A Phase 1/2 interventional study of alemtuzumab and cyclosporine in Leukemia, Lymphoma and Multiple Myeloma and Plasma Cell Neoplasm, sponsored by Alliance for Clinical Trials in Oncology. Withdrawn at 24 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 1/2, Interventional, and Treatment
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects of alemtuzumab, fludarabine, and melphalan with or without cyclosporine, mycophenolate mofetil, and total-body irradiation before donor peripheral blood stem cell transplant and to see how well they work in treating patients with relapsed or refractory hematologic cancer.
OBJECTIVES:
OUTLINE: This is a multicenter, pilot study. Patients are initially treated with conditioning regimen A. If adequate donor engraftment is not achieved, subsequent patients are treated with conditioning regimen B.
All patients undergo allogeneic, T-cell-depleted, CD34-positive peripheral blood stem cell transplantation on day 0. Patients receive sargramostim (GM-CSF) subcutaneously beginning on day 1 and continuing until blood counts recover.
Patients are followed every 3 months for 1 year and then every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 14-56 patients (14-28 per regimen) will be accrued for this study.
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DISEASE CHARACTERISTICS:
Histologically confirmed hematological malignancy of 1 of the following types:
Acute myeloid leukemia meeting at least 1 of the following criteria:
Acute lymphoblastic leukemia meeting 1 of the following criteria:
High-risk myelodysplasia
Chronic myeloid leukemia (CML)* with an inadequate response to imatinib meeting 1 of the following criteria:
Non-Hodgkin's lymphoma meeting 1 of the following criteria:
Chronic lymphocytic leukemia meeting both of the following criteria:
Multiple myeloma meeting 1 of the following criteria:
Available suitable family donor meeting the following criteria:
Mismatched with respect to KIR class I epitopes graft-vs-host directional activity
PATIENT CHARACTERISTICS:
Age
Performance status
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Conditioning regimen A: Patients receive alemtuzumab IV over 2 hours on days -14 to -12; fludarabine IV over 30 minutes on days -7 to -3; and melphalan IV over 20-30 minutes on day -2. Conditioning regimen B: Patients receive oral or IV cyclosporine twice daily and oral or IV mycophenolate mofetil twice daily on days -15 to 0. Patients also receive alemtuzumab, fludarabine, and melphalan as in conditioning regimen A. Patients undergo low-dose total body irradiation twice daily on days -2 and -1. All patients undergo allogeneic, T-cell-depleted, CD34-positive peripheral blood stem cell transplantation on day 0. Patients receive sargramostim (GM-CSF) subcutaneously beginning on day 1 and continuing until blood counts recover. Patients are followed every 3 months for 1 year and then every 6 months for 5 years.
Biological: alemtuzumab · Drug: cyclosporine · Drug: fludarabine phosphate · Drug: melphalan · Drug: mycophenolate mofetil · Procedure: peripheral blood stem cell transplantation · Radiation: radiation therapy
Engraftment rate
Time frame: Up to 6 years
Risk of graft-vs-host disease
Time frame: Up to 6 years
Progression-free survival (PFS)
Time frame: Up to 6 years
This study is withdrawn, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology