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The Patient Has Not Hodgkin's Lymphoma . When Physicians During

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Posted on Sun, 23 Feb 2020
Question: The patient has not 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??
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Follow up: Dr. Indranil Ghosh (0 minute later)
The patient has not 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??
doctor
Answered by Dr. Indranil Ghosh (1 hour later)
Brief Answer:
it depends on trial protocol

Detailed Answer:
Hi
Thanks for your query.

It depends on trial drug and the formulated protocol. Every trial has its own stopping rules. The clinician needs to follow that. Criteria are very rigid in trials.

So you can be rest assured that the protocol allowed continuation of the drug and reassess after pre specified interval. Sometimes investigation for low hemoglobin can be carried out in conjunction with continuation of drug. We commonly do serum iron profile, vit B12, folate and stool occult blood analysis for such cases.

Red blood aplasia and aplastic anemia can be easily distinguished by associated low neutrophil and platelet counts in the latter, also confirmed by bone marrow assay.

Hope this helps.
regards
Above answer was peer-reviewed by : Dr. Vaishalee Punj
doctor
doctor
Answered by Dr. Indranil Ghosh (0 minute later)
Brief Answer:
it depends on trial protocol

Detailed Answer:
Hi
Thanks for your query.

It depends on trial drug and the formulated protocol. Every trial has its own stopping rules. The clinician needs to follow that. Criteria are very rigid in trials.

So you can be rest assured that the protocol allowed continuation of the drug and reassess after pre specified interval. Sometimes investigation for low hemoglobin can be carried out in conjunction with continuation of drug. We commonly do serum iron profile, vit B12, folate and stool occult blood analysis for such cases.

Red blood aplasia and aplastic anemia can be easily distinguished by associated low neutrophil and platelet counts in the latter, also confirmed by bone marrow assay.

Hope this helps.
regards
Note: Do you have more questions on diagnosis or treatment of blood disorders? Ask An Expert/ Specialist Now

Above answer was peer-reviewed by : Dr. Vaishalee Punj
doctor
Answered by
Dr.
Dr. Indranil Ghosh

Oncologist

Practicing since :2004

Answered : 1712 Questions

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The Patient Has Not Hodgkin's Lymphoma . When Physicians During

The patient has not 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??