-
Mantle Cell Lymphoma Treatment Question.
Hi,
I'm 74 years old and was just diagnosed with Mantle Cell Lymphoma and asked my Oncologist if he would consider treating me with Acalabrutinib pills which apprently a derivative of Ibrutinib. He wasn't 100% sure; but, thinks he would only be able to prescribe this as a second line of treatment, but again not he's not sure?
My questions are:
1. Does anyone know if Acalabrutinib has been approved at this time for first line treatment for MCL ?
2. If NOT will the new "Right To Try" legislation override that and allow me to use these pills as a first line of treatment?
I realize these are complicated questions; but, didn't know where else to turn !
Thank you very much !
-
This is the FDA approval, as I am in the UK I can only refer you to this so cannot answer question 2 and hope this answers Q1
https://www.fda.gov/drugs/resources-...-cell-lymphoma
It states you must have had a previous treatment, whether this has been updated since approval I don't know
John
NHL DLBC aggressive stage 4B advanced
diagnosed april 09
after 8 rchop and a couple of delays, in remission
some long term side effects to manage post treatment
some blips and investigations on the journey but now
22nd oct 2014 discharged no more hospital visits
we are all on a roller coaster ride, riding blind never knowing where the highs and lows are.
-
Super Moderator
Top User
Sorry to hear of your diagnosis. Normally, it takes some years of using a drug as second line therapy before it is allowed to be used as first line. Case in point is Adcetris, which was approved in 2011, but only approved for first line use in 2018.
Regarding Mantle Cell, there are several drugs in use or under investigation now (the list may not be up to date):
Treatments Under Investigation
Many new approaches are being studied as initial therapy in clinical trials for MCL. These include attempts to determine who most benefits from stem cell transplantation and the use of new drugs to replace or shorten the course of chemotherapy.
New agents being investigated alone or as a part of combination therapy include the following:
Follow-up
• Acalabrutinib (Calquence) • Bendamustine (Treanda) • Ibrutinib (Imbruvica)
• Lenalidomide (Revlimid)
• Obinutuzumab (Gazyva) • Ofatumumab (Arzerra)
• Venetoclax (Venclexta)
As to right to try, several qualifiers must be met. However, there is also "off-label" use of an already approved drug if there is some evidence that it is efficacious against other malignancies. Are you at an NCI designated center?
05/08-07/08 Tumor appears behind left ear. Followed by serial medical incompetence on the parts of PCP, veteran oncologist and pathologist (misdiagnosis via non-diagnosis). Providential guidance to proper care at an NCI designated comprehensive cancer center.
07/08 Age 56 DX 1) Peripheral T-Cell Lymphoma-Not Otherwise Specified. Stage IV-B, >50 ("innumerable") tumors, bone marrow involvement.
08/08-12/08 Four cycles CHOEP14 + four cycles GND (Cyclofosfamide, Doxorubicin, Vincristine, Etoposide, Prednisone & Gemcitabine, Navelbine, Doxil)
02/09 2) Relapse.
03/09-06/13 Clinical trial of Romidepsin > long-term study. NED for 64 twenty-eight day cycles, dose tapered.
07/13 3) Relapse, 4) Suspected Mutation.
08/13-02/14 Romidepsin increased, stopped for lack of response. Watch & Wait.
09/14 Relapse/Progression. Visible cervical nodes appear within 4 days of being checked clear.
10/06/14 One cycle Belinostat. Discontinued to enter second clinical trial.
10/25/14 Clinical trial of Alisertib/Failed - Progression.
01/12/15 Belinostat resumed/Failed - Progression. 02/23/15
02/24/15 Pralatrexate/Failed - Progression. 04/17/15
04/15 Genomic profiling reveals mutation into PTCL-NOS + AngioImmunoblastic T-Cell Lymphoma. Stage IV-B a second time. Two dozen tumors + small intestine (Ileum) involvement.
04/22/15 TEC (Bendamustine, Etoposide, Carboplatin). Full response in two cycles. PET/CT both clear. Third cycle followed.
06/15-07/15 Transplant preparation (X-rays, spinal taps, BMB, blood test, MUGA scan, lung function, CMV screening, C-Diff testing etc. etc. etc.) Intrathecal Methotrexate during spinal tap.
