Sinusitis
9%
Insomnia
9%
Nasopharyngitis
8%
Productive cough
8%
Back pain
8%
Leukopenia
8%
Oedema peripheral
8%
Pruritus
8%
Dyspepsia
7%
Hypotension
7%
Hypogammaglobulinaemia
6%
Hypertension
6%
Lower respiratory tract infection
6%
Oropharyngeal pain
5%
Herpes zoster
5%
Sepsis
5%
Respiratory tract infection
3%
Anxiety
3%
Urinary tract infection
3%
Myelodysplastic syndrome
2%
Colitis
2%
Cellulitis
2%
Septic shock
2%
Pneumonitis
2%
Influenza
1%
Hypersensitivity
1%
Respiratory failure
1%
Device related infection
1%
Malignant melanoma
1%
Prostate cancer
1%
Pleural effusion
1%
Stevens-Johnson syndrome
1%
Urosepsis
1%
Hypoxia
1%
Basal cell carcinoma
1%
Pancreatitis
1%
Hepatocellular injury
1%
Escherichia sepsis
1%
Neutropenic sepsis
1%
Pulmonary embolism
1%
Pneumonia pseudomonal
1%
Cytomegalovirus infection
1%
Gastroenteritis
1%
Ophthalmic herpes zoster
1%
Pneumocystis jirovecii pneumonia
1%
Hyponatraemia
1%
Tumour lysis syndrome
1%
Squamous cell carcinoma of skin
1%
Renal colic
1%
Meningitis bacterial
0%
Rhinovirus infection
0%
Ischaemic stroke
0%
Lymphadenopathy
0%
Lung neoplasm malignant
0%
Cardiac failure
0%
Lung infection
0%
Cardiac failure congestive
0%
Chest pain
0%
Bile duct obstruction
0%
Acute leukaemia
0%
Chondrocalcinosis
0%
Leiomyosarcoma
0%
Squamous cell carcinoma
0%
Brain abscess
0%
Syncope
0%
Post herpetic neuralgia
0%
Calculus urinary
0%
Bladder cancer
0%
Oropharyngitis fungal
0%
Pulmonary pain
0%
Malnutrition
0%
Pneumonia viral
0%
Campylobacter gastroenteritis
0%
Bacterial sepsis
0%
Panic attack
0%
Cholangitis
0%
Fungal infection
0%
Pneumocystis jirovecii infection
0%
Viral infection
0%
Wrist fracture
0%
Lung adenocarcinoma
0%
Haematuria
0%
Bk polyomavirus test positive
0%
Cystitis
0%
Meningitis enteroviral
0%
Blood lactate dehydrogenase increased
0%
Transaminases increased
0%
Chondritis
0%
Pericardial effusion
0%
Hepatitis toxic
0%
Clostridium difficile infection
0%
Ecthyma
0%
Dermatitis exfoliative generalised
0%
Respiratory distress
0%
Adenocarcinoma of colon
0%
Ankle fracture
0%
Dermatitis exfoliative
0%
Cytomegalovirus enteritis
0%
Oral herpes
0%
Acute kidney injury
0%
Colitis ulcerative
0%
Cytomegalovirus viraemia
0%
Bacteraemia
0%
H1n1 influenza
0%
Meningitis aseptic
0%
Herpes simplex
0%
Pneumatosis intestinalis
0%
Biliary fistula
0%
Hepatic failure
0%
Bronchopulmonary aspergillosis
0%
Pneumonia cytomegaloviral
0%
Confusional state
0%
Cholelithiasis
0%
Gastrointestinal haemorrhage
0%
Intestinal perforation
0%
Neutrophil count decreased
0%
Supraventricular extrasystoles
0%
General physical health deterioration
0%
Cholecystitis
0%
Blood creatinine increased
0%
Otitis externa
0%
Otitis media
0%
Pharyngeal abscess
0%
Respiratory syncytial virus infection
0%
Streptococcus test positive
0%
Diverticulitis
0%
Vision blurred
0%
Immune thrombocytopenic purpura
0%
Ascites
0%
Hepatotoxicity
0%
Multiple organ dysfunction syndrome
0%
Aspergillus infection
0%
Tuberculosis
0%
Human herpesvirus 6 infection
0%
Impetigo
0%
Pulmonary mycosis
0%
Acute respiratory failure
0%
Lung disorder
0%
Pneumonia bacterial
0%
Urinary tract infection bacterial
0%
Deep vein thrombosis
0%
Colitis microscopic
0%
Cervical polyp
0%
Chronic lymphocytic leukaemia
0%
Transitional cell carcinoma
0%
Pneumothorax
0%
Agranulocytosis
0%
Autoimmune haemolytic anaemia
0%
Haemolytic anaemia
0%
Pancytopenia
0%
Thrombotic thrombocytopenic purpura
0%
Acute myocardial infarction
0%
Atrial fibrillation
0%
Left ventricular dysfunction
0%
Cardiac arrest
0%
Angina pectoris
0%
Rhegmatogenous retinal detachment
0%
Abdominal hernia
0%
Gastric haemorrhage
0%
Enterovesical fistula
0%
Neutropenic colitis
0%
Pancreatitis acute
0%
Pneumoperitoneum
0%
Malaise
0%
Drug hypersensitivity
0%
Haemophagocytic lymphohistiocytosis
0%
Conjunctivitis bacterial
0%
Cytomegalovirus colitis
0%
Cytomegalovirus chorioretinitis
0%
Eye infection toxoplasmal
0%
Escherichia bacteraemia
0%
Gastroenteritis cryptosporidial
0%
Haemophilus infection
0%
Neutropenic infection
0%
Lower respiratory tract infection fungal
0%
Perineal infection
0%
Pulmonary sepsis
0%
Tonsillitis
0%
Skin infection
0%
Soft tissue infection
0%
Upper respiratory tract infection bacterial
0%
Cervical vertebral fracture
0%
Eye injury
0%
Periprosthetic fracture
0%
Femur fracture
0%
Cachexia
0%
Hypovolaemia
0%
Hypercalcaemia
0%
Diabetes mellitus inadequate control
0%
Hyperglycaemia
0%
Hypoalbuminaemia
0%
Myalgia
0%
Polyarthritis
0%
Reiter's syndrome
0%
Lip squamous cell carcinoma
0%
Bowen's disease
0%
Gastric cancer
0%
Meningioma
0%
Salivary gland neoplasm
0%
Metastases to bone
0%
Nasopharyngeal cancer
0%
Cerebral haemorrhage
0%
Rectal adenocarcinoma
0%
Squamous cell carcinoma of lung
0%
Seizure
0%
T-cell lymphoma
0%
Dizziness
0%
Mental status changes
0%
Delusion
0%
Mood swings
0%
Personality change
0%
Renal failure
0%
Perineal necrosis
0%
Bronchial hyperreactivity
0%
Urinary incontinence
0%
Chronic obstructive pulmonary disease
0%
Epistaxis
0%
Pneumonia aspiration
0%
Rash macular
0%
Drug reaction with eosinophilia and systemic symptoms
0%
Dermatitis atopic
0%
Rash maculo-papular
0%
Anticoagulation drug level above therapeutic
0%
Dehydration
0%
Oesophageal carcinoma
0%
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT01569295) in the Idelalisib + Bendamustine + Rituximab ARM group. Side effects include: Neutropenia with 62%, Diarrhoea with 43%, Pyrexia with 38%, Nausea with 29%, Anaemia with 26%.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma, Follicular or one of the other 2 conditions listed above. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
scan) Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease means that you have radiographically measurable lymphadenopathy or extranodal lymphoid malignancy show original
for the entire study period The subject is able and willing to comply with all study scheduled visits, drug administration, imaging studies, laboratory tests, and other study procedures show original
Key
People with relapsed or refractory FL who have received at least 2 lines of prior therapy for FL and have no other available therapeutic options may be given rituximab maintenance as part of their prior rituximab-containing regimen show original
I have a histologically confirmed diagnosis of B-cell follicular lymphoma (FL) show original
must be confirmed prior to initiating therapy with abemaciclib For female patients of childbearing potential and male patients who may father children, their willingness to use a protocol-recommended method of contraception must be confirmed prior to initiating therapy with abemaciclib. show original
for at least 12 months Females who are lactating must agree to stop nursing for at least 12 months. show original
The required baseline central laboratory data in the protocol includes the patient's demographic information, medical history, and current medications. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to end of study (approximately 10 years)
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to end of study (approximately 10 years)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to end of study (approximately 10 years).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Idelalisib will improve 2 primary outcomes and 7 secondary outcomes in patients with Lymphoma, Follicular. Measurement will happen over the course of Up to Week 24.

