Non-Myeloablative Chemotherapy Followed by Unrelated Allogeneic Stem Cell Transplantation in Patients With Advanced Hematologic Malignancies: A Pilot Study


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma, Myelodysplastic Syndromes

Thank you

Trial Information

Non-Myeloablative Chemotherapy Followed by Unrelated Allogeneic Stem Cell Transplantation in Patients With Advanced Hematologic Malignancies: A Pilot Study


OBJECTIVES: I. Determine the feasibility of allogeneic engraftment after unrelated matched
allogeneic peripheral blood stem cell transplantation preceded by a nonmyeloablative,
fludarabine based conditioning regimen in patients with advanced hematologic malignancies.
II. Determine the toxicities of this regimen, especially graft versus host disease, in these
patients.

OUTLINE: Patients receive fludarabine IV over 30-60 minutes on days -7 to -4,
cyclophosphamide IV over 30 minutes on days -7 to -5, and cytarabine IV over 2 hours on days
-4 and -3. Allogeneic peripheral blood stem cells are infused on day 0. Filgrastim (G-CSF)
is administered IV over 1 hour or subcutaneously beginning on day 1 and continuing until
blood counts recover. Patients are followed weekly until day 60 and then monthly for 10
months.

PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven advanced hematologic malignancy unsuitable
for standard allogeneic bone marrow transplantation One of the following types: Refractory
or relapsed acute myelogenous or lymphocytic leukemia Over 55 years Chronic myelogenous
leukemia and failed interferon treatment Over 55 years Lymphoma, chronic lymphocytic
leukemia, Hodgkin's disease, or multiple myeloma: Refractory OR More than 2 relapses OR
Relapse after autologous peripheral blood stem cell transplantation Myelodysplastic
syndrome other than refractory anemia Severe aplastic anemia Under 55 years and either
organ dysfunction or not eligible for standard allogeneic bone marrow transplant due to
one or more of the following: Chronic hepatitis LVEF less than 50% Karnofsky less than 70%
Unrelated matched donor available

PATIENT CHARACTERISTICS: Age: See Disease Characteristics Adult Performance status: See
Disease Characteristics Karnofsky 60-100% Life expectancy: Not specified Hematopoietic:
Not specified Hepatic: See Disease Characteristics SGOT/SGPT no greater than 4 times upper
limit of normal Renal: Creatinine no greater than 2 mg/dL Cardiovascular: See Disease
Characteristics Pulmonary: DLCO at least 50% predicted Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: Not
specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not
specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Christos E. Emmanouilides, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067340

NCT ID:

NCT00004114

Start Date:

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • recurrent adult Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • chronic myelomonocytic leukemia
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • previously treated myelodysplastic syndromes
  • AIDS-related peripheral/systemic lymphoma
  • recurrent mantle cell lymphoma
  • anaplastic large cell lymphoma
  • refractory cytopenia with multilineage dysplasia
  • recurrent mycosis fungoides/Sezary syndrome
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia

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