A Phase 1 interventional study of anti-thymocyte globulin and filgrastim in Chronic Myeloproliferative Disorders, Leukemia and Lymphoma, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged Up to 120 Years. Per ClinicalTrials.gov, last updated 2020-07-27.
Sponsored by Case Comprehensive Cancer Center · Phase 1, 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 cells destroyed by chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by umbilical cord blood transplantation in treating patients who have hematologic cancer or severe aplastic anemia.
OBJECTIVES:
OUTLINE: Patients receive a non-myeloablative conditioning regimen comprising fludarabine IV over 30 minutes on days -8 to -4, cyclophosphamide IV over 2 hours on days -3 to -2, and anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1. Patients unable to tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1.
Patients undergo multiple unit umbilical cord blood transplantation on days 0-1. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood counts recover.
Patients are followed monthly for 6 months; at 9, 12, 14, 16, 18, and 24 months; and then annually thereafter.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 55 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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DISEASE CHARACTERISTICS:
One of the following histologically confirmed diagnoses:
Acquired severe aplastic anemia
Meets at least 2 of the following criteria:
Acute myeloid leukemia (AML), meeting 1 of the following criteria:
In first complete remission (CR) with any of the following high-risk features:
Acute lymphoblastic leukemia, meeting 1 of the following criteria:
In first CR with the following high-risk features:
Chronic myelogenous leukemia
Myelodysplastic syndromes meeting 1 of the following criteria:
= 5q- = 7q-
Evidence of evolution to AML (e.g., refractory anemia with excess blasts [RAEB], or RAEB in transformation)
Chronic lymphocytic leukemia
Multiple myeloma
Hodgkin's lymphoma
Non-Hodgkin's lymphoma (NHL)
Myeloproliferative disorders
Allografting required unless grade 3 or greater myelofibrosis by bone marrow biopsy
Organ toxicity or infection precluding eligibility for allogeneic transplantation with full ablation conditioning
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No other concurrent investigational agents that would preclude study participation or increase risk to patient
Biological: anti-thymocyte globulin · Biological: filgrastim · Drug: cyclophosphamide · Drug: fludarabine phosphate · Procedure: umbilical cord blood transplantation · Drug: methylprednisolone
anti-thymocyte globulin (ATG) IV over at least 4 hours on days -2 to -1
Patients receive filgrastim (G-CSF) subcutaneously beginning on day 7 and continuing until blood counts recover.
cyclophosphamide IV over 2 hours on days -3 to -2
fludarabine IV over 30 minutes on days -8 to -4
Patients undergo multiple unit umbilical cord blood transplantation on days 0-1.
Patients unable to tolerate ATG may receive methylprednisolone IV over 1 hour on days -3 to -1.
Event-free survival by disease assessment
Time frame: at 28 and 100 days and then at 6, 9, 12, 18, and 24 months
Umbilical cord blood donor engraftment by chimerism and complete blood count (CBC)
Time frame: monthly for 6 months and then at 9, 12, 18, and 24 months
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Case Comprehensive Cancer Center