CLINICAL TRIAL

Duvelisib for Leukemia, Lymphocytic, Acute, L1

Recruiting · 18+ · All Sexes · Saint Louis, MO

This study is evaluating whether a drug that inhibits a protein called PI3K can increase the persistence of CAR T-cells.

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About the trial for Leukemia, Lymphocytic, Acute, L1

Eligible Conditions
Acute Lymphoblastic Leukemia (ALL) · Non-hodgkin Lymphoma · Precursor Cell Lymphoblastic Leukemia-Lymphoma

Treatment Groups

This trial involves 3 different treatments. Duvelisib 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 1 and are in the first stage of evaluation with people.

Experimental Group 1
Duvelisib
DRUG
Experimental Group 2
Duvelisib
DRUG
Experimental Group 3
Duvelisib
DRUG

About The Treatment

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

Side Effect Profile for Ofatumumab

Ofatumumab
Show all side effects
Neutropenia
21%
Infusion related reaction
18%
Cough
14%
Rash
12%
Diarrhoea
12%
Fatigue
12%
Asthenia
11%
Nausea
11%
Paraesthesia
10%
Anaemia
10%
Pyrexia
10%
Headache
8%
Constipation
8%
Upper respiratory tract infection
8%
Bronchitis
8%
Paraesthesia oral
6%
Pruritus
6%
Thrombocytopenia
6%
Vomiting
6%
Insomnia
6%
Dyspnoea
6%
Back pain
5%
Hypotension
5%
Muscle spasms
5%
Oedema peripheral
5%
Hypertension
3%
Hyperkalaemia
3%
Abdominal pain upper
3%
Pneumonia
3%
Dyspepsia
3%
Decreased appetite
3%
Nasopharyngitis
3%
Arthralgia
3%
Dizziness
3%
Respiratory tract infection
2%
Abdominal pain
2%
Pain in extremity
2%
Hypokalaemia
2%
Alanine aminotransferase increased
2%
Weight decreased
2%
Rhinorrhoea
2%
Febrile neutropenia
2%
Aspartate aminotransferase increased
2%
Oesophageal ulcer
1%
Ischaemic stroke
1%
Escherichia sepsis
1%
Dehydration
1%
Atrial fibrillation
1%
Streptococcal bacteraemia
1%
Hepatic failure
1%
Infusion site extravasation
1%
Pneumonia viral
1%
Disease progression
1%
Hyponatraemia
1%
Laryngeal stenosis
1%
Deep vein thrombosis
1%
Cholecystitis
1%
Contrast media allergy
1%
Malignant melanoma
1%
Pulmonary embolism
1%
Hyperglycaemia
1%
Squamous cell carcinoma of lung
1%
Drug hypersensitivity
1%
Portal hypertensive gastropathy
1%
Device related infection
1%
Hypervolaemia
1%
Clostridium difficile infection
1%
Sepsis
1%
Hypercalcaemia
1%
Renal failure acute
1%
Lymph node pain
1%
Colitis
1%
Glioblastoma multiforme
1%
Neutropenic sepsis
1%
Haemolytic anaemia
1%
Squamous cell carcinoma
1%
Peripheral embolism
1%
Malignant pleural effusion
1%
Herpes virus infection
1%
Pneumonia bacterial
1%
Fall
1%
Angina pectoris
1%
Escherichia urinary tract infection
1%
Gastroenteritis
1%
Cardiac failure
1%
Tachycardia
1%
Enterocolitis
1%
Lower respiratory tract infection
1%
Chronic sinusitis
1%
Bronchitis viral
0%
Respiratory tract infection bacterial
0%
Mental impairment
0%
Acute respiratory distress syndrome
0%
Rash maculo-papular
0%
Pneumonia staphylococcal
0%
Lipase increased
0%
Fungal infection
0%
Arthritis
0%
Pneumonia mycoplasmal
0%
Urinary tract infection
0%
Bone pain
0%
Renal failure chronic
0%
Splenic rupture
0%
Multi-organ failure
0%
Death
0%
Mucosal inflammation
0%
Streptococcal sepsis
0%
Skin infection
0%
Cytomegalovirus colitis
0%
Bronchiolitis
0%
Septic shock
0%
Cervical vertebral fracture
0%
Subdural haematoma
0%
Haemorrhagic stroke
0%
Haemophilus infection
0%
Dementia
0%
Pneumonia klebsiella
0%
Intestinal adenocarcinoma
0%
Pleural effusion
0%
Fungal oesophagitis
0%
Thrombosis
0%
Diverticulitis
0%
Infusion site cellulitis
0%
Lobar pneumonia
0%
Upper gastrointestinal haemorrhage
0%
Pancreatitis acute
0%
Pseudomonal sepsis
0%
Enteritis
0%
Pneumonia aspiration
0%
Gastroenteritis viral
0%
Enterococcal infection
0%
Traumatic haematoma
0%
Renal failure
0%
Nephrolithiasis
0%
Pericarditis
0%
Ventricular tachycardia
0%
Pneumocystis jirovecii pneumonia
0%
Brain stem haemorrhage
0%
Pancytopenia
0%
Pleural haemorrhage
0%
Myocardial infarction
0%
General physical health deterioration
0%
Respiratory failure
0%
Clostridium difficile colitis
0%
Influenza
0%
Accidental overdose
0%
Dermatitis exfoliative
0%
Enterococcal sepsis
0%
Lung disorder
0%
Pneumonitis
0%
Chronic obstructive pulmonary disease
0%
Dermatitis allergic
0%
Pneumonia respiratory syncytial viral
0%
Pyelonephritis
0%
Gastritis
0%
Sudden death
0%
Lung infection
0%
Cardiac failure congestive
0%
Malnutrition
0%
Rash erythematous
0%
Interstitial lung disease
0%
Lower respiratory tract infection viral
0%
Pneumonia escherichia
0%
Colitis ischaemic
0%
Aspergillus infection
0%
Pseudomonas bronchitis
0%
Renal colic
0%
Campylobacter gastroenteritis
0%
Pneumonia pneumococcal
0%
Tumour lysis syndrome
0%
Pneumonia pseudomonas aeruginosa
0%
Bronchopulmonary aspergillosis
0%
Bronchopneumonia
0%
Femur fracture
0%
Neuroendocrine carcinoma of the skin
0%
Toxic skin eruption
0%
Proctitis
0%
Mallory-Weiss syndrome
0%
Wound infection staphylococcal
0%
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT02004522) in the Ofatumumab ARM group. Side effects include: Neutropenia with 21%, Infusion related reaction with 18%, Cough with 14%, Rash with 12%, Diarrhoea with 12%.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia, Lymphocytic, Acute, L1 or one of the other 2 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You must be at least 18 years old to use this service. show original
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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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: At 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: At 6 months.
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 Duvelisib will improve 1 primary outcome and 10 secondary outcomes in patients with Leukemia, Lymphocytic, Acute, L1. Measurement will happen over the course of By Day 28.

