Comparison of Cy-Atg Vs Cy-Flu-Atg for the Conditioning Therapy in Allo-HCT
Condition: Bone Marrow Failure Syndromes
MeSH terms: Bone Marrow Failure Disorders; Pancytopenia; Anemia, Aplastic; Hemoglobinuria, Paroxysmal; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized comparison of cyclophosphamide versus reduced-dose cyclophosphamide plus
      fludarabine in addition to anti-thymocyte globulin for the conditioning therapy in allogeneic
      hematopoietic cell transplantation for bone marrow failure syndrome.
    

Detailed description: 
      This is a prospective, randomized, non-blind study.

      Conditioning therapy will start on day -5 in patients who are randomized to receive Cy+ATG.
      Hydration with 0.45% NaCl at 6 liters/24 hours will be started on day -5. Cy 50 mg/kg in D5W
      200 ml i.v. over 1-2 hours on days -5 to -2 by pump through a central venous catheter. Mesna
      12 mg/kg iv push immediately before Cy and 3, 6, 9, and 12 hours after Cy. Thymoglobuline 3
      mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL
      (less than 2 mg/mL) iv daily at 8 am on days -4 to -2. Premedication for ATG (ALG) will
      include methylprednisolone 2 mg/kg iv infusion, Tylenol 600 mg po, and Avil 45.5 mg iv push.
      The doses of cyclophosphamide and ATG (ALG) will be calculated using actual body weight.

      Conditioning therapy will start on day -6 in patients who are randomized to receive
      Cy+fludarabine (FludaraÂ®, Berlex Laboratories, Richmond, CA)+ATG. Fludarabine 30 mg/m2 will
      be infused intravenously over 30 minutes in D5W 100 ml for 5 consecutive days (days -6 to
      -2). Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15
      mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2. Premedication
      for ATG (ALG) will include methylprednisolone 2 mg/kg iv infusion, Tylenol 600 mg po, and
      Avil 45.5 mg iv push. Hydration with 0.45% NaCl at 6 liters/24 hours will be started on day
      -3. Cy 50 mg/kg in D5W 200 ml i.v. over 1-2 hours on days -3 to -2 by pump through a central
      venous catheter. Mesna 12 mg/kg iv push immediately before Cy and 3, 6, 9, and 12 hours after
      Cy. The doses of cyclophosphamide and ATG (ALG) will be calculated using actual body weight.
    

Intervention name(s): Cyclophosphamide-fludarabine-anti thymocyte globulin
Intervention type(s): Drug
Intervention description(s): Cyclophosphamide 50 mg/kg in D5W 200 ml i.v. over 1-2 hours on days -5 to -2 by pump through a central venous catheter.
Fludarabine 30 mg/m2 will be infused intravenously over 30 minutes in D5W 100 ml for 5 consecutive days (days -6 to -2).
Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2.
Other intervention name(s): CYCLOPHOSPHAMIDE,FLUDARA,ANTI-THYMOCYTE GLOBULINE
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment