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  #1  
Old Thu Dec 4, 2008, 05:45 PM
flowerlady flowerlady is offline
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e1905 Clinical Trial

Hi Everyone!

Does anyone participate in the e1905 clinical trial or have any prior experience with it? Would love some feedback please.

Sunny Regards,
Flowerlady
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Flowerlady, 49, Diagnosed MDS 5q- 06/07, Revlimid 07/07 - 11/08. Vidaza 12/08 - 3/09. Allogeneic Stem Cell Transplant 4/14/09.
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  #2  
Old Sun Dec 7, 2008, 05:03 PM
Marrowforums Marrowforums is offline
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e1905 is the trial ID number for a trial named Azacitidine With or Without MS-275 in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia.

Azacitidine is Vidaza, used in treatment of MDS.

MS-275 inhibits HDACs (histone deacetylases). Since HDACs regulate gene transcription, HDAC inhibitors have the potential to reduce the production of targeted (disease) cells.

This trial will study the safety and efficacy of MS-275 when given in conjunction with Vidaza. The study details can be found at clinicaltrials.gov and at the two centers running the trial: Johns Hopkins and Stanford. A previous study found MS-275 to have potential benefits for MDS treatment and therefore to be worth further study.

Last edited by Ruth Cuadra : Sat Mar 28, 2009 at 02:45 AM.
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  #3  
Old Fri Mar 27, 2009, 11:25 PM
launch launch is offline
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Will start this trial next week (4/01/09)

My husband just signed on for this clinical trial through Emory. Not sure if he'll be in the group that receives the MS-275 yet, but will know by Wed. Please keep my husband Ron in your prayers.
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  #4  
Old Sat Mar 28, 2009, 12:09 PM
Vera W Vera W is offline
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Trial

I was offered this trial but decided it was too far to drive (106 miles) since I could get the azacitidine close to home. I was also told that it could hinder my transplant process for quite some time(insurance issues) so I opted out. But even if your husband just gets the azacitidine I have to say that the results have been remarkable for me. My hemoglobin went from 10.2 and has been holding strong at 13.8 and I feel so much better. Initially his counts will drop but it is wonderful as they start coming up. Tell him to drink lots of water it is very dehydrating.Best wishes!
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Vera, 56 yo female Dx RAEB II 10-08, 11-12% blasts. Normal chromosomes. Started Vidaza 10-08. . Improved Dx 3-09 MDS RA 2% blasts 8 cycles Vidaza! SCT transplant 7-1-09 at UCSF. Normal bone marrow and MDS free as of 10-09
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  #5  
Old Sat Mar 28, 2009, 10:01 PM
launch launch is offline
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Encouraging!

Vera,
Thank you for the response! you're right, 106 miles is quite the drive... we're lucky that we're so much closer. I'm so happy to hear the encouring news that you're doing so much better with the azacitidine. Are you receiving the injections too? And, what are your cycles? And, when did you start feeling better?

Thanks, Cindy
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  #6  
Old Mon Mar 30, 2009, 11:54 AM
Vera W Vera W is offline
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Vidaza Shots

Hi Cindy, barely a week passed after my DX last Oct and I was receiving my first Vidaza injection. I started with 160MG, Half a dose on each side of my stomach for 7 days. November was rough, it is not unusual for your counts to go down before they go up. ALWAYS while I am receiving the drug my counts are all normal.It cycles down to the nadir (LOW) point after about two weeks. Right before Thanksgiving my WBC was 1.9 and my neutrophils 14. The doctor was worried that I would get sick but I did fine and even though I was very low I was never neutrophenic. I didn't have to have any blood boosters but my doc wanted the Vidaza to follow it's natural course. He was pleased because it was doing it's job. I was very tired and had to take things a little at a time. My December injections were a little late as we were waiting for my counts to come back up. He wanted the neutrophils above 20%. He lowered my dose to 130mg for 2 cycles. in February I went back to my normal dose. Again for about two weeks my counts are remarkable, My wbc was 10 and neuts were 65% in the beginning, they still cycle down but not as low. Last week (3rd week) I was 4.9 my neutrophils are about 40% and seem to like to stay there. My Hemo has been normal since Febuary and so are my reds that alone gives me more energy. I had my BMB after my 4th cycle and my blasts went from 12% to 2%. I will be going into my transplant in optimal condition. I had on site reactions to the Vidaza..Red, hot and itchy and some hematomas. It doesn't happen with everyone. It is a small price to pay for my life. My liver enzymes also shoot up but always come back down. I strongly suggest a daily laxative like Milk of Magnesia for your husband even if he experiences some diarrhea at first. He will have ups and downs, take it a day at a time and make sure he rests as his body asks him to! Since my transplant has been moved forward I will be starting round six of Vidaza today and will be thinking of your husband. Take care, Vera
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Vera, 56 yo female Dx RAEB II 10-08, 11-12% blasts. Normal chromosomes. Started Vidaza 10-08. . Improved Dx 3-09 MDS RA 2% blasts 8 cycles Vidaza! SCT transplant 7-1-09 at UCSF. Normal bone marrow and MDS free as of 10-09
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  #7  
Old Mon Mar 30, 2009, 10:03 PM
launch launch is offline
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Thank you Vera! I appreciate the details! And suggestions! We're both very anxious, but, so looking forward to progress so he can start feeling better and we can get to a bit of normalcy again... I miss his smile... he's been feeling pretty bad lately. But - chin up! He's been diagnosed, we have a plan, and we start on Wed or Thurs... we'll find out Wed this week. :-) I will also keep you in my prayers...

