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CompletedNCT02399085L-MINDUpdated Oct 23, 2023Results posted

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

A Phase 2 interventional study of Tafasitamab and Lenalidomide in Diffuse Large B-cell Lymphoma, sponsored by MorphoSys AG. Completed at 57 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by MorphoSys AG · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
81
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL).

Read the detailed description

The aim of this single-arm, multicentre, open-label Phase II study is to evaluate the Lenalidomide (LEN) combined with Tafasitamab (MOR00208) in adult participants with DLBCL who had relapsed after or were refractory to at least one, but no more than three previous systemic regimens administered for the treatment of their DLBCL and who were not candidates for high-dose chemotherapy and subsequent Autologous stem cell transplants and were thus considered to have exhausted their therapeutic options. One prior therapy line had to include an anti-CD20 targeted therapy (e.g., rituximab [RTX]).

MOR00208 and LEN were administered for up to 12 cycles (28 days each), followed by MOR00208 monotherapy until progression, in participants with at least stable disease or a better response.

02

Conditions studied

  • Diffuse Large B-cell Lymphoma

Keywords

  • DLBCL
  • Efficacy
  • MOR00208
  • Tafasitamab
  • lenalidomide
03

In context

Lymphoma

5,577 studies on the registry are indexed under Lymphoma; 824 are open to participants now.

This study's enrollment of 81 is above the median of 40 across 4,507 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

MorphoSys AG is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Major Inclusion Criteria:

  1. Age >18 years
  2. Histologically confirmed diagnosis of DLBCL
  3. Tumour tissue for central pathology review and correlative studies had to be provided.

  4. Participants must had:

    • relapsed and/or refractory disease
    • at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)
    • received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must had included a CD20-targeted therapy
    • Eastern Cooperative Oncology Group 0 to 2
  5. Participants were not considered in the opinion of the investigator eligible, or participants unwilling to undergo intensive salvage therapy including ASCT

  6. Participants had to meet the following laboratory criteria at screening:

    • absolute neutrophil count ≥1.5 × 10˄9/L
    • platelet count ≥90 × 10˄9/L
    • total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma
    • alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or \<5 × ULN in cases of liver involvement
    • serum creatinine clearance ≥60 mL/minute

  7. Females of childbearing potential (FCBP) must:

    • not be pregnant
    • refrain from breastfeeding and donating blood or oocytes
    • agreed to ongoing pregnancy testing
    • committed to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception

  8. Males (if sexually active with a FCBP) had to

    • use an effective barrier method of contraception
    • refrain from donating blood or sperm

  9. In the opinion of the investigator the participants had to:

    • be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events
    • be able to understand, give written informed consent and comply with all study-related procedures, medication use, and evaluations
    • had no history of noncompliance in relation to medical regimens or not be considered potentially unreliable and/or uncooperative
    • be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and gave written acknowledgement of this.

Major Exclusion Criteria:

  1. Participants who had:

    • other histological type of lymphoma
    • primary refractory DLBCL
    • a history of "double/triple hit" genetics

  2. Participants who had, within 14 days prior to Day 1 dosing:

    • not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
    • underwent major surgery or suffered from significant traumatic injury
    • received live vaccines.
    • required parenteral antimicrobial therapy for active, intercurrent infections

  3. Participants who:

    • had, in the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies
    • were previously treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs)® (e.g., thalidomide, LEN)
    • had a history of hypersensitivity to compounds of similar biological or chemical composition to MOR00208, IMiDs® and/or the excipients contained in the study drug formulations
    • had undergone ASCT within the period ≤ 3 months prior to the signing of the Informed Consent Form. Patients who had a more distant history of ASCT had to exhibit full haematological recovery before enrolment into the study
    • had undergone previous allogenic stem cell transplantation
    • had a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or were at a high risk for a thromboembolic event in the opinion of the investigator and who were not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
    • concurrently used other anti-cancer or experimental treatments
  4. Prior history of malignancies other than DLBCL, unless the participant had been free of the disease for ≥5 years prior to screening.

  5. Participants with:

    • positive hepatitis B and/or C serology.
    • known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
    • CNS lymphoma involvement
    • history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromised the participant's ability to give informed consent.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    Tafasitamab (MOR00208) + lenalidomide (LEN)

    MOR00208: MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle. LEN: Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.