Cumulative incidence of cytokine release syndrome (CRS)
BY DAY 28
-Any and grade 3-4 per ASTCT criteria
Cumulative incidence of immune effector cell-associated neurotoxicity syndrome (ICANS)
BY DAY 28
-Any and grade 3-4 per ASCT criteria
Proportion of participants with partial response (PR) on Day 30 with improved response on Day 90
DAY 90
Proportion of participants with partial response (PR) on Day 30 with improved response on Day 180
DAY 180
Toxicity as measured by number of adverse events
THROUGH DAY 56 FOR DOSE EXPANSION AND COHORT A AND THROUGH DAY 210 FOR COHORT B
Toxicity is graded using NCI CTCAE v 5.0
Number of participants with complete response (CR)
THROUGH COMPLETION OF FOLLOW-UP (ESTIMATED TO BE 6 MONTHS)
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Patient Q & A Section

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

Does duvelisib improve quality of life for those with leukemia, lymphocytic, acute, l1?

Duvelisib was effective in reducing disease symptoms and improving QOL in this population of patients. Further research into its toxicity profile and its potential role in treating CLL are warranted.

Anonymous Patient Answer

What is leukemia, lymphocytic, acute, l1?

The number of people affected by leukemia, lymphocytic, acute, l1 was estimated at 2.4 million in 2010, up from 1.6 million in 1990. In 2010, more than 443,000 Americans were living with chronic myeloid leukemia (CML) and 312,000 with CML in 2015. In 2016, about 47,500 people were living with feline leukemia virus (FeLV), about 20,000 with canine leukemia virus (CaLV), and about 15,000 with equine leukemia virus (EuLV). Cancer Prevention and Control. 2016 Feb 21;52(6):335–39.