Hugs, Cindy
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  #8  
Old Tue Mar 31, 2009, 10:16 PM
launch launch is offline
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Rough Night for Ron....

Ron had his pre-clinical trial BMB Friday (3/27/09) and was extremely run down afterwards. He should start Vidaza treatment at least tomorrow afternoon, or Thurs. (We find out tomorrow, as there were some preliminary tests that had to be accomplished before we start the clinical trial.

He had a bad night last night, temp 102.9F. He felt so bad. We called Emory and talked with the on-call Doctor for the Oncology Dept. He cautioned us to keep what he called a "Short Fuse".... meaning, don't try to wait it out. He knew we had an appt on Wed (4/01/09) and that Ron didn't really want to go to the ER. He discussed other symptoms, etc... very thorough. He then said to take one dose of Tylenol & we had already told him we were applying ice to Ron's back of his neck... seems to really bring his temp down easily. But, said, if it went any higher to come into the ER immediately, but, if it started going down, monitor it closely.

I checked him throughout the evening. It finally went down to 98.8F. He's been running low-grade temps daily since dx Feb'09, but, normally never goes over 100.5F He has nightly sweats from the neck up every single night though. He gets really clamy and has difficulty sleeping....

I've been talking him through "Visualizing" good health and reading him scriptures about "God's Medicine" and healing.... Now, tomorrow, along with God's Medicine, we start Vidaza.....

I appreciate this Forum, you all are wonderful!
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  #9  
Old Wed May 6, 2009, 10:10 PM
launch launch is offline
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Smile Update... Clinical Trial - Azacitidine Without MS-275

My Husband, Ron, started this clinical trial April 1, 2009. He's on a 10-day cycle of Vidaza, by injection - 105 is the dosage. He was in the group that would not receive the MS-275. The first cycle was a tough one for Ron. He was nauseated and constipated. He kept saying he felt "weird". He was very tired and run down and his legs ached. He developed mouth sores for just a few days and he used a mouthwash called BIOTENE. Seemed to work good for him. He's continued using the Biotene mouthwash and toothpaste regularly. He also took off work during his 10 days cycle of Chemo and during the 18 days before his next cycle, he tried to work fulltime but just ran himself down. He finally agreed he should only work half days and this seems to have helped him tremendously. During Cycle #1, Ron needed a RBC transfusion.


At the beginning of Cycle #2, Ron's WBCs were low - at 1200 and Neutraphils are down to only 15%. One week prior, they were at 33%, and one week prior to that, they were at 65%. So, they are dropping right now. The Doctor changed Ron's antibiotic. He takes it daily. Amazingly, Ron's platelets, had been running between 89,000 and 112,000. Now they're at 240,000. So those have increased.

Now, on with Cycle # 2.... so far, it's been like night and day compared to Cycle #1. Ron's spirits have also been lifted tremendously. The amazing thing is, although he's still tiring easily, he's aleady feeling somewhat better. He hasn't had any mouth sores, but, as mentioned earlier, he's continued to use the Biotene mouthwash and toothpaste as a preventative maintenance. He also uses a toothbrush steralizer. The 2nd and 3rd day of chemo (Vidaza), Ron's left bottom teeth hurt. He said they felt like they were going to explode.? I gave him some regular strength Tylenol and told him to ensure he drinks plenty of water... He only had 2 days of this type pain. He saw his doctor today and the doctor said, after cycle #3, Ron should start feeling even better... Right now, with cycle# 2, once again, Ron has constipation.

