Non Hodgkin Lymphoma Clinical Trial

Clinical Trial Finder Non Hodgkin Lymphoma Trials

A Trial of GS-9219 in Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin’s Lymphoma (NHL) or Multiple Myeloma (MM)

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Summary

Multi-center, open-label, single-dose, dose-escalating Phase I/II study of GS 9219 in adult patients with relapsed or refractory CLL, NHL or MM. Patients will be enrolled into the study in sequential dose cohorts.

Patients will be administered a single IV infusion of GS 9219 on Day 1 of a 21 day cycle and may receive a total of six treatment cycles based on toxicities and response. Patients who demonstrate disease progression will be discontinued from the study. Patients who, at the completion of six treatment cycles, tolerate treatment and show evidence of disease control (response or stabilization) will be eligible to continue receiving treatment at the same dose.

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Full Description

The primary objective of this study is as follows:

To assess the safety, toxicity, and maximum tolerated dose (MTD) of GS 9219 administered via IV administration once every three weeks (21 days) for six treatment cycles, i.e. for a total of 18 weeks, in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM).

The secondary objectives of this study are as follows:

To determine the pharmacokinetic parameters of GS 9219 for this regimen and patient population.

To assess the antitumor activity of GS 9219 based on Response Rate and Duration of Response. Progression-free Survival and Overall Survival will be assessed if applicable.

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Eligibility Criteria

Inclusion Criteria:

Relapsed or refractory CLL, NHL or MM
ECOG Performance Status of 0, 1, or 2
Adequate organ function (protocol defined)
ECG without evidence of clinically significant ventricular arrhythmias

Exclusion Criteria:

AIDS-related lymphoma
Subjects with NHL who present exclusively with non-measurable lesions
Subjects with MM who have non-secretory and/or non-measurable disease
Recent anticancer therapy (chemotherapy, radiotherapy, and/or biotherapy)within four weeks prior to starting treatment
Evidence of pulmonary fibrosis
Other concurrent malignancy
Uncontrolled concurrent illness
Receiving chronic, systemically administered steroids
Known hypersensitivity to nucleoside analogues

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

32

Study ID:

NCT00499239

Recruitment Status:

Terminated

Sponsor:

Gilead Sciences

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There are 19 Locations for this study

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UCSF
San Francisco California, 94143, United States
Northwestern University
Chicago Illinois, 60611, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Nevada Cancer Institute
Las Vegas Nevada, 89135, United States
MD Anderson Cancer Center
Houston Texas, 77303, United States
Fakultni nemocnice Brno - Bohunice
Brno , 625 0, Czech Republic
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500, Czech Republic
Fakultni nemocnice Olomouc
Olomouc , 775 2, Czech Republic
Fakultni nemocnice Kralovske Vinohrady
Praha , 10 10, Czech Republic
Vseobecna fakultni nemocnice
Praha , 2 128, Czech Republic
State Institution: Medical Radiological Research Center under the Russian Academy of Medical Sciences
Kaluga Region , 24903, Russian Federation
State institution Main Military Clinical Hospital n.a.academician N.N. Burdenko under the Ministry of Defense of Russia
Moscow , 10522, Russian Federation
State Institution Hematological Research Center under the Russian Academy of Medical Sciences
Moscow , 12516, Russian Federation
Moscow State Medical Institution: Municipal Clinical Hospital n.a. S.P. Botkin
Moscow , 12528, Russian Federation
Non-State Medical Institution Central Clinical Hospital #2 n.a. N.A. Semashko under OJSC "Russian Railways"
Moscow , 12912, Russian Federation
State Public Medical Institution of Novosibirsk Region: State Novosibirsk Regional Clinical Hospital
Novosibirsk , 63008, Russian Federation
Federal State Institution: Research Institute of Hematology and Blood Transfusion under Federal Agency for High-Tech Medical Care
St Petersburg , 19102, Russian Federation
State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development, Institute of Hematology and Transplantology n.a. R.M. Gorbacheva
St. Petersburg , 19702, Russian Federation
State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development
St. Petersburg , 19702, Russian Federation
Federal State Institution Russian Research Center of Radiology and Surgical Technologies under the Federal Agency for High-Tech Medical Care
St. Petersburg , 19775, Russian Federation
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How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

32

Study ID:

NCT00499239

Recruitment Status:

Terminated

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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