Houston, Texas 77030


Purpose:

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, alemtuzumab, before transplant and tacrolimus before and after transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects of giving fludarabine and busulfan together with alemtuzumab followed by donor stem cell transplant and to see how well it works in treating patients with hematological cancer or other disease.


Study summary:

OBJECTIVES: - To assess the safety and feasibility of reduced-intensity preparative regimen comprising fludarabine, busulfan, and alemtuzumab followed by allogeneic hematopoietic stem cell transplantation in patients with hematological malignancies or other diseases. - To assess the rate of donor engraftment in patients treated with this regimen. OUTLINE: This is a multicenter study. - Reduced-intensity preparative regimen: Patients receive busulfan IV over 3 hours on days -5 and -4, fludarabine IV on days -5 to -2, and alemtuzumab IV on days -6 to -4. - Allogeneic hematopoietic stem cell transplantation (HSCT): Patients undergo allogeneic HSCT on day 0. - Graft-versus-host disease (GVHD) prophylaxis: Patients receive tacrolimus IV continuously over 24 hours or orally every 12 hours beginning on day -2 and continuing until day 30, followed by a taper. After completion of study treatment, patients are followed periodically.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of 1 of the following: - Myelodysplastic syndromes or myeloproliferative disorders - Acute myelogenous leukemia (AML) - No refractory AML - Acute lymphoblastic leukemia (ALL) - No refractory ALL - Chronic myelogenous leukemia (CML) - No untreated blast crisis for CML - Multiple myeloma (MM) - Plasma cell dyscrasia - Lymphoproliferative disorders, including non-Hodgkin lymphoma, hairy cell leukemia, chronic lymphocytic leukemia, or Hodgkin lymphoma - No uncontrolled high-grade lymphoproliferative disease or lymphoma - Non-malignant hematologic disease considered treatable with an allogeneic stem cell transplantation (SCT) including, but not limited to, bone marrow failure syndrome, hemoglobinopathy, or severe immunodeficiency states - At increased risk for treatment-related mortality as indicated by ≥ 2 of the following: - Over 35 years of age - Ejection fraction < 45% - DLCO < 50% of predicted and FEV_1 50-75% of predicted - Diabetes mellitus - Renal insufficiency, defined by an increase in serum creatinine level of 1.5 times or decrease in glomerular filtration rate by 25% - Prior recent history of systemic fungal infection - Significant grade III or IV neurologic or hepatic toxicity as defined by NCI CTC toxicity from prior treatment - AML or ALL in third or greater remission - Diagnosed with CML or MM > 1 year ago - Received ≥ 3 prior treatment regimens - Has undergone prior autologous or allogeneic SCT - No matched sibling donor available - No active CNS disease from hematological disorder - Healthy 5/6 or 6/6 related OR 5/6 or 6/6 unrelated (molecular typing for DRB1) donor available - No contraindications for donation PATIENT CHARACTERISTICS: - Zubrod performance status 0-2 - Total bilirubin ≤ 4 times normal - AST/ALT ≤ 4 times normal - Creatinine ≤ 2 times upper limit of normal - Ejection fraction > 30% - DLCO > 40% of predicted - FEV_1 > 1.0 L of predicted - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No HIV positivity - No concurrent uncontrolled infection - No active hepatitis or cirrhosis with total bilirubin, ALT, and AST > 3 times normal - No unstable angina or uncompensated congestive heart failure (i.e., Zubrod performance status 3-4) - No severe chronic pulmonary disease requiring oxygen (i.e., Zubrod performance status 3-4) - Not hemodialysis dependent - No unstable cerebral vascular disease or hemorrhagic stroke within the past 6 months PRIOR CONCURRENT THERAPY: - See Disease Characteristics


NCT ID:

NCT00625144


Primary Contact:

Study Chair
Rammurti Kamble, MD
Baylor College of Medicine


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor
Phone: 713-798-1297

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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