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New Clinical Trials by State or World | CLL or Lymphoma
Since: : Aug 
Phase III:  Lymphoma / CLL | Indolent | Aggressive
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Experts on Health Care Reform 2009 at NEJM.org 
Topics Latest CDC information on vaccination for H1N1  CDC.gov

News Items 

Relapsed or refractory nongastric marginal zone B-cell lymphoma: Multicenter retrospective analysis of 92 cases.
Am J Hematol. 2009.  PubMed - Related Articles

BEACOPP in refractory and relapsed Hodgkin lymphoma. Leuk Lymphoma. 2009;50:1803-8. (n=23)
PubMed - Related Articles

Interim PET scan in Hodgkin lymphoma:
 
Leuk Lymphoma. 2009;50:1761-4.
PubMed - Related Articles

Concurrent Radiation and Weekly Cisplatin Followed by VIPD in Newly Diagnosed, Stage IE to IIE, Nasal, Extranodal NK/T-Cell Lymphoma, J Clin Oncol. 2009. (n=32, newly diagnosed pt) PubMed - Related Articles 

Mucosa-associated lymphoid tissue lymphoma of the breast: bilateral metachronous presentation. Leuk Lymphoma. 2009. PubMed - Related Articles
A phase 1/2 trial of arginine butyrate and ganciclovir (anti-viral) in patients with EBV–associated lymphomas http://bit.ly/3g1dn6
Systematic review: 131I–Tositumomab (bexxar) in lymphoma  http://bit.ly/3zGtur 

Azacytidine is a so-called epigenetic agent, which might "activate tumor suppressor genes silenced by hypermethylation, resulting in an antitumor effect."  The goal of pre-treating with this agent is to make the tumor cells more sensitive to standard treatments.

... The concept of the following two studies is a bit like pre-soaking your clothes before putting them in the regular wash.

* Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma
  http://clinicaltrials.gov/ct2/show/NCT01004991


* Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory
Follicular Lymphoma
http://clinicaltrials.gov/ct2/show/NCT00901069

* All CLL/Lymphoma studies incorporating Azacytidine http://bit.ly/2qDAXc

* One report on clinical safety report for Azacytidine:
http://clincancerres.aacrjournals.org/content/14/19/6296.full

Getting closer to curing pediatric acute lymphoblastic lymphoma http://bit.ly/35rUl3 
Immunotherapy Demonstrates Long-Term Success in Treating EBV+ Lymphoma http://bit.ly/71qLT 
Oncologists: Challenges to Enrolling Our Patients in Trials 
Obstacles: Chart PDF  | Most Significant Chart PDF
When Children get Cancer: Help for Mom and Dad   
When Mom or Dad Has Cancer: Help For Children  
Lymphoma Patients Benefit From Exercise http://bit.ly/4A5sXL 
Cheson: The case against maintenance Rituxan for follicular lymphoma http://bit.ly/2XZODb 
Ofatumumab (ant-cd20 mAb) approved for CLL http://bit.ly/1KvFvf  
CAL 101 Shows "Encouraging" Preliminary Results in 
Small Lymphoma/CLL Studies http://bit.ly/45ieDF 
Understanding Population and Individual Risk Assessment: The Case of Polychlorinated Biphenyls and Lymphoma http://cebp.aacrjournals.org/content/15/5/830.full 
Flavopiridol in Relapsed Chronic Lymphocytic Leukemia Demonstrating High Response Rates in Genetically High-Risk Disease  http://bit.ly/2nx4Ue 
The use of PET scanning in lymphoma: progress and problems 
by Morton Coleman, MD http://bit.ly/2YqBvQ 
New strategies to deliver anticancer drugs to brain tumors (technical, Oct 2009) http://bit.ly/37NTog 
Potential efficacy of the oral histone deacetylase inhibitor vorinostat in a phase I trial in follicular and mantle cell lymphoma.

n = 10  http://www.ncbi.nlm.nih.gov/pubmed/19817748
Phase I Study of Ipilimumab, an Anti-CTLA-4 Monoclonal Antibody, in Patients with Relapsed and Refractory B-Cell NHL

n = 18  http://www.ncbi.nlm.nih.gov/pubmed/19808874
Study of KRX-0401 (Perifosine) in Relapsed or Refractory CLL/SLL Open for Enrollment at Duke CCC http://bit.ly/ WVFAT
Regarding FDA transparency policy  
FDA warns against fake online H1N1 remedy claims http://bit.ly/4nTjiY
Mapping the Emotional Journey (through Cancer)  
(Excellent coping skills and tips!)
 
