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Completed

NCT Number: NCT00809276

Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY

The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.

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Key information

About this study

A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT)

However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ages between 0 to and 65 years of age.
  • Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.
  • Acute lymphocytic leukemia (ALL) in CR1 with high risk features
  • Acute myeloid leukemia (AML) in CR1 with high risk features defined as:

i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype [> 3 abnormalities]

  • Acute Leukemias in 2nd or greater remission
  • Refractory or Relapsed AML
  • AML transformed from MDS
  • Myelodysplastic syndrome (MDS) beyond refractory anemia
  • Chronic myeloid leukemia (CML)
  • Chronic myelomonocytic leukemia
  • Philadelphia-negative myeloproliferative disorder
  • Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma
  • Multiple Myeloma-Stage III

Exclusion criteria

  • Prior autologous or allogeneic stem cell transplant.
  • Performance status greater than 2
  • Active infection.
  • Inadequate cardiac function; arrythmias or symptomatic cardiac disease.
  • Inadequate pulmonary function; FEV1, FVC, DLCO <50% of predicted
  • Inadequate Serum creatinine clearance <60
  • InadequatebHepatic function
  • Positive serology for HIV-1, 2 or HTLV-1, 2.
  • Pregnancy. Female patient must have negative pregnancy test

Treatment and study plan

Busulfan, Fludarabine, Cytoxan

Drug

Busulfan once a day for 4 days

Fludarabine once a day for 4 days

Bone marrow transplant

Cytoxan two doses

Other names: BMT, Cyclophosphamide, Allogeneic, Transplantation

Primary outcomes

  1. To Determine the Optimal Regimen of Post-graft Immunosuppression With High-dose Cy Following Fludarabine, Busulfan, and Transplantation of Fully HLA-matched Bone Marrow That Leads to an Acceptable Incidence of Grades III/IV Acute GVHD

    Time frame: 1 year

    Percentage of participants with grade III-IV acute graft versus host disease (GVHD). GVHD is graded on a combination of skin symptoms (rash), gut symptoms (diarrhea), and liver symptoms (using a lab test called bilirubin). Grades range from I to IV, where I is the least severe and IV is the most severe.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • Fred Hutchinson Cancer Center
  • M.D. Anderson Cancer Center
  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 17, 2008
Registry last updated
Feb 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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