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

Johns Hopkins Medicine

Status and phase

Completed

Phase 2

Phase 1

Conditions

Multiple Myeloma

Lymphoma

Myelodysplastic Syndrome

Leukemia

Treatments

Drug: Busulfan, Fludarabine, Cytoxan

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00809276

J0844

NA_00017193 (Other Identifier)

Details and patient eligibility

About

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

Full description

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

Enrollment

92 patients

Sex

All

Ages

Under 65 years old

Volunteers

No Healthy Volunteers

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