Trial Outcomes & Findings for Daratumumab Plus Gemcitabine, Dexamethasone, Cisplatin in pt R/R CD38+ PTCL-NOS, AITL and TFH (NCT NCT04251065)
NCT ID: NCT04251065
Last Updated: 2025-03-28
Results Overview
The Complete Response Rate is defined as the percentage of patient in Complete Remission (according to Lugano classification response Criteria). It will be assessed after the first 4 cycles of D-GDP chemotherapy. In case of early discontinuation, efficacy will be assessed at the End Of Treatment (EOT) visit. Patients without response assessment (due to whatever reason) will be considered as non-responders. CR: complete radiological response, no extralymphatic sites, no new lesions, organ enlargement regress to normal and normal morphology of bone marrow; PR: \>=50% decrease of sum of the product of perpendicular diameter of up to 6 dominant, measurable nodes and and extranodal sites.
TERMINATED
PHASE2
8 participants
the endpoint will be assessed from the start date of therapy to the end of the first four cycles of therapy (cycles of 21 days).
2025-03-28
Participant Flow
Study stopped after the enrollment of 8 patients over the planned 35.
Participant milestones
| Measure |
One Arm
Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
One Arm
Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
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|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
Baseline Characteristics
Daratumumab Plus Gemcitabine, Dexamethasone, Cisplatin in pt R/R CD38+ PTCL-NOS, AITL and TFH
Baseline characteristics by cohort
| Measure |
One Arm
n=8 Participants
Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
|
|---|---|
|
Age, Continuous
|
64.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Disease status at study entry
Relapse
|
5 Participants
n=99 Participants
|
|
Disease status at study entry
Refractory
|
3 Participants
n=99 Participants
|
|
Systemic B symptoms
Absent
|
4 Participants
n=99 Participants
|
|
Systemic B symptoms
Present
|
4 Participants
n=99 Participants
|
|
Ann Arbor Stage
III
|
1 Participants
n=99 Participants
|
|
Ann Arbor Stage
IV
|
7 Participants
n=99 Participants
|
|
ECOG Performance Status
0
|
4 Participants
n=99 Participants
|
|
ECOG Performance Status
1
|
4 Participants
n=99 Participants
|
|
Bone marrow involvement
Negative
|
4 Participants
n=99 Participants
|
|
Bone marrow involvement
Positive
|
4 Participants
n=99 Participants
|
|
Number extra-nodal sites
1
|
2 Participants
n=99 Participants
|
|
Number extra-nodal sites
2
|
2 Participants
n=99 Participants
|
|
Number extra-nodal sites
3
|
2 Participants
n=99 Participants
|
|
Number extra-nodal sites
4
|
1 Participants
n=99 Participants
|
|
Number extra-nodal sites
5
|
1 Participants
n=99 Participants
|
|
Type of the 1st Line Treatment
6 cy CHOEP + 1 cy DHAP + ASCT
|
1 Participants
n=99 Participants
|
|
Type of the 1st Line Treatment
6 cy CHOP+DHAP+ASCT
|
2 Participants
n=99 Participants
|
|
Type of the 1st Line Treatment
CHOEP
|
1 Participants
n=99 Participants
|
|
Type of the 1st Line Treatment
6cy CHOEP + ARA-C + ABMT
|
1 Participants
n=99 Participants
|
|
Type of the 1st Line Treatment
CHOP
|
1 Participants
n=99 Participants
|
|
Type of the 1st Line Treatment
COEP
|
1 Participants
n=99 Participants
|
|
Type of the 1st Line Treatment
CHOEP +HSCT
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: the endpoint will be assessed from the start date of therapy to the end of the first four cycles of therapy (cycles of 21 days).The Complete Response Rate is defined as the percentage of patient in Complete Remission (according to Lugano classification response Criteria). It will be assessed after the first 4 cycles of D-GDP chemotherapy. In case of early discontinuation, efficacy will be assessed at the End Of Treatment (EOT) visit. Patients without response assessment (due to whatever reason) will be considered as non-responders. CR: complete radiological response, no extralymphatic sites, no new lesions, organ enlargement regress to normal and normal morphology of bone marrow; PR: \>=50% decrease of sum of the product of perpendicular diameter of up to 6 dominant, measurable nodes and and extranodal sites.
Outcome measures
| Measure |
One Arm
n=8 Participants
Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
|
|---|---|
|
Complete Response Rate (CRR)
CRR
|
0 Participants
|
|
Complete Response Rate (CRR)
Less than CRR
|
8 Participants
|
SECONDARY outcome
Timeframe: the endpoint will be assessed from the start date of therapy to the end of the first four cycles of therapy (cycles of 21 days) and at each restagingOverall Response Rate is defined as the percentage of patients in complete remission or in partial remission (according to the Lugano 2014 criteria) after the first 4 cycles of therapy (cycles of 21 days). Patients without response assessment (due to whatever reason) will be considered as non-responders. CR: complete radiological response, no extralymphatic sites, no new lesions, organ enlargement regress to normal and normal morphology of bone marrow; PR: \>=50% decrease of sum of the product of perpendicular diameter of up to 6 dominant, measurable nodes and and extranodal sites.
