Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005244

Trial Description

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Title

A Phase II Trial to Evaluate the Safety, Feasibility and Efficacy of a Salvage Therapy Consisting of Temsirolimus Added to the Standard Therapy R-DHAP for the Treatment of Patients With Relapsed or Refractory DLBCL - the STORM Trial

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Trial Acronym

STORM

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URL of the Trial

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Brief Summary in Lay Language

The STORM-trial consists of two parts. In the part I (dose escalation of Temsirolimus) the
primary objective is to establish a maximum tolerated dose of Temsirolimus in combination
with Rituximab and DHAP. Secondary objective is to prove ability to mobilize stem cells in
patients scheduled to high dose therapy.

In the part II (full target dose) the primary objective is to evaluate the ORR in patients
with relapsed diffuse large B cell lymphoma (DLBCL). The secondary objective is to evaluate
progression free survival (PFS), overall survival (OS) and Toxicity.

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Brief Summary in Scientific Language

This is a multicenter, open label, single arm, phase II study. There will be no placebo
usage within this trial. In the part I, dose escalation part, of this trial 6 patients will
be included in each dose level. There will be 4 cohorts, administering up to a maximum of 4
cycles 25 mg, 50 mg, 75mg or 100mg Temsirolimus in combination with Rituximab and DHAP.

Treatment regimen part I:

Part I - Cohort A, B, C, D, X Temsirolimus 25 (A), 50 (B), 75 (C),100 (D) or 15 (X) mg, Day
1, 8, Rituximab (375 mg/m² day 2) Dexamethasone 40mg day 3-6 Cisplatine 100 mg/m² day 3
Cytarabine 2x2 g/m² day 4

...repeat day 22, up to a maximum of 4 cycles In part I, after inclusion of 6 patients, each
patient has to receive at least 1 complete cycle w/o dose limiting toxicity until the
enrollment into the next cohort can be initiated.

In the part II of the trial 40 patients will be included to receive the full target dose,
established within the part I of the study.

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Organizational Data

  •   DRKS00005244
  •   2013/10/21
  •   2012/07/17
  •   yes
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Secondary IDs

  •   2011-001491-20 
  •   NCT01653067  (ClinicalTrials.gov)
  •   STORM-2011  (Mathias Witzens-Harig)
  •   2011-001491-20 
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Health Condition or Problem studied

  •   Diffuse Large B-Cell Lymphoma
  •   C85.1 -  B-cell lymphoma, unspecified
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Interventions/Observational Groups

  •   Drug: Rituximab, Temsirolimus, DHAP, intravenous
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- Safety, Tolerability and Efficacy of a combination therapy of Temsirolimus added to the standard therapy, Rituximab and DHAP (Cytarabine, Cisplatine, Dexamethasone); time frame: 09-2012 to 06-2018 (up to six years); In the part I (dose escalation of Temsirolimus) the primary objective is to establish a maximum tolerated dose of Temsirolimus in combination with Rituximab and DHAP.

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Secondary Outcome

- Safety, Tolerability and Efficacy of a combination therapy of Temsirolimus added to the standard therapy, Rituximab and DHAP (Cytarabine, Cisplatine, Dexamethasone); time frame: 09-2012 to 06-2018 (up to six years); In the part I (dose escalation of Temsirolimus) secondary objective is to prove ability to mobilize stem cells in patients scheduled to high dose therapy.
- Safety, Tolerability and Efficacy of a combination therapy of Temsirolimus added to the standard therapy, Rituximab and DHAP (Cytarabine, Cisplatine, Dexamethasone); time frame: 09-2012 to 06-2018 (up to six years); In the part II (full target dose) the secondary objective is to evaluate Progression Free Survival
- Safety, Tolerability and Efficacy of a combination therapy of Temsirolimus added to the standard therapy, Rituximab and DHAP (Cytarabine, Cisplatine, Dexamethasone); time frame: 09-2012 to 06-2018 (up to six years); In the part II (full target dose) the secondary objective is to evaluate Overall Survival
- Safety, Tolerability and Efficacy of a combination therapy of Temsirolimus added to the standard therapy, Rituximab and DHAP (Cytarabine, Cisplatine, Dexamethasone); time frame: 09-2012 to 06-2018 (up to six years); In the part II (full target dose) the secondary objective is to evaluate Toxicity

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2012/09/30
  •   88
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patients with histologically proven diagnosis of diffuse large cell B-cell lymphoma
(DLBCL) according to the World Health Organization classification.

- Documented relapse or progression following at least one treatment but a maximum of 2
prior treatments. Prior treatment must have included at least 3 cycles of
anthracycline containing chemotherapy (e.g. CHOP-like)

- Any of the following: at least 1 measurable tumor mass (>1.5 cm x >1.0 cm),
involvement of any organ or bone marrow infiltration

- Subjects 18 years or older

- Subjects (or their legally acceptable representatives) must have signed an informed
consent document indicating that they understand the purpose of and procedures
required for the study and are willing to participate in the study.

- Adequate bone marrow reserve: Platelets of at least 75000/µl, absolute neutrophil
count at least 1500/µl

- Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN); Aspartate
aminotransferase (AST) < 2.5 x ULN, Total bilirubin < 1.5 x ULN

- Calculated creatinine clearance (MDRD) > 70 mL/min

- Eastern Cooperative Oncology Group [ECOG] performance Status < 3

- Female subject must be postmenopausal (for at least 6 months), surgically sterile,
abstinent, or, if sexually active, be practicing an effective method of birth control
(e.g., prescription oral contraceptives, contraceptive injections, intrauterine
device, double-barrier method, contraceptive patch, male partner sterilization)
before entry and throughout the study; and have a negative serum ß-hCG pregnancy test
at screening

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Exclusion Criteria

- Active central nervous System lymphoma. Brain MRI is required only if clinically
indicated

- Pregnancy or breast feeding women

- Lymphoma other than DLBCL

- Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure
(NYHA III-IV), uncontrolled diabetes mellitus, pulmonary fibrosis, uncontrolled
hyperlipoproteinemia)

- Active uncontrolled infections including HIV-positivity, active Hep B or C

- Mental status precluding patient's compliance

- Prior treatment with Temsirolimus

- Known CD20 negativity

- Patients refractory to DHAP in a prior treatment line

- Prior autologous or allogeneic stem cell or bone marrow transplantation

- Peripheral neuropathy or neuropathic pain of Grade 2 or worse

- Diagnosed or treated for a malignancy other than NHL except: adequately treated
non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, DCIS of
the breast, or other solid tumors curatively treated with no evidence of disease for
>5 years

- Concurrent treatment with another investigational agent during the conduct of the
trial.

- Concurrent participation in non-treatment studies is not excluded

- Known intolerance to Sirolimus or derivates, Cytarabine, Cisplatine or Rituximab.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Mathias Witzens-Harig
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    • Johannes Gutenberg University Mainz
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    • Technische Universität München
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    • Ludwig-Maximilians - University of Munich
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    • University Hospital Ulm
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    • University Hospital Erlangen
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    • Charite University, Berlin, Germany
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    • University Hospital Freiburg
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    • Johann Wolfgang Goethe University Hospitals
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    • University Hospital of Heidelberg, Department 5 Hematology, Oncology, Rheumatology, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany
    • Mathias Witzens-Harig, MD 
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  • start of 1:1-Block address public-contact
    • Mathias Witzens-Harig, MD 
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   115
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.