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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
Must not have
Known CNS involvement
Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I have been diagnosed with CLL and need treatment.
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I have not received any treatment for chronic lymphocytic leukemia.
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I am between 18 and 65 years old.
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I can carry out all my self-care but cannot do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to my brain or spinal cord.
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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 haven't taken any strong or moderate CYP3A affecting drugs in the last week.
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I cannot take preventive treatment for pneumocystis.
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My liver tests are not within the normal range, but it's not due to hemolysis or Gilbert's syndrome.
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My kidney function is poor, with high creatinine levels.
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I am not taking any medication that affects my heart's electrical cycle.
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I am on blood thinners due to a clot in my veins.
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I have a history of alcohol abuse or chronic liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Determine the Association of Established CLL Prognostic Factors With Clinical Response
Duration of Remission Rate
Event Free Survival Rate
+6 more

Side effects data

From 2020 Phase 3 trial • 99 Patients • NCT02049515
48%
Diarrhoea
26%
Neutropenia
23%
Rash
23%
Pyrexia
17%
Cough
14%
Pneumonia
12%
Decreased appetite
12%
Asthenia
11%
Vomiting
11%
Nausea
10%
Thrombocytopenia
10%
Lipase increased
10%
Abdominal pain
10%
Arthralgia
9%
Anaemia
9%
Bronchitis
9%
Colitis
8%
Hypokalaemia
8%
Weight decreased
8%
Headache
8%
Abdominal pain upper
8%
Upper respiratory tract infection
7%
Oedema peripheral
7%
Urinary tract infection
6%
Constipation
6%
Pain in extremity
6%
Dyspepsia
6%
Respiratory tract infection
6%
Influenza like illness
4%
Sepsis
4%
Renal failure acute
3%
Pneumocystis jirovecii pneumonia
3%
Gastrooesophageal reflux disease
3%
Pseudomonal sepsis
3%
Skin lesion
3%
Dyspnoea
3%
Febrile neutropenia
2%
Hypertension
2%
Respiratory failure
2%
Vertigo
2%
General physical health deterioration
2%
Oesophagitis
2%
Hyperuricaemia
2%
Disease progression
2%
Rash maculo-papular
2%
Pancytopenia
1%
Interstitial lung disease
1%
Flank pain
1%
Arterial rupture
1%
Osteoarthritis
1%
Mucosal infection
1%
Urosepsis
1%
Basosquamous carcinoma
1%
Actinic keratosis
1%
Dermatitis
1%
Laryngitis
1%
Subdural haematoma
1%
Pityriasis lichenoides et varioliformis acuta
1%
Enterococcal bacteraemia
1%
Back pain
1%
Lung infection
1%
Muscle contractions involuntary
1%
Squamous cell carcinoma of skin
1%
Toxic skin eruption
1%
Colitis ischaemic
1%
Hypopituitarism
1%
Cerebral ischaemia
1%
Stomatitis
1%
Non-cardiac chest pain
1%
Encephalitis
1%
Cardiac failure
1%
Campylobacter gastroenteritis
1%
Anxiety
1%
Staphylococcal skin infection
1%
Azotaemia
1%
Pneumonitis
1%
Nasopharyngitis
1%
Pneumonia haemophilus
1%
Pneumonia pneumococcal
1%
Pneumonia pseudomonas aeruginosa
1%
Psoriasis
1%
Squamous cell carcinoma
1%
Vena cava thrombosis
1%
Mouth ulceration
1%
Drug intolerance
1%
Transaminases increased
1%
Enterocolitis
1%
Staphylococcal bacteraemia
1%
Gastritis
1%
Mental impairment
1%
Pollakiuria
1%
Cardiac failure chronic
1%
Pneumonia cytomegaloviral
1%
Renal impairment
1%
Malignant melanoma
1%
Lung infiltration
1%
Pityriasis rubra pilaris
1%
H1N1 influenza
1%
Influenza
1%
Salmonellosis
1%
Toxicity to various agents
1%
Cerebrovascular accident
1%
Dizziness
1%
Dysuria
1%
Pleural effusion
1%
Aortic dissection
1%
Haemolytic anaemia
1%
Atrioventricular block complete
1%
Large intestinal ulcer
1%
Campylobacter infection
1%
Device related infection
1%
Acute myocardial infarction
1%
Multi-organ failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
IPI-145
Ofatumumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 4
~1860
Cyclophosphamide
2010
Completed Phase 4
~2310
Rituximab
1999
Completed Phase 4
~2990

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,205 Total Patients Enrolled
Verastem, Inc.Industry Sponsor
41 Previous Clinical Trials
2,803 Total Patients Enrolled
Secura Bio, Inc.Industry Sponsor
8 Previous Clinical Trials
187 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT02158091 — Phase 1 & 2
Chronic Lymphocytic Leukemia Research Study Groups: IPI-145
Chronic Lymphocytic Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02158091 — Phase 1 & 2
Cyclophosphamide (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02158091 — Phase 1 & 2
~3 spots leftby Nov 2025