Tafasitamab for Lymphoma, Large B-Cell, Diffuse

Phase-Based Estimates
2
Effectiveness
3
Safety
MorphoSys Research Site, Eugene, OR
Lymphoma, Large B-Cell, Diffuse+3 More
Tafasitamab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Lymphoma, Large B-Cell, Diffuse

Study Summary

This study is evaluating whether a drug which targets a specific protein on white blood cells may help treat lymphoma.

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Eligible Conditions

  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma
  • Lymphoma, B-Cell
  • Diffuse Large B-cell Lymphoma

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Tafasitamab will improve 1 primary outcome and 9 secondary outcomes in patients with Lymphoma, Large B-Cell, Diffuse. Measurement will happen over the course of 36 months after randomization.

36 months after randomization
EFS at 3 years
OS at 3 years
PFS at 3 years
Week 2
MRD status at EOT
ORR as per INV at EOT
Week 8
Metabolic PET-negative CR-rate at EOT by BIRC
Metabolic PET-negative CR-rate at EOT by INV
Month 43
PFS-INV
Month 62
OS
Month 43
EFS-INV

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP
Tafasitamab plus lenalidomide in addition to R-CHOP
Placebo group

This trial requires 880 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tafasitamab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Tafasitamab plus lenalidomide in addition to R-CHOPPatients will receive tafasitamab plus lenalidomide in addition to R-CHOP for six 21-day cycles: Tafasitamab dose: 12 mg/kg body weight. Each 21-day cycle (cycles 1-6) will comprise of a tafasitamab IV infusion on Day 1, Day 8 and Day 15. Lenalidomide dose: 25 mg as a starting dose per os (orally) once per day on Days 1-10 of each 21-day cycle R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle
Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOPPatients will receive tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP for six 21-day cycles: Tafasitamab placebo: 0.9% saline solution Days 1, 8 and 15 of each 21-day cycle Lenalidomide placebo: Days 1-10 of each 21-day cycle R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
FDA approved
Lenalidomide
FDA approved
Tafasitamab
FDA approved
Vincristine
FDA approved
Prednisone
FDA approved
Rituximab
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization until the date of death from any cause (up to 62 months)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from randomization until the date of death from any cause (up to 62 months) for reporting.

Closest Location

MorphoSys Research Site - Eugene, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Lymphoma, Large B-Cell, Diffuse or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Availability of archival or freshly collected tumor tissue sent for retrospective central pathology review
IPI status of 3 to 5 (for patients > 60 years of age) or aaIPI 2 to 3 (for patients ≤ 60 years of age)
Human herpes virus-8 (HHV8)-positive DLBCL, NOS
DLBCL, NOS including GCB type, ABC type
T-cell rich large BCL
Epstein-Barr virus-positive DLBCL, NOS
Anaplastic lymphoma kinase (ALK)-positive large BCL
High-grade BCL with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma). Please note: Patients must be appropriate candidates for R-CHOP. If an investigator deems a patient with a known double- or triple-hit lymphoma (HGBL) should be treated more aggressively (e.g. dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab [DA-EPOCH-R] or cyclophosphamide, vincristine, doxorubicin and dexamethasone (CVAD) followed by methotrexate and cytarabine [Hyper CVAD]), this patient would not be considered eligible for this study
DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT lymphoma or non-gastric MALT lymphoma
FL grade 3b

Patient Q&A Section

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

What is lymphoma, large b-cell, diffuse?

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LBDL is an aggressive lymphoma that will frequently involve the bone marrow by the time it is diagnosed, typically involves one of the immunoglobulin gene families, and presents with a very poor to fair prognosis.

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What causes lymphoma, large b-cell, diffuse?

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Most patients with large B-cell, diffuse NHL were diagnosed with extranodal disease. The most common clinical features were B symptoms, bulky masses, and extranodal involvement. The prognosis of large B-cell, diffuse NHL was similar to large B-cell lymphomas of other sites.

