Navigation Links
Phase II Study of Zevalin(R) Consolidation Following Fludarabine and Mitoxantrone Chemotherapy Results in 100 Percent Complete Remission Rate and 89 Percent Three-Year Progression Free Survival in Patients with Previously Untreated Non-Follicular Indolent

Phase II Investigational Trial Published in CANCER: the Journal of the

American Cancer Society

SEATTLE, Jan. 22 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTAX) announced today that results of a phase II clinical study, published in the journal CANCER demonstrate that the addition of radioimmunotherapy (RIT) to chemotherapy for previously untreated patients with non-follicular indolent non-Hodgkin's lymphoma (NHL) was both well tolerated and effective, producing a 100 percent complete remission at end of treatment with an estimated 89 percent of patients remaining in remission at three years.

The study, conducted at the Institute of Hematology and Medical Oncology at University of Bologna, Italy, investigated the use of a single dose of Zevalin(R) (Ibritumomab Tiuxetan) as consolidation therapy following treatment with a regimen of fludarabine and mitoxantrone (FM chemotherapy) among 26 patients with newly diagnosed non-follicular indolent NHL. Non-follicular lymphomas are also referred to as intermediate grade compared to the low grade follicular or high grade diffuse B cell variety. FM chemotherapy resulted in 50 percent of patients achieving a complete remission (CR) and 30 percent achieving a partial remission (PR). Of the 20 patients (13 with CR and 7 with PR) who were evaluable for Zevalin consolidation, 100 percent obtained a CR at the end of treatment. With a median follow up of 20 months, the estimated three-year progression free survival (PFS) was 89.5 percent. The most common greater than or equal to grade 3 toxicities included neutropenia (11 patients) and thrombocytopenia (16 patients).

"This single arm, non-randomized phase II trial provides additional insights into the potential utility of RIT in intermediate grade NHL, a subtype where CRs are infrequent with rituximab therapy," noted Jack W. Singer, M.D., Chief Medical Officer of CTI.

The study results are reported in the current issue of CANCER at

Study Details

Between February 2005 and June 2006 26 eligible patients with previously untreated, indolent, nonfollicular NHL (10 marginal zone, 8 lymphocytoplasmic, and 8 small lymphocytic) were treated using a novel regimen that consisted of 6 cycles of fludarabine/mitoxantrone (FM) chemotherapy followed 6 to 10 weeks later by yttrium-90(90Y) ibritumomab tiuxetan (Zevalin(R)). After chemotherapy the overall response rate was 80.5% and included 50% CR and 30.5% PR. Of the 20 patients (13CR/7PR) who were evaluable (at least a PR with normal platelet counts and bone marrow infiltration <25%) for subsequent Zevalin, 100% obtained a CR at the end of treatment. With a median follow up of 20 months, the estimated three-year progression free survival (PFS) was 89.5 percent. The FM treatment was well-tolerated; there were no treatment-related deaths. Reversible hematologic toxicities included neutropenia grade 4 in 5 patients and grade 3 in 13 patients. Only 1 patient developed febrile neutropenia. Following Zevalin administration grade 3-4 thrombocytopenia occurred in 16 of 20 patients with grade 3-4 neutropenia reported in 11 of 20 patients. Four patients received GCSF and 3 patients received platelet transfusions. Only 1 patient experience febrile neutropenia. The authors concluded "In this study we established the feasibility, tolerability and efficacy of sequential treatement with 6 cycles of FM chemotherapy followed by 90Y ibritumomab tiuxetan as front line therapy for patients with untreated, indolent, nonfollicular NHL. To our knowledge the data represent the first demonstration in the literature of the real role of 90Y ibritumomab tiuxetan in the treatment of indolent nonfollicular NHL. Because this novel sequential treatment appears to be promising compared with results reported for CHOP and CVP- containing regimens plus rituximab, we believe the current phase II trial represents an important first step and positive new angle in therapy to combat indolent, nonfollicular NHL"

About Zevalin(R)

Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated for the treatment of patients with relapsed or refractory low-grade or follicular B-cell NHL, including patients with Rituximab-refractory NHL. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia, and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic toxicity correlated with the degree of bone marrow involvement prior to Zevalin therapy. Myelodysplasia or acute myelogenous leukemia was observed in 2 percent of patients (8 to 34 months after treatment). Zevalin should only be used by health care professionals qualified by training and experience in the safe use of radionuclides.

