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A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With High Risk Hematologic Malignancies


Phase 2
N/A
54 Years
Not Enrolling
Both
Graft Versus Host Disease, Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

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Trial Information

A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With High Risk Hematologic Malignancies


OBJECTIVES:

- Determine the rates of hematologic and immune reconstitution in patients with high risk
hematologic malignancies who are undergoing high dose chemoradiotherapy followed by
unrelated umbilical cord blood (UCB) transplantation.

- Determine the incidence of graft-versus-host-disease in this setting.

- Describe the incidence of recurrent disease in these patients post UCB transplant.

- Describe the incidence of serious infections and secondary lymphoproliferative diseases
following transplantation with UCB in these patients.

- Determine specifically whether larger recipients can be durably engrafted with
unrelated UCB, and determine whether nucleated cell or progenitor cell content of the
graft is predictive of hematological engraftment.

OUTLINE: Patients may undergo a back-up peripheral blood stem cell collection prior to
treatment.

Patients receive 9 fractions of total body irradiation (TBI) on days -9 to -5 followed by
melphalan IV for three days on days -4 to -2 and antithymocyte globulin IV or
methylprednisolone IV for three days on days -3 to -1. On day 0, patients receive umbilical
cord blood infusion. If TBI is not tolerated, busulfan is substituted and administered
orally every 6 hours for 4 days on days -8 to -5. Cyclosporine and methylprednisolone begin
on day -2 and continue for 6 months.

Patients are followed at least monthly for 1 year, then every 6 months for the second year,
and then annually thereafter.

PROJECTED ACCRUAL: There will be a maximum of 48 patients accrued into this study over 4
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed high risk malignancy including:

- Acute nonlymphocytic leukemia (ANLL) after induction failure, or in first
complete remission with high risk features including stem cell or biphenotypic
classification (acute myeloid leukemia (AML) M0), erythroleukemia (AML M6),
acute megakaryocytic leukemia (AML M7), cytogenic markers indicative of poor
prognosis, or failure to achieve complete remission after standard induction
therapy

- Acute lymphocytic leukemia (ALL) or ANLL in second or subsequent remission

- Chronic myeloid leukemia (CML) in chronic phase

- CML with accelerated phase or blast crisis are eligible after reinduction
chemotherapy converts disease to chronic phase

- High risk ALL in first complete remission

- Myelodysplastic syndrome with evidence of evolution to acute myeloid leukemia

- Refractory anemia with excess blasts

- Refractory anemia with excess blasts in transformation

- Non-Hodgkin's lymphoma (NHL), ANLL, or ALL with recurrent disease after
autologous stem cell transplantation

- Must also meet all the following conditions:

- No HLA-ABC/DR identical related bone marrow or UCB donor

- No 5/6 antigen matched related bone marrow or UCB donor

- Condition precludes waiting to search and find a donor in the National Marrow
Donor Registry

- Must have an available serologic matched umbilical cord blood unit in the New York
Blood Center's Placental Blood Project

- No active CNS disease

PATIENT CHARACTERISTICS:

Age:

- Under 55 at time of umbilical cord blood transplantation

Performance status:

- Zubrod 0-1

- Karnofsky 80-100%

Life expectancy:

- At least 3 months

Hematopoietic:

- For patients with ALL or ANLL in remission, CML in chronic phase, or NHL without
marrow involvement who elect to undergo autologous peripheral blood stem cell
collection and storage:

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- ALT/AST no greater than 4 times normal

Renal:

- Creatinine no greater than 2.0 mg/dL

- Creatinine clearance at least 50 mL/min

Cardiovascular:

- Normal cardiac function by echocardiogram or radionuclide scan (shortening fraction
or ejection fraction at least 80% of normal value for age)

Pulmonary:

- FVC and FEV_1 at least 60% of predicted for age

- For adults:

- DLCO at least 60% of predicted

Other:

- HIV negative

- No active infections at time of autologous stem cell harvest or pretransplant
cytoreduction

- Not pregnant or nursing

- Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Prior autologous stem cell transplantation allowed

Chemotherapy:

- See Disease Characteristics

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

rates of durable engraftment in patients

Outcome Description:

The primary study end point will be hematologic engraftment. Engraftment is defined as achieving ANC larger than or equal to 500 ul/mm3 of donor origin for three consecutive measurements on different days by day +42.

Outcome Time Frame:

day 42

Safety Issue:

No

Principal Investigator

Brenda W. Cooper, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU4Y97

NCT ID:

NCT00003335

Start Date:

January 1998

Completion Date:

January 2012

Related Keywords:

  • Graft Versus Host Disease
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood lymphoblastic lymphoma
  • recurrent adult acute lymphoblastic leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • 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
  • adult acute erythroid leukemia (M6)
  • adult acute megakaryoblastic leukemia (M7)
  • childhood acute erythroleukemia (M6)
  • childhood acute megakaryocytic leukemia (M7)
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • 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
  • graft versus host disease
  • 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
  • childhood chronic myelogenous leukemia
  • 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
  • Graft vs Host Disease
  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065