BMB reveals 5) 26% blast cells of 20q Deletion Myelodysplastic Syndrome MDS), a bone marrow cancer and precursor to Acute Myeloid Leukemia.
07/11-12/15 Cyclofosfamide + Fludarabine conditioning regimen.
07/16/15 Total Body Irradiation.
07/17/15 Moderate intensity Haploidentical Allogeneic Stem Cell Transplant receiving my son's peripheral blood stem cells.
07/21-22/15 Triple dose Cyclofosfamide + Mesna, followed by immunosuppressants Tacrolimus and Mycophenolate Mofetil.
07/23-08/03/15 Marrow producing zero blood cells. Fever. Hospitalized two weeks.
08/04/15 Engraftment occurs, and blood cells are measurable - released from hospital.
08/13/15 Day 26 - Marrow is 100% donor cells. Platelets climbing steadily, red cells follow.
09/21/15 Acute skin Graft versus Host Disease arrives.
DEXA scan reveals Osteoporosis.
09/26/-11/03/15 Prednisone to control skin GvHD.
11/2015 Acute GvHD re-classified to Chronic Graft versus Host Disease.
05/2016 Tacrolimus stopped. Prednisone from 30-90mg daily tried. Sirolimus begun. Narrow-band UV-B therapy started, but discontinued for lack of response. One treatment of P-UVAreceived, but halted due to medication reaction.
09/16/16 Three skin punch biopsies.
11/04/16 GvHD clinical trial of Ofatumumab (Arzerra) + Prednisone + Methylprednisolone begun.
12/16 Type II Diabetes, Hypertension - both treatment-related.
05/17 Extracorporeal Photopheresis (ECP) begun in attempt to control chronic Graft-versus-Host-Disease (cGvHD. 8 year old Power Port removed and replaced with Vortex (Smart) Port for ECP.
05/2017 Chronic anemia (low hematocrit). Chronic kidney disease. Cataracts from radiation and steroids.
06/17 Trying various antibiotics in a search for tolerable prophylaxis.
08/17 Bone marrow biopsy reveals the presence of 2% cells with 20q Deletion Myelodysplastic Syndrome, considered to be Minimum Residual Disease.
12/17 Bone marrow biopsy reveals no abnormalities in the marrow - MDS eradicated. The steroid taper continues.
01/18 Consented for Kadmon clinical trial.
03/18 Began 400mg daily of KD025, a rho-Associated Coiled-coil Kinase 2 Inhibitor (ROCK2).
09/18 Due to refractory GvHD, Extracorporeal Photopheresis halted after 15 months ue to lack of additional benefit.
10/18 I was withdrawn from the Kadmon KD025 clinical trial due to increasing fatigue/lack of benefit.
11/18 Began therapy with Ruxolitinib (Jakafi), a JAK 1&2 inhibitor class drug. Started at half-dose due to concerns with drug interactions.
11/19 MRI of brain reveals apparently benign frontal lobe tumor. Has the appearance of a cerebral cavernoma. Watch & wait on that.
To date: 1 cancer, relapse, second relapse/mutation into 2 cancers, then 3 cancers simultaneously, 20 chemotherapy/GVHD drugs in 11 regimens (4 of them at least twice), 5 salvage regimens, 4 clinical trials, 5 post-transplant immuno-suppressant/modulatory drugs, the equivalent of 1,000 years of background radiation from 40+ CT series scans and about 24 PET scans.
Both lymphoid and myeloid malignancies lend a certain symmetry to the hematological journey.
Believing in the redemptive value of suffering makes all the difference.
-
Thank you all very much for your help.
After several phone calls it appears "The Right To Try" is only intended for un-approved drugs and will not help a second line of treatment to be used as a first line of treatment.
I was also told my best chance for being treated with Acalabrutinib as a first line is to have my oncologist formerly support this on my behalf which could be a long and complicated process.
I'll keep trying !!
-
Super Moderator
Top User
If your underlying health will allow, just begin with the current state of the art in treatment. If it works, fine! If it does not, wish granted! Ask about "off-label use", as that would be reasonably easy for a motivated hematologist to do for you. My hematologist - granted he is a researcher at Fred Hutch - offered more than once to write up a clinical trial with me as the only patient.
|
|
|
Reply With Quote