I qualify for the CAR-T trial at Stanford

I got a call yesterday from the Stanford new patient coordinator. The second pathology report is in and I do qualify for the study. She set me up for a meeting Tuesday. This must mean they think this is DLBCL, not follicular lymphoma. 

The pessimist (realist?) in me considers the following totally hypothetical & unsubstantiated scenario: What if Stanford ‘finagled’ the pathology report such that I’ll qualify for their study…the diagnosis was nebulous anyway and this is a fairly rare diagnosis especially in my age bracket (see below). So recruitment for this study is likely hard; I know they’ve only successfully recruited 10 patients in over a year. I also I know that Stanford and my Kaiser doctor discussed my case other day. In their discussion perhaps they disagreed on the diagnosis, second pathology report findings. That might be seen as reflecting poorly on Kaiser, if only given how questionable the first pathology report was. If you’re Kaiser then perhaps better to say nothing, hence the cagey answers to my questions the other day. Not trying to hatch any conspiracies but am I nuts for thinking about such a possibility? I’m sure stranger things have happened.

That got me thinking about the size of my age-bracket cohort for this disease so I dug up some stats. From my napkin math based on Cancer.gov and rates I’ve heard elsewhere, I’m estimating that I’m one of fewer than 300:

New cases, U.S., 2018: 74,680
Cases 35-44 yrs old: 3,958 (5.3%)
% DLBCL: 1,187 (30%, assuming it’s equally distributed across all ages)
% DLBCL that fail 1st line treatment: 297 (~25% fail rate)

Then at about 6pm I got a call from the study coordinator. She asked me what questions I had about the study. We discussed what happens in the scenario when CAR-T fails as 2nd line (assuming I got that arm, it’s 50/50 and not blinded). Turns out I would in fact switch back to the standard treatment and do the second round chemo with a goal of getting to the stem cell transplant if CAR-T failed! That was the key piece of information that had been missing. It’s not clear how passing through CAR-T before the chemo treatment would change the odds, if at all. That will be a follow up for the doctor. I also asked about the CAR-T odds vs. standard treatment – here’s what the document they sent me says, verbatim:

The Stanford Cancer Cellular Therapy Program is offering a clinical trial for patients who are affected by Diffuse Large B Cell Lymphoma (DLBCL) that is relapsed or refractory to first line chemotherapy. The sponsor of this study, Kite Pharma, Inc, conducted ZUMA1, a Phase 1/2 clinical trial using the same CAR-T cells, now called axicabtagene ciloleucel (Axi-cel). ZUMA 1 investigated the safety and efficacy of Axi-cel in subjects with refractory aggressive NHL, and axicabtagene ciloleucel significantly improved ORR (P < 0.0001). The ORR was 82% with a complete response (CR) rate of 54%. At the primary analysis, 44% of subjects had ongoing responses (39% in CR) and 42% were disease free more than one year following Axi-cel therapy. Axi-cel received FDA approval to treat relapsed/refractory DLBCL after two or more lines of systemic therapy in October 2017 and is marketed as Yescarta. Axi-cel may have an improved efficacy and tolerability in patients with less chemo-refractory disease and lower disease burden treated earlier in their DLBCL disease course.  In this randomized control trial, axicabtagene ciloleucel will be compared to standard of care (SOC) therapy.

I’m just getting up to speed on the trial outcomes lingo: ORR (objective response rate) vs. CR (complete response) etc. I’m going to need to ensure I understand the various measures for BOTH the traditional vs. the CAR-T arms of the trial. My schematic the other day didn’t look at these nuances, it was simple yes/no outcomes that track to CR (which is defined as no detectable evidence of tumor).     

This study is 50/50 randomization which means that there’s a 50% chance I’d get CAR-T therapy and 50% chance I get standard chemo; same as if I did it at Kaiser except that infusions are done on a 3-day inpatient basis. Also I’d be the youngest participant by about 10 years (at least at the Stanford site, there are others around the country). Most participants are in their 60’s, 70’s which probably makes sense given the disease rates. This is the specific study for those interested. I left the conversation feeling much more comfortable with the situation despite my wild speculations noted above. 

I’ll head down to Palo Alto and meet with them Tuesday to get more information…