Genentech has announced an Expanded Access Program (EAP) for Obinutuzumab (GA101)

EAPS are used for compassionate reasons ...

The patient has:

A serious, life-threatening illness

Exhausted all available therapies typically used to treat the disease and is no longer responsive to, or able to tolerate, these treatments

No other viable therapy options, including participation in ongoing relevant clinical trials

The request to Genentech for access to the investigational medicine comes from the patient's qualified doctor

Announcement... Press Release.

'The FDA has granted GA101 Breakthrough Therapy Designation. This designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible.

Genentech will open an Expanded Access Program (EAP) to provide GA101 to people with CLL under certain circumstances while the company seeks regulatory approval.'
LINK HERE

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Obinutuzumab (GA101) Significantly Reduced the Risk of Disease Progression or Death

GA101 is the first type II anti-CD20 medicine that is glycoengineered, which means specific sugar molecules in GA101 were modified (using GlycoMAb technology) to change its interaction with the body's immune cells with the goal of helping the immune system remove cancer cells from the body. In addition, as a type II anti-CD20 antibody, GA101 binds to CD20 with the aim of killing cancerous cells directly.

GA101 combined with chlorambucil demonstrated a significant 86 percent reduction in the risk of disease progression, relapse or death. Additionally, the length of time during which people lived without their disease worsening (median progression-free survival, PFS) was more than doubled (23 months compared to 10.9 months, HR=0.14, 95 percent CI 0.09-0.21, when compared to chlorambucil alone. The full data, including the comparison of Rituxan plus chlorambucil with chlorambucil alone will be presented in an oral session at the 49th Annual Meeting of the ASCO in Chicago on Tuesday, June 4.
LINK HERE

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PI3K-delta Inhibitor Prolongs Survival

The substantial clinical activity of idelalisib that we observed justifies its further clinical development in CLL,” said Jennifer R. Brown, MD, PhD, director of the Chronic Lymphocytic Leukemia center at Dana-Farber Cancer Institute in Massachusetts and lead author of the study.

LINK HERE

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Ibrutinib mono therapy in Canada? Don't hold your breath

Dr. Jeff Sharman... 'I bet that ibrutinib costs about $150k per year... that is my prediction.'

Sharpen your pencils and mortgage the farm.

LINK HERE

ALSO SEE

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Watch & Wait

Nothing can make a patients head spin faster than the two juxtaposed statements, “you have cancer” and “we’re not going to treat it right now.”

Huh?

Dr. Sharman explains this CLL oddity...

LINK HERE

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Ibrutinib Phase III trial open in Vancouver

Called 'LYTHELIOS' the randomized, double-blind placebo-controlled phase III study of ibrutinib, a Bruton's Tyrosine Kinase (BTK) inhibitor in combination with bendamustine and rituximab (BR) in subjects with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.

Ontario, Juravinski in Hamilton is open with other locations pending.

This is a Canadian location for a U.S. trial.
DETAILS HERE

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Bendamustine funded in Saskachewan

Saskachewan is now the first province in Canada to fund Treanda, bendamustine, for CLL/SLL in some cases...

First line treatment of patients with CLL/SLL as a single agent for a maximum of 6 cycles in patients medically unfit for immune-chemotherapy with FCR (Fludarabine-Cyclophosphamide-Rituximab)

Notes:
Bendamustine in combination with Rituximab is not approved for patients with CLL/SLL;
Bendamustine is not approved for patients who have received previous treatment for CLL/SLL;
Maintenance Rituximab is not approved for patients with CLL/SLL.

SCA Formulary LINK HERE

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Ibrutinib

The wild story behind a promising, experimental cancer drug.
LINK HERE

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Ibrutinib begins approval process for 17p CLL/SLL only

Pharmacyclics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted an additional Breakthrough Therapy Designation for the investigational oral agent ibrutinib as monotherapy for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) patients with deletion of the short arm of chromosome 17 (deletion 17p), which begins the approval process.

