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

Status: Recruiting
Phase: Phase 2
Diagnosis: Hematopoietic Stem Cell Transplant
NCT ID: NCT01696461 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-053

 

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.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute

Overall PI:
Yi-Bin Chen, MD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility 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.
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