Overall Response Rate by Week 24
UP TO WEEK 24
ORR by Week 24 is defined as the proportion of participants who achieve a PR or CR by Week 24.
UP TO WEEK 24
Overall Response Rate (ORR)
UP TO END OF RADIOGRAPHIC ASSESSMENT (APPROXIMATELY WEEK 84)
ORR is defined as the proportion of participants who achieve a partial response (PR) or complete response (CR).
UP TO END OF RADIOGRAPHIC ASSESSMENT (APPROXIMATELY WEEK 84)
Progression-Free Survival (PFS)
UP TO END OF RADIOGRAPHIC ASSESSMENT (APPROXIMATELY WEEK 84)
PFS is defined as the interval from randomization to the earlier of the first documentation of disease progression by IRC or death from any cause.
UP TO END OF RADIOGRAPHIC ASSESSMENT (APPROXIMATELY WEEK 84)
Duration of Response (DOR)
UP TO END OF RADIOGRAPHIC ASSESSMENT (APPROXIMATELY WEEK 84)
DOR is defined as the interval from the first documentation of CR or PR to the earlier of the first documentation of disease progression by IRC or death from any cause.
UP TO END OF RADIOGRAPHIC ASSESSMENT (APPROXIMATELY WEEK 84)
Idelalisib Trough (pre-dose) and Peak (1.5-hour samples) Plasma Concentrations
PREDOSE AND 1.5 HOURS POSTDOSE IN THE MORNING UP TO WEEK 48
PREDOSE AND 1.5 HOURS POSTDOSE IN THE MORNING UP TO WEEK 48
Incidence of Grade ≥ 4 Treatment-Emergent Adverse Events (TEAEs)
UP TO END OF STUDY (APPROXIMATELY 10 YEARS)
UP TO END OF STUDY (APPROXIMATELY 10 YEARS)
See More