    Drug: Tafasitamab · Drug: Lenalidomide

Interventions

  • DrugTafasitamab

    12 mg/kg

    Also known as: MOR00208

  • DrugLenalidomide

    25 mg

    Also known as: LEN, Revlimid®

06

What researchers measure

Primary outcomes

  1. Number of Participants With Best Objective Response Rate (ORR)

    ORR = complete response \[CR\] + partial response \[PR\]; Independent Radiology/Clinical Review Committee (IRC) Evaluation. ORR after MOR00208 and Lenalidomide combination therapy assessed by the IRC evaluation. ORR was defined as the number of participants of the total number of participants treated with MOR00208 + LEN with CR or PR as best response achieved at any time during the study.

    Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

Secondary outcomes

  1. Duration of Response (DoR) by IRC Evaluation

    DoR \[months\] = (date of assessment of tumor progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.

    Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

  2. DoR by Investigator (INV) Evaluation

    DoR \[months\] = (date of assessment of tumour progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.

    Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

  3. Progression-free Survival (PFS) by IRC Evaluation

    PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.

    Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

  4. PFS by INV Evaluation

    PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.

    Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

  5. Overall Survival (OS)

    OS was defined as the time from the date of the first administration of any study drug until death from any cause (documented by the date of death).

    Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

  6. Disease Control Rate (DCR) by IRC Evaluation

    DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.

    Time frame: Approximately 2.5 years after first participant enrolled

  7. DCR by INV Evaluation

    DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.

    Time frame: Approximately 2.5 years after first participant enrolled

  8. Time to Progression (TTP) by IRC Evaluation

    TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.

    Time frame: Approximately 2.5 years after first participant enrolled

  9. TTP by INV Evaluation

    TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.

    Time frame: Approximately 2.5 years after first participant enrolled

  10. Time to Next Treatment (TTNT)

    Kaplan-Meier analysis of TTNT in FAS population. TTNT is defined as the time from the first administration of any study drug to the institution of next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity and participant preference) or death of any cause, whatever comes first.

    Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

  11. Event-free Survival (EFS) by IRC Evaluation

    EFS is defined as the time (in months) from the date of the first administration of any study drug to the date of tumour progression, first initiation of a new non-study anti-neoplastic therapy or death from any cause whichever comes first.

    Time frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled

  12. Serum Drug Levels of MOR00208

    The pharmacokinetics (PK) profile of MOR00208 was investigated by quantifying serum drug levels at baseline and after repeated IV administrations for up to 24 treatment cycles using sparse sampling. MOR00208 PK sample was taken pre-dose and 1 hour ± 10 min after the end of MOR00208 infusion for Cycle 1 to Cycle 23. MOR00208 PK sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21, 23).

    Time frame: Cycle 1 Days 1, 4, 15 predose and 1 hr post-dose; Cycle 2 Days 1, 15 predose and 1 hr post-dose; Cycle 3 Days 1, 15 predose and 1 hr post-dose; Cycles 4, 5, 6, 7, 9, 11,13, 15, 17, 19, 21, 23 Day 1 predose; End of Treatment

  13. Number of Participants Who Developed Anti-MOR00208 Antibodies

    The Anti-MOR00208 Antibodies were investigated by quantifying serum drug levels at baseline and after repeated intravenous (IV) administrations planned for up to 24 treatment cycles using sparse sampling. Anti-MOR00208 antibody sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21,23).

    Time frame: Baseline, Up to a maximum of 23 cycles.

  14. Number of Participants That Experienced Treatment-emergent Adverse Events (TEAEs)

    TEAEs are defined as any adverse event reported in the following time interval (including the lower and upper limits): date of first administration of study treatment; date of last administration of study treatment + 30 days, or if they are considered to be related to the study drug.

    Time frame: Approximately 6.5 years after first participant enrolled

  15. Severity of Treatment-emergent Adverse Events (TEAEs)

    Number of participants with Severity of TEAEs during MOR00208 and LEN combination therapy.

    Time frame: Approximately 6.5 years after first participant enrolled

07

Results

Posted Feb 5, 2020

Participant flow

The participants were enrolled into this study at sites in Hungary, Belgium, Czechia, France, Poland, Italy, Germany, Spain, United Kingdom, and the United States.