Patients and healthcare professionals can visit for more information.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of Zevalininclude risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with Zevalin in particular including, without limitation, the potential failure of Zevalin to prove safe and effective as consolidation therapy following treatment with a regimen of fludarabine and mitoxantrone for treatment of non-Hodgkin's lymphoma, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling Zevalin, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

Media Contact:

Dan Eramian

T: 206.272.4343

C: 206.854.1200

Susan Callahan

T: 206.272.4472

F: 206.272.4434


Investors Contact:

Leah Grant

T: 206.282.7100

F: 206.272.4434


SOURCE Cell Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Genaera Begins Dosing Second Phase 1 Trial of Type 2 Diabetes and Obesity Compound Trodusquemine (MSI-1436)
2. Vical Receives Payment from AnGes MG for Allovectin-7(R) Phase 3 Pivotal Trial
3. Cerimon Pharmaceuticals Initiates Phase II/III Clinical Studies to Evaluate its Diclofenac Patch for Mild to Moderate Pain
4. CeNeRx BioPharma Announces Successful Completion of Phase l Clinical Program for Novel Antidepressant Agent Tyrima(TM)
5. Morria Biopharmaceuticals Plc Announces Preliminary Safety and Tolerability Results From Its Phase I Clinical Study of MRX-4 in Allergic Rhinitis Patients
6. SGX Initiates Phase I Trials for SGX523
7. Fundamental Applied Biology, Inc. Is Awarded SBIR Phase IIB Grant for the Commercialization of Protein Therapeutics Using Cell Free Technology
8. Anthera Announces Preliminary Positive Results From Once-Daily A-002 Phase II Cardiovascular Trial
9. Tolerx Achieves Milestone with Completion of Phase Ib Clinical Study of TRX1 in Cutaneous Lupus Erythematosus
10. Isolagen Inc. Completes Injections of Isolagen Therapy(TM) in Phase III Wrinkle and Phase II Full Face Studies
11. First Patient Enrolled in Cogentus Pharmaceuticals Pivotal Phase 3 Trial of Novel Combination Medicine
Post Your Comments:
(Date:11/25/2015)... , November 25, 2015 ... Investors"), pursuant to which BioLight and the New Investors ... Ltd. subsidiary ("IOPtima") via a private placement. The financing ... its innovative IOPtimate™ system used in the treatment of ... pathway process for the IOPtimate™ system with the U.S. ...
(Date:11/25/2015)... 2015 Developmental, commercial, and regulatory/legal ... profitability of pharmaceutical products, says GBI Research ... regulatory/legal strategies all play a key role in boosting ... . --> Developmental, commercial, ... in boosting the profitability of pharmaceutical products, says ...
(Date:11/25/2015)... Research and Markets ( ) has ... Global Forecast to 2020" report to their offering. ... 37.21% of the total market share in 2014. The ... is projected to growth at the highest CAGR between ... to the fast growing water, industrial gas treatment, pharmaceutical, ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... Bcureful—a non-profit organization devoted to ... raising public awareness of the disorder while helping to bring expert medical care ... to bolster progress at the Tuberous Sclerosis Complex Center at Ann & Robert ...
(Date:11/24/2015)... , ... November 24, 2015 , ... ... to offer their patients the many benefits of the revolutionary BIOLASE WaterLase iPlus ... cutting and scraping tools traditionally used by a dentist in Gettysburg, PA ...
(Date:11/24/2015)... ... 24, 2015 , ... ThirdLove, the fast-growing bra company that ... offering 40% off select bras and underwear styles, now through Saturday, November 28th. ... technology and the latest fashion, quickly becoming the next generation of luxury bras. ...
(Date:11/24/2015)... ... 24, 2015 , ... Preparing for the LDT Regulation:, CLIA Won’t Satisfy the ... , FDA has long asserted that design and manufacture of Laboratory Developed Tests ... do not meet the device regulations. , Come up short in an inspection and ...
(Date:11/24/2015)... ... November 24, 2015 , ... United Benefit Advisors (UBA), ... & Company as its newest Partner Firm. Based in Jefferson City, Missouri, their ... trusted advisor regardless of whether that client is a business, a family, or ...
Breaking Medicine News(10 mins):