Intravenous (IV) AMD3100 for Mobilization and Matched Related Transplant for Advanced Hematological Malignancies
Condition: Hematologic Neoplasms
MeSH terms: Hematologic Neoplasms
Intervention: AMD3100; Leukopheresis; Stem cell transplant
Intervention MeSH terms: Plerixafor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To reduce the number of donors treated with IV AMD3100 who require a second collection to
      obtain the minimum cells necessary for allogeneic stem cell transplant.
    

Eligibility criteria:

        Inclusion Criteria:

        Donor Eligibility

          -  Donor is 18 to 70 years of age inclusive.

          -  If female and of child-bearing age: must be non-pregnant, not breast feeding and agree
             to use adequate contraception.

          -  Donor is a 6/6 HLA-matched sibling willing to donate PBSC for transplant.

          -  Donor must be willing to provide written informed consent.

          -  Adequate cardiac function with no history of congestive heart failure and no history
             of atrial fibrillation or ventricular tachyarrhythmia.

          -  Adequate renal function as defined by a calculated serum creatinine clearance of ≥75%
             of normal (Cockcroft-Gault equation).

          -  Adequate hepatic function as defined by a total bilirubin <2x normal or absence of
             hepatic fibrosis/cirrhosis.

          -  Adequate neurologic function as defined by NO evidence of a severe central or
             peripheral neurologic abnormality. No history of cerebrovascular accident or seizure
             disorder requiring anticonvulsant medication.

          -  Donor must be HIV-1&2 antibody and HTLV-I&II antibody sero-negative, by Food and Drug
             Administration (FDA) licensed test.

          -  Donor must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0
             or 1.

          -  Donor must demonstrate ability to be compliant with study regimen.

          -  Donor must not have an active infection at the time of study entry.

          -  Donor does not have active alcohol or substance abuse within 6 months of study entry.

          -  Donor is not currently enrolled on another investigational agent study.

          -  Donor does not have any medical condition, which, in the opinion of the clinical
             investigator, would interfere with his/her evaluation.

        Recipient Eligibility

          -  Recipient must have available the successful collection of an AMD3100 mobilized
             product. When an adequate collection cannot be obtained using G-CSF, some recipients
             may need to receive a combined product of mobilized cells with AMD3100 and g
             granulocyte-colony stimulating factor (G-CSF). Recipients who receive less than 2.0 X
             106 CD34+ cells/kg/actual recipient weight after two days of IV AMD3100 will not be
             considered "eligible" but followed per protocol for safety purposes only.

          -  Patient is 18 to 65 years of age inclusive.

          -  Patient is willing and has a 6/6 HLA-matched sibling willing to donate PBSC for
             transplant.

          -  Patient must provide signed informed consent.

          -  If female and of child-bearing age: must be non-pregnant, not breast feeding, and uses
             adequate contraception.

          -  Patient must have one of the following diagnoses:

               -  Acute myelogenous leukemia (AML) in 1st or subsequent remission or in relapse,

               -  Acute lymphoblastic leukemia (ALL) in 1st or subsequent remission or in relapse,

               -  Myelodysplastic syndrome either intermediate 1 or 2, or high risk by the
                  International Prognostic Scoring System,

               -  Chronic myelogenous leukemia (CML) in accelerated or second chronic phase,

               -  Non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD) in 2nd or greater complete
                  remission, partial remission, or refractory relapse,

               -  Chronic lymphocytic leukemia (CLL), Rai Stage 2-4, failing at least 2 prior
                  regimens, OR

               -  Multiple myeloma (MM), Stage 2-3.

          -  Adequate cardiac function with a left ventricular ejection fraction ≥ 40%.

          -  Adequate pulmonary function defined as NO severe or symptomatic restrictive or
             obstructive lung disease, and formal pulmonary function testing showing an FEV1 ≥50%
             of predicted and a DLCO ≥40% of predicted, corrected for hemoglobin.

          -  Adequate renal function as defined by a serum creatinine clearance of ≥75% of normal
             (Cockcroft-Gault equation).

          -  Adequate hepatic function as defined by a total bilirubin <2x normal or absence of
             hepatic fibrosis/cirrhosis.

          -  Adequate neurologic function as defined by NO evidence of a severe central or
             peripheral neurologic abnormality. Patients with a history of previous central nervous
             system (CNS) tumor involvement are eligible provided they are without symptoms or
             signs and the CNS is now free of disease on lumbar puncture and CT scan of the brain.

          -  No evidence of active infection at the time of the transplant preparative regimen or
             at time of transplantation.

          -  Patient must be HIV-1&2 antibody and HTLV-I & II antibody sero-negative, by FDA
             licensed test.

          -  Patient has an ECOG performance status of 0 or 1.

          -  Patient must demonstrate ability to be compliant with medical regimen.

          -  Patient must not have active alcohol or substance abuse within 6 months of study
             entry.

          -  Patient must not be enrolled on another investigational agent concurrently.

          -  Patient must not have any medical condition, which, in the opinion of the clinical
             investigator, would interfere with the evaluation of the patient.

        Exclusion Criteria:

          -  See Inclusion criteria above