We keep praying... and trying to do the right things.... we keep reading, and learning....and try to apply what we learn to help improve Ron's condition...

Hugs & Prayers to all of you! Cindy

Last edited by launch : Thu May 21, 2009 at 09:40 PM. Reason: Adding one constipation as Vidaza side effect. Changed "Aspirin to Tylenol"... he hasn't taken aspirin since diagnosed.
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  #10  
Old Thu May 7, 2009, 05:35 AM
Birgitta-A Birgitta-A is offline
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Vidaza

Hi Cindy,
Good that Ron seems to respond !
Kind regards
Birgitta-A
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  #11  
Old Thu May 7, 2009, 10:43 AM
Vera W Vera W is offline
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Vidaza Constipation

I use milk of magnesia every night before bed after literally screaming through the first cycle and being scolded for using an anemia! You know infection worries! I keep water by my bed stand and Make myself drink whenever I think of it. Stools are watery but it is better than being impacted!! Ron has a major battle going on in his body..I never want to give it up but rest is always the best remedy!! Glad things are progressing better!
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Vera, 56 yo female Dx RAEB II 10-08, 11-12% blasts. Normal chromosomes. Started Vidaza 10-08. . Improved Dx 3-09 MDS RA 2% blasts 8 cycles Vidaza! SCT transplant 7-1-09 at UCSF. Normal bone marrow and MDS free as of 10-09
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  #12  
Old Thu May 7, 2009, 09:41 PM
launch launch is offline
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Milk of Magnesia

Vera,
Thanks for the reminder. I did tell Ron to take Milk of Magnesia and he did... but, he wasn't getting relief quick enough. Finally, the doctor prescribed something that works - a liquid he takes when constipated. Prune juice helps him, if he can remember to take it regularily. And, I agree with lots of water and Rest....

Sincerely, Cindy
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  #13  
Old Thu May 7, 2009, 09:46 PM
launch launch is offline
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Smile Thanks Birgitta

Birgitta,

Thanks for the reply... I know I've been a stranger lately.... but, things are looking up. We've also met another couple.. the husband is on the same clinical trial and he did receive the MS-275. He gets the same dosage of Vidaza as my husband, Ron, but, he's also getting the MS-275. He said he started feeling better cycle #4. He is in really good spirits, and it's funny because he doesn't have fat on his body, so he's gotten creative with the injections. He's asked "Where else" can he get the injections? So, he alternates, telling the nurses where to inject him. During a 10-Day cycle, he gets them in his stomach, inner-upper thigh, and upper arm (inside, where the fat tissue is). He use to be a marathon runner, so he doesn't have much fat anyway. He and his wife have really been an inspiration to Ron and me. It's so encouraging to see him doing so well too.

Take care, Cindy
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  #14  
Old Fri May 8, 2009, 06:17 AM
Birgitta-A Birgitta-A is offline
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Vidaza and MS-275

Hi Cindy,
It should be very interesting with info from a patient that is treated with MS-275. As far as I understand it is common that patients respond at the 4th Vidaza cycle so this far his results are not different from other Vidaza patients. Did you get any info about his counts?

Hope Ron continues to feel better!
Kind regards
Birgitta-A
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  #15  
Old Fri May 8, 2009, 09:08 AM
launch launch is offline
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He said his counts continued to drop through the 3rd cycle, and he started feeling better only after his 4th cycle. His counts did not start rising until after the 4th cycle. I can get more details to share... they keep all of their lab reports. I'll post more as I know....

But, so far, you're right, no big difference from normal Vidaza treatment. He just finished up his 5th cycle, and after the 6th, he'll receive the bone marrow biopsy to check progress. We stay in pretty close contact, so, I'll let everyone know how his progress is. Also, will find out exactly what his stage of MDS was. He had mentioned he was stage-4, but, I'll get the specifics.

