A Multicenter Clinical Trial of Daratumumab in Combination With Gemcitabine, Dexamethasone and Cisplatin in Patients With Relapsed/Refractory CD38 Positive PTCL-NOS, Angioimmunoblastic T-cell Lymphoma AITL and Other Nodal Lymphomas of T Follicular Helper Cells Origin

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Brief Title

A Multicenter Clinical Trial of Daratumumab in Combination With Gemcitabine, Dexamethasone and Cisplatin in Patients With Relapsed/Refractory CD38 Positive PTCL-NOS, Angioimmunoblastic T-cell Lymphoma AITL and Other Nodal Lymphomas of T Follicular Helper Cells Origin

Official Title

A Phase II, Open Label, Multicenter Trial of 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

Brief 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.
    

Detailed Description

      This is an open-label, multicenter, single arm, single-stage phase II trial. After the
      patient signs the written informed consent the patient will enter the screening phase
      planning baseline assessments and a concomitant upfront confirmation of diagnosis of
      Peripheral T-Cell Lymphoma Not Otherwise Specified (PTCL-NOS), Angioimmunoblastic T-cell
      lymphoma (AITL) or Nodal Lymphoma of T Follicular Helper cells (TFH cells) origin and a
      central evaluation of immunohistochemical positivity of CD38 (cluster of differentiation 38)
      on bioptic material used to perform local diagnosis of relapsed disease, or that used for the
      more recent biopsy in the case of refractory patients. A core needle biopsy is considered
      sufficient for review and CD38 evaluation. Evaluation at central laboratory can be performed
      in bone marrow sections in those patients with only bone marrow lymphoma infiltration.

      Only patients with confirmed eligible diagnosis and a percentage of CD38 positive tumor cells
      ≥ 5% will be considered eligible for study treatment.

      The treatment consists of an induction phase and a maintenance phase.

      Induction phase:

      4-6 courses (according to response after cycle 4 and to patient compliance) of D-GDP
      (Daratumumab in combination with Gemcitabine, Cisplatin, Dexamethasone) every 21 days
      pursuant to the following schedule:

        -  Daratumumab cycle 1: 8 mg/kg i.v. on day 2 and on day 9; cycle 2-6: 16 mg/kg i.v. on day
           2 and day 9)

        -  Gemcitabine 1000 mg/sm i.v. day 1 and day 8 (gemcitabine on day 8 to be skipped in case
           of grade 3-4 toxicity)

        -  Cisplatin 75 mg/sm i.v. day 1

        -  Dexamethasone 40 mg i.v. or po days 1-2-3-4-9

        -  Granulocyte-colony stimulating factor (G-CSF) from day 3 to 6, and from day 10 to 13 (to
           be prolonged if necessary) After 4 courses of D-GDP (Daratumumab in combination with
           Gemcitabine, Cisplatin, Dexamethasone), patients in Complete Remission/Partial Remission
           (CR/PR) and eligible for allogeneic stem cell transplantation (allo-SCT) will be
           addressed to allo-SCT consolidation.

      Otherwise, patients in Complete Remission (CR) will enter the maintenance phase at this point
      of the study.

      Patients in Partial Remission (PR) (not eligible for allogeneic stem cell transplantation) or
      in Stable Disease (SD) after D-GDP x 4 cycles can receive 2 additional courses of D-GDP
      before maintenance or can move directly to maintenance, according to center choice (based on
      patient condition, performance status and quality of response).

      Patients who respond (Complete Remission/Partial Remission) after 6 courses of induction
      phase (end of induction, EOI) and eligible to allogeneic stem cell transplantation (allo-SCT)
      will be addressed to allo-SCT consolidation.

      Patients who respond to the induction phase (Complete Remission/Partial Remission) and are
      not eligible for allogeneic stem cell transplantation (allo-SCT) and patients in stable
      disease (SD) at the End Of Induction (EOI), will move to the maintenance phase.

      Patients in Progressive disease (PD) at any time will discontinue treatment, as well as
      patients experiencing at any time unacceptable toxicity.