Participant flow — Overall Study
MilestoneTreatment (MOR00208, Lenalidomide)
Started81
Received mor00208 + len80
Received mor00208 only1
Completed: participants who were still on treatment at eos8
Not completed: participants who were no longer receiving treatment at eos73
Completed8
Not completed73
Withdrew: Adverse event16
Withdrew: Death2
Withdrew: Withdrawal by subject8
Withdrew: Progressive disease/ disease relapse42
Withdrew: Physician decision5

Outcome measures

PrimaryNumber of Participants With Best Objective Response Rate (ORR)

ORR = complete response \[CR\] + partial response \[PR\]; Independent Radiology/Clinical Review Committee (IRC) Evaluation. ORR after MOR00208 and Lenalidomide combination therapy assessed by the IRC evaluation. ORR was defined as the number of participants of the total number of participants treated with MOR00208 + LEN with CR or PR as best response achieved at any time during the study.

Time frame:
Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Reported as:
Count of participants · Participants
Number of Participants With Best Objective Response Rate (ORR)
ParticipantsTreatment (MOR00208, Lenalidomide)
Approximately 4.5 years after first participant enrolled46
Approximately 6.5 years after first participant enrolled46
SecondaryDuration of Response (DoR) by IRC Evaluation

DoR \[months\] = (date of assessment of tumor progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.

Time frame:
Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Reported as:
Median · Months
Duration of Response (DoR) by IRC Evaluation
MonthsTreatment (MOR00208, Lenalidomide)
Approximately 4.5 years after first participant enrolled43.9 (26.1 to NA)
Approximately 6.5 years after first participant enrolledNA (33.8 to NA)
SecondaryDoR by Investigator (INV) Evaluation

DoR \[months\] = (date of assessment of tumour progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.

Time frame:
Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Reported as:
Median · Months
DoR by Investigator (INV) Evaluation
MonthsTafasitamab (MOR00208) + Lenalidomide (LEN)
Approximately 4.5 years after first participant enrolled43.9 (13.9 to NA)
Approximately 6.5 years after first participant enrolled43.4 (14.1 to NA)
SecondaryProgression-free Survival (PFS) by IRC Evaluation

PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.

Time frame:
Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Reported as:
Median · Months
Progression-free Survival (PFS) by IRC Evaluation
MonthsTafasitamab (MOR00208) + Lenalidomide (LEN)
Approximately 4.5 years after first participant enrolled11.6 (6.3 to 45.7)
Approximately 6.5 years after first participant enrolled11.6 (5.7 to 45.7)
SecondaryPFS by INV Evaluation

PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.

Time frame:
Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Reported as:
Median · Months
PFS by INV Evaluation
MonthsTafasitamab (MOR00208) + Lenalidomide (LEN)
Approximately 4.5 years after first participant enrolled9.1 (5.5 to 28.0)
Approximately 6.5 years after first participant enrolled9.1 (5.5 to 45.5)
SecondaryOverall Survival (OS)

OS was defined as the time from the date of the first administration of any study drug until death from any cause (documented by the date of death).

Time frame:
Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Reported as:
Median · Months
Overall Survival (OS)
MonthsTafasitamab (MOR00208) + Lenalidomide (LEN)
Approximately 4.5 years after first participant enrolled33.5 (18.3 to NA)
Approximately 6.5 years after first participant enrolled33.5 (18.3 to NA)
SecondaryDisease Control Rate (DCR) by IRC Evaluation

DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.

Time frame:
Approximately 2.5 years after first participant enrolled
Reported as:
Count of participants · Participants
Disease Control Rate (DCR) by IRC Evaluation
ParticipantsTafasitamab (MOR00208) + Lenalidomide (LEN)
Disease Control Rate (DCR) by IRC Evaluation59
SecondaryDCR by INV Evaluation

DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.

Time frame:
Approximately 2.5 years after first participant enrolled
Reported as:
Count of participants · Participants
DCR by INV Evaluation
ParticipantsTafasitamab (MOR00208) + Lenalidomide (LEN)
DCR by INV Evaluation60
SecondaryTime to Progression (TTP) by IRC Evaluation

TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.

Time frame:
Approximately 2.5 years after first participant enrolled
Reported as:
Median · Months
Time to Progression (TTP) by IRC Evaluation
MonthsTafasitamab (MOR00208) + Lenalidomide (LEN)
Time to Progression (TTP) by IRC Evaluation16.2 (7.4 to NA)
SecondaryTTP by INV Evaluation

TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.

