Relapsed Multiple Myeloma Clinical Trial
— GLIDEOfficial title:
An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Anti-minor Histocompatibility Complex (MiHA) Donor T-lymphocytes Expanded ex Vivo, in Patients With a Hematologic Malignancy, With Molecular or Clinical Relapse After Hematopoietic Stem Cell Transplantation From a Matched Donor
This study will evaluate the safety of infusing an anti-MiHA T cell line in patients suffering from an hematologic malignancy that has relapsed following hematopoietic stem cell transplantation from a matched donor.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | March 31, 2019 |
Est. primary completion date | March 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Prior allogeneic HLA-matched stem cell transplantation - Any of the following hematologic malignancies: - Acute myeloid leukemia (AML) - Acute lymphoblastic leukemia (ALL) - Biphenotypic leukemia - Chronic lymphoblastic leukemia (CLL) - Hodgkin Lymphoma - Non-Hodgkin Lymphoma (NHL) - Multiple Myeloma (MM) - Myelodysplastic syndrome (MDS) - Presence of HLA2:01 and / or HLA44:02 and / or HLA-B*44:03, HLA-A*01:01; HLA-A*03:01; HLA-A*11:01;HLA A*24:02; HLA-A*29:02; HLA-A*32:01; HLA-B*07:02; HLA-B*08:01; HLA B*13:02; HLA-B*14:02; HLA-B*15:01; HLA-B*18:01; HLA-B*27:05; HLA B*35:01; HLA-B*40:01; or HLA-B*57:01 - At least 6 months after allogeneic hematopoietic stem cell transplantation - Presence of detectable malignant disease post-transplantation in the form of molecular, cytogenetic or hematologic relapse of the malignant disorder. - Eligible to receive cytoreductive chemotherapy - Original stem cell donor available for leukocyte donation. - ECOG performance status =2. - Ability to provide written consent. - Accessible for treatment and follow up. - Presence of a targetable MiHA based on exome sequencing of the patient and donor Exclusion Criteria: - Active acute GVHD > grade I - Prior grade III-IV acute GVHD within the last year - Uncontrolled chronic GVHD - Prior administration of donor lymphocyte infusion (DLI) - Use of T-cell depleting antibodies in the previous 30 days - Treatment with immune suppressors (oral or parenteral steroids corresponding to a dose of prednisone greater than 7.5 mg/day, calcineurine inhibitors, rapamycin, mycophenolate mofetil, etc) during the last 30 days. - Uncontrolled active infection - Uncontrolled central nervous system involvement by leukemia cells (blasts). - AST or ALT > 2.5 x ULN (CTCAE grade 2) - Bilirubin > 1.5 x ULN (CTCAE grade 2) - Creatinine clearance < 50 mL/min - Positive test for human immunodeficiency virus (HIV) - Positive pregnancy test (women of childbearing age only) - Lactating women: the safety of this therapy on breast milk is not known. - Estimated probability of surviving less than 3 months - Known allergy to any of the components of GLIDE (e.g., dimethyl sulfoxide) - Intercurrent illness or medical condition precluding safe administration of the planned protocol treatment or required follow-up. |
Country | Name | City | State |
---|---|---|---|
Canada | CIUSSS d l'Est-de-l'Île-de-Montréal | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Ciusss de L'Est de l'Île de Montréal |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Non-hematologic toxicity related to GLIDE post injection | No death or other toxic events directly related to GLIDE injection | 6 months | |
Secondary | Response of hematologic malignancy (acute leukemia (ALL, AML, biphenotypic), CLL, HL, NHL, MM or MDS) post-injection | Disease progression following GLIDE injection | up to 12 months | |
Secondary | Incidence and severity of acute and chronic graft versus host disease (GvHD) | Progression (if any) or induction of GvHD | up to 12 months | |
Secondary | Persistence of GLIDE in the host and homing to peripheral blood, bone marrow and other tissues | Monitoring of GLIDE product persistence in host | up to 12 months | |
Secondary | Non-Relapse mortality (NRM) | Time to deaths without relapse/recurrence | up to 12 months | |
Secondary | Relapse-incidence (RI) | Time to relapse | up to 12 months | |
Secondary | Overall survival (OS) | Time to death, irrespective of the cause | up to 12 months | |
Secondary | Progression-free survival (PFS) | It is time to any of the following: OS, RI, NRM, Time to relapse, Relapse free survival | up to 12 months |
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