Fludarabine, Busulfan, and Alemtuzumab Followed By Donor Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disease

Fludarabine, Busulfan, and Alemtuzumab Followed By Donor Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disease
This study is currently recruiting participants.
Verified on June 2009 by National Cancer Institute (NCI)

First Received on February 27, 2008.  
Last Updated on May 12, 2011  
History of Changes
Sponsor: Baylor College of Medicine
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00625144

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.

Condition Intervention Phase
Chronic Myeloproliferative Disorders
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Precancerous Condition
Biological: alemtuzumab
Drug: busulfan
Drug: fludarabine phosphate
Drug: tacrolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Phase I
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduced -Intensity Preparative Regimen With Fludarabine, Busulfan, And Alemtuzumab Followed By Allogeneic Hematopoietic Stem Cell Transplant For Malignant And Non-Malignant Hematological Diseases

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

  • Safety and feasibility [ Designated as safety issue: Yes ]
  • Rate of donor engraftment [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • Hematopoietic engraftment [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Acute and chronic graft-versus-host disease [ Designated as safety issue: Yes ]
  • Relapse [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2007
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

Detailed Description:


  • 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.


Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625144

United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Trials Office – Dan L. Duncan Cancer Center at Baylor     713-798-1297        
Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: George Carrum, MD     713-441-1450        
Sponsors and Collaborators
Baylor College of Medicine
Study Chair: Rammurti Kamble, MD Baylor College of Medicine
  More Information

Additional Information:

No publications provided

Responsible Party: Rammurti Kamble, Dan L. Duncan Cancer Center at Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00625144    
History of Changes
Other Study ID Numbers: CDR0000582339, BCM-H-19386, BCM-FAB
Study First Received: February 27, 2008
Last Updated: May 12, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):

accelerated phase chronic myelogenous leukemia
atypical chronic myeloid leukemia, BCR-ABL1 negative
chronic myelomonocytic leukemia
juvenile myelomonocytic leukemia
myelodysplastic/myeloproliferative neoplasm, unclassifiable
refractory multiple myeloma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
adult acute lymphoblastic leukemia in remission
childhood acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
childhood acute myeloid leukemia in remission
chronic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
refractory hairy cell leukemia
progressive hairy cell leukemia, initial treatment
refractory chronic lymphocytic leukemia
stage I chronic lymphocytic leukemia
stage II chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult Hodgkin lymphoma
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma

Additional relevant MeSH terms:

Hematologic Diseases
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Myeloproliferative Disorders
Precancerous Conditions
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Large-Cell, Anaplastic
Myelodysplastic-Myeloproliferative Diseases
Pathologic Processes
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hemorrhagic Disorders
Bone Marrow Diseases
Lymphoma, T-Cell

ClinicalTrials.gov processed this record on December 02, 2011

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