Chronic Myeloid Leukemia
Conditions
Brief summary
Donors with CM will be solicited from a waiting list of patients awaiting BMT from the waiting list of MUD searches. Maximally matched donor will be searched for each eligible CML patient with a goal in mind to find other patients with CML that share both class I and class II determinants. Sharing of one class I II will be considered eligible for participation in the study. Peripheral blood and PBMC from the donors will be isolated, washed and irradiated. The cells will be injected into the consenting patients intracutaneously at 2 weeks intervals for a total of 6 injections.
Interventions
BIOLOGICALAllogeneic tumor cell vaccine
Sponsors
Hadassah Medical Organization
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients above the age of 55 consenting to participate in the study. * Patients with documented CML with Philadelphia chromosome t (9:21) * Patients with no HLA matched sibling. * Patients eligible for BMT for who no matched unrelated donor can be identified after completion of an international donor search lasting for more than six months, or patients that have failed BMT. * Patients with contra-indication to BMT. * Patients refusing BMT. * Patients who failed interferon alpha, ARAc and/or Glivec.
Exclusion criteria
* Patients requiring immunosuppressive therapy or corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigate the feasibility of allogeneic tumor cell vaccine for patients with resistant CML. | — |
Secondary
| Measure | Time frame |
|---|---|
| To induce immunity against a putative bcr/abl peptide bound to MHC identical class I, II or preferably both. | — |
Countries
Israel
Outcome results
None listed