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Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hematologic Malignancies

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Trial Information

Reduced Intensity Stem Cell Transplantation (RIST) for Patients With Hematological Malignancies Conditioned With Fludarabine and Busulfan


Inclusion Criteria:



- • Diagnosed with (any of the following)

Disease Subtype Disease Status Leukemia Acute myelogenous leukemia (AML) Recurrent disease
in remission* OR CR1 with poor-risk cytogenetics, antecedent hematological disease (i.e.
myelodysplasia) or treatment-related leukemia Acute lymphoblastic leukemia (ALL) Recurrent
disease in remission* OR CR1 with Philadelphia chromosome or poor risk cytogenetics
Chronic myelogenous leukemia (CML) First or second chronic phase. There must be
documented disease progression after imatinib mesylate (Gleevec) therapy OR documented
lack of cytogenetic response 6 months post-imatinib initiation OR imatinib intolerance.

Patient - Inclusion criteria (Continued) Chronic lymphocytic leukemia (CLL) Recurrent
disease after fludarabine-based therapy. Patients must have chemosensitive** disease at
the time of relapse.

Lymphoma Recurrent Hodgkin's Lymphoma

Recurrent Non-Hodgkin's lymphoma (NHL) (Low, intermediate or high grade)

Transformed NHL Patients must have had prior autologous transplantation and received
cytoreductive therapy at the time of relapse to achieve complete remission (CR) or
CR/unconfirmed (CRu) as defined by the International Workshop

OR

Patient with relapsed disease and required >2 salvage regimens to achieve CR or CRu.

Multiple Myeloma Recurrent Myeloma Patients must have had prior autologous transplantation
and demonstrate chemosensitivity** at the time of relapse Myelodysplastic Syndrome #
RA/RARS RCMD/RCMD-RS RAEB-1 Patients must be transfusion-dependent and have International
prostate symptom score (IPSS) of 1.5 or higher Advanced myeloproliferative disease
Myelofibrosis with myeloid metaplasia; primary or evolved from other MPD Patient must be
transfusion dependent or have evidence of progressive organomegaly or evidence of
myelodysplasia

- remission is defined as morphological remission with bone marrow aspirate/biopsy
showing <= 5% blasts within 4 weeks before the start of therapy. (Cytogenetic or
molecular remission is not required)

- In CLL, chemosensitivity is defined as greater than 50% reduction of wbc and
lymphadenopathy. In MM, it is defined as greater than 50% reduction of
M-component or plasma-cell marrow infiltration.

- based on WHO classification system. Patients with RAEB-2 or del(5q) are
excluded

- 5-6/6 HLA-matched sibling or 9-10/10 matched unrelated donor

- Age > 50 OR age 18-50, but have preexisting medical conditions, or
have received prior therapy (i.e. prior) autologous transplantation)
and are considered to be a too high a risk for conventional
myeloablative transplantation

Exclusion Criteria:

- • Karnofsky performance status of less than 50%

- Positive pregnancy test, inability or unable to pursue effective means of birth
control, failure to willingly accept or comprehend irreversible sterility as a
side effect of therapy

- Corrected pulmonary-diffusing capacity of less than 35%

- A cardiac ejection fraction of less than 30%

- A serologic evidence of infection with the human immunodeficiency virus

- Inability to give informed consent

- Psychiatric illness or mental deficiency making compliance with treatment or
informed consent impossible

- Decompensated liver disease with serum bilirubin > 2.0 mg/dl

- Serum creatinine > 2.0 mg/dl

- Uncontrolled active infection

- Uncontrolled CNS metastasis

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the efficacy and toxicity of Reduced Intensity Transplant (RIST) for patients with hematological malignancies, conditioned with fludarabine (Fludara®) and busulfan intravenous (Busulfex™)

Outcome Time Frame:

3 years

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

UCD196

NCT ID:

NCT00843947

Start Date:

June 2007

Completion Date:

June 2010

Related Keywords:

  • Hematologic Malignancies
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

University of CA, Davis Cancer CenterSacramento, California  95817