      Maintenance phase:

      starting 28 days after the beginning of cycle 4 or 6 (or, in case of toxicity grade > 1,
      after toxicity is resolved) and up to 24 cycles from start of D-GDP (Daratumumab in
      combination with Gemcitabine, Cisplatin, Dexamethasone) according to the following schedule:

      • Daratumumab 16 mg/kg single administration every 28 days

      Treatment with D-GDP (Daratumumab in combination with Gemcitabine, Cisplatin, Dexamethasone)
      or daratumumab single agent will be discontinued before completion of 24 cycles in case of:

        -  decision of the investigator to consolidate D-GDP (Daratumumab in combination with
           Gemcitabine, Cisplatin, Dexamethasone) response with allogeneic stem cell transplant

        -  disease progression

        -  unacceptable toxicity

        -  withdrawal of consent

        -  investigator determines that further therapy is not in the patient's best interest
           (e.g., due to non-compliance, toxicity, etc.) Adverse events ("Common Terminology
           Criteria for Adverse Events", CTCAE v. 5.0) will be monitored from the first
           study-related procedure, throughout treatment, maintenance and for 30 days after the end
           of treatment with the study drug.

      Safety monitoring and stopping rules:

      In order to monitor the safety and the activity of the treatment in small cohorts of
      patients, the Bayesian approach of Thall et al. (1995), as extended by Thall and Sung (1998)
      will be used.

      Monitoring of relevant toxicity after 4 cycles of D-GDP (Daratumumab in combination with
      Gemcitabine, Cisplatin, Dexamethasone) will be done to ensure that it is not higher than an
      acceptable toxicity of 30% (as defined in the safety endpoints) and the monitoring of
      activity after 4 cycles of D-GDP (Daratumumab in combination with Gemcitabine, Cisplatin,
      Dexamethasone) will be done to ensure that Complete Remission (CR) proportion is not lower
      than 40%.

      The prior probability of toxicity and activity are modeled by beta distributions [Beta
      (0.6,1.4) and Beta (0.8,1.2), respectively].

      The enrolment will be stopped if the posterior probability of the treatment being more toxic
      or less active than expected is greater than 95%.

      The primary efficacy analysis will be performed after enrolment of 35 patients. The primary
      efficacy analysis will consist of an estimate of Complete Remission Rate (CRR) on the
      efficacy population after 4 cycles of D-GDP (Daratumumab in combination with Gemcitabine,
      Cisplatin, Dexamethasone) therapy, with 90% confidence intervals (according to 1-sided alpha
      error of 0.05). To conclude that the new treatment is promising, the minimum number of
      patients with a Complete Remission (CR) is 12/35.

      The time-to-event functions (Overall Survival (OS) and Progression Free Survival (PFS)) will
      be estimated by the Kaplan-Meier product-limit method.

      Subgroup analyses on primary efficacy parameter (Complete Remission Rate (CRR)) will be
      performed to assess the role of daratumumab maintenance and to explore potential prognostic
      role of CD38 expression. A logistic regression model will be used and the effect (Complete
      Remission Rate (CRR)) and its 95% Interval of Confidence (CI) will be presented.

      For safety analysis, both at patient level and at therapy cycle level, summaries of incidence
      rates (frequencies and percentages) and intensity of individual adverse events by CTCAE
      (Common Terminology Criteria for Adverse Events (CTCAE)) v. 5.0 will be reported.

      The results of this study will support the rationale of a phase III randomized trial if both
      efficacy and safety endpoints will be considered promising.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Complete Response Rate (CRR)

Secondary Outcome

 Overall Response Rate (ORR)

Condition

Refractory T-Cell Lymphoma

Intervention

Daratumumab

Study Arms / Comparison Groups

 Daratumumab-GDP
Description:  This is an open-label, multicenter, single arm, single-stage phase II trial. After the patient signs the written informed consent the patient will enter the screening phase planning baseline assessments and a concomitant upfront confirmation of diagnosis of PTCL-NOS, AITL or nodal lymphoma of TFH cell origin and a central evaluation of immunohistochemical positivity of CD38 on bioptic material used to perform local diagnosis of relapsed disease, or that used for the more recent biopsy in the case of refractory patients. A core needle biopsy is considered sufficient for review and CD38 evaluation. Evaluation at central laboratory can be performed in bone marrow sections in those patients with only bone marrow lymphoma infiltration.
Only patients with confirmed eligible diagnosis and a percentage of CD38 positive tumor cells ≥ 5% will be considered eligible for study treatment.
The treatment consists of an induction phase and a maintenance phase.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

35

Start Date

September 3, 2020

Completion Date

December 1, 2023

Primary Completion Date

March 1, 2022

Eligibility Criteria

        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:

               -  Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit
                  of normal (ULN)

               -  Bilirubin ≤1.5 x upper limit of normal (ULN)(unless bilirubin rise is due to
                  Gilbert's syndrome or of non-hepatic origin)

          -  Subject understands and voluntarily signs an informed consent form approved by an
             Independent Ethics Committee (IEC), prior to the initiation of any screening or
             study-specific procedures

