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Alkylating agent
IPI-145 + FCR for Chronic Lymphocytic Leukemia
Phase 1 & 2
Waitlist Available
Led By Matthew Davids, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of CLL and an indication for treatment as per IW-CLL 2008 criteria
No prior therapy for CLL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new drug to see if it can help treat CLL when used with other drugs.
Who is the study for?
This trial is for younger patients aged 18-65 with confirmed chronic lymphocytic leukemia (CLL) who need treatment but haven't had any yet. They should be relatively healthy, not pregnant, and free from other cancers unless it's low-risk or treated within the past 5 years. People with poor liver or kidney function, heart issues, certain infections or diseases like HIV are excluded.Check my eligibility
What is being tested?
The study tests a new drug called IPI-145 combined with standard CLL treatments: fludarabine, cyclophosphamide, and rituximab (FCR). It aims to see if adding IPI-145 improves outcomes for those who have never been treated for CLL before.See study design
What are the potential side effects?
IPI-145 may cause birth defects; hence pregnant women can't take part. Side effects might include abnormal liver tests due to potential liver damage, increased risk of infection due to immune system suppression by FCR drugs, and possible heart rhythm problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with CLL and need treatment.
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I have not received any treatment for chronic lymphocytic leukemia.
Select...
I am between 18 and 65 years old.
Select...
I can carry out all my self-care but cannot do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I
Number of Patients Who Had a Minimal Residual Disease (MRD) Negative Complete Response (CR) 2 Months After Chemotherapy
Secondary outcome measures
Determine the Association of Established CLL Prognostic Factors With Clinical Response
Duration of Remission Rate
Event Free Survival Rate
+6 moreSide effects data
From 2020 Phase 3 trial • 99 Patients • NCT0204951548%
Diarrhoea
26%
Neutropenia
23%
Rash
23%
Pyrexia
17%
Cough
14%
Pneumonia
12%
Decreased appetite
12%
Asthenia
11%
Nausea
11%
Vomiting
10%
Abdominal pain
10%
Lipase increased
10%
Thrombocytopenia
10%
Arthralgia
9%
Colitis
9%
Anaemia
9%
Bronchitis
8%
Weight decreased
8%
Hypokalaemia
8%
Upper respiratory tract infection
8%
Headache
8%
Abdominal pain upper
7%
Urinary tract infection
7%
Oedema peripheral
6%
Pain in extremity
6%
Influenza like illness
6%
Constipation
6%
Dyspepsia
6%
Respiratory tract infection
4%
Sepsis
4%
Renal failure acute
3%
Febrile neutropenia
3%
Pneumocystis jirovecii pneumonia
3%
Pseudomonal sepsis
3%
Dyspnoea
3%
Skin lesion
3%
Gastrooesophageal reflux disease
2%
Pancytopenia
2%
Oesophagitis
2%
Respiratory failure
2%
Vertigo
2%
Disease progression
2%
General physical health deterioration
2%
Rash maculo-papular
2%
Hyperuricaemia
2%
Hypertension
1%
Stomatitis
1%
Interstitial lung disease
1%
Vena cava thrombosis
1%
Dizziness
1%
Psoriasis
1%
Encephalitis
1%
Pityriasis rubra pilaris
1%
Non-cardiac chest pain
1%
Toxic skin eruption
1%
Mental impairment
1%
Haemolytic anaemia
1%
Acute myocardial infarction
1%
Atrioventricular block complete
1%
Cardiac failure
1%
Cardiac failure chronic
1%
Hypopituitarism
1%
Colitis ischaemic
1%
Enterocolitis
1%
Gastritis
1%
Large intestinal ulcer
1%
Mouth ulceration
1%
Multi-organ failure
1%
Laryngitis
1%
Lung infection
1%
Mucosal infection
1%
Nasopharyngitis
1%
Pneumonia cytomegaloviral
1%
Pneumonia haemophilus
1%
Salmonellosis
1%
Staphylococcal bacteraemia
1%
Staphylococcal skin infection
1%
Urosepsis
1%
Subdural haematoma
1%
Transaminases increased
1%
Back pain
1%
Flank pain
1%
Osteoarthritis
1%
Basosquamous carcinoma
1%
Malignant melanoma
1%
Squamous cell carcinoma
1%
Squamous cell carcinoma of skin
1%
Cerebral ischaemia
1%
Cerebrovascular accident
1%
Azotaemia
1%
Dysuria
1%
Pollakiuria
1%
Renal impairment
1%
Aortic dissection
1%
Arterial rupture
1%
Anxiety
1%
Drug intolerance
1%
Campylobacter gastroenteritis
1%
Campylobacter infection
1%
H1N1 influenza
1%
Influenza
1%
Pneumonia pneumococcal
1%
Pneumonia pseudomonas aeruginosa
1%
Toxicity to various agents
1%
Lung infiltration
1%
Pleural effusion
1%
Pneumonitis
1%
Actinic keratosis
1%
Dermatitis
1%
Pityriasis lichenoides et varioliformis acuta
1%
Device related infection
1%
Enterococcal bacteraemia
1%
Muscle contractions involuntary
100%
80%
60%
40%
20%
0%
Study treatment Arm
IPI-145
Ofatumumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: IPI-145Experimental Treatment4 Interventions
Phase I-Dose escalation will occur using a standard 3-3 dose escalation beginning in dose level 1 with dose cohorts and escalation.