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What are the signs of lymphoma, large b-cell, diffuse?

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LBCL, lg and LPD are often diagnosed in elderly patients but are also found in younger patients. The most common presenting signs are lymphadenopathy, abdominal pain and a history of previous malignancy. There is no difference in the clinical features between those with and without AIDS, and the risk of HIV positivity was low in this group.

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What are common treatments for lymphoma, large b-cell, diffuse?

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Treatment for large B-cell diffuse cutaneous lymphoma is dependent on the lymphoma stage at presentation and the patient's overall health. It usually consists of local therapy.

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How many people get lymphoma, large b-cell, diffuse a year in the United States?

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Although most lymphomas occur in people ages 40 to 60 years, the incidence of large B-cell diffuse lymphoma seems to be increasing in an age-independent way. Lymphoma, large B-cell diffuse, is estimated to be found in about 2,000 people in the United States per year. While the incidence of Hodgkin's lymphoma and non-Hodgkin's lymphoma are in decline, LZD seems to be becoming more important.

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Can lymphoma, large b-cell, diffuse be cured?

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[The cancer might be cured in 3 out of 7 cases of this lymphoma type] If it is treated, it is important that the disease does not come back. [The cancer might be cured in 3 out of 7 cases] Although it is not yet clear whether it is possible to cure the lymphoma, chemotherapy may improve the prognosis. It is important that the lymphoma is treated appropriately and that it is monitored carefully by physicians in order to detect any relapse. [The cancer might be cured in 3 out of 7 cases] Clinical trials aim to develop new drug or vaccine treatments for lymphoma, which may help the disease be cured. Clinical trials are available at [Power(https://www.withpower.

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Have there been any new discoveries for treating lymphoma, large b-cell, diffuse?

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There are few studies on new treatments for lymphoma, large b-cell, diffuse. We believe that future studies on combination treatments with new agents, and more intensive therapies with fewer side effects are needed.

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How serious can lymphoma, large b-cell, diffuse be?

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It can be quite serious for many patients. There is currently no evidence to help in the planning of treatment. In order for a good outcome, all patients need to be assessed and managed in an appropriate way. To achieve this, patients need to be offered a full course of medical assessment and treatment.

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What is the latest research for lymphoma, large b-cell, diffuse?

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In a large and well-studied cohort of diffuse large B-cell lymphomas, we found no evidence supporting increased mortality or morbidity after a course of chemotherapy plus rituximab. Results from a recent clinical trial suggest that chemotherapy with rituximab achieves response rates (complete response and partial response) similar to other regimens, and it is not associated with increased risk of secondary malignancy or chemotherapy induced myelosuppression.

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What are the chances of developing lymphoma, large b-cell, diffuse?

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The following characteristics were associated with developing large B-cell, diffuse: high cumulative number of genital warts, involvement of two or more internal organs, and having more than four warts on the vulva. With a total of 6,507 cases identified in the current analysis, the incidence for large B-cell, diffuse was 0.5% and the 5-year OS was 90%. A future prospective cohort study of the incidence of large B-cell, diffuse versus small B-cell, non-diffuse will be required.

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Does tafasitamab improve quality of life for those with lymphoma, large b-cell, diffuse?

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The improvement in QoL over time was significant in this pilot study at a dose of 400mg/m(2) and supports the use of tafasitamab and further investigation as a treatment for patients with NHL.

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Has tafasitamab proven to be more effective than a placebo?

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Tafasitinib showed promise in reducing progression of relapsing-remitting multiple sclerosis, however, with no difference from placebo in disability at 16 weeks of treatment, nor improvement in cognitive or brain MRI measures at 12 weeks of treatment. Data from a recent study suggest that tafasitinib has minimal systemic effects with no clinical benefit at the time of onset. Further safety and efficacy trial of tafasitinib and a longer duration of treatment are recommended.

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