A Phase 2 interventional study of anti-thymocyte globulin and filgrastim in Leukemia, Lymphoma and Myelodysplastic Syndromes, sponsored by Fred Hutchinson Cancer Center. Completed at 23 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2010-04-02.
Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of umbilical cord blood transplantation plus combination chemotherapy in treating patients who have hematologic cancer or nonmalignant hematologic disease.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to disease group (malignant vs nonmalignant). Patients with malignant disease are further stratified according to quality of HLA match (1 or 2/6 vs 3/6 vs 4/6 vs 5/6 or 6/6), cell dose, and age.
Patients are assigned to one of three conditioning regimens, depending on disease.
Patients in all groups receive cord blood IV over a maximum of 30 minutes on day 0. Patients also receive MePRDL IV with the first half of the infusion administered immediately before the cord blood infusion and filgrastim (G-CSF) IV beginning 4 hours after transplantation and continuing until blood counts recover.
Patients are followed at 30, 60, and 90 days; at 6 months; and then annually thereafter.
PROJECTED ACCRUAL: Approximately 390 patients will be accrued for this study within 5 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 390 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Acute myeloid leukemia (AML), with or without myelodysplastic syndromes
Not in first CR* with translocations t(15;17) abnormality unless:
Acute lymphocytic leukemia (ALL)
High-risk ALL in first CR, with high risk defined as one of the following:
Elevated WBC at presentation
Patients with B-ALL must not be in first CR, must meet at least one of the high-risk criteria specified above, or must not meet any of the following criteria:
Chronic myelogenous leukemia, meeting criteria for 1 of the following:
Blast crisis, defined as greater than 30% promyelocytes plus blasts in bone marrow
Acute undifferentiated leukemia (AUL), infant leukemia, or biphenotypic leukemia
Juvenile myelomonocytic leukemia meeting the following criteria:
At least 2 of the following:
Myelodysplastic syndromes defined by the following:
Inborn error of metabolism including, but not limited to, Hurler's syndrome, adrenoleukodystrophy (ALD), Maroteaux-Lamy syndrome, globoid cell leukodystrophy, metachromatic leukodystrophy, fucosidosis, or mannosidosis
Combined immune deficiencies including, but not limited to:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
If symptomatic:
Pulmonary:
If symptomatic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fred Hutchinson Cancer Center