Each treatment cycle lasts 28 days (except cycle 1, which is 35 days) during which time IPI-145 will be taken twice daily. The study begins with 1 week of IPI-145 monotherapy.
Fludarabine, cyclophosphamide, rituximab (iFCR) - FCR will subsequently be introduced after 1 week and administered at standard dosing for up to 6 cycles, with dose reductions permitted. IPI-145 will be continued through the course of chemotherapy and for up to 2 years maintenance after completing chemotherapy Phase II - 20 additional patients treated with IPI-145 at the Recommended Phase II Dose (RP2D) + fludarabine, cyclophosphamide, rituximab (FCR) with standard dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IPI-145
2013
Completed Phase 3
~710
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3780
Rituximab
1999
Completed Phase 4
~1880
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,840 Total Patients Enrolled
Verastem, Inc.Industry Sponsor
38 Previous Clinical Trials
2,566 Total Patients Enrolled
Secura Bio, Inc.Industry Sponsor
8 Previous Clinical Trials
216 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to my brain or spinal cord.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I've been cancer-free for 5 years, except for certain low-risk types.I have not had active tuberculosis in the last two years.I haven't taken any strong or moderate CYP3A affecting drugs in the last week.I cannot take preventive treatment for pneumocystis.My liver tests are not within the normal range, but it's not due to hemolysis or Gilbert's syndrome.My kidney function is poor, with high creatinine levels.I am not taking any medication that affects my heart's electrical cycle.I am on blood thinners due to a clot in my veins.I have been diagnosed with CLL and need treatment.I have not received any treatment for chronic lymphocytic leukemia.I am between 18 and 65 years old.I can carry out all my self-care but cannot do heavy physical work.I have a history of alcohol abuse or chronic liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: IPI-145
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.
To whom is this treatment opportunity available?
"This experimental medication study has room for 32 patients suffering from leukemia or lymphoid cancer. The ideal candidate is aged 18-65, with an ECOG performance status of 1 or lower, and no prior treatment history for CLL."
Answered by AI
For what purpose is IPI-145 most often prescribed?
"IPI-145 is a medication that can be used to effectively treat diffuse large b-cell lymphoma (dlbcl), as well as other conditions like lung cancers, two prior therapies, and multiple sclerosis."
Answered by AI
Are people with the relevant medical condition able to participate in this trial right now?
"The trial in question, as reflected on clinicaltrials.gov, is not presently looking for participants. This particular study was originally posted on June 27th, 2014 but was most recently updated on September 28th, 2022. There are 2,793 other trials that are actively recruiting patients right now."
Answered by AI
Could you please tell me if IPI-145 has been explored in other research?
"There are a total of 1216 clinical trials testing IPI-145 worldwide, with 227 of those being Phase 3 trials. Many of these studies are based in Philadelphia, but there are 37047 locations conducting research on IPI-145."
Answered by AI
What are the main goals that researchers are hoping to achieve with this clinical trial?
"The aim of this trial is to evaluate the efficacy of a new treatment for cancer over a period of time. The primary outcome measure is the number of patients who achieve complete remission after two months of treatment. Secondary outcome measures include progression-free survival, duration of remission, and response rate. Patients will be assessed on a regular basis during the course of the study, and follow-up visits are recommended for at least one year after completing treatment."
Answered by AI
Are patients over the age of 45 able to participate in this clinical trial?
"The age limit for this particular clinical trial is 65 years or younger. Out of the 804 studies available for patients under 18 and 2245 for those over 65, this study stands out as an opportunity."
Answered by AI
How many participants will be included in this research?
"Unfortunately, this clinical trial is not presently looking for new patients to enroll. The study was initially posted on June 27th, 2014 and was most recently updated on September 28th, 2022. However, there are 1577 other studies actively recruiting participants with leukemia and 1216 trials involving IPI-145 that are currently seeking patients."
Answered by AI
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