Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-01-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pilot Study Of Unrelated UCB Transplant for Non-Malignant Hematologic Conditions

NCT00003336

Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases

COMPLETED PHASE2

Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Other Hematologic or Metabolic Diseases

NCT00003662

Graft Versus Host Disease Leukemia Myelodysplastic Syndromes +1 more

COMPLETED PHASE2

Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Nonmalignant Hematologic Disease

NCT00003913

Leukemia Lymphoma Myelodysplastic Syndromes +1 more

COMPLETED PHASE2

Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer

NCT00003661

Graft Versus Host Disease Leukemia Lymphoma +2 more

COMPLETED PHASE2

Donor Umbilical Cord Blood Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders

NCT00055653

Leukemia Lymphoma Myelodysplastic Syndromes +1 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Graft Versus Host Disease Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

anti-thymocyte globulin

antithymocyte globulin IV for three days on days -3 to -1

Intervention Type BIOLOGICAL

busulfan

If TBI is not tolerated, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5.

Intervention Type DRUG

cyclosporine

Cyclosporine begin on day -2 and continue for 6 months.

Intervention Type DRUG

melphalan

melphalan IV for three days on days -4 to -2

Intervention Type DRUG

methylprednisolone

Methylprednisolone IV for three days on days -3 to -1. Methylprednisolone begin on day -2 and continue for 6 months.

Intervention Type DRUG

umbilical cord blood transplantation

On day 0, patients receive umbilical cord blood infusion.

Intervention Type PROCEDURE

radiation therapy

9 fractions of total body irradiation (TBI) on days -9 to -5

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No