Outcome measures
| Measure |
One Arm
n=8 Participants
Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
|
|---|---|
|
Overall Response Rate (ORR)
ORR
|
1 Participants
|
|
Overall Response Rate (ORR)
Less than ORR
|
7 Participants
|
SECONDARY outcome
Timeframe: The end point will be assessed from the start date of therapy up to 3 months.Overall Survival, the percentage of patients alive, is defined from the start date of therapy to the date of death from any cause. Patients alive and those who are lost to follow-up at the time of the final analysis will be censored at the date of the last contact.
Outcome measures
| Measure |
One Arm
n=8 Participants
Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
|
|---|---|
|
Overall Survival (OS)
|
62.5 Percent probability at 3 months
Interval 22.9 to 86.1
|
SECONDARY outcome
Timeframe: The endpoint will be assessed from the start date of therapy up to 3 months.The length of time during and after the treatment that patients live with the disease, but it does not get worse. Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause. Responding patients, according to the Lugano classification response Criteria, and patients who are lost to follow-up will be censored at their last assessment date.
Outcome measures
| Measure |
One Arm
n=8 Participants
Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
|
|---|---|
|
Progression-Free Survival (PFS)
|
50.0 Percent probability at 3 months
Interval 15.2 to 77.5
|
SECONDARY outcome
Timeframe: the endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the studyPopulation: Monitoring planned after the first 5 patients treated.
Frequency of relevant toxicities. Toxicities will be classified according to Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. This endpoint will be evaluated from the start date of therapy and at any time during therapy and follow-up.
Outcome measures
| Measure |
One Arm
n=5 Participants
Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
|
|---|---|
|
Toxicity - Frequency of Relevant Toxicities
Septic shock multi-organ failure
|
1 Participants
|
|
Toxicity - Frequency of Relevant Toxicities
Acute myocardial infraction
|
1 Participants
|
|
Toxicity - Frequency of Relevant Toxicities
Thrombocytopenia
|
2 Participants
|
|
Toxicity - Frequency of Relevant Toxicities
No relevant event
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: The endpoint will be assessed at each restaging through study completion, up to 26 months.Population: Due the early interruption of the trial, this end point was not evaluated.
Comparison between the Complete Remission Rate (CRR), percentage of patient in complete remission, before and after maintenance therapy
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: The endpoint will be assessed at each restaging through study completion, up to 26 months.Population: Due the early interruption of the trial, this end point was not evaluated. So, data were not collected.
The evaluation of the rate of conversion in Complete Remission with daratumumab maintenance therapy for patients in Partial Remission after the induction. With this endpoint it will be measured the number of responses that will be converted from Partial Remission (PR) to Complete Remission (CR) in those patients that after induction therapy continued the treatment with the maintenance therapy.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: The endpoint will be assessed from the start date of therapy to the end of the first four cycle of therapy (cycles of 21 days) and at each restaging through study completion, up to 26 months.Population: No data displayed because Outcome Measure has zero total participants analyzed. So, data were not collected.
This endpoint will evaluate the correlation between intensity of CD38 expression (percentage of expression) and response to the treatment. The extent of CD38 expression evaluated by the central designed laboratory of FIL (Fondazione Italiana Linfomi) will be performed on fresh sections cut from the paraffin block (or on unstained sections), and the percentage of positive tumor cells will be scored according to Bossard C. et al as follows: 4: \>75%; 3: 50-75%; 2: 25-49%; 1: 5-24%; 0: \<5%. The percentage of CD38 expression will be correlated with response measured according to the Lugano 2014 criteria
Outcome measures
Outcome data not reported
Adverse Events
One Arm
Serious adverse events
| Measure |
One Arm
n=8 participants at risk
Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Infections and infestations
septic shock multiorgan failure
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Cardiac disorders
Acute myocardial infarction
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Cardiac disorders
Heart failure
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Thenth rib fracture
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Infections and infestations
EBV infection
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
Other adverse events
| Measure |
One Arm
n=8 participants at risk
Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP) in patients with relapsed/refractory CD38 positive peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of TFH cell origin.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
2/8 • Number of events 2 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
2/8 • Number of events 2 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Blood and lymphatic system disorders
Neutropenia
|
62.5%
5/8 • Number of events 5 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
62.5%
5/8 • Number of events 7 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Cardiac disorders
Cardiac disorder
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
25.0%
2/8 • Number of events 2 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
General disorders
General disorder
|
50.0%
4/8 • Number of events 4 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Hepatobiliary disorders
Hepatobiliary disorder
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Immune system disorders
Immuno system
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Infections and infestations
Infections
|
50.0%
4/8 • Number of events 4 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Investigations
Investigations
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Metabolism and nutrition disorders
Metabolism
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Renal and urinary disorders
Renal and urinary
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
Skin and subcutaneous tissue disorders
Skin
|
12.5%
1/8 • Number of events 1 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
|
General disorders
Other
|
37.5%
3/8 • Number of events 3 • The endpoint was assessed after 26 months from the date of starting therapy in place of the planned 42 months, due the early interruption of the study
CTCAE
|
Additional Information
Prof. Francesco Zaja
SC Ematologia - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Trieste
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place