A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II, open-label, two strata, multicenter, prospective study of plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor for this purpose.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center for International Blood and Marrow Transplant Research
• Collaborators: Genzyme, a Sanofi Company; Sanofi
• Treatments: JM 3100; Plerixafor

Criteria

Inclusion Criteria:

Donor:

• Donor eligibility will be determined according to applicable federal, state and local regulations and institutional standards

• 18-65 years of age

• 6/6 HLA-matched sibling

• Fulfill individual Transplant Center criteria to serve as a mobilized blood cell donor

• Serum creatinine <2.0mg/dl

Recipient:

• 18 to 65 years of age

• 6/6 HLA antigen matched sibling willing to donate PBSC for transplant

• Fulfill individual Transplant Center Criteria for transplant

• One of the following diagnoses:

• Acute myelogenous leukemia (AML) in 1st remission or beyond with <5% marrow blasts and no circulating blasts. Marrow must be done within 30 days of the start of transplant conditioning regimen in alignment with other pre-transplant assessments.

• Acute lymphoblastic leukemia (ALL) in 1st remission or beyond with <5% marrow blasts and no circulating blasts

• Myelodysplastic syndrome, either intermediate-1,2, or high risk by International Prognostic Scoring System or transfusion dependent

• Chronic myelogenous leukemia (CML) failing or intolerant to tyrosine kinase inhibitor based therapy

• Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete remission, partial remission, or in relapse (but with at least stable disease after most recent therapy)

• Chronic lymphocytic leukemia (CLL), relapsing after at least one prior regimen, or in remission with 17p deletion

• Serum creatinine must be <2.0mg/dl

• Total bilirubin and AST <3x normal

• Infectious disease marker (IDM) monitoring will be performed per institutional standards

• Karnofsky performance status of 70% or greater.

• Patients who have undergone a prior autologous transplantation are eligible for a reduced intensity transplant only

Exclusion Criteria:

Donor:

• Donor unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing

• Donor already enrolled on another investigational agent study

• Pregnant or breast feeding females, or females not willing or able to use adequate contraception if sexually active

Recipient:

• Patient unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing

• Patients with active, uncontrolled infection at the time of the transplant preparative regimen

• Pregnant or breast feeding females, or females not willing or able to use adequate contraception if sexually active

• Patients with a history of previous CNS tumor involvement showing active symptoms or signs along with documented disease on lumbar puncture and MRI of the brain within 30 days of start of conditioning

• A condition, which, in the opinion of the clinical investigator, would interfere with the evaluation of primary and secondary endpoints.