Time frame:
Approximately 2.5 years after first participant enrolled
Reported as:
Median · Months
TTP by INV Evaluation
MonthsTafasitamab (MOR00208) + Lenalidomide (LEN)
TTP by INV Evaluation14.1 (6.3 to NA)
SecondaryTime to Next Treatment (TTNT)

Kaplan-Meier analysis of TTNT in FAS population. TTNT is defined as the time from the first administration of any study drug to the institution of next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity and participant preference) or death of any cause, whatever comes first.

Time frame:
Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Reported as:
Median · Months
Time to Next Treatment (TTNT)
MonthsTafasitamab (MOR00208) + Lenalidomide (LEN)
Approximately 4.5 years after first participant enrolled12.1 (7.3 to 24.7)
Approximately 6.5 years after first participant enrolled12.5 (7.3 to 28)
SecondaryEvent-free Survival (EFS) by IRC Evaluation

EFS is defined as the time (in months) from the date of the first administration of any study drug to the date of tumour progression, first initiation of a new non-study anti-neoplastic therapy or death from any cause whichever comes first.

Time frame:
Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Reported as:
Median · Months
Event-free Survival (EFS) by IRC Evaluation
MonthsTafasitamab (MOR00208) + Lenalidomide (LEN)
Approximately 4.5 years after first participant enrolled8.7 (5.3 to 21.0)
Approximately 6.5 years after first participant enrolled9.1 (5.3 to 23.5)
SecondarySerum Drug Levels of MOR00208

The pharmacokinetics (PK) profile of MOR00208 was investigated by quantifying serum drug levels at baseline and after repeated IV administrations for up to 24 treatment cycles using sparse sampling. MOR00208 PK sample was taken pre-dose and 1 hour ± 10 min after the end of MOR00208 infusion for Cycle 1 to Cycle 23. MOR00208 PK sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21, 23).

Time frame:
Cycle 1 Days 1, 4, 15 predose and 1 hr post-dose; Cycle 2 Days 1, 15 predose and 1 hr post-dose; Cycle 3 Days 1, 15 predose and 1 hr post-dose; Cycles 4, 5, 6, 7, 9, 11,13, 15, 17, 19, 21, 23 Day 1 predose; End of Treatment
Reported as:
Mean · ng/mL
Serum Drug Levels of MOR00208
ng/mLTafasitamab (MOR00208) + Lenalidomide (LEN)
Cycle 1 Day 1 (Predose)6.7 ± 53.09
Cycle 1 Day 1 (1 hour post dose)249075.9 ± 53724.93
Cycle 1 Day 4 (pre-dose)126306.8 ± 39105.37
Cycle 1 Day 4 (1 hour post-dose)363626.2 ± 82971.54
Cycle 1 Day 15 (pre dose)157722.3 ± 50655.86
Cycle 1 Day 15 (1 hour post-dose)396262.1 ± 97215.09
Cycle 2 Day 1 (predose)181870.8 ± 72582.62
Cycle 2 Day 1 (1 hour post-dose)439788.2 ± 126930.55
Cycle 2 Day 15 (Pre Dose)217846.9 ± 77799.93
Cycle 2 Day 15 (1 hour post-dose) )442940.2 ± 85475.90
Cycle 3 Day 1 (predose)208520.6 ± 68866.46
Cycle 3 Day 1 (1 hour post-dose)466135.8 ± 112647.31
Cycle 3 Day 15 (predose)223909.4 ± 85170.91
Cycle 3 Day 15 (1 hour post-dose)455635.0 ± 104198.64
Cycle 4 Day 1 (predose) )216328.4 ± 94553.25
Cycle 5 Day 1 (pre dose)142134.4 ± 72691.16
Cycle 6 Day 1 (pre dose)115132.3 ± 55774.77
Cycle 7 Day 1 (pre dose)114661.5 ± 73328.15
Cycle 9 Day 1 (pre dose)108640.4 ± 52282.72
Cycle 11 Day 1 (pre dose)126472.0 ± 64872.47
Cycle 13 Day 1 (pre dose)100853.5 ± 61229.42
Cycle 15 Day 1 (pre dose)159676.5 ± 61199.32
Cycle 17 Day 1 (pre dose)175855.1 ± 64592.17
Cycle 19 Day 1 (pre dose)197045.0 ± 69962.05
Cycle 21 Day 1 (pre dose)197228.0 ± 53222.03
Cycle 23 Day 1 (pre dose)224253.3 ± 64686.85
End of Treatment141240.7 ± 114804.40
SecondaryNumber of Participants Who Developed Anti-MOR00208 Antibodies

The Anti-MOR00208 Antibodies were investigated by quantifying serum drug levels at baseline and after repeated intravenous (IV) administrations planned for up to 24 treatment cycles using sparse sampling. Anti-MOR00208 antibody sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21,23).

Time frame:
Baseline, Up to a maximum of 23 cycles.
Reported as:
Count of participants · Participants
Number of Participants Who Developed Anti-MOR00208 Antibodies
ParticipantsTafasitamab (MOR00208) + Lenalidomide (LEN)
Yes (Treatment-emergent ADAs)0
No (Negative baseline and post baseline results)72
Not evaluable (Positive baseline results)2
Missing (No post baseline results available)7
SecondaryNumber of Participants That Experienced Treatment-emergent Adverse Events (TEAEs)

TEAEs are defined as any adverse event reported in the following time interval (including the lower and upper limits): date of first administration of study treatment; date of last administration of study treatment + 30 days, or if they are considered to be related to the study drug.

Time frame:
Approximately 6.5 years after first participant enrolled
Reported as:
Count of participants · Participants
Number of Participants That Experienced Treatment-emergent Adverse Events (TEAEs)
ParticipantsTafasitamab (MOR00208) + Lenalidomide (LEN)
Number of Participants That Experienced Treatment-emergent Adverse Events (TEAEs)81
SecondarySeverity of Treatment-emergent Adverse Events (TEAEs)

Number of participants with Severity of TEAEs during MOR00208 and LEN combination therapy.

Time frame:
Approximately 6.5 years after first participant enrolled
Reported as:
Count of participants · Participants
Severity of Treatment-emergent Adverse Events (TEAEs)
ParticipantsTafasitamab (MOR00208) + Lenalidomide (LEN)
Severe43
Moderate31
Mild6
Missing1

Adverse events

Collected over From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (MOR00208, Lenalidomide)45/81 (55.6%)47/81 (58%)75/81 (92.6%)
Most frequent serious events
Showing 10 of 67
Most frequent serious events
EventTreatment (MOR00208, Lenalidomide)
PneumoniaInfections and infestations7/81
Febrile neutropeniaBlood and lymphatic system disorders5/81
Pulmonary embolismRespiratory, thoracic and mediastinal disorders3/81
COVID-19Infections and infestations3/81
BronchitisInfections and infestations2/81
Lower respiratory tract infectionInfections and infestations2/81
Atrial fibrillationCardiac disorders2/81
Cardiac failure congestiveCardiac disorders2/81
DyspnoeaRespiratory, thoracic and mediastinal disorders2/81
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/81
Most frequent other events
Showing 10 of 54
Most frequent other events
EventTreatment (MOR00208, Lenalidomide)
NeutropeniaBlood and lymphatic system disorders40/81
AnaemiaBlood and lymphatic system disorders30/81
DiarrhoeaGastrointestinal disorders30/81
CoughRespiratory, thoracic and mediastinal disorders24/81
ThrombocytopeniaBlood and lymphatic system disorders23/81
AstheniaGeneral disorders21/81
Oedema peripheralGeneral disorders20/81
PyrexiaGeneral disorders18/81
Decreased appetiteMetabolism and nutrition disorders18/81
Back painMusculoskeletal and connective tissue disorders16/81

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treatment (MOR00208, Lenalidomide)
<=18 years0
Between 18 and 65 years23
>=65 years58
Age, Continuous
Age, Continuous(years)Treatment (MOR00208, Lenalidomide)
Mean69.3 ± 9.53
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (MOR00208, Lenalidomide)
Female37
Male44
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (MOR00208, Lenalidomide)
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American0
White72
More than one race0
Unknown or Not Reported7
Region of Enrollment
Region of Enrollment(Participants)Treatment (MOR00208, Lenalidomide)
Hungary7
Belgium5
United States6
Czechia3
Poland7
Italy13
United Kingdom5
France9
Germany11
Spain15
08

