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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


Phase 1/Phase 2
N/A
65 Years
Not Enrolling
Both
Lymphoma, Multiple Myeloma, Leukemia, Myelodysplastic Syndrome

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Leo Luznik, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

J0844

NCT ID:

NCT00809276

Start Date:

May 2009

Completion Date:

December 2011

Related Keywords:

  • Lymphoma
  • Multiple Myeloma
  • Leukemia
  • Myelodysplastic Syndrome
  • Acute lymphocytic leukemia (ALL)
  • Acute myeloid leukemia (AML)
  • Acute Leukemia
  • Refractory or Relapsed AML
  • Myelodysplastic syndrome (MDS)
  • Chronic myeloid leukemia (CML)
  • Chronic myelomonocytic leukemia
  • Hodgkin's Lymphoma
  • Non-Hodgkin's lymphoma
  • Philadelphia-negative myeloproliferative disorder
  • Hematologic Malignancies
  • Transplantation
  • Busulfan
  • Fludarabine
  • Cytoxan
  • Bone Marrow
  • Allogeneic
  • Related donor
  • unrelated donor
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms

Name

Location

The Sydney Kimmel Comprehensive Cancer centerBaltimore, Maryland  21231
Marcos deLima, MDHouston, Texas  77030
Paul V. O'Donnell, M.D., Ph.D.Seattle, Washington  98109