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Lymphoma

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

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Lymphoproliferative Disorders

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Lymphoma, Non-Hodgkin

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Diffuse Large B-Cell Lymphoma

Anti-Inflammatory Agents

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Dexamethasone

Cytarabine

Rituximab

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Dexamethasone acetate

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Temsirolimus

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Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

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 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.

Maximum tolerated dose of Temsirolimus Rituximab (375 mg/m²) Dexamethasone (120 mg) Cisplatin (100mg/m²) Cytarabine (2x2g/m²))

Rituximab, Temsirolimus, DHAP, intravenous

Mathias Witzens-Harig, MD

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.

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.

STORM: Temsirolimus, Rituximab and DHAP for Relapsed and Refractory Diffuse Large B-cell Lymphoma

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

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.

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.

In the part II (full target dose) the secondary objective is to evaluate Progression Free Survival

In the part II (full target dose) the secondary objective is to evaluate Overall Survival

In the part II (full target dose) the secondary objective is to evaluate Toxicity

Johannes Gutenberg University Mainz

Technical University of Munich

Ludwig-Maximilians - University of Munich

University Hospital Ulm

University Hospital Erlangen

Charite University, Berlin, Germany

University Hospital Freiburg

Johann Wolfgang Goethe University Hospital

Mathias Witzens-Harig

PD Dr. med. Mathias Witzens-Harig

Nervous System Diseases

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Epratuzumab

Veltuzumab

1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

Chelating Agents

Veltuzumab and 90Y-Epratuzumab Tetraxetan target different b-cells. Veltuzumab will be administered in all 4 weekly study drug treatments. 90Y-Epratuzumab Tetraxetan will be administered only on days 8 \& 15. The dose of veltuzumab remains the same for all patients.

90Y-epratuzumab tetraxetan will be administered 6 mCi/m2 on days 8 and 15.

Veltuzumab will be administered subcutaneously in phase 2. 90Y-Epratuzumab tetraxetan will be administered intravenously. Veltuzumab is given once weekly for 4 weeks. 90Y-Epratuzumab is also given at treatment weeks 2 \& 3 (days 8 \& 15).

Veltuzumab and 90Y-Epratuzumab Tetraxetan

90Y-epratuzumab tetraxetan

Veltuzumab will be administered subcutaneously on days 1, 8, 15 and 23

veltuzumab

William Wegener, MD, PhD

The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Because of this, treatment with the combination may provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given alone.

The treatment portion of this study consists of study drug administrations each week for four weeks in a row (a total of 4 treatment days). Patients will then return at intervals up to 12 weeks for blood samples and for evaluations to see if their disease responded and to monitor any adverse effects related to treatment. Some blood tests may then need to be repeated at least a few times and/or until any abnormal findings at earlier evaluations have resolved. Otherwise, patients will continue to be evaluated every 3 months for two years, then every 6 months up to 5 years or until the disease worsens. Participation in the study will end when NHL disease worsens.

Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL

Phase I/II Study of Veltuzumab Combined With 90Y-Epratuzumab Tetraxetan in Patients With Relapsed/Refractory, Aggressive Non- Hodgkin's Lymphoma

Patients are closely monitored during and after all infusions, and then at intervals over a 12-week post-treatment evaluation period. Safety evaluations required in all patients include vital signs, physical examination, CBC, serum chemistries, serum immunoglobulins, urinalysis, peripheral blood B-cell levels (immunophenotyping based on CD19), and HAHA (to be analyzed by Sponsor). Adverse events and abnormal laboratories will be graded for toxicity according to NCI CTC v3.0 criteria.

CT or PET/CT imaging will be used to quantify changes in index lesions identified on baseline imaging, with responses classified according to revised response criteria for NHL (Cheson, 2007).

Patients with stable disease or objective responses continue limited follow-up evaluations, including CT evaluations, physical examinations and serum laboratories every 3 months for the first year and then every 6 months up to a total of 5 years or until progression of disease.

Gilead Sciences

Lymphoma, Follicular

Follicular Lymphoma

Gemcitabine

Pixantrone

Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.

Pixantrone + Rituximab

Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.

Gemcitabine + Rituximab

Simran B Singh, MS, GWCP

The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma.

Eligible patients will be randomized to treatment with pixantrone plus rituximab or gemcitabine plus rituximab in up to six 28-day cycles. At the time patients experience progressive disease during study treatment, early follow- up, or intermediate follow-up, they enter the survival follow up period. Patients who complete study treatment or discontinue study treatment for any other reason will participate in the follow-up periods.