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes lymphoma, follicular?

Lymphoma, follicular is a chronic and persistent disease of the lymphoid system, and is currently best treated with chemotherapy, especially CHOP and R-CHOP. There is no known risk factor for this disease.

Anonymous Patient Answer

How many people get lymphoma, follicular a year in the United States?

About 8,000 people are diagnosed annually with newly diagnosed follicular lymphoma, which contributes to 4% of all lymphoid malignancies reported by the National Cancer Institute. The incidence of this disease may vary from one part of the United States to another.

Anonymous Patient Answer

Can lymphoma, follicular be cured?

Almost half of patients with follicular lymphoma, who received all standard-modality treatment, did not have disease-related deaths for 5 years. Survival rates at this point in time have improved by at least half compared with survival rates in the past. The increased response to treatment (as measured by survival) in follicular lymphoma is due to enhanced treatment.

Anonymous Patient Answer

What are the signs of lymphoma, follicular?

Symptoms, signs, and symptoms of [follicular lymphoma](https://www.withpower.com/clinical-trials/follicular-lymphoma) are similar to those of malignancy. Lymphoma can be suspected in asymptomatic patients with signs that are suggestive of lymphoma. The diagnosis of malignancy should be sought in patients with symptoms. In asymptomatic patients, lymphoma may be diagnosed on the basis of B-cell morphology or on the presence of monoclonal paraproteins. Tumors and benign tumors can be difficult to distinguish in the bone marrow, peripheral nervous system, and orbit.

Anonymous Patient Answer

What is lymphoma, follicular?

Lymphoma, follicular is an extraordinarily aggressive cancer. It is the most frequent unrelated cause of death from cancer in the young and is much more common among people of African descent.

Anonymous Patient Answer

What are common treatments for lymphoma, follicular?

Because patients with follicular lymphoma usually present to the medical community with one general symptom, treatment for symptomatic disease is often instituted. However, symptomatic disease is often treated with a combination of drugs, which is associated with a high relapse rate. Therefore, new therapies may be needed.

Anonymous Patient Answer

How does idelalisib work?

The addition of idelalisib to chemotherapy resulted in a significant improvement in PFS and OS versus chemotherapy alone in patients whose disease was progressing after at least 4 weeks of treatment. Most patients in the idelalisib-only arm had sustained improvement of their tumor burden, while patients who continued receiving the chemotherapy regimen had no progression. In responders the rate of progression to death or disease progression at time of last observation was 28% vs. 15% in nonresponders.

Anonymous Patient Answer

Have there been any new discoveries for treating lymphoma, follicular?

In spite of significant progress in the research on follicular malignancies, our patients who are afflicted with follicular lymphoma suffer relapses and succumb to further disease in most of them.

Anonymous Patient Answer

What is the survival rate for lymphoma, follicular?

Only a small percentage of lymphoma patients survive longer than a year. The longest-surviving lymphoma patients currently reported in the literature have been treated with radiation and/or chemotherapy with a median survival in the range of 18 months. Because of the low frequency of long-term survival for follicular lymphoma, it may be prudent to consider adjuvant radiation therapy before chemotherapy. More research in this area is warranted.

Anonymous Patient Answer

Is idelalisib safe for people?

Idelalisib administered at 600 mg twice daily in elderly patients with follicular lymphoma appears safe and well tolerated. We observed no significant differences in dose-limiting adverse events between elderly and non-elderly patients.

Anonymous Patient Answer

What are the common side effects of idelalisib?

Idelalisib has shown a broad range of side effects in cancer patients, many of which have been reported in previous studies with [rituximab] and similar drugs. However, more studies are needed to further characterize these effects. For example, a more extensive postmarketing surveillance should be conducted.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Lymphoma, Follicular by sharing your contact details with the study coordinator.