Question: The patient has non-Hodgkin's lymphoma.

When physicians during clinical trials see the drop in hemoglobin level 30% in less than 30 days after infusion of the drug, what should be his reaction?

Stop trial, continue for the next step in the trial and deeply investigate the problem or do nothing and continue for the next infusion approx in one month. If investigate how to investigate??
I got an answer from one physician already, I just would like to be sure, that I formulated m question correctly. My clinical trial was based on blood tests. I expected that exists a template or matrix from FDA with limiting values when a physician must do a deeper investigation of patient condition or stop the procedure. In my case, my doctor did nothing and my blood hemoglobin dropped to level 5.5 g/dl because I got pure red aplasia with serious consequences for me. I google to find the answer without success if exists something as clinical trial stopping rules templets or matrix form a blood test which would show clearly stopping points.

So my question is: stopping rules are statistical for trial or they are fixed values as matrix applying for each patient. This was a clinical trial, where anything was possible, the drug was known high risk attacking organs to stimulate immunity system. Or the safety of clinical trials is completely in the hand of physician without control. It does not have for me to much sense.

The patient has non-Hodgkin's lymphoma.

When physicians during clinical trials see the drop in hemoglobin level 30% in less than 30 days after infusion of the drug, what should be his reaction?

Stop trial, continue for the next step in the trial and deeply investigate the problem or do nothing and continue for the next infusion approx in one month. If investigate how to investigate??
I got an answer from one physician already, I just would like to be sure, that I formulated m question correctly. My clinical trial was based on blood tests. I expected that exists a template or matrix from FDA with limiting values when a physician must do a deeper investigation of patient condition or stop the procedure. In my case, my doctor did nothing and my blood hemoglobin dropped to level 5.5 g/dl because I got pure red aplasia with serious consequences for me. I google to find the answer without success if exists something as clinical trial stopping rules templets or matrix form a blood test which would show clearly stopping points.

So my question is: stopping rules are statistical for trial or they are fixed values as matrix applying for each patient. This was a clinical trial, where anything was possible, the drug was known high risk attacking organs to stimulate immunity system. Or the safety of clinical trials is completely in the hand of physician without control. It does not have for me to much sense.

I like what you wrote and I should be more to the point. I have Waldenstrom disease diagnosed 7 years ago, I was treated twice with succes Dexamethason+Rituxan and Bendamusteen+Rituxan. The tested drug was Pembrolizumab (manufacture Merk), effective but also a drug with dangerous side-effects, which need close attention. In my case, during Clinical Trial Pebroziumab somehow changed my immune system and my immune system attacked my reticulates of red blood cells, and consequently, my hemoglobin was dropping in natural speed, because not replacing red blood cells, which were dying with rate 33%/month.

But my second question is and was: Is somewhere published list by FDA, or sponsoring institution with clearly written stopping for clinical trials, as a response to the test procedure?

I like what you wrote and I should be more to the point. I have Waldenstrom disease diagnosed 7 years ago, I was treated twice with succes Dexamethason+Rituxan and Bendamusteen+Rituxan. The tested drug was Pembrolizumab (manufacture Merk), effective but also a drug with dangerous side-effects, which need close attention. In my case, during Clinical Trial Pebroziumab somehow changed my immune system and my immune system attacked my reticulates of red blood cells, and consequently, my hemoglobin was dropping in natural speed, because not replacing red blood cells, which were dying with rate 33%/month.

But my second question is and was: Is somewhere published list by FDA, or sponsoring institution with clearly written stopping for clinical trials, as a response to the test procedure?

Thank you for yours answer. I have this time very simple question:

after heavy chemotherapy of my Waldenstrom disease and restarting immunity system by heaviest recommended dosages of steroids, how many years need patients in my age group to recover bone marrow and if is full bone maroow recovery possible?

Thank you for yours answer. I have this time very simple question:

after heavy chemotherapy of my Waldenstrom disease and restarting immunity system by heaviest recommended dosages of steroids, how many years need patients in my age group to recover bone marrow and if is full bone maroow recovery possible?

Thank for your answer.

In my case, they spoke about completely restarting my immunity system!, and for this reason, they used the highest possible dosage of steroids (this I was told). Also I got 4 liters of blood transfusion , platelets and white blood cells. After about 10 months I got new strong symptoms of Waldenstrom disease, stronger than anytime before. Then I was treated by Bendamusteen+Rituxan. Against my platelets and white cells were down and I received platelets that went below 10% and white blood cells from a donor. I never had such problems before, I had just a very mild case of Waldenstrom.

So my question is: "It is my understanding that possibly my bone marrow and immune system were not fully recovered"?? I read that to recover bone marrow and immune system could need time easily up to 3 years"

Thanks

Thank for your answer.

In my case, they spoke about completely restarting my immunity system!, and for this reason, they used the highest possible dosage of steroids (this I was told). Also I got 4 liters of blood transfusion , platelets and white blood cells. After about 10 months I got new strong symptoms of Waldenstrom disease, stronger than anytime before. Then I was treated by Bendamusteen+Rituxan. Against my platelets and white cells were down and I received platelets that went below 10% and white blood cells from a donor. I never had such problems before, I had just a very mild case of Waldenstrom.

So my question is: "It is my understanding that possibly my bone marrow and immune system were not fully recovered"?? I read that to recover bone marrow and immune system could need time easily up to 3 years"

Thanks