Fludarabine / Total Body Irradiation Regimen for ALLO HCT in Acute Lymphoblastic Leukemia
Condition: Adult Lymphoblastic Lymphoma
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Fludarabine; Total Body Irradiation
Intervention MeSH terms: Fludarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: ALL

Summary:

      The goal of this research is to test if the conditioning regimen, fludarabine and total body
      irradiation (FluTBI), can lead to a safer and more effective stem cell transplant treatment
      regimen for ALL patients older than 40 years of age and/or younger patients with high risk
      medical conditions. The primary objective is to establish the efficacy of allo HCT in older
      ALL patients using myeloablative FluTBI conditioning regimen. The investigators are also
      assessing the safety and toxicity of allo HCT in older ALL patients using myeloablative
      FluTBI conditioning regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Disease Criteria:

               -  ALL in complete remission (CR) at the time of transplant. Remission is defined as
                  "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone
                  marrow aspirate obtained within 2 weeks of study registration.

               -  Philadelphia chromosome positive ALL is allowed.

               -  Lymphoid blastic crisis of CML will be included (provided that patients achieve
                  CR).

          -  Age Criteria: Equal or above age 40 and up to 65 years. If younger than 40, there must
             be comorbidities which preclude the patient to undergo CyTBI conditioning regimen.

          -  Organ Function Criteria: All organ function testing should be done within 28 days of
             study registration.

          -  Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated
             Acquisition) scan or echocardiogram.

          -  Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity)
             ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for
             hemoglobin) ≥ 50% of predicted.

          -  Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60
             mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula:

        CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL).

          -  Hepatic:

               -  Serum bilirubin 2.0 g/dL

               -  Aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 ULN

               -  Alkaline phosphatase 2.5 ULN

          -  Performance status: Karnofsky ≥ 70%

          -  Consent: Patient must be informed of the investigational nature of this study in
             accordance with institutional and federal guidelines and have the ability to provide
             written informed consent prior to initiation of any study-related procedures, and
             ability,in the opinion of the principal investigator, to comply with all the
             requirements of the study.

          -  Presence of a willing adult HLA-matched sibling (excluding identical twin) or
             HLA-matched unrelated donor meeting all the criteria for routine allo HSCT. All donors
             will be evaluated for eligibility and suitability per the standard of care according
             to the FACT and NMDP guidelines.

        Exclusion Criteria:

          -  Non-compliant to medications.

          -  No appropriate caregivers identified.

          -  HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive

          -  Active life-threatening cancer requiring treatment other than ALL

          -  Uncontrolled medical or psychiatric disorders.

          -  Uncontrolled infections, defined as positive blood cultures within 72 hours of study
             entry, or evidence of progressive infection by imaging studies such as chest CT scan
             within 14 days of registration.

          -  Active central nervous system (CNS) leukemia

          -  Preceding allogeneic HSCT

          -  Receiving intensive chemotherapy within 21 days of registration. Maintenance type of
             chemotherapy will be allowed.