Cindy
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  #16  
Old Fri May 8, 2009, 10:24 AM
Vera W Vera W is offline
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BMB after fourth Vidaza cycle

I guess that four months is the standard time to have the BMB but after that first month of shots I felt so much better. All of these Vidaza tests are so new it will be interesting to see if by the addition of drugs like ms 275 we can suppress the bad guys into a dormant stage that would last forever? Wouldn't that be a breakthrough? One of my doctors patients who has MDS and PHN and was in really bad shape had such remarkable results from the Vidaza that they are writing her up! Keep up the good fight!!
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Vera, 56 yo female Dx RAEB II 10-08, 11-12% blasts. Normal chromosomes. Started Vidaza 10-08. . Improved Dx 3-09 MDS RA 2% blasts 8 cycles Vidaza! SCT transplant 7-1-09 at UCSF. Normal bone marrow and MDS free as of 10-09
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  #17  
Old Fri May 8, 2009, 02:58 PM
launch launch is offline
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Lab Results for 10th day of 2nd Cycle Vidaza

We just got home from Emory and Ron had the following lab results today:

HGB 9.6, Hemacrit 29.7%, RBC 3.06, WBC 1.9, Neutrophils 29%, PLT 277. Ron's feeling pretty good, but of course, tired. He's taking a nap now. (Like Vera said, Rest is very important).

Next doctors visit is Wed (5/13/09) for lab work again.

Continued Prayers that my husband will continue to improve with this Vidaza Treatment.
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  #18  
Old Wed May 13, 2009, 10:23 PM
launch launch is offline
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Smile Weekly Blood Work Results - 4/13/2009 (On Clinical Trial w/o MS-275)

Since last post, things have continued to look up. Ron's feeling better and seems to have a lot more energy. He's very upbeat too!

Here are the lab results from today...

HGB 10.4, Hemacrit 31.3%, RBC 3.11, WBC 2.6, Neutrophils 41%, PLT 239. We go back in 1 week for lab work only (5/20/09), then, Ron begins his 3rd Cycle of Vidaza on 5/27/09.

We praise God for his progress so far, and we continue to pray that he'll continue on this path... Thank all of you for your prayers and your support. You are all an incrediable group!!! Full of stength and Hope... you've helped me & Ron tremendously and I gain strength from knowing you... and being a part of this group... again, "Thank you All"....

God Bless you All,
Cindy
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  #19  
Old Fri May 15, 2009, 03:33 PM
Birgitta-A Birgitta-A is offline
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Vidaza

Hi Cindy,
Congratulations to you both ! Ron's HGB and platelets are really very good and the white blood cells are increasing too already.
Kind regards
Birgitta-A
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  #20  
Old Wed May 20, 2009, 10:20 PM
launch launch is offline
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Smile Weekly Blood Work Results - 5/20/2009 (On Clinical Trial w/o MS-275)

Ron continues to feel well & has energy. He tried to add a few extra hours at work this week and felt drained later after he got home. We talked about it and I convienced him he may be pre-mature about increasing his hours. He agreed to continue only on half days and to concentrate on continuing to "Rest" so his body can continue to heal...

Here are the lab results from today...

HGB 12.9, Hemacrit 39.0%, RBC 3.73, WBC 3.0, Neutrophils 45%, PLT 209.

All numbers are up more, except PLT, but, they have fluctuated over past several weeks, but, remained within normal band. I'm especially impressed with Ron's HGB increasing from 10.4 last week to 12.9 !!!! WBCs are on the rise too...

We continue to thank everyone for Prayers and Praise God for his response to Vidaza! We go back in 1 week (5/27/09), then, Ron begins his 3rd Cycle of Vidaza on 5/27/09.

PS. Ron initially had fevers and night sweats when first dx (Feb09). The fevers stopped after his last transfusion, just over 3 wks ago, and now the night sweats have stopped as well :-)

Thank you for your continued Prayers...
Cindy
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  #21  
Old Thu May 21, 2009, 05:08 AM
Birgitta-A Birgitta-A is offline
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Vidaza

Hi Cindy,
You know Ron's counts could not be much better - his platelet count is very, very good . Many patients treated with Vidaza have really very low platelets and have to get platelet transfusions or get lower doses of Vidaza. Good that Ron was brave enough and entered the trial because Vidaza in a lower dose during 10 days in a 28 days cycle seems to be perfect for him.
Kind regards
Birgitta-A
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  #22  
Old Thu May 21, 2009, 07:28 AM
launch launch is offline
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Birgitta,

I agree! The low dose is doing wonders for Ron! The great thing is, hopefully, through this trial, as with all of them, they learn what works better for some people, providing for more options! You're right about him being brave. I was so nervous (as you well know) when we had to personally "Choose" what option to go with... seems so overwhelming.