          -  Subject must be able to adhere to the study visit schedule and other protocol
             requirements

          -  Life expectancy ≥ 3 months

          -  Women must be:

               -  postmenopausal for at least 1 year (must not have had a natural menses for at
                  least 12 months)

               -  surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal
                  ligation, or otherwise be incapable of pregnancy),

               -  completely abstinent (periodic abstinence from intercourse is not permitted) or
                  if sexually active, be practicing two highly effective methods of birth control
                  (e.g., prescription oral contraceptives, contraceptive injections, contraceptive
                  patch, intrauterine device, double barrier method (e.g.: condoms, diaphragm, or
                  cervical cap, with spermicidal foam, cream, or gel, male partner sterilization)
                  as local regulations permit, before entry, and must agree to continue to use the
                  same method of contraception throughout the study. They must also be prepared to
                  continue birth control measures for at least 3 months after terminating
                  treatment.

               -  Women of childbearing potential must have a negative pregnancy test at screening

          -  Men must agree to use an acceptable method of contraception (for themselves or female
             partners as listed above) for the duration of the study. Men must agree to use a
             double barrier method of birth control and to not donate sperm during the study and
             for 3 months after receiving the last dose of study drug.

          -  Male even if surgically sterilized (i.e., status post vasectomy) must agree to 1 of
             the following:

               -  practice effective barrier contraception during the entire study treatment period
                  and through 3 months after the last dose of study drug, or

               -  agree to practice true abstinence, when this is in line with the preferred and
                  usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation,
                  symptothermal, post ovulation methods for the female partner] and withdrawal are
                  not acceptable methods of contraception)

        Exclusion Criteria:

          -  Histological diagnosis different from CD38 positive PTCL-NOS, AITL, and other nodal
             lymphomas of TFH cell origin

          -  More than two lines of previous treatment (autologous stem cell transplant performed
             as part of consolidation to a previous line of therapy should not be considered as a
             line of therapy)

          -  Previous treatment with Gemcitabine or Platinum based regimens; patients who received
             a single course of Platinum based course (i.e. DHAP) are not excluded

          -  Prior therapy with monoclonal antibody anti CD38 (against cluster of differentiation
             38)

          -  Concomitant experimental therapy

          -  Relapse after allo SCT

          -  Central nervous system (CNS) involvement with lymphoma

          -  Subject has received any anti-cancer therapy including chemotherapy, immunotherapy,
             radiotherapy, investigational therapy, including targeted small molecule agents within
             14 days prior to the first dose of study drug

          -  Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment

          -  Subject is:

               -  Known to be seropositive for human immunodeficiency virus (HIV)

               -  Seropositive for hepatitis B (defined by a positive test for hepatitis B surface
                  antigen [HBsAg]). Subjects with resolved infection (i.e., subjects who are HBsAg
                  negative but positive for antibodies to hepatitis B core antigen [anti-hepatitis
                  B core antigen (HBc)] ± antibodies to hepatitis B surface antigen [anti-HBs])
                  must be screened using real-time polymerase chain reaction (PCR) measurement of
                  hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded.
                  EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination
                  (anti-HBs positivity as the only serologic marker) AND a known history of prior
                  HBV vaccination, do not need to be tested for HBV DNA by PCR

               -  Known to be seropositive for hepatitis C (except in the setting of a Sustained
                  Virologic Response(SVR), defined as aviremia at least 12 weeks after completion
                  of antiviral therapy)

          -  Cardiovascular disease (NYHA class ≥2)

          -  Creatinine Clearance < 40 mL/min (Cockcroft-Gault formula)

          -  Significant history of neurologic, psychiatric, endocrinological, metabolic,
             immunologic, or hepatic disease that would preclude participation in the study or
             compromise ability to give informed consent

          -  Any history of other active malignancies within 3 years prior to study entry, with the
             exception of adequately treated in situ carcinoma of the cervix uterine, basal cell
             carcinoma of the skin or localized squamous cell carcinoma of the skin, previous
             malignancy confined and surgically resected with curative intent.

          -  Uncontrolled and/or active systemic infection (viral, bacterial or fungal)

          -  Evidence of any other clinically significant uncontrolled condition(s)

          -  If female, the patient is pregnant or breast-feeding
      

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Francesco Zaja, +0039 0131033154, [email protected]

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT04251065

Organization ID

FIL_Dara-GDP


Responsible Party

Sponsor

Study Sponsor

Fondazione Italiana Linfomi ONLUS


Study Sponsor

Francesco Zaja, Principal Investigator, S.C. Ematologia, Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia


Verification Date

August 2021