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Allogeneic Peripheral Blood Progenitor Cell Transplantation Using Histocompatible Sibling-Matched Donor Cells After High-Dose Busulfan/Cyclophosphamide as Therapy for Hematologic Malignancies


Phase 2
4 Years
55 Years
Not Enrolling
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

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Trial Information

Allogeneic Peripheral Blood Progenitor Cell Transplantation Using Histocompatible Sibling-Matched Donor Cells After High-Dose Busulfan/Cyclophosphamide as Therapy for Hematologic Malignancies


OBJECTIVES:

- Determine the safety and feasibility of using allogeneic peripheral blood progenitor
cell infusions obtained from normal histocompatible sibling donors for reconstituting
bone marrow and immunologic function when given after high-dose
busulfan/cyclophosphamide in patients with a hematologic malignancy.

- Determine the efficacy of this treatment in these patients.

- Determine the ability to mobilize hematopoietic progenitor cells from normal donors
given filgrastim (G-CSF) by determining the hematopoietic progenitor cell content of
allogeneic peripheral blood progenitor cell collections.

- Determine the incidence of engraftment failures in these patients.

- Determine the incidence of severe acute graft-versus-host disease in these patients.

OUTLINE: Patients receive high-dose oral busulfan every 6 hours on days -8 to -5,
cyclophosphamide IV twice a day on days -4 and -3, and cyclosporine IV over 6 hours on day
-1 and then 10 hours on day 0 for 2 doses (allogeneic only). Allogeneic peripheral blood
progenitor cells IV are administered on day 0.

Filgrastim (G-CSF) is administered subcutaneously twice a day beginning 3 hours after
completion of cell infusion and continuing until blood counts recover.

Patients are followed every month for 2 months, every 3 months for 6 months, and then every
6 months until disease progression.

PROJECTED ACCRUAL: A total of 40 patients will be accrued over a 15 month period.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically diagnosed:

- Acute myeloid leukemia in first, second, or third complete remission or first or
second early relapse

- Acute lymphoblastic leukemia in first, second, or third complete remission or
first or second early relapse

- Hodgkin's lymphoma in second or third remission or first, second, or third
relapse, or refractory

- Non-Hodgkin's lymphoma in second or third remission or first, second, or third
relapse, or refractory

- Multiple myeloma and plasma cell leukemia in second or third remission or first,
second, or third relapse, or refractory

- Myelodysplastic syndrome deemed suitable for allogeneic bone marrow
transplantation

- No symptoms or signs of CNS involvement and CNS is disease free on lumbar puncture
and brain CT scan

- No active meningeal cancer

PATIENT CHARACTERISTICS:

Age:

- 4 to 55 (4 to 60 if donor is identical twin)

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- SGOT/SGPT less than 3 times normal

- Bilirubin less than 2.0 mg/dL

Renal:

- Creatinine less than 2.1 mg/dL

- Creatinine clearance at least 60 mL/min (no greater than 1.5 times normal for
children under 40 kg)

Cardiovascular:

- No uncontrolled hypertension

- No uncontrolled congestive heart failure

- No active angina pectoris requiring nitrates

- At least 6 months since prior myocardial infarction

- No major ventricular arrhythmia

- Left ventricular ejection fraction at least 45% on MUGA

Pulmonary:

- No severe or symptomatic restrictive or obstructive lung disease

- FEV_1 greater than 50% of predicted

- DLCO greater than 50% of predicted

Neurologic:

- No severe central or peripheral neurologic abnormality

Other:

- Must have HLA-A,B,C,D/DR identical sibling age 4 to 65, in good health

- No insulin-dependent diabetes mellitus

- No major thyroid or major adrenal dysfunction

- No active infection

- No other active malignancy

- Not pregnant

- HIV negative

- HTLV-I and HTLV-II negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No excessive anthracycline exposure, unless endomyocardial biopsy shows less than
grade 2 drug effect and cardiac scan shows at least 50% ejection fraction

- At least 1 year since prior autologous bone marrow or peripheral blood progenitor
cell transplant or allogeneic bone marrow transplant

Chemotherapy:

- At least 3 weeks since prior chemotherapy

- No prior excessive carmustine and bleomycin

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 3 weeks since prior radiotherapy

Surgery:

- Not specified

Other:

- No concurrent nitroglycerin for angina pectoris

- No concurrent anti-arrhythmic drugs for major ventricular dysrhythmias

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Hematopoietic reconstitution measured daily during transplant

Outcome Time Frame:

at months 2, 4, 7, and 10, and then every 6 months until disease progression

Safety Issue:

No

Principal Investigator

Hillard M. Lazarus, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU1995T

NCT ID:

NCT00003116

Start Date:

May 1997

Completion Date:

June 2009

Related Keywords:

  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult Hodgkin lymphoma
  • refractory multiple myeloma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • childhood acute myeloid leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • recurrent/refractory childhood Hodgkin lymphoma
  • 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
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • recurrent mantle cell lymphoma
  • atypical chronic myeloid leukemia
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • 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
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • childhood myelodysplastic syndromes
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Ireland Cancer Center at University Hosptials Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065