Patients harboring a deletion within chromosome 17 generally have poor response to chemoimmunotherapy and have limited treatment options. The presence of deletion 17p is one of the worst prognostic factors in patients with CLL.

This beginning to the approval process ONLY applies to patients with this genetic marker, not all CLL/SLL patients. This will come later.
LINK HERE

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TRU-016 trials to expand for CLL

Emergent BioSolutions Inc. announced its decision to expand the protocol for its ongoing Phase 1b, single arm, open label study (Protocol 16009) evaluating the safety and efficacy of TRU-016 in combination with rituximab in previously untreated patients with chronic lymphocytic leukemia (CLL).

The expanded protocol will include two new study cohorts to examine a lower dose of TRU-016 with rituximab in front line CLL and to evaluate the combination in relapsed CLL patients. This decision is based on strong patient enrollment along with encouraging early safety and efficacy data from this study.

TRU-016 is the company’s humanized anti-CD37 monospecific protein therapeutic, built on its ADAPTIRTM (Modular Protein Technology) platform, for the treatment of CLL.


LINK HERE

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New Antibody Targets CD44

The molecule, called a monoclonal antibody, is being readied for human clinical trials for CLL "in the not-too-distant future," said lead researcher Thomas J. Kipps in a statement on the results.

Kipps holds the Evelyn and Edwin Tasch Chair in Cancer Research ath the UCSD Moores Cancer Center.

Named RG7356, the "humanized" monoclonal antibody targets a receptor or surface molecule, called CD44, found on the CLL cells. The antibody is toxic to the cells, according to laboratory studies.
LINK HERE

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New CLL Trial in Canada

A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

This trial will be run at Juravinski, Hamilton - Sunnybrook, Toronto - London, Ont.

TRIAL LINK HERE

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Scottish research finds new drug

Researchers at the University of Dundee have found a new way to kill cancer cells in people with CLL.

The team looked at chronic lymphocytic leukaemia (CLL) and its reaction to treatment with the drug Tenovin in a pilot study.

The study was led by Dr Sudhir Tauro from the Dundee Cancer Centre at Dundee University. "This process, called autophagy, is important to the survival of all cells. "It is noteworthy that while it has the important effect of disrupting this process in CLL cells, Tenovin did not affect normal blood-forming cells. "Based on these findings, we can now exploit that difference and begin to develop safer anti-leukaemic drugs for CLL."

Thanks to Dick M ...for this
LINK HERE

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Bendamustine recommend to Provinces for funding

The pan-Canadian Oncology Drug Review (pCODR) has just recommend the funding of Bendamustine for first line CLL. Now the provinces need to fund it and add it to their formulary.

Regrettably they did not recommend it for second line CLL were it is needed the most...

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Dr. Sharman's list of CLL doctors in the U.S.

Dr. Sharman states... 'I wanted to compile a list of docs that I endorse. The criteria for getting on the list include 1) I've personally met or worked with them on a research project 2) They have to have a specific disease interest in CLL/NHL beyond just the occasional patient that comes into their clinic. 3) I could feel comfortable telling a friend that if they lived close to this doc - I would endorse them for their care. In a few cases that left me with some areas where I didn't have a good doc to recommend. In such cases, I allowed academic reputation alone serve as one last benchmark for making it onto the list.'
LIST LINK HERE

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Genetic Evolution in CLL

"Our findings have important implications for the future of diagnostic programs for patients with CLL," said the study's co-first author, Dan Landau, MD, of Dana-Farber, the Broad Institute, and Yale Cancer Center. "

"They can help us better understand how to not only predict which patients are likely to relapse, but also predict the genetic makeup of the relapse and tailor our therapy to those specific future mutations. Perhaps more importantly, these data challenge us to understand cancer evolution better in order to develop novel therapeutic paradigms that address the cancer evolutionary landscape."

"One of the biggest challenges that patients with CLL and their physicians face is how to deal with relapse," said study co-senior author, Catherine Wu, MD, of Dana-Farber.