 http://bit.ly/24mplA   or
 

Dr. Joseph Himle, PhD, Director, Psychosocial Programs, 
University of Michigan Depression Center
Rationale for Consolidation to Improve Progression-Free Survival in Patients with Non-Hodgkin's Lymphoma: A Review of the Evidence Full text:   http://bit.ly/2ttiY3 

"With the higher CR rates and longer Progression Free Survival (PFS) times observed in patients with FL and DLBCL, as well as encouraging early data from MZL and MCL consolidation trials, RIT appears to have an important role in the treatment of patients with NHL."
Researchers Urge Quicker Approval for Biosimilars http://bit.ly/2lYndn 
Gene Activity Networks That Let Tumors Thrive And Suggests New Modes Of Therapy http://bit.ly/1418dI 
Cancer survivors: Managing late effects of cancer treatment  http://bit.ly/2pRN9B 
Reproductive factors, exogenous hormone use and risk of lymphoid neoplasms among women in the National Institutes of Health-AARP Diet and Health Study Cohort. http://bit.ly/1gEc3z 
Green tea consumption and hematologic malignancies in Japan: the Ohsaki study http://bit.ly/LH0Bk 
Lymphoma 101, Dr. Klein  
Lenalidomide (Revlimid) Oral Monotherapy Produces Durable Responses in Relapsed or Refractory Indolent NHL http://bit.ly/1SKZQH 
Transplants in lymphoma: Current Use and Outcomes http://bit.ly/TfFqK 

Rationale for Consolidation to Improve Progression-Free Survival in Patients with Non-Hodgkin's Lymphoma: A Review of the Evidence Full text:   http://bit.ly/2ttiY3 

"With the higher CR rates and longer Progression Free Survival (PFS) times observed in patients with FL and DLBCL, as well as encouraging early data from MZL and MCL consolidation trials, RIT appears to have an important role in the treatment of patients with NHL."

Radiotherapy showed favorable outcome in treating early stage extranodal nasal-type NK/T-cell lymphoma in children and adolescents.  Pubmed/19812381 
Stem cell mimicry: key to lymphoma transformation? http://bit.ly/2bTkKc 
Zevalin® Active for Treatment of Extranodal Marginal-zone Lymphoma 
http://bit.ly/63o6Y 
Advance Directives: Five Wishes:  http://bit.ly/362YEO  

Five Wishes lets your family and doctors know:  Link to PDF
 

HIN1 vaccine: Myths and Controversies  PAL perspectives

Few Risks To Newborn Offspring Of Parents Who Are Childhood Cancer Survivors, Studies Find http://bit.ly/2RbjHM 
Study recruiting: Bendamustine with Rituxan , then Revlimid Maintenance for relapsed CLL and SLL http://bit.ly/ah5Ie 

This seems a study worth considering, given the proven activity of Bendamustine and Revlimid in CLL and the need for protocols that may induce more complete remissions in the relapse setting ... that are also longer lasting. 
High-dose methotrexate plus high-dose cytarabine improved outcome in CNS lymphoma http://bit.ly/151Qss 

After chemotherapy, more patients in the combination therapy group achieved complete remission (46%; 95% CI, 31-61) than in the methotrexate alone therapy group (18%; 95% CI, 6-30). The overall response rate was 69% (95% CI, 55-83) in the combination group vs. 40% (95% CI, 25-55) in the monotherapy group. 

The three-year failure-free survival rate was 38% in the combination group compared with 21% in the group assigned to methotrexate alone (P=.01). 
NEW Chronic pain treatments work better together http://bit.ly/M0rip  

"When given both an anti-seizure drug (gabapentin) and an antidepressant (nortriptyline), patients suffering from neuropathic pain caused by nerve damage or disease experienced less pain than when they took one or the other individually, reports Ian Gilron"
Tumor suppressor gene methylation in follicular lymphoma: a comprehensive review http://bit.ly/4Eih9o 

