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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04824092




Registration number
NCT04824092
Ethics application status
Date submitted
22/03/2021
Date registered
1/04/2021

Titles & IDs
Public title
Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients
Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL)
Secondary ID [1] 0 0
MOR208C310
Universal Trial Number (UTN)
Trial acronym
frontMIND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tafasitamab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone
Treatment: Drugs - Tafasitamab placebo
Treatment: Drugs - Lenalidomide placebo

Experimental: Tafasitamab plus lenalidomide in addition to R-CHOP - Patients 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

Placebo comparator: Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP - Patients 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: Drugs: Tafasitamab
Tafasitamab IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Lenalidomide
Lenalidomide PO will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Rituximab
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Cyclophosphamide
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Doxorubicin
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Vincristine
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Prednisone
Prednisone PO will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Tafasitamab placebo
0.9% saline solution IV infusion will be administered as per the schedule specified in the respective arm.

Treatment: Drugs: Lenalidomide placebo
Placebo matching to lenalidomide PO will be administered as per the schedule specified in the respective arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PFS-INV
Timepoint [1] 0 0
Time from date of randomization until Progressive Disease or death from any cause. In this trial, the primary endpoint is PFS as assessed by the investigator (up to 43 months)
Secondary outcome [1] 0 0
EFS-INV
Timepoint [1] 0 0
From randomization until the first occurrence of disease progression or relapse as assessed by the INV using, start of new anti-lymphoma treatment or death from any cause, whichever occurs first (up to 43 months)
Secondary outcome [2] 0 0
OS
Timepoint [2] 0 0
From randomization until the date of death from any cause (up to 62 months)
Secondary outcome [3] 0 0
Metabolic PET-negative CR-rate at EOT by BIRC
Timepoint [3] 0 0
End of treatment, 4-8 weeks after last dose
Secondary outcome [4] 0 0
Metabolic PET-negative CR-rate at EOT by INV
Timepoint [4] 0 0
End of treatment, 4-8 weeks after last dose
Secondary outcome [5] 0 0
ORR as per INV at EOT
Timepoint [5] 0 0
6 ± 2 weeks after End of Treatment
Secondary outcome [6] 0 0
Time to next anti-lymphoma treatment (TTNT)
Timepoint [6] 0 0
From randomization date to start of next anti-lymphoma therapy (for any reason including disease progression, treatment toxicity, and patient preference) or death due to any cause, whatever comes first (up to 43 months)
Secondary outcome [7] 0 0
Duration of Complete Response (CR) as assessed by the investigator
Timepoint [7] 0 0
From the date of the first occurrence of a documented CR, to the date of progression, relapse, or death from any cause, whichever is earlier (up to 43 months)
Secondary outcome [8] 0 0
EFS at 3 years
Timepoint [8] 0 0
36 months after randomization
Secondary outcome [9] 0 0
PFS at 3 years
Timepoint [9] 0 0
36 months after randomization
Secondary outcome [10] 0 0
OS at 3 years
Timepoint [10] 0 0
36 months after randomization

Eligibility
Key inclusion criteria
Major

* Previously untreated patients with local biopsy-proven, CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms are eligible:

1. DLBCL, NOS including GCB type, ABC type
2. T-cell rich large BCL
3. Epstein-Barr virus-positive DLBCL, NOS
4. Anaplastic lymphoma kinase (ALK)-positive large BCL
5. Human herpes virus-8 (HHV8)-positive DLBCL, NOS
6. 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
7. HGBL-NOS
8. DLBCL coexistent with either follicular lymphoma (FL) of any grade, gastric MALT lymphoma or non-gastric MALT lymphoma
9. FL grade 3b
* 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)
* Diagnosis to treatment interval, defined as the time between the date of DLBCL diagnosis (date of the first biopsy specimen containing B Cell lymphoma according to the local pathology report) and the start of treatment (C1D1) = 28 days
* ECOG performance status of 0, 1, or 2
* Left ventricular ejection fraction equal to or greater 50% as assessed by local echocardiography or cardiac multi-gated acquisition (MUGA) scan
* Adequate hematologic function
* Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from breast feeding and donating eggs; agreement to ongoing pregnancy testing during the course of the study, and after study therapy has ended
* Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm

Major
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any other histological type of lymphoma according to WHO 2016 classification of lymphoid neoplasms, e.g., primary mediastinal (thymic) large B-cell lymphoma, Burkitt's lymphoma, BCL, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma); primary effusion lymphoma; primary cutaneous DLBCL, leg type; primary DLBCL of the CNS; DLBCL arising from CLL or indolent lymphoma
* History of prior non-hematologic malignancy except for the following:

1. Malignancy treated with curative intent and with no evidence of active disease present for more than 2 years before screening
2. Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer
3. Adequately treated carcinoma in situ without current evidence of disease
* Any systemic anti-lymphoma and/or investigational therapy prior to the start of C1D1, except for permitted pre-phase treatment
* Contraindication to any of the individual components of R-CHOP, including prior receipt of anthracyclines
* Known CNS lymphoma involvement
* Known active systemic bacterial, viral, fungal, or other infection at screening, including patients with suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
* History or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that in the investigator's opinion would preclude participation in the study or compromise the patient's ability to give informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
Accrual to date
Final
899
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
MorphoSys Research Site - Adelaide
Recruitment hospital [2] 0 0
MorphoSys Research Site - Ballarat
Recruitment hospital [3] 0 0
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Recruitment hospital [4] 0 0
MorphoSys Research Site - Brisbane
Recruitment hospital [5] 0 0
MorphoSys Research Site - Canberra
Recruitment hospital [6] 0 0
MorphoSys Research Site - Clayton
Recruitment hospital [7] 0 0
MorphoSys Research Site - Frankston
Recruitment hospital [8] 0 0
MorphoSys Research Site - Geelong
Recruitment hospital [9] 0 0
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MorphoSys Research Site - Wahroonga
Recruitment hospital [25] 0 0
MorphoSys Research Site - Waratah
Recruitment hospital [26] 0 0
MorphoSys Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3353 - Ballarat
Recruitment postcode(s) [3] 0 0
4575 - Birtinya
Recruitment postcode(s) [4] 0 0
4101 - Brisbane
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2605 - Canberra
Recruitment postcode(s) [6] 0 0
3168 - Clayton
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VIC 3199 - Frankston
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3220 - Geelong
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QLD 4217 - Gold Coast
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2250 - Gosford
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4120 - Greenslopes
Recruitment postcode(s) [12] 0 0
7000 - Hobart
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2747 - Kingswood
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2217 - Kogarah
Recruitment postcode(s) [15] 0 0
TAS 7250 - Launceston
Recruitment postcode(s) [16] 0 0
3144 - Malvern
Recruitment postcode(s) [17] 0 0
3065 - Melbourne
Recruitment postcode(s) [18] 0 0
3084 - Melbourne
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6009 - Nedlands
Recruitment postcode(s) [20] 0 0
6000 - Perth
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6150 - Perth
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3121 - Richmond
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3021 - St. Albans
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2050 - Sydney
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2145 - Sydney
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4817 - Townsville
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8833 - Wahroonga
Recruitment postcode(s) [28] 0 0
2298 - Waratah
Recruitment postcode(s) [29] 0 0
2500 - Wollongong
Recruitment outside Australia
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Cipolletti
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Linz
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Rankweil
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Fukuoka
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Gifu
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Osaka
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Incyte Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Incyte Medical Director
Address 0 0
Incyte Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04824092