"The instances where patients donated CLL samples several years apart proved particularly interesting. Cells from patients who received chemotherapy during those years underwent a great deal of genetic evolution, showing marked increases in some cell subgroups and decreases in others, whereas samples from patients who didn't undergo such therapy were remarkably stable. "This suggests that, in some patients, treatment can actually hasten the evolution of the disease and speed its recurrence," Wu observed.

Article LINK HERE

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Obinutuzumab increases progression free survival

The CLL11, Phase III randomized study investigated the efficacy and safety profile of obinutuzumab (GA101) plus chlorambucil, a chemotherapy, compared with chlorambucil alone in people with previously untreated CLL. An improvement in progression-free survival (PFS) was achieved: GA101 plus chlorambucil significantly reduced the risk of disease worsening or death compared to chlorambucil alone.

The trial data will be presented in the next few months.
LINK HERE

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CLL and Secondary Cancers

CLL is associated with an increased risk of developing second cancers. However, it is unknown whether CLL alters the disease course of these cancers once they occur.

Researchers at the Mayo Clinic, looked at SEER data and OS overall survival of CLL patients with breast, colorectal, kidney, prostate or lung cancers.

They found that CLL patients had inferior OS with cancers of the breast, colorectum, and prostate after excluding or censoring CLL-related deaths. Cancer-specific survival was also inferior for patients with cancers of the breast and colorectum who had pre-existing CLL after adjusting for age, sex, race, and disease stage.

The study concluded, ' Inferior OS and cancer-specific survival was observed for several common cancers in patients with pre-existing CLL. Additional studies are needed to determine the optimal management of these malignancies in patients with CLL and whether more aggressive screening or alternative approaches to adjuvant therapy are needed.'
LINK HERE

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Larynx and nasal cavity cancers in CLL

A study using the SEER database finds that larynx and nasal cavity cancers were more common in patients with CLL. For the SIR calculation, 36 985 patients with CLL contributed a mean 6.36 years of follow-up each, for a total of 235 314 person-years of follow-up.

Overall incidence of upper aerodigestive tract (UADT) cancers was not significantly elevated.

Cancers of the UADT in patients with CLL were more likely to be localized at diagnosis than those in patients without CLL.

CLL was associated with poorer survival outcomes.

Abstract:
LINK HERE

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Couple of Brochures from the LLS

Theses are from the Leukemia and Lymphoma Society in the U.S.

Understanding Lab and Imaging Tests
Link Here for .PDF

Understanding Clinical Trials for Blood Cancers Link Here for .PDF

Note... these are based on the American system and may not apply in other countries exactly.

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Risk categories and refractory CLL in the era of chemoimmunotherapy

Refractory CLL has been defined as no response or response lasting less than 6 months from last therapy.

The clinical importance of refractory CLL is based on the fact that, unlike most CLL patients, this subgroup was shown to have very poor prognosis (median, 1-2 years overall survival [OS] in most studies) despite various salvage therapy strategies.

This paper gives a complete overview of responses in CLL from both a historical perspective, the current situation and future options that need to be considered...
Full PDF Blood Journal LINK HERE

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CLL LIVE 2012 videos from Patient Power

Patient Power videos by Andrew Schorr from the CLL LIVE 2012 Conference in Niagara Falls Canada.

New Support Group in UK

The CLL Support Association in partnership with Healthunlocked is pleased to invite you to join our on-line community. The new interactive facility is designed to connect those affected by CLL and encourage the sharing of experiences, knowledge and support. It can be reached via the following link:

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Flow Cytometry ~ Everything you need to know and more...

Flow Cytometry is a blood test used to diagnose CLL. This video tutorial education program explains how flow cytometry actually works.

This takes about 12 minutes to view... Will NOT work on iPad etc. Needs Flash 8

Flow Tutorial LINK HERE

Many other tutorials : LINK HERE

Also see the "How does FISH work?" LINK HERE

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One of the most complete up-to-date website about blood tests can be found at this link. Well worth bookmarking for future reference.

Lab Tests Online

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