What side effects are associated with this type of intervention?

Common treatments for Peripheral T-Cell Lymphoma (PTCL) include chemotherapy regimens such as CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) and immunotherapy agents like brentuximab vedotin. These treatments can cause a range of side effects. Chemotherapy often leads to cytopenias (low blood cell counts), gastrointestinal issues (nausea, vomiting, diarrhea), hair loss, and increased risk of infections. Immunotherapy can cause infusion reactions, peripheral neuropathy, and fatigue. Both treatment types may also result in liver function abnormalities and increased susceptibility to opportunistic infections.

What prior FDA approvals exist?

FDA-approved treatments for Peripheral T-Cell Lymphoma (PTCL) include pralatrexate, romidepsin, and belinostat, which are primarily chemotherapeutic agents and histone deacetylase inhibitors. These treatments do not specifically target viral replication like Letermovir, which is used to prevent cytomegalovirus reactivation in patients with hematological malignancies. Therefore, while there are effective treatments for PTCL, they do not share the same mechanism of action as Letermovir.

What other types of research exist?

Promising novel alternatives to Letermovir for preventing CMV reactivation in PTCL patients include maribavir and brincidofovir. Both have shown efficacy in clinical trials for CMV prophylaxis in patients with hematological malignancies.

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Virus Therapy

Letermovir for Preventing Infection in Blood Cancer Patients

Phase 2

Waitlist Available

Led By John C Reneau, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed diagnosis of T-cell or B-cell prolymphocytic leukemia, chronic lymphocytic leukemia, peripheral T-cell lymphoma, cutaneous T-cell lymphoma, or Sezary syndrome

Is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy

Must not have

Ganciclovir

CMV hyper-immune globulin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial studies how well letermovir prevents CMV reactivation in patients with blood cancers treated with alemtuzumab. Letermovir works by stopping the virus from making more copies of itself. The goal is to see if it can effectively prevent CMV infections in these patients. Letermovir is an antiviral drug approved for preventing CMV infections, primarily studied for a few months after treatment.

Who is the study for?

This trial is for adults with certain blood cancers (like leukemia or lymphoma) who are being treated with alemtuzumab and have a risk of cytomegalovirus reactivation. They must not be pregnant, should agree to use birth control, and cannot have severe kidney or liver problems, recent CMV disease, HIV with low CD4 count, or be on conflicting medications.

What is being tested?

The study tests if letermovir can prevent cytomegalovirus (CMV) infection in patients receiving alemtuzumab for blood cancers. It's a phase II trial where the effectiveness of letermovir as a preventive measure against CMV reactivation is being evaluated.

What are the potential side effects?

Letermovir may cause side effects like headaches, nausea, vomiting, diarrhea, coughing and potential allergic reactions. Since it targets virus replication specifically, it generally has fewer impacts on blood counts compared to other antiviral drugs.

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 a specific type of leukemia or lymphoma.

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It has been 6 weeks since my surgery to remove both ovaries, with or without uterus removal.

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I am capable of only limited self-care, confined to a bed or chair more than 50% of waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking or have taken Ganciclovir.

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I have received CMV hyper-immune globulin.

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My kidneys are in end stage disease with very low filtration.

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I have moderate liver and kidney problems.

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I take more than 20 mg of Atorvastatin daily.

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My liver function is severely impaired.

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I am taking Cyclosporine A.

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I haven't taken certain drugs in the last 7 days and won't during the study.

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I am taking high doses of Acyclovir.

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I am not taking any medications related to ergot alkaloids.

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I have had a stem cell transplant from a donor.

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I am taking more than 1500 mg of Famciclovir daily.

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I have not used experimental CMV treatments.

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I am not on any medications that are not allowed in the study due to an infection or disease.

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I am HIV positive with a CD4 count below 350 and on stable antiretroviral therapy.

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My liver function is moderately impaired.

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I am taking more than 3000 mg of Valacyclovir daily.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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

Cytomegalovirus (CMV) Reactivation

Secondary study objectives

Development of CMV Disease

Number of Participants With Adverse Events Grade 3 or Above

Overall Survival (OS)

+1 more

Other study objectives

Genotyping of Mutations in CMV Terminase Complex Genes

Side effects data

From 2016 Phase 3 trial • 570 Patients • NCT02137772

39%

Graft versus host disease

29%

Diarrhoea

28%

Nausea

24%

Rash

23%

Pyrexia

21%

Vomiting

17%

Cough

16%

Oedema peripheral

16%

Headache

15%

Cytomegalovirus infection

15%

Fatigue

13%

Abdominal pain

12%

Mucosal inflammation

12%

Decreased appetite

10%

Blood creatinine increased

10%

Dyspnoea

Hypertension

Acute kidney injury

Oropharyngeal pain

Insomnia

Erythema

Febrile neutropenia

Hyperkalaemia

Asthenia

Hyperglycaemia

Constipation

Arthralgia

Dizziness

Tremor

Dry skin

Pruritus

Alanine aminotransferase increased

Epistaxis

Thrombocytopenia

Dyspepsia

Stomatitis

Bacteraemia

Aspartate aminotransferase increased

Acute myeloid leukaemia recurrent

Anaemia

Dry eye

Abdominal pain upper

Dry mouth

Hypokalaemia

Hypomagnesaemia

Hyponatraemia

Back pain

Myalgia

Anxiety

Nasopharyngitis

Dysuria

Neutropenia

Chest pain

Pain in extremity

Dysgeusia

Hypotension

Pneumonia

Rhinorrhoea

Viraemia

Muscle spasms

Gastrooesophageal reflux disease

Acute lymphocytic leukaemia recurrent

Respiratory failure

Sepsis

Acute myeloid leukaemia

Hepatic function abnormal

Pneumonia bacterial

Gastrointestinal haemorrhage

Viral haemorrhagic cystitis

Multiple organ dysfunction syndrome

Sinusitis

Staphylococcal bacteraemia

Urinary tract infection

Pneumothorax

Venoocclusive liver disease

Squamous cell carcinoma

Plasma cell myeloma recurrent

Gastroenteritis

Herpes zoster

Pleural effusion

Pancytopenia

Bronchopulmonary aspergillosis

Cellulitis

Clostridium difficile colitis

Transplant failure

Myelodysplastic syndrome

Epstein-Barr virus infection

Gastroenteritis viral

Rhinovirus infection

Septic shock

Neurotoxicity

Acute lymphocytic leukaemia

Mantle cell lymphoma

Sciatica

Syncope

Cystitis haemorrhagic

Acute respiratory distress syndrome

Venoocclusive disease

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Letermovir

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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: Treatment (letermovir)Experimental Treatment1 Intervention

Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir PO (or IV over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Letermovir

FDA approved

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral T-Cell Lymphoma (PTCL) treatments primarily include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents, such as CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), work by killing rapidly dividing cancer cells. Targeted therapies, like brentuximab vedotin, target specific proteins on cancer cells to deliver cytotoxic agents directly, minimizing damage to normal cells. Immunotherapy, including checkpoint inhibitors like pembrolizumab, enhances the immune system's ability to recognize and destroy cancer cells. These treatments are crucial for PTCL patients as they offer multiple mechanisms to combat the aggressive nature of the disease, potentially improving survival rates and quality of life.