Allogeneic Tumor Cell Vaccination in Patients With Chronic Myeloid Leukemia

Hadassah Medical Center

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Chronic Myeloid Leukemia

Treatments: Biological: Allogeneic tumor cell vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00162513

191199-HMO-CTIL

Details and patient eligibility

About

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.

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)