Early Follow-Up: After treatment completion or discontinuation, patient will enter a 24-week follow-up period.

Intermediate Follow-Up: After completing the 24-week early follow-up period, patient will enter an additional 72-week follow-up period.

Survival Follow-Up: All patients will be monitored for survival.

Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant

A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant

To characterize the PK profile of pixantrone when co-administered with rituximab. Plasma samples for PK analysis will be collected relative to the D-1 dose of pixantrone in one of the 6 treatment cycles for each participating patient. The goal is to enroll approx. 20 patients, active at 20 sites- Beatson West of Scotland Cancer Center, Uni. Hospital Kralovske Vinohrady, Uni. Hospital Hradec Kralove Hematooncology, Hospital Nuernberg, St. Marien Hospital Hamm, Puerta del Mar Hospital, Tokuda Hospital Sofia, National Center of Hematology \& Transfusiology, UMHAT "SV. IVAN RILSKI", Moritz Kaposi General Hospital, Uni. of Debrecen, Polish Red Cross Marine Hospital, Kharkiv Regional Clinical Oncology Center, National Inst. of Cancer Ukraine, Cherkasy Regional Oncology Center, Inst. of Blood Pathology \& Transfusion Medicine, Uni. Hospital Martin, National Onclogy Inst., Uni. Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Uni. Hospital J.A. Reiman Presov

PFS is defined as the time of randomization to the date of disease progression or death due to any cause (whichever occurs first)

Overall survival is from randomization to death due to any cause

CRR is defined as the proportion of patients who achieve a Complete Response (CR) without additional therapy. CR is defined as the disappearance of all target lesions.

ORR is defined as the proportion of patients who achieve a CR or PR without additional therapy.

The number of Participants with Treatment Emergent Adverse Events (TEAE) related to study drug (pixantrone or gemcitabine)

CTI BioPharma

Safety will be assessed by monitoring and recording adverse events, serious adverse events, cardiac, hematologic and blood chemistry parameters, vital signs, performance status, and any abnormal findings observed on physical examinations

Pixantrone and Rituximab

Pixantrone + Rituximab: Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.

Gemcitabine and Rituximab

Gemcitabine + Rituximab: Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

International Prognostic Index (IPI) Score Calculation:

IPI Points Characteristic:

1pt - Age \> 60 years

1pt - Performance Status 2, 3 or 4

1pt - NHL Stage III or IV

1pt - Elevated LDH

1pt - More than 1 extranodal site

Maximum Score Possible: 5

IPI Score 0-2 = better outcome IPI Score 3 or greater = worse outcome

IPI Score

Ann Arbor Staging System I = Involvement of a single lymph node or a single extranodal organ/site, II = Involvement of ≥ 2 lymph node regions on the same side of the diaphragm, or localized involvement of an extranodal site/organ, III = Involvement of lymph node regions on both sides of the diaphragm, which may be also accompanied by local involvement of an extranodal organ/site, IV = Diffuse or disseminated involvement of one or more distant extranodal organs with or without associated lymph node involvement I-III = better outcome, IV = worse outcome

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
STORM: Temsirolimus, Rituximab and DHAP for Relapsed and Refractory Diffuse Large B-cell Lymphoma	NCT01653067	Diffuse Large B...	Rituximab, Tems...	18 Years -	University Hospital Heidelberg
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL	NCT01101581	Non Hodgkin's L... NHL Aggressive NHL Diffuse Large B...	Veltuzumab and ... 90Y-epratuzumab... veltuzumab	18 Years -	Gilead Sciences
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL	NCT01101581	Non Hodgkin's L... NHL Aggressive NHL Diffuse Large B...	Veltuzumab and ... 90Y-epratuzumab... veltuzumab	18 Years -	Gilead Sciences
Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant	NCT01321541	Diffuse Large B... de Novo DLBCL DLBCL Transform... Follicular Grad...	Pixantrone + Ri... Gemcitabine + R...	18 Years -	CTI BioPharma
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL	NCT01101581	Non Hodgkin's L... NHL Aggressive NHL Diffuse Large B...	Veltuzumab and ... 90Y-epratuzumab... veltuzumab	18 Years -	Gilead Sciences
Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL	NCT01101581	Non Hodgkin's L... NHL Aggressive NHL Diffuse Large B...	Veltuzumab and ... 90Y-epratuzumab... veltuzumab	18 Years -	Gilead Sciences

Spots Global Cancer Trial Database for aggressive nhl