Hyper-methylation: similar to car with an ignition that is filled with a glue (methyl).  The ignition (the gene) cannot be turned off so the car runs continuously .  See PAL
Boosting your immune system to fight cancer?  http://bit.ly/1euzrK 
What is Lymphoma?  PDF 
Free to print and distribute
Update: The PROBLEMS with Testimonials PDF
FDA grants accelerated approval for FOLOTYN (pralatrexate) to treat relapsed peripheral t-cell lymphoma  http://bit.ly/29Rb4l 
Expert perspectives on follicular lymphoma vaccine http://bit.ly/kJKQL 
Folate, B vitamins, methionine and risk of NHL http://bit.ly/j2Ugq 
Randomized Controlled Trial of the Effects of Aerobic Exercise on Physical Functioning and Quality of Life in Lymphoma Patients http://bit.ly/3q2BEf 
Extranodal natural killer/T-cell lymphoma: 
current concepts in biology and treatment. Kohrt H, Advani R Leuk Lymphoma. 2009 Sep 10:1-12. PMID: 19757316  
study: Health Insurance and Mortality in US Adults http://bit.ly/2E9sv3 
Comment: on advocacy that demonizes FDA PAL  
Progenitor and lymphoma cells in blood stem cell harvests: impact on survival following transplantation http://bit.ly/tk7sJ  

"Lymphoma contamination of transplanted apheresis products had no apparent impact on event-free and overall survival." Bone Marrow Transplantation (2001) 28, 207-212.
Regarding ABT-263 - inhibitor of inhibitors of lymphoma cell death - a Dose Finding Study http://bit.ly/10qBna 
Skin cancers occur more frequently in lymphoma survivors - could be secondary to treatment or a risk factor of the disease

Action: Be sure to self-check for suspicious moles (see chart below), and have your doctor examine you regularly - once a year.   See for additional information
GVHD (Graft-Versus-Host Disease): 
A Guide for Patients and Families After Stem Cell Transplant  http://bit.ly/DrGiY
Bid on Drawing donated to support Patients Against Lymphoma http://bit.ly/sIeiS 
Controversies in the Treatment of Lymphoma with Autologous Transplantation http://bit.ly/EG68R 
The Biology of Human Lymphoid Malignancies Revealed by Gene Expression Profiling Louis M. Staudt and Sandeep Dave http://www.pubmedcentral.nih.gov (full text)
What's Really in Supplements?
Regulators and Physicians Raise Alarms About Dangerous Ingredients in Many Herbal Remedies
GVHD: Prochymal no better than a placebo in two final trials http://bit.ly/BkDo9 

Osiris said Tuesday preliminary results for two Phase III trials evaluating Prochymal for the treatment of acute graft versus host disease showed no statistical difference between the drug and a placebo in either trial. Osiris said Prochymal did show significant improvements in response rates in difficult-to-treat liver and gastrointestinal graft versus host disease even as it failed to meet its primary endpoint in both trials.
The late adverse events of rituximab therapy--rare but there!  http://bit.ly/m9Zjw 

"... late adverse events of rituximab are indeed uncommon but at the same time probably under-reported. In this review, we detail late adverse events reported since its use in hemato-oncological neoplasias and other disorders. These adverse events include the development of late-onset neutropenia, defects of immune reconstitution with associated immune compromise, infections, progressive multifocal leukoencephalopathy, reactivation of hepatitis, intestinal perforation and interstitial pneumonitis."
John Hopkins Radioimmunotherapy Survey of Lymphoma for Medical Oncologists http://bit.ly/W0RuE    
Encouraging report: Arsenic trioxide, interferon alpha, and zidovudine in newly diagnosed adult T-cell leukemia/lymphoma (ATL). http://bit.ly/3t5gvg 

n = 10 newly diagnosed ATL

"An impressive 100 percent response rate was observed including 7 complete remissions, 2 complete remissions but with more than 5% circulating atypical lymphocytes, and 1 partial response. Responses were rapid and no relapse was noted. Side effects were moderate and mostly hematologic. In conclusion, treatment of chronic ATL with arsenic, interferon-alpha, and zidovudine is feasible and exhibits an impressive response rate with moderate toxicity."
Support for immunologic therapy research lacking
http://bit.ly/MyIWo  

comment: NCI should dedicate more resources to the study of immunotherapy against lymphomas and other cancers, including how tumors hide, escape, or promote tolerance.  The rationale is that such research is not only promising (as described nicely in the article), but discoveries would likely have broad application, well beyond lymphomas/cancers, such as improving our understanding and treatment of autoimmune diseases.
Zevalin wins approval for first line use in follicular lymphoma as consolidation therapy http://bit.ly/k0bm9  

