Non Hodgkin Lymphoma Clinical Trial

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

Summary

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

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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

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Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

92

Study ID:

NCT00809276

Recruitment Status:

Completed

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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There are 3 Locations for this study

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The Sydney Kimmel Comprehensive Cancer center
Baltimore Maryland, 21231, United States
Marcos deLima, MD
Houston Texas, 77030, United States
Paul V. O'Donnell, M.D., Ph.D.
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

92

Study ID:

NCT00809276

Recruitment Status:

Completed

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

How clear is this clinincal trial information?

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