Study of Melphalan HCl for Injection (Propylene Glycol-free), Carmustine, Etoposide, Cytarabine (BEAM Regimen) and Autologous Stem Cell Transplantation for Lymphoma
Condition: Hodgkin Disease; Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin
Intervention: Carmustine; Etoposide phosphate; Cytarabine; Melphalan HCl (propylene glycol-free)
Intervention MeSH terms: Cytarabine; Etoposide; Melphalan; Carmustine; Etoposide phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Phase II study is being conducted to confirm the safety and efficacy of high-dose Melphalan
      HCl for Injection (Propylene Glycol-Free) when included in the BEAM regimen for myeloablative
      conditioning in lymphoma patients undergoing ASCT
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma.

          -  Eligible for autologous stem cell transplantation.

          -  18 to 75 years of age at time of enrollment.

          -  Adequate autologous graft, defined as an unmanipulated, cryopreserved, peripheral
             blood stem cell graft containing at least 2 x 10^6 CD34+ cells/kg based on patient
             body weight

          -  ECOG performance status ≤ 2

          -  Normal organ function as defined below:

               -  Creatinine clearance > 40 ml/min

               -  Total bilirubin ≤2.0 x IULN

               -  AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN

               -  LVEF > 40% (by ECHO or MUGA)

               -  FEV1 > 50% of predicted and DLCO > or = 50% of predicted

          -  Women of childbearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control, abstinence) prior to study entry and for
             the duration of study participation. Should a woman become pregnant or suspect she is
             pregnant while participating in this study, she must inform her treating physician
             immediately.

          -  Able to understand and willing to sign an IRB approved written informed consent
             document.

        Exclusion Criteria:

          -  A history of other malignancy ≤ 5 years previous with the exception of basal cell or
             squamous cell carcinoma of the skin which were treated with local resection only or
             carcinoma in situ of the cervix.

          -  Currently receiving any other experimental therapy or has received any other
             experimental therapy within the 4 weeks prior to enrollment.

          -  A history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to melphalan HCl for injection (propylene glycol-free), Captisol,
             or other agents used in the study.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, unstable
             cardiac arrhythmias, or psychiatric illness/social situations that would limit
             compliance with study requirements.

          -  Pregnant and/or breastfeeding women. Women of childbearing potential must have a
             negative serum pregnancy test within 14 days of study entry.

          -  Known HIV-positivity. These patients are excluded because of the potential for
             pharmacokinetic interactions with the study regimen and their antiretroviral therapy
             and because these patients are at increased risk of lethal infections when treated
             with marrow-suppressive therapy. .