"the FIT trial demonstrated that when used as part of first-line chemotherapy for patients with follicular NHL, ZEVALIN significantly improved the median progression-free survival time from 18 months (control arm) to 38 months (ZEVALIN arm) (p<0.0001)."
A Tale of Two FDA ODAC Deliberations see comments
H-pylori infection and dermatologic diseases (including lymphoma) http://bit.ly/2JXMPF 
Anxiety screening test  http://bit.ly/13xVBV  

helps  "determine whether you might have an anxiety disorder that needs professional attention. This screening measure is not designed to make a diagnosis of an anxiety disorder or take the place of a professional diagnosis or consultation."
Second SCT for lymphoma patients who relapse after autotransplantation?  Freytes CO, Lazarus HM. Bone Marrow Transplant. 2009 Aug 24.  
Primary central nervous system mucosa-associated lymphoid tissue lymphoma: case report and literature review.  Razaq W, Goel A, Amin A, Grossbard ML. Clin Lymphoma Myeloma. 2009 Jun;9(3):E5-9.
PMID: 19525185 
Phase I of AR-12, a PDK-1 Inhibitor Targeting the PI3K/Akt Pathway   http://bit.ly/13CT7p  
‘‘America’s Affordable Health Choices Act of 2009’’ H. R. 3200   http://bit.ly/EAPTw 
Financial Management During a Medical Crisis http://bit.ly/LnWLy  

By Linda Foster, MA  Medically reviewed by Cynthia Haines, MD ... When your loved one has a medical crisis, the last thing you want to — or can —  think about is money. Sound financial planning will give everyone peace of mind.  
Autologous transplantation for relapsed or primary refractory peripheral T-cell lymphoma. http://bit.ly/yYvN9 

"With a median follow-up time of 6 years for surviving patients with PTCL and DLBCL, the 5-year progression-free survival (PFS) rates for PTCL and DLBCL patients were 24% and 34% respectively (P = 0.14); the corresponding overall survival (OS) rates were 33% and 39% respectively. There were no significant differences between the two groups with respect to time to disease progression or survival after progression." 
Also see Long-term results of autologous hematopoietic cell transplantation for peripheral T cell lymphoma: the Stanford experience. www.ncbi.nlm.nih.gov/pubmed/18541192  

"Disease status at AHCT had a significant impact on PFS and OS. The 5-year PFS for patients in CR1/PR1, CR2/PR2+, and REF was 51%, 12%, and 0%, respectively, and the corresponding figures for OS were 76%, 40%, and 30%, respectively. The pretransplant factors that impacted survival were disease status and the number of prior regimens. Histology, age, sex, stage, B symptoms, bone marrow involvement, and duration of first response did not significantly affect PFS or OS."
Patients Against Lymphoma - letter to CMS on Radioimmunotherapy reimbursement policy  2009-CMS-letter.PDF 

"While PAL supports the Proposed Rule policy of using ASP (Average Sales Price) methodology, we respectfully request that claims default to cost-to-charge per MIPPA rather than hospital claims. This would give patients the “safety net” we need for continued access to these lifesaving drugs should a default claims procedure be necessary."
Technical: How lymphoma cells may become resistant to Rituxan  http://bit.ly/ClWzy 
regarding: Transformation of medicine from a 'one size fits all' to one much more narrowly focused. http://bit.ly/3H8TH 
 
It's a good read.  Initially, scanning too quickly,  I misinterpreted the following line: "Washington can't help. The Fourteenth Amendment doesn't guarantee equal *protection* at the pharmacy. " 

... to mean a guarantee of *access* to effective drugs for all of its citizens, which I think is the correct policy, morally and fiscally. 

Certainly, there's no guarantee that any drug will be *effective* in individuals, because of disease and patient heterogeneity (variations), but in future (assuming our culture survives current trends), we will inch slowly towards personalized medicine.

Regarding the author's comments on FDA policy, it is not authorized to restrict the off-label use of drugs, and it clearly favors marketing approval based on biomarkers that predict individual responses or toxicities. (For example, the agency would likely  approve Ofatumumab in a heartbeat  if the sponsor identified a marker that predicted benefit in refractory  lymphoma, so that the 95% non-responders could be spared toxicity and choose another treatment)

I think it is the industry that has been slow to catch on, with a few  exceptions, and the industry (owing to its competitive nature) is also unwilling to pool (share) data, which is needed to identify and validate biomarkers that predict benefit or harm from drugs in individuals. This is why I favor an NCI (government)-sponsored databank of biospecimens and biospecimen data. ~ KarlS  (click here to comment)
Responses to the panobinostat (pan HDAC inhibitor) in refractory Hodgkin Lymphoma  http://bit.ly/11whFy   | Open studies http://bit.ly/1hGznY
Dr. J. Leonard, 2007 audio: Clinical use of radioimmunotherapy 

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