Tag Archives: clinical trial


CBCI’ve charted some of the metrics from a few months of weekly CBC tests. Treatment in the clinical trial began the first week of September and outcome so far is both expected and good. Most of my blood counts have returned to where they were about 3-6 months before I started any treatment. The neutrophil counts have been the most stubborn and variable but they do seem to be rebounding now. The ipi-145 clinical trial (now in cycle 4) will continue open-ended for me so the values should hopefully continue to normalize.


Cycle 4


I’ve now completed 3 28 day treatment cycles in the Phase 1 clinical trial for IPI-145. Most of my blood counts with the frequent exception of the neutrophils have been rebounding steadily. Most are back to where they were in May 2013, 3 months before I began treatment. The initial goal was to drop-kick this CLL. So far, we seem to be doing just that.

Partial Remission?

Screenshot from 2013-11-20 14:18:59

From what I’ve read, this seems to be the minimum goal for success in treatment of this CLL but a definition has eluded me until now. According to the journal “blood” 2008 111: 5446-5456 Prepublished online January 23, 2008;doi:10.1182/blood-2007-06-093906 it is:

5.2. Partial remission (PR)
PR is defined by the criteria described in sections 5.2.1, 5.2.2, or
5.2.3 (if abnormal before therapy), as well as one or more of the
features listed in section 5.2.4. To define a PR, these parameters need to be documented for a minimal duration of 2 months (Table
4). Constitutional symptoms persisting for more than 1 month
should be recorded.
5.2.1. A decrease in the number of blood lymphocytes by 50%
or more from the value before therapy.
5.2.2. Reduction in lymphadenopathy (by CT scans in clinical
trials 57 or by palpation in general practice) as defined by the
following: A decrease in lymph node size by 50% or more either in
the sum products of up to 6 lymph nodes, or in the largest diameter
of the enlarged lymph node(s) detected prior to therapy. No increase in any lymph node, and no new enlarged
lymph node. In small lymph nodes (< 2 cm), an increase of less
than 25% is not considered to be significant.
5.2.3. A reduction in the noted pretreatment enlargement of
the spleen or liver by 50% or more, as detected by CT scan (in
clinical trials) or palpation (in general practice).
5.2.4. The blood count should show one of the following
results: Neutrophils more than 1.5 ϫ 109/L (1500/uL) without need for exogenous growth factors. Platelet counts greater than 100 ϫ 109/L (100,000/uL) or 50% improvement over baseline without need for exogenous growth factors. Hemoglobin greater than 110 g/L (11.0 g/dL) or 50%
improvement over baseline without requiring red blood cell
transfusions or exogenous erythropoietin.

Failure is not an option! We are going to get there and hope and pray for eventual full remission.

Novel B-Cell Receptor Signaling Inhibitors Show Promise

Jeffrey A Jones MD, MPH

Jeffrey A Jones MD, MPH

I came across a good and recent article about the new class of cancer drug I am taking (via clinical trial) to manage my CLL. It’s a little up there in terminology level but still reads well. It mentions ipi-145 but says openly that not much is known about it yet. Click the link to read the full article at OncLive.

“It is clear that B-cell receptor signaling plays an important role in chronic lymphocytic leukemia,” Jones said.In CLL, initiation of treatment with the PI3K inhibitor idelalisib causes prompt and dramatic regression in lymph node volume with a concomitant risk in absolute lymphocyte count (ALC).

“Marked regression of lymphadenopathy—usually an 85% reduction in lymph node volume—is a common feature of treatment response, he noted. “Because the ALC rises and causes lymphocytosis, many patients fail to achieve complete response by conventional criteria,” Jones explained

What do I know now?


After completing two months (28 day cycles) of IPI-145 clinical trial, two CT scans, one (more) bone marrow biopsy and a lot of ekgs & lab draws the preliminary results are:
White Blood Cell Count ↓
Red Blood Cell Count ↑
Hemoglobin ↑
Neutrophil Count & Percentage ↑
Lymph Node Size ↓
Platelet Count ↑
Every trend is in the right direction and seemingly on the way to at least a partial remission (PR) from this CLL. Onward to treatment cycle #3. Happy dance time! 😀


Has it been two months?

CTIt’s that time again… I’ve now been through two 28 day cycles of treatment with ipi-145 trial ‘oral chemo’. The clinical trial protocol calls for me to have a CT scan today to re-measure my lymph nodes, spleen and liver to see how well the trial drug has begun to help them begin reducing back to a more normal size. So far, they’ve been packed like sardines with abnormal lymphocytes. Please pray that these rogue B cells have truly begun their great retreat.