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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Anaemia

Bronchitis

Colitis

Hypokalaemia

Weight decreased

Headache

Abdominal pain upper

Upper respiratory tract infection

Oedema peripheral

Urinary tract infection

Dyspepsia

Constipation

Respiratory tract infection

Pain in extremity

Influenza like illness

Renal failure acute

Sepsis

Gastrooesophageal reflux disease

Pseudomonal sepsis

Skin lesion

Dyspnoea

Pneumocystis jirovecii pneumonia

Febrile neutropenia

Hypertension

Respiratory failure

Vertigo

General physical health deterioration

Oesophagitis

Hyperuricaemia

Disease progression

Rash maculo-papular

Pancytopenia

Flank pain

Arterial rupture

Osteoarthritis

Interstitial lung disease

Urosepsis

Actinic keratosis

Dermatitis

Staphylococcal skin infection

Laryngitis

Subdural haematoma

Back pain

Lung infection

Muscle contractions involuntary

Toxic skin eruption

Colitis ischaemic

Hypopituitarism

Cerebral ischaemia

Stomatitis

Non-cardiac chest pain

Encephalitis

Cardiac failure

Pityriasis lichenoides et varioliformis acuta

Campylobacter gastroenteritis

Anxiety

Azotaemia

Pneumonitis

Nasopharyngitis

Pneumonia haemophilus

Pneumonia pneumococcal

Pneumonia pseudomonas aeruginosa

Psoriasis

Squamous cell carcinoma

Vena cava thrombosis

Mouth ulceration

Drug intolerance

Transaminases increased

Enterocolitis

Staphylococcal bacteraemia

Enterococcal bacteraemia

H1N1 influenza

Gastritis

Pollakiuria

Cardiac failure chronic

Pneumonia cytomegaloviral

Renal impairment

Lung infiltration

Pityriasis rubra pilaris

Squamous cell carcinoma of skin

Influenza

Salmonellosis

Cerebrovascular accident

Dysuria

Pleural effusion

Aortic dissection

Toxicity to various agents

Malignant melanoma

Dizziness

Mucosal infection

Basosquamous carcinoma

Mental impairment

Haemolytic anaemia

Atrioventricular block complete

Large intestinal ulcer

Campylobacter infection

Device related infection

Acute myocardial infarction

Multi-organ failure

100%

80%

60%

40%

20%

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