Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer - Article High blood pressure (hypertension)
Clinical Trial: Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer
This study is currently recruiting patients.
PURPOSE: This phase II trial is studying allogeneic umbilical cord blood transplantation to see how well it works when given with chemotherapy or radiation therapy in treating patients with high-risk hematologic cancer.
|Condition||Treatment or Intervention||Phase|
|childhood non-Hodgkin's lymphoma |
Graft Versus Host Disease
myelodysplastic and myeloproliferative diseases
| Drug: anti-thymocyte globulin |
Procedure: biological response modifier therapy
Procedure: bone marrow ablation with stem cell support
Procedure: graft versus host disease prophylaxis/therapy
Procedure: radiation therapy
Procedure: supportive care/therapy
Procedure: umbilical cord blood transplantation
|Phase II |
MedlinePlus related topics: Blood and Blood Disorders; Cancer; Cancer Alternative Therapy; Immune System and Disorders; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma
Study Type: Interventional
Study Design: Treatment
- 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.
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.
Ages Eligible for Study: up to 54 Years, Genders Eligible for Study: Both
- 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
- Zubrod 0-1
- Karnofsky 80-100%
- At least 3 months
- 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
- Bilirubin no greater than 2.0 mg/dL
- ALT/AST no greater than 4 times normal
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance at least 50 mL/min
- Normal cardiac function by echocardiogram or radionuclide scan (shortening fraction or ejection fraction at least 80% of normal value for age)
- FVC and FEV_1 at least 60% of predicted for age
- For adults:
- DLCO at least 60% of predicted
- 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
- See Disease Characteristics
- Not specified
- Not specified
- Not specified
Location and Contact Information
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio, 44106-7284, United States; Recruiting
Mary J. Laughlin, MD, Study Chair, Ireland Cancer Center
Record last reviewed: July 1999
Last Updated: February 9, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003335
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005
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