Anonymous Patient Answer

What is the primary cause of leukemia, lymphocytic, acute, l1?

The data suggest that EBV infection, with involvement of NK/T cells and T helper cells, may be strongly associated with primary and secondary AML, whereas other infections, including HTLV 1, may be risk factors for a subset of cases.

Anonymous Patient Answer

What are the signs of leukemia, lymphocytic, acute, l1?

A complete blood count with differential shows white blood cells, red blood cells, platelets, and hematocrit. Lymphocytes and monocytes are found below normal levels. Reducing the number of white blood cells in the bloodstream increases the amount of platelets in the bloodstream, while increasing red blood cell counts increases the amount of hemoglobin. It is important to remember that bone marrow is shrinking over time and becoming less productive because of aging. Bone marrow failure is most commonly seen in people with chronic illness. The bone marrow may stop producing blood cells altogether. Blood tests for dipstick protein is also helpful in diagnosing leukemia.

Anonymous Patient Answer

Have there been other clinical trials involving duvelisib?

Duvelisib was well tolerated and may have therapeutic potential in two of the Phase I clinical studies. Additional clinical studies are warranted in order to determine optimal dosing of this compound.

Anonymous Patient Answer

Can leukemia, lymphocytic, acute, l1 be cured?

Data from a recent study provides evidence that marrow [transplant](https://www.withpower.com/clinical-tri[als](https://www.withpower.com/clinical-trials/als)/transplant)ation may be an effective therapy for most patients with AML/MDS. The overall survival rates observed In a recent study are comparable with those reported in the literature. We believe that these results support the use of hematopoietic stem cell transplantation as a therapeutic tool in the treatment of AML/MDS. We also think that further investigations of the role of transplanted bone marrow in the therapy of MDS are necessary.

Anonymous Patient Answer

What are the latest developments in duvelisib for therapeutic use?

Duvelisib is a potent and selective inhibitor of both BCR-ABL1 and PI3K/AKT signaling and has been shown to effectively inhibit cell growth and stimulate apoptosis in vitro and in vivo. Duvelisib was recently approved by the US Food and Drug Administration for relapsed or refractory chronic myeloid leukemia (CML), Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), and Ph+ relapsed or refractory follicular lymphoma (FL); it is currently being investigated in combination with other agents for use in chemotherapy-naive adult B-cell chronic lymphocytic leukemias and relapsed or refractory relapsed or refractory FL.

Anonymous Patient Answer

Is duvelisib safe for people?

Duvelisib was well tolerated in people with relapsed or refractory CLL who received prior systemic therapy. The most commonly reported adverse events were fatigue (40%), nausea (37%), headache (21%) and diarrhea (16%); all were mild or moderate in severity. Longer follow-up data are now awaited.

Anonymous Patient Answer

How serious can leukemia, lymphocytic, acute, l1 be?

AML is a very serious disease. It has a relatively high rate of mortality (21% overall), especially if it progresses quickly (> 7 days) and involves the CNS (central nervous system). After remission, the long-term prognosis remains poor. Lymphoblastic lymphoma is a less aggressive disease that may respond well to chemotherapy. However, it has a relatively good long-term prognosis after remission. Patients with myeloid leukemias should be treated according to their disease-specific characteristics rather than the WHO classification system.

Anonymous Patient Answer

What is duvelisib?

Duvelisib (RDEB573) is an inhibitor of CDK4/6 and CDK7, which are important kinases involved in the cell cycle transition.[founding drug development] It inhibits these kinases by binding between their ATP binding pockets of both CDK4/6 and CDK7. This leads to p16 and p21 expression and inhibition of G1 phase progression. Duvelisib also acts as a dual p53 specific inhibitor.

Anonymous Patient Answer

What are the chances of developing leukemia, lymphocytic, acute, l1?

The risk factors were similar to those reported in previous studies. There was no significant difference between patients with ALL and age-matched controls in terms of development of CLL. Patients with CLL had a higher risk for developing ALL as compared to age-matched controls.

Anonymous Patient Answer
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