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Evaluation of Allogeneic Peripheral Blood Stem Cell Transplants From a Related Donor Without Graft-Versus-Host Prophylaxis in Patients With High Risk of Relapse


Phase 2
N/A
N/A
Not Enrolling
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes

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Trial Information

Evaluation of Allogeneic Peripheral Blood Stem Cell Transplants From a Related Donor Without Graft-Versus-Host Prophylaxis in Patients With High Risk of Relapse


OBJECTIVES: I. Evaluate the use of donor peripheral blood stem cells without
graft-versus-host disease prophylaxis to maximize the probability of graft-versus-tumor
effect in patients with hematologic malignancies refractory to standard chemotherapy and
unlikely to be cured with high dose chemotherapy and radiotherapy.

OUTLINE: Prior to peripheral blood stem cell transplant, patients undergo preparative
cytoreduction. Patients receive total body irradiation (TBI) beginning on day -5.
Radiotherapy is administered in 9 doses over 3 days (3 doses per day for 3 days). Male
patients with acute lymphocytic leukemia receive an additional dose of radiation to the
testicles. Patients who are ineligible for TBI due to prior radiotherapy receive 2 doses of
melphalan IV on day -3. All patients receive cyclophosphamide IV over 1 hour on days -2 and
-1. Anti-thymocyte globulin is also administered IV over 6 hours on days -2 and -1.
Approximately 24-36 hours after the last dose of cyclophosphamide, peripheral blood stem
cells obtained from the HLA matched related donor are infused into the patient. Patients do
not receive graft-versus-host disease prophylaxis after transplant; however, all other forms
of supportive care are provided. Patients are followed for 1 year.

PROJECTED ACCRUAL: A maximum of 42 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Patients with HLA identical family donors and any one of the
following conditions documented by marrow aspiration and biopsy: -Acute leukemia
refractory to induction treatment or after 1 or more relapses -Acute myeloid leukemia with
t(9;22), -5/5q-, -7/7q-, and 11q23 involvement in first remission (not M4 or M5) -Acute
lymphocytic leukemia with t(9;22) or t(4;11) in first remission -Myelodysplastic syndrome
with greater than 5% bone marrow blasts -Chronic myeloid leukemia in accelerated phase or
nonlymphoid blast crisis -Myeloma, chronic lymphocytic leukemia, non-Hodgkin's lymphoma,
or Hodgkin's disease refractory to 2 lines of standard treatment or progression on
standard treatment No evidence of active extramedullary disease

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Life
expectancy: Greater than 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than
2.0 mg/dL SGOT no greater than 4 times upper limit of normal and not increasing for 2-4
weeks prior to transplant Renal: Creatinine less than 2 times normal and not increasing
for 2-4 weeks prior to transplant OR Creatinine clearance greater than 60 mL/min
Cardiovascular: LVEF greater than 50% by MUGA Pulmonary: DLCO greater than 50% Other: Not
HIV positive Not pregnant or nursing Fertile patients must use effective contraceptive

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Barry R. Meisenberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Maryland Greenebaum Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066397

NCT ID:

NCT00003396

Start Date:

September 1998

Completion Date:

December 2002

Related Keywords:

  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult Hodgkin lymphoma
  • refractory multiple myeloma
  • Waldenstrom macroglobulinemia
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous 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
  • adult acute erythroid leukemia (M6)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute promyelocytic leukemia (M3)
  • adult acute eosinophilic leukemia
  • adult acute basophilic leukemia
  • adult acute megakaryoblastic leukemia (M7)
  • childhood acute myeloblastic leukemia without maturation (M1)
  • childhood acute myeloblastic leukemia with maturation (M2)
  • childhood acute promyelocytic leukemia (M3)
  • childhood acute erythroleukemia (M6)
  • childhood acute eosinophilic leukemia
  • childhood acute basophilic leukemia
  • childhood acute megakaryocytic leukemia (M7)
  • 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
  • previously treated myelodysplastic syndromes
  • adult acute minimally differentiated myeloid leukemia (M0)
  • childhood acute minimally differentiated myeloid leukemia (M0)
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • recurrent mantle cell lymphoma
  • 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
  • childhood myelodysplastic syndromes
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201