I am so HAPPY!!!! Continued prayers... I'll update all next week. By the way, we love Ron's doctor! He's awesome! He came wallking down the hallway while we were awaiting lab results. We didn't have a doctors appt yesterday, only lab work. We always have to stay to see results to ensure no tranfusions are required. The doctor stopped and talked to Ron a few moments asking Ron what he was up to. Ron smiled and said, I'm waiting to see if I need a transfusion. The doctor smiled really big and said, I don't believe you'll need one... Ron smiled back and replied, Neither do I...

Ron looks Fantastic!

Hugs, Cindy
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  #23  
Old Wed May 27, 2009, 07:43 PM
launch launch is offline
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Clinical Trial e1905 w/o MS-275 (Cycle #3)

Today (5/27/09) was Ron's first day of his 3rd Cycle of treatment on clinical trial e1905. As previously mentioned, he is in the group that receives the 10 consecutive days of low dose (105 mg) Vidaza injections, he does not receive the additional pill (MS-275).

Today was another wonderful day for us reviewing the lab results... My spirit remains lifted and my heart continues to sing.. Praise God! HGB 13.1, Hemacrit 40.2%, RBC 3.86, WBC 3.0, Neutrophils 42%, PLT 250

Looking at previous labs (Last week), all levels have continued to increase a little bit, except the WBCs are holding steady at 3.0 so far. The Neutrophils are slightly down from last weeks 45%. I'll be very happy when the whites get up above 5000 and the Neutraphils are within normal % range.

Ron has had a lot of energy this past week, and I had to remind him to slow down. Seems he's trying to catch up on lost time... I'm trying to hobble him a bit so he continues to get the rest he needs to continue to heal. I'll update everyone next week.... and report how Ron's doing on the Vidaza this Cycle #3.

God Bless You All!
Cindy

Last edited by launch : Wed May 27, 2009 at 09:19 PM. Reason: Signed Name :-)
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  #24  
Old Wed Jun 3, 2009, 06:00 PM
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e1905 Clinical Trial w/o MS-275 (Lab Results 6/03/09)

Today (6/03/09) was Ron's 8th day of his 3rd Cycle of treatment on clinical trial e1905.

HGB 13.9, Hemacrit 41.7%, RBC 4.04, WBC 2.2, Neutrophils 14%, PLT 336

Looking at previous labs (Last week), all levels have continued to increase a little bit, except the WBCs have dropped from last week's 3.0 to 2.2 and Neutrophils are way down from last weeks 42% to 14%.

Not sure what's going on with the WBCs/Neutrophils... but, I'm just praying it's all part of the process.... The clinical coordinator (Another Doctor) sat down with Ron today and told him she had reviewed all of his blood work and his progress so far, and they're fully expecting full remission by the end of the 6 mons treatment cycle.

As previous mentioned, I'll be at ease more when the whites start "Behaving"... I am very pleased with all of the other numbers and we continue to Praise God for the improvements.... and the good news the Coordinator shared with us today!

God Bless you All,
Cindy
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  #25  
Old Wed Jun 10, 2009, 04:00 PM
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e1905 Clinical Trial w/o MS-275 (Lab Results 6/10/09)

Today (6/10/09) was Ron's 15th day of his 3rd Cycle of Vidaza (by injection) treatment on clinical trial e1905.
NOTE: The cycles in this trial consist of 28 Days per cycle. Day 1-10 Ron recieves 105mg Vidaza by injection. Then, he's off 18 days.... but, has weekly lab work to check blood counts, etc.

Today, his blood counts were: HGB 14.5, Hemacrit 42.6%, RBC 4.16, WBC 3.9, Neutrophils 42%, PLT 226

Looking at previous labs (Last week), all levels have continued to increase, and I'm especially pleased with the WBCs increasing from last week's 2.0 to 3.9 and Neutrophils came up from last weeks low of 14% to 42%.

We were told it's normal for WBCs to bounce back and forth while receiving Chemo... I'm happy for them to keep bouncing "up".... and forget the "down"...


God Bless you All,
Cindy

Last edited by launch : Wed Jun 10, 2009 at 06:59 PM. Reason: Clarificaion of cycle treatment regime.
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