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A Phase I Open-Label, Safety Study of Haploidentical Bone Marrow Transplantation (BMT) After Ex Vivo Treatment of Bone Marrow With Anti-B7.1 and Anti-B7.2 Antibodies


Phase 1
N/A
40 Years
Open (Enrolling)
Both
Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes

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Trial Information

A Phase I Open-Label, Safety Study of Haploidentical Bone Marrow Transplantation (BMT) After Ex Vivo Treatment of Bone Marrow With Anti-B7.1 and Anti-B7.2 Antibodies


OBJECTIVES: I. Determine if patients with refractory, high risk hematologic malignancies or
bone marrow failure who receive HLA haploidentical bone marrow treated with anti-B7 antibody
have normal engraftment. II. Determine if these patients are free of hyperacute graft versus
host disease (GVHD), defined as grade D GVHD in the first 10 posttransplant days, when
treated with this regimen. III. Determine if these patients have an acceptable incidence of
life threatening grade D GHVD in the first 50 posttransplant days following this treatment
regimen. IV. Determine the safety and tolerability of this treatment regimen in this patient
population.

OUTLINE: This is a multicenter study. Patients undergo leukapheresis to collect white blood
cells which are incubated with donor bone marrow cells in the presence of anti-B7.1 and
anti-B7.2 antibodies for 36 hours. Patients receive total body irradiation twice daily on
days -6 to -3, cyclophosphamide IV daily on days -2 and -1, and methylprednisolone IV every
12 hours for a total of 4 doses on days -2 to 0. Patients are infused with the treated donor
bone marrow on day 0. Patients then receive methotrexate IV on days 1, 3, 6, and 11 and
leucovorin calcium IV 24 hours after each dose of methotrexate every 6 hours for 3-8 doses
each time. Patients also receive cyclosporine IV or orally twice daily on days -2 to 100.
Patients are followed every 2 months for 1 year.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Any of the following hematologic malignancies or bone marrow
failure syndromes: Acute myelogenous leukemia after induction failure, in relapse, or in
second or greater complete remission (CR) Acute lymphocytic leukemia after induction
failure, in relapse, in second or greater CR, or in first CR with t(9;22), t(8;14), or
t(4;11) Non-Hodgkin's lymphoma (intermediate or high grade) that has failed to achieve CR
with at least 2 induction regimens, in relapse, or in second or greater CR Multiple
myeloma with poor prognostic features (elevated beta-2 microglobulin or high labeling
index) Hodgkin's disease in relapse or that failed to achieve CR after 2 chemotherapy
regimens Congenital or acquired bone marrow failure that is poorly responsive to or
intolerant of current therapy Myelodysplastic syndrome of all subtypes except refractory
anemia No Fanconi's anemia Patients must have a haploidentical donor and meet the
following criteria: Likely to have clinical deterioration and rapid disease progression
during an unrelated donor search OR Already had an unproductive donor search OR Ineligible
for or has refused autologous transplant Lack an HLA A, B, DR, and DQ matched related
donor (evaluated via both genotype and phenotype) Lack an HLA A, B, and DR matched
unrelated donor (evaluated via both genotype and phenotype) A new classification scheme
for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or
"aggressive" lymphoma will replace the former terminology of "low", "intermediate", or
"high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS: Age: 40 and under Performance status: ECOG 0-2 OR Lansky 50-100%
for patients under 16 years Life expectancy: At least 12 weeks Hematopoietic: Blood
differential count with greater than 25% blasts at time of leukapheresis Hepatic: ALT and
AST no greater than 5.0 times upper limit of normal (ULN) Bilirubin no greater than 2
times ULN unless due to Gilbert's syndrome or hemolytic anemia Renal: Creatinine less than
2 times ULN Cardiovascular: Adequate cardiac function for age Pulmonary: Adequate
pulmonary function for age Other: Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception for 1 month prior to study until at least 2
months after study No active uncontrolled infection HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplant No other
concurrent monoclonal antibody therapies or ex vivo T-cell depletion therapies
Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy:
Not specified Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Eva Guinan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067977

NCT ID:

NCT00005988

Start Date:

February 2000

Completion Date:

Related Keywords:

  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult Hodgkin lymphoma
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • stage I childhood lymphoblastic lymphoma
  • stage II childhood lymphoblastic lymphoma
  • stage III childhood lymphoblastic lymphoma
  • stage IV childhood lymphoblastic lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • childhood diffuse large cell lymphoma
  • childhood immunoblastic large cell lymphoma
  • 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
  • stage I grade 3 follicular lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I adult Burkitt lymphoma
  • chronic myelomonocytic leukemia
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt 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
  • graft versus host disease
  • stage I childhood small noncleaved cell lymphoma
  • stage I childhood large cell lymphoma
  • stage II childhood small noncleaved cell lymphoma
  • stage II childhood large cell lymphoma
  • stage III childhood small noncleaved cell lymphoma
  • stage III childhood large cell lymphoma
  • stage IV childhood small noncleaved cell lymphoma
  • stage IV childhood large cell lymphoma
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • refractory cytopenia with multilineage dysplasia
  • childhood myelodysplastic syndromes
  • Neoplasms
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Dana-Farber Cancer InstituteBoston, Massachusetts  02115