TREATMENT OF PATIENTS WITH HEMATOLOGIC MALIGNANCIES USING MARROW TRANSPLANTATION FROM UNRELATED DONORS MATCHED FOR HLA OR INCOMPATIBLE FOR ONE HLA LOCUS ANTIGEN


Phase 2
N/A
55 Years
Not Enrolling
Both
Leukemia, Lymphoma

Thank you

Trial Information

TREATMENT OF PATIENTS WITH HEMATOLOGIC MALIGNANCIES USING MARROW TRANSPLANTATION FROM UNRELATED DONORS MATCHED FOR HLA OR INCOMPATIBLE FOR ONE HLA LOCUS ANTIGEN


OBJECTIVES: I. Determine whether the use of donors with a one non crossreactive group (CREG)
mismatch for HLA-A or B in patients less than 36 years of age is associated with more
frequent graft versus host disease (GVHD) of grades III-IV than previously observed with
donors with one CREG mismatch. II. Determine whether the use of donors with a one CREG
mismatch for HLA-A or B in patients 36-50 years of age is associated with more frequent GVHD
of grades III-IV than previously observed with matched donors. III. Determine the relevance
of HLA-A allele mismatching in bone marrow transplants from donors matched for HLA-A, B, and
DR phenotypes.

OUTLINE: This is a parallel, open label study. Patients are assigned to 1 of 3 treatment
arms. Arm I: Patients receive cyclophosphamide IV on days -7 and -6 and total body
irradiation (TBI) 3 times a day on days -4 through -1. Allogeneic bone marrow (ABM) is
infused on day 0. Arm II: Patients receive therapy as in arm I, except TBI is administered
twice a day on day -1 only. ABM is infused on day 0. Arm III: Patients receive
cyclophosphamide IV on days -6 and -5 and TBI twice a day on days -3 through -1. ABM is
infused on day 0. Males with ALL receive an additional radiation boost to the testes during
TBI. Patients are followed at least every 6 months for 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients under 36 years old and 50 patients 36-50 years old
will be accrued for this study within 5 years. Additional patients will be accrued for the
standard therapy arm of this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Hematologic malignancies of the following types: Chronic
myelogenous leukemia (CML) in chronic or accelerated phase Newly diagnosed acute leukemia
at high risk of relapse following chemotherapy alone Early referral encouraged so that
donor search can begin as soon as possible Acute leukemia failing one cycle of induction
chemotherapy Acute leukemia beyond first remission High-risk Hodgkin's disease and
non-Hodgkin's lymphoma in first remission Hodgkin's disease, non-Hodgkin's lymphoma, or
other malignant lymphoproliferative disease after first remission No suitable related
donor available (i.e., no HLA genotypically identical sibling) No haploidentical relative
with no more than 1 unshared haplotype for an HLA-A, -B, or -D locus Acute leukemia in
relapse and CML in blast crisis eligible only under the following conditions: Patient's
clinical condition is likely to remain stable for the 2-6 month period necessary to find a
marrow donor Remission induction has been attempted Local physician and patient accept
that the search or transplant may be canceled if the patient's condition deteriorates
during the search No leukoencephalopathy Donor requirements: Age less than 60 In good
health Phenotypically identical for HLA-A, -B, and -DRB1 1-antigen mismatch for HLA-A, -B,
or -DRB1 locus allowed for patients below age 36 Patients for whom TBI is contraindicated
may be treated on protocol FHCRC-739 Severe aplastic anemia should be transplanted
according to protocols FHCRC-174.2 or FHCRC-800 Myelodysplastic syndrome should be
transplanted according to protocol FHCRC-179.3 or FHCRC-844

PATIENT CHARACTERISTICS: Age: Under 56 Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: No acute hepatitis No other severe
hepatic disease Renal: Creatinine less than 2 times normal for age, weight, and sex
Cardiovascular: No symptomatic cardiac disease Pulmonary: No active pulmonary disease No
history of pulmonary fibrosis No severe hypoxemia (pO2 less than 70 mm Hg and DLCO less
than 70%) No mild hypoxemia (pO2 less than 80 mm Hg and DLCO less than 60%) Other: HIV
negative No severe limitations due to diseases other than malignancy

PRIOR CONCURRENT THERAPY: No more than 3,000 cGy to the whole brain No more than 1,500 cGy
to the chest or abdomen At least 6 months since involved-field irradiation to the chest or
abdomen

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Claudio Anasetti, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

160.06

NCT ID:

NCT00002553

Start Date:

August 1990

Completion Date:

June 2003

Related Keywords:

  • Leukemia
  • Lymphoma
  • stage IV adult Hodgkin lymphoma
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult Hodgkin lymphoma
  • Waldenstrom macroglobulinemia
  • stage IV childhood lymphoblastic lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • untreated childhood acute myeloid leukemia and other myeloid malignancies
  • untreated childhood 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
  • stage IV childhood Hodgkin lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent adult non-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
  • stage IV childhood small noncleaved cell lymphoma
  • stage IV childhood large cell lymphoma
  • 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
  • Leukemia
  • Lymphoma

Name

Location
Fred Hutchinson Cancer Research Center Seattle, Washington  98109