Daratumumab Plus Gemcitabine, Dexamethasone, Cisplatin in pt R/R CD38+ PTCL-NOS, AITL and TFH (NCT04251065) | Clinical Trial Compass
TerminatedPhase 2
Daratumumab Plus Gemcitabine, Dexamethasone, Cisplatin in pt R/R CD38+ PTCL-NOS, AITL and TFH
Stopped: The enrolment was prematurely terminated after the planned monitoring of the first 5 patients because of an unacceptable level of relevant toxicities, according to statistical stopping rules and the DSMB recommendation.
Italy8 participantsStarted 2020-09-03
Plain-language summary
FIL\_Dara-GDP is a phase II, open label, multicenter clinical trial. The sponsor of this clinical trial is Fondazione Italiana Linfomi (FIL). The primary objective is to evaluate the efficacy of 4 courses of D-GDP (Daratumumab in combination with Gemcitabine, Cisplatin, Dexamethasone) in terms of complete response in patients with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL) and other nodal lymphomas of T follicular helper cells (TFH cells) origin refractory/relapsed after at least one and no more than two previous lines of therapy.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
• Histologically documented diagnosis of CD38 (cluster of differentiation 38) positive PTCL-NOS, AITL and other nodal lymphomas of TFH cell origin as defined in the 2017 edition of the World Health Organization (WHO) classification. Patients with only bone marrow involvement are eligible.
Note: Only patients with a centrally assessed percentage of CD38 positive tumor cells ≥ 5% in the relapse biopsy, or in the more recent biopsy in the case of refractory patients, will be considered eligible for protocol study treatment.
* Age 18-70 years
* Relapsed or refractory to one previous lines of treatment (autologous transplantation as a consolidation to the first line of therapy should not be considered a second line)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \< 2
* At least one site of measurable nodal disease at baseline ≥ 2.0 cm in the longest transverse diameter as determined by CT scan (MRI is allowed only if CT scan cannot be performed). Note: Patients with only bone marrow involvement are eligible
* Adequate hematological counts defined as follows:
* Absolute Neutrophil count (ANC) \> 1.0 x 109/L unless due to bone marrow involvement by lymphoma
* Platelet count \> 100.000/mm3 unless due to bone marrow involvement by lymphoma
* Adequate renal function defined as follows:
\- Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
* Adequate hepatic function per local laboratory reference range as follows:
* Asparta…
What they're measuring
1
Complete Response Rate (CRR)
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).