A Phase 2 interventional study of therapeutic allogeneic lymphocytes and cyclosporine in Leukemia, Lymphoma and Multiple Myeloma and Plasma Cell Neoplasm, sponsored by University of Texas Southwestern Medical Center. Completed at 14 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by University of Texas Southwestern Medical Center · Phase 2, Interventional, and Treatment
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have hematologic cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups (high-risk vs low-risk hematologic malignancy). The high-risk group includes acute myelogenous leukemia, myelodysplastic syndromes, accelerated phase chronic myelogenous leukemia (CML), second chronic phase CML, and non-Hodgkin's lymphoma. The low-risk group includes Hodgkin's lymphoma, first chronic phase CML, multiple myeloma, and chronic lymphocytic leukemia.
Patients receive fludarabine IV on days -4 to -2. Patients undergo total-body irradiation on day 0 followed by allogeneic stem cell transplantation. Patients also receive oral mycophenolate mofetil on days 0-28.
High-risk patients receive oral cyclosporine twice daily on days -2 to day 60. Patients with persistent disease, T-cell chimerism, and no graft-vs-host disease (GVHD) on day 90 receive up to 3 doses of donor leukocyte infusion (DLI) over the next 4 months.
Low-risk patients receive oral cyclosporine twice daily on days -2 to day 150. Patients with persistent disease, T-cell chimerism, and no GVHD on day 180 receive up to 3 doses of DLI over the next 4 months.
Quality of life is assessed at baseline and at 1, 3, 6, 9, 12, 18, and 24 months.
Patients are followed at 1, 3, 6, 9, and 12 months and then annually for 2 years.
PROJECTED ACCRUAL: A total of 120 patients (60 per group) will be accrued for this study.
5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.
Browse Leukemia studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,009 studies on the registry; 201 are open to participants now.
Of its 138 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of one of the following hematologic malignancies:
Chronic myelogenous leukemia (CML)
Acute myelogenous leukemia (AML)
Myelodysplastic syndromes (MDS)
Hodgkin's lymphoma
Non-Hodgkin's lymphoma (NHL)
Chronic lymphocytic leukemia (CLL)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Ran from Nov 1999 to primary completion in Nov 2006, 84 months.
Of 411 non-industry phase 2 interventional studies under Leukemia, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 104. This study's 84 months is above that.
Counting every sponsor, half of 511 studies reached it within 59 months; a quarter within 36 and three quarters within 97.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fludarabine phosphate
University of Texas Southwestern Medical Center →