[CML] CML Vaccine Trial Entry Criteria

Sat, 16 Jul 2005 12:45:58 -0700

Dear Listmembers:
 
       I have just received the entry criteria for the CML vaccine trial now open at MSKCC.  As I learn more about the trial from Dr. Seema Gupta, the trial head, I will pass the information on to you. Please note that either the b2a2 breakpoint or the b3a2 breakpoint must be present for you to qualify.
 
Best Regards,
Carl
 
Here are the trial criteria as per Dr. Gupta:

 ·        Patients must have a diagnosis of CML as evidenced by a (9;22) translocation or bcr/abl transcript.  Cytogenetics or molecular analysis will be confirmed at Memorial Hospital....

 

·        The b2a2 or b3a2 breakpoint must be present. The laboratory of Dr. Richard O’Reilly or Dr. Ladanyi or their designates will assay the bcr/abl transcript. Rare patients with both breakpoints are eligible and will be treated as if they are b3a2 only.

 

·        Patients must be in major (<35% Ph+ cells, MCR) or complete (0% Ph+ cells, CCR) cytogenetic remission. Patients in CCR must have disease that is detectable by qualitative or quantitative reverse transcriptase polymerase chain reaction (RT-PCR) for bcr-abl.

 

·        Patients may enter the study on imatinib and remain on their entry dose of imatinib throughout the study. Patients on interferon may also enter the study and remain on their entry dose of interferon throughout the study.

 

·        Patients who have been vaccinated with either of the two previous b3a2 vaccine preparations may be enrolled. This is to allow exposure to the additional heteroclitic peptides not present in either of the previous trials.

 

·        Patients may be post allogeneic or autologous bone marrow transplant, if at least six months after the graft.

 

·        Concomitant donor leukocyte infusions will be allowed within 72 hours after vaccination.

 

·        Karnofsky performance status should be > 70.

 

·        Creatinine <2.0 mg/100 ml, bilirubin <2.0 mg/100 ml, LDH <2.0 x normal, granulocytes >1,200/mm3, platelets >70,000/mm3, hemoglobin >9g%.

 

·        Patients must be 18 years of age or older and must be able to give written informed consent.

 

 

 

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