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Immunomodulatory imide drugs (IMiDs)

Tafasitamab for Central Nervous System Lymphoma

Phase 1 & 2

Recruiting

Led By James Rubenstein, MD, PhD

Research Sponsored by James Rubenstein

Eligibility Criteria Checklist

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

Must have

Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

Participants must have histologically or cytologically confirmed relapsed primary or secondary B-cell CNS lymphoma, DLBCL type (recurrence documented by flow-cytometry is also acceptable).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial will test a new combination therapy for relapsed central nervous system lymphoma. This is the first study to use this particular therapy, which includes an anti-CD19 antibody and an immunomodulatory drug, in patients with this type of lymphoma. The hypothesis is that the therapy will increase blood-brain barrier permeability, which could have wide-ranging implications.

Who is the study for?

Adults with relapsed B-cell CNS lymphoma, including those who've had stem cell transplants but not recent anti-cancer treatments or certain other therapies. Must have good organ function and no serious medical issues that could affect safety. Women of childbearing age must agree to pregnancy testing and use contraception.Check my eligibility

What is being tested?

The trial is exploring the effectiveness of Tafasitamab combined with Lenalidomide in patients with relapsed CNS lymphoma. It's an open-label study, meaning everyone knows what treatment they're getting, focusing on how well this combination crosses the blood-brain barrier.See study design

What are the potential side effects?

Potential side effects include reactions related to the immune system, such as infusion reactions from Tafasitamab and birth defects if taken during pregnancy due to Lenalidomide. Other risks may involve changes in blood counts and liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

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My B-cell CNS lymphoma has returned, confirmed by tests.

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My hepatitis B virus load is undetectable with treatment.

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My blood counts and liver/kidney functions are within normal ranges.

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My cancer has spread to my brain, spinal cord, and eyes.

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I have had treatment specifically for lymphoma in my brain.

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I am mostly active and can care for myself.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) (Phase 1)

Percentage of participants with demonstrated Clinical Benefit Rate (CBR) (Phase 2)

Proportion of participants with dose limiting toxicities (DLTs) (Phase 1)

+1 more

Secondary outcome measures

Median Overall Survival (OS)

Median Progression-free survival (PFS) (Phase 2)

Proportion of participants with Treatment-Related Adverse Events

Side effects data

From 2023 Phase 2 trial • 81 Patients • NCT02399085

64%

Any TEAE

49%

Neutropenia

37%

Diarrhoea

37%

Anaemia

30%

Cough

28%

Thrombocytopenia

26%

Asthenia

25%

Oedema peripheral

22%

Pyrexia

22%

Decreased appetite

20%

Back pain

19%

Hypokalaemia

19%

Constipation

16%

Fatigue

15%

Vomiting

15%

Bronchitis

15%

Muscle spasms

15%

Nausea

12%

Leukopenia

12%

Urinary tract infection

12%

Dyspnoea

11%

Respiratory tract infection

11%

C-reactive protein increased

10%

Abdominal pain

10%

Nasopharyngitis

10%

Upper respiratory tract infection

10%

Pruritus

10%

Rash

10%

Pain in extremity

10%

Hypomagnesaemia

Rhinitis

Pneumonia

Headache

Paraesthesia

Blood creatinine increased

Hypertension

Sinusitis

Abdominal pain upper

Mucosal inflammation

Gastroenteritis

Gamma-glutamyltransferase increased

Anxiety

Oropharyngeal pain

Arthralgia

Hypotension

Dysuria

Febrile neutropenia

Blood alkaline phosphatase increased

Sciatica

Hyperglycaemia

Productive cough

Rash maculo-papular

Lymphopenia

Hypocalcaemia

Hypogammaglobulinaemia

Infusion related reaction

COVID-19

Pulmonary embolism

Basal cell carcinoma

Lower respiratory tract infection

Squamous cell carcinoma

Atrial fibrillation

Cardiac failure congestive

Cardio-respiratory arrest

Escherichia bacteraemia

Lung adenocarcinoma

Gastroenteritis rotavirus

Cerebrovascular accident

Cholecystitis

Haematoma

Influenza

Cervicobrachial syndrome

Bowen's disease

Bronchopulmonary aspergillosis

Febrile infection

Transient ischaemic attack

Myelodysplastic syndrome

Transient global amnesia

Sudden death

Breast cancer

Myeloproliferative neoplasm

COVID-19 pneumonia

Klebsiella sepsis

Enterobacter bacteraemia

Intervertebral discitis

Prostate cancer

Cytomegalovirus infection

Neutropenic sepsis

Parainfluenzae virus infection

Progressive multifocal leukoencephalopathy

Respiratory syncytial virus infection

Sepsis

Soft tissue infection

Streptococcal sepsis

Urinary tract infection enterococcal

Varicella zoster virus infection

Lower limb fracture

Wound complication

Tumour flare

Biliary colic

Muscular weakness

Agranulocytosis

Cardiac failure

Myocardial ischaemia

Cognitive disorder

Facial paralysis

Chronic obstructive pulmonary disease

Respiratory failure

Arthritis

Osteonecrosis

Pathological fracture

Femur fracture

Renal failure

Deep vein thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (MOR00208, Lenalidomide)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2 (Tafasitamab, Lenalidomide)Experimental Treatment2 Interventions

Participants will be given 12mg of Tafasitamab on days 1, 4, 8, 15, and 22 of cycle 1, days 1, 8, 15, and 22 of cycles 2 & 3, and days 1 and 15 for any cycle thereafter. Participants will also be given daily Lenalidomide on days 1-21 of each cycle at the recommended phase 2 dose.

Group II: Phase 1 (Tafasitamab, Lenalidomide)Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tafasitamab

2016

Completed Phase 2

~180

Lenalidomide

2005

Completed Phase 3

~1480

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

James RubensteinLead Sponsor

2 Previous Clinical Trials

39 Total Patients Enrolled

Incyte CorporationIndustry Sponsor

367 Previous Clinical Trials

55,372 Total Patients Enrolled

James Rubenstein, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco

3 Previous Clinical Trials

86 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available slots for participants of this research project?

"Data hosted on clinicaltrials.gov demonstrates that this medical experiment is actively seeking participants, with the initial announcement posted on June 8th 2022 and a recent update dated August 10th 2022."

Answered by AI

What is the scope of individuals participating in this medical experiment?

"Affirmative. The clinical trial, which was unveiled on 8th June 2022 and revised most recently on 10th August 2022 is currently open for recruitment. 35 patients must be recruited from a single medical site to meet the study's criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma

James Rubenstein 2022. "Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05351593.