Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Condition: Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Combining chemotherapy with donor bone marrow transplantation
      may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of busulfan and cyclophosphamide followed
      by bone marrow transplantation in treating patients who have acute myelogenous leukemia or
      myelodysplastic syndrome.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the remission duration, disease-free survival, and overall survival of
           patients with acute myelogenous leukemia in remission or early relapse or
           myelodysplastic syndrome treated with high-dose busulfan and cyclophosphamide followed
           by allogeneic bone marrow transplantation.

      OUTLINE: Patients receive oral high-dose busulfan every 6 hours for 14-16 doses on days -9 to
      -6, followed by high-dose cyclophosphamide IV over 1 hour on days -5 to -2. Allogeneic bone
      marrow is infused on day 0.

      Patients who have already had 1 transplant receive high-dose cyclophosphamide IV on days -6
      and -5, total body irradiation twice a day on days -4 to -1, and allogeneic bone marrow
      infusion on day 0.

      All patients receive prophylaxis for graft versus host disease.

      Patients are followed every 6 months for at least 2 years.

      PROJECTED ACCRUAL: A total of 25-40 patients will be accrued for this study.
    

Intervention name(s): busulfan; cyclophosphamide; allogeneic bone marrow transplantation; bone marrow ablation with stem cell support; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Busulfan
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult acute myeloid leukemia; adult acute myeloid leukemia in remission; adult acute erythroid leukemia (M6); adult acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); adult acute promyelocytic leukemia (M3); adult acute myelomonocytic leukemia (M4); adult acute monoblastic leukemia (M5a); adult acute megakaryoblastic leukemia (M7); refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; adult acute monocytic leukemia (M5b); previously treated myelodysplastic syndromes; myelodysplastic/myeloproliferative disease, unclassifiable; atypical chronic myeloid leukemia; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12); childhood myelodysplastic syndromes