Study locations

57 sites
  • CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
    Bakersfield, California 93309, United States
  • UCLA - David Geffen School of Medicine
    Los Angeles, California 90095, United States
  • Cancer Care - Torrance Memorial Physician Network
    Redondo Beach, California 90277, United States
  • Central Coast Medical Oncology Corporation
    Santa Maria, California 93454, United States
  • St. Mary's Hospital And Regional Medical Center
    Grand Junction, Colorado 81501, United States
  • Norwalk Hospital
    Norwalk, Connecticut 06856, United States
  • St. Joseph Mercy Hospital Cancer Care Center
    Ypsilanti, Michigan 48179, United States
  • Ohio State University Medical Center
    Columbus, Ohio 43210, United States
  • Charleston Hematology Oncology Associates
    Charleston, South Carolina 29414, United States
  • Tyler Hematology-Oncology
    Tyler, Texas 75701, United States
  • ZNA Middelheim dep Klinische studies Hematologie
    Antwerp, 2020, Belgium
  • AZ Groeninge-Campus Maria's Voorzienigheid
    Kortrijk, 8500, Belgium
  • Centre Hospitalier Universitaire (CHU) de Liege
    Liege, 4000, Belgium
  • Clinique Universitaire de Mont Godinne
    Yvoir, 5530, Belgium
  • University Hospital Olomouc Hematoonkologicka klinika
    Olomouc, 779 00, Czechia
  • CHU De Clermont Ferrand - Hopital Estaing Service Hematologie Clinique Et Thrapie Cellulaire
    Clermont-Ferrand, 63000, France
  • Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
    Limoges, 87042, France
  • Centre Hospitalier Lyon-Sud (CHLS)
    Lyon, 69495, France
  • Hopital Universitaire Necker Enfants Malades Service de Hematologie Adultes
    Paris, 75015, France
  • Universitatsklinikum Essen, Abteilung Haematologie
    Essen, 45147, Germany
  • Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
    Frankfurt, 60488, Germany
  • Klinikum Grosshadern-Klinikum Der Ludwig-Maximilian Universitaet Muenchen
    Munich, 81337, Germany
  • Klinikum Nuernberg Nord Medizinische Klinik 5 Hamatologie
    Nürnberg, 90419, Germany
  • Universitaetsklinikum Wuerzburg
    Würzburg, 97080, Germany
  • Semmelweis Egyetem I. Sz. Belgyogyaszati Klinika-Semmelweis University
    Budapest, 1038, Hungary
  • National Institute of Oncology Hematological Department
    Budapest, 1122, Hungary
  • DEKK, Belgyogyaszati Klinika
    Debrecen, 4032, Hungary
  • Somogy Megyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital)
    Kaposvár, 7400, Hungary
  • Azienda Ospedaliera Univerisitaria Policlinico Consorziale Di Bari UOC Ematologia con Trapianto
    Bari, 70124, Italy
  • Ist.Ematologia E Oncologia Medica L.E A.Seragnoli Azienda Ospedaliero-Universitaria, Policlinico S.Orsola-Malpighi
    Bologna, 40138, Italy
  • Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica
    Firenze, 50134, Italy
  • Azienda Ospedaliero - Universitaria Policlinico di Modena Dip di Medicina Diagnostica, Clinica e di Sanità Pubblica
    Modena, 41124, Italy
  • AOU Maggiore della Cartia
    Novara, 28100, Italy
  • A .O. S. Maria della Misericordia
    Perugia, 6132, Italy
  • Tor Vergata University Department Of Hematology
    Roma, 00133, Italy
  • Az Ospedaliera Santa Maria Facolta di Medicina e Chirurgia
    Terni, 5100, Italy
  • A.O.U. Citta della Salute e della Scienza di Torino
    Torino, 10126, Italy
  • Pratia MCM Krakow
    Krakow, 30-510, Poland
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmimsko
    Olsztyn, 10228, Poland
  • Szpital Wojewodzk I w Opolu SP ZOZ Oddzial Hematologii i Onkologii Hematologicznej
    Opole, 45061, Poland
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Poznaniu im. prof. Ludwika Bierkowskiego
    Poznan, 60631, Poland
  • Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie
    Rzeszow, 35055, Poland
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
    Warsaw, 02781, Poland
  • MTZ Clinical Research Sp. z o.o
    Warszawa, 02106, Poland
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Klinika Nowotworow Ukladu Chlonnego Ul.
    Warszawa, 02781, Poland
  • Hospital Universitari Germans Trias i Pujol (HUGTP)
    Badalona, 08916, Spain
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
  • Institut Catala D'Oncologia-Hospital Duran Y Reynals
    Barcelona, 08097, Spain
  • Hospital Universitario Fundacion Jimenez Diaz Servicio de Hematologia Unidad de Linformas Oncohealth Institute
    Madrid, 28040, Spain
  • Hospital Universitario Puerta de Hierro de Majadahonda
    Madrid, 28222, Spain
  • Complejo Hospitalario de Navarra (CHN)
    Pamplona, 31008, Spain
  • Hospital Universitario Quiron Salud Madrid
    Pozuelo De Alarcón, 28223, Spain
  • Hospital Universitario Virgen del Rocio, Hospital de la Mujer Servicio de Hematologia
    Sevilla, 41013, Spain
  • The Royal Bournemouth & Christchurch Hospitals
    Bournemouth, BH77DW, United Kingdom
  • Royal Liverpool University Hospital - Liverpool University Hospitals NHS Foundation Trust
    Liverpool, L7 8XP, United Kingdom
  • Sarah Cannon Research Institute
    London, W1G 6AD, United Kingdom
  • The Newcastle Hospitals NHS Foundation Trust
    Newcastle, NE7 7DN, United Kingdom
09

