A Phase 2 interventional study of Tafasitamab and Idelalisib in Leukemia, Lymphocytic, Chronic, B-Cell, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by MorphoSys AG. Completed at 17 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-20.
Sponsored by MorphoSys AG · Phase 2, Interventional, and Treatment
This is a two-cohort, multicenter, open-label study of tafasitamab (MOR208) combined with idelalisib or venetoclax in adult patients with R/R CLL or R/R SLL pretreated with a BTK inhibitor (e.g., ibrutinib) as single agent or as part of combination therapy. Patients completing the study treatment are invited to participate in an optional biomarker sub-study.
The purpose of this study is to evaluate the clinical safety and preliminary efficacy of tafasitamab (MOR208) combined with idelalisib or venetoclax. The study will include safety run-in phase for each cohort with an evaluation of the safety data by an Independent Data Monitoring Committee.
An optional sub-study has been introduced to collect biological samples for investigations on biomarkers (e.g., CD19 expression) after tafasitamab treatment.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 24 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →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.
Major inclusion criteria
Diagnosis/Trial Population
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):
Patients must have both of the following:
Laboratory Values
Other Inclusion Criteria
Major exclusion criteria
Diagnosis
Previous and Current Treatment
Patients who have, within 14 days prior to D1 dosing:
tafasitamab (MOR208) in combination with idelalisib
Biological: Tafasitamab · Drug: Idelalisib
tafasitamab (MOR208) in combination with venetoclax
Biological: Tafasitamab · Drug: Venetoclax
tafasitamab (MOR208) dose: 12 mg/kg intravenous infusion
Also known as: MOR208, MOR00208
idelalisib dose: 150 mg twice daily orally
Also known as: Zydelig; GS-1101 or CAL-101
venetoclax dose: 400 mg once daily orally
Also known as: Venclexta, Venclyxto; ABT-199
Incidence and Severity of Adverse Events (AEs)
For details please see Section of Adverse Events Overview
Time frame: 2 years
Best Objective Response Rate (ORR)
ORR = complete response \[CR\] + partial response \[PR\]; Local Evaluation
Time frame: 2 years
Number of Participants With Treatment-emergent or Treatment-boosted Anti-MOR00208 Antibody Formation
Number of participants with treatment-emergent or treatment-boosted anti-MOR00208 (anti-tafasitamab) antibody formation
Time frame: 2 years
Maximum Plasma Concentration (Cmax) of MOR00208
Mean Cmax of tafasitamab (MOR00208) at Cycle 3 Day 15 (after the weekly dosing of tafasitamab in Cycles 1 to 3 including a loading dose at C1D4)
Time frame: At Cycle 3 Day 15
Proportion of Patients With MRD-negativity
Proportion of patients who reached MRD-negativity in peripheral blood
Time frame: 2 years
| Milestone | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
|---|---|---|
| Started | 11 | 13 |
| Completed | 7 | 5 |
| Not completed | 4 | 8 |
For details please see Section of Adverse Events Overview
| Participants | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
|---|---|---|
| Incidence and Severity of Adverse Events (AEs) | 11 | 13 |
ORR = complete response \[CR\] + partial response \[PR\]; Local Evaluation
| Percentage of participants | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
|---|---|---|
| Intention-to-treat patient population | 90.9 | 76.9 |
| Pts with tumor response assessment by CT | 90.9 | 100 |
Number of participants with treatment-emergent or treatment-boosted anti-MOR00208 (anti-tafasitamab) antibody formation
| Participants | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
|---|---|---|
| Number of Participants With Treatment-emergent or Treatment-boosted Anti-MOR00208 Antibody Formation | 0 | 0 |
Mean Cmax of tafasitamab (MOR00208) at Cycle 3 Day 15 (after the weekly dosing of tafasitamab in Cycles 1 to 3 including a loading dose at C1D4)
| ng/mL | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of MOR00208 | 278379.9 ± 118746.34 | 306998.9 ± 41254.20 |
Proportion of patients who reached MRD-negativity in peripheral blood
| Participants | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
|---|---|---|
| Proportion of Patients With MRD-negativity | 1 | 6 |
Collected over From the first administration of any study drug to the patient until the 30-day safety follow-up visit as per protocol or until the cut-off date of 09 November 2018 whichever comes first.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort A (Tafasitamab+Idelalisib) | 2/11 (18.2%) | 8/11 (72.7%) | 11/11 (100%) |
| Cohort B (Tafasitamab+Venetoclax) | 0/13 (0%) | 9/13 (69.2%) | 12/13 (92.3%) |
| Event | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
|---|---|---|
| PyrexiaGeneral disorders | 0/11 | 3/13 |
| PneumoniaInfections and infestations | 2/11 | 1/13 |
| Infusion related reactionInjury, poisoning and procedural complications | 0/11 | 2/13 |
| BronchitisInfections and infestations | 1/11 | 0/13 |
| Gastroenteritis salmonellaInfections and infestations | 1/11 | 0/13 |
| Pulmonary sepsisInfections and infestations | 1/11 | 0/13 |
| Septic shockInfections and infestations | 1/11 | 0/13 |
| Upper respiratory tract infectionInfections and infestations | 1/11 | 0/13 |
| AnaemiaBlood and lymphatic system disorders | 1/11 | 1/13 |
| PancytopeniaBlood and lymphatic system disorders | 1/11 | 0/13 |
| Event | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 5/11 | 6/13 |
| AnaemiaBlood and lymphatic system disorders | 5/11 | 2/13 |
| PyrexiaGeneral disorders | 5/11 | 2/13 |
| Infusion related reactionInjury, poisoning and procedural complications | 5/11 | 5/13 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/11 | 3/13 |
| NauseaGastrointestinal disorders | 1/11 | 5/13 |
| HyperuricaemiaMetabolism and nutrition disorders | 0/11 | 5/13 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/11 | 5/13 |
| Blood lactate dehydrogenase increasedInvestigations | 0/11 | 4/13 |
| HypophosphataemiaMetabolism and nutrition disorders | 0/11 | 4/13 |
| Age, Categorical(Participants) | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 8 | 11 |
| >=65 years | 8 | 5 | 13 |
| Age, Continuous(years) | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) | Total |
|---|---|---|---|
| Median | 69 (51 to 79) | 64 (50 to 77) | 65 (50 to 79) |
| Sex: Female, Male(Participants) | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) | Total |
|---|---|---|---|
| Female | 5 | 3 | 8 |
| Male | 6 | 10 | 16 |
| Race (NIH/OMB)(Participants) | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 11 | 13 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) | Total |
|---|---|---|---|
| Austria | 2 | 4 | 6 |
| United States | 0 | 6 | 6 |
| Poland | 5 | 0 | 5 |
| Italy | 1 | 0 | 1 |
| United Kingdom | 0 | 2 | 2 |
| Germany | 3 | 1 | 4 |
| Number of previous systemic treatment lines(Lines) | Cohort A (Tafasitamab+Idelalisib) | Cohort B (Tafasitamab+Venetoclax) | Total |
|---|---|---|---|
| Median | 5 (2 to 9) | 3 (1 to 5) | 4 (1 to 9) |
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MorphoSys AG