References and documents

Publications

  • Salles G, Duell J, Gonzalez Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, Andre M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. Epub 2020 Jun 5. PubMed 32511983 ↗
  • Duell J, Maddocks KJ, Gonzalez-Barca E, Jurczak W, Liberati AM, De Vos S, Nagy Z, Obr A, Gaidano G, Abrisqueta P, Kalakonda N, Andre M, Dreyling M, Menne T, Tournilhac O, Augustin M, Rosenwald A, Dirnberger-Hertweck M, Weirather J, Ambarkhane S, Salles G. Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958. PubMed 34196165 ↗
  • Duell J, Obr A, Augustin M, Endell J, Liu H, Geiger S, Silverman IM, Ambarkhane S, Rosenwald A. CD19 expression is maintained in DLBCL patients after treatment with tafasitamab plus lenalidomide in the L-MIND study. Leuk Lymphoma. 2022 Feb;63(2):468-472. doi: 10.1080/10428194.2021.1986219. Epub 2021 Nov 15. No abstract available. PubMed 34779360 ↗
  • Cherng HJ, Westin JR. Broadening the MIND: Tafasitamab and Lenalidomide versus Synthetic Controls. Clin Cancer Res. 2022 Sep 15;28(18):3908-3910. doi: 10.1158/1078-0432.CCR-22-1626. PubMed 35861632 ↗
  • Nowakowski GS, Yoon DH, Peters A, Mondello P, Joffe E, Fleury I, Greil R, Ku M, Marks R, Kim K, Zinzani PL, Trotman J, Huang D, Waltl EE, Winderlich M, Kurukulasuriya NC, Ambarkhane S, Hess G, Salles G. Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study. Clin Cancer Res. 2022 Sep 15;28(18):4003-4017. doi: 10.1158/1078-0432.CCR-21-3648. PubMed 35674661 ↗
  • Zinzani PL, Rodgers T, Marino D, Frezzato M, Barbui AM, Castellino C, Meli E, Fowler NH, Salles G, Feinberg B, Kurukulasuriya NC, Tillmanns S, Parche S, Dey D, Fingerle-Rowson G, Ambarkhane S, Winderlich M, Nowakowski GS. RE-MIND: Comparing Tafasitamab + Lenalidomide (L-MIND) with a Real-world Lenalidomide Monotherapy Cohort in Relapsed or Refractory Diffuse Large B-cell Lymphoma. Clin Cancer Res. 2021 Nov 15;27(22):6124-6134. doi: 10.1158/1078-0432.CCR-21-1471. Epub 2021 Aug 25. PubMed 34433649 ↗

Study documents

  • Study protocol · Feb 24, 2021
  • Statistical analysis plan · Feb 10, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02399085
Lead sponsor
MorphoSys AG
Responsible party
Sponsor
First posted
Mar 26, 2015
Start date
Mar 29, 2016
Primary completion
Nov 14, 2022
Completion
Apr 19, 2023
Results posted
Feb 5, 2020
Last update
Oct 23, 2023

Study contacts

Johannes Duell, MD
principal investigator · MorphoSys AG

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
View the source record on ClinicalTrials.gov ↗

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