A Phase 2 interventional study of anti-thymocyte globulin and G-CSF in Leukemia, Lymphoma and Multiple Myeloma, sponsored by Alliance for Clinical Trials in Oncology. Completed at 12 sites in United States. Open to participants aged Up to 69 Years. Per ClinicalTrials.gov, last updated 2016-07-01.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 2, Interventional, and Treatment
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or 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. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving immunosuppressive therapy after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor bone marrow or peripheral stem cell transplant works in treating patients with relapsed hematologic cancer after treatment with chemotherapy and autologous stem cell transplant.
OBJECTIVES:
OUTLINE: This is an open-label study.
NOTE: *Tacrolimus may be tapered on days 60-90 if donor chimerism of CD3+ cells is less than 50% at day 60 or patient has progressive disease
Patients are followed within 2-3 months, every 3 months for 2 years, and then every 6 months for 3 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 82 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
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DISEASE CHARACTERISTICS:
Histologically confirmed hematologic malignancy, including one of the following:
Chronic lymphocytic leukemia (CLL)
Prolymphocytic leukemia (PLL)
Non-Hodgkin's lymphoma or Hodgkin's lymphoma
Multiple myeloma
Acute myeloid leukemia
Myelodysplastic syndromes
Availability of any of the following donor types:
9/10 matched related donor by high-resolution molecular typing at HLA A, B, C, DRB1, and DQB1 loci
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Non myeloblative allogeneic hematopoietic cell transplantation after prior autologous transplantation
Biological: anti-thymocyte globulin · Biological: G-CSF · Drug: busulfan · Drug: fludarabine phosphate · Drug: methotrexate · Drug: mycophenolate mofetil · Drug: tacrolimus · Procedure: allogeneic cell transplantation · Drug: allopurinol
2.5mg/kg/day IV infusion over 6 hrs x 4 doses Days -4 to -1 (for MUD and 9/10 related donor transplants only)
5 ug/kg/day subQ injection Day 7 until ANC\> 1000/uL for 3 consec days
Also known as: filgrastim
0.8mg/kg IV infusion over 2 hrs q 6 hrs x 8 doses Days -4 thru -3
30 mg/sq m/day IVBP over 30 min Days -7 thru -3
5 mg/sq m/day IV infusion Days 1, 3, \& 6 for HLA-identical donor transplants and Days 1, 3, 6, \& 11 for MUD \& 9/10 related donor transplants
15mg/kg PO bid Day -2 to Day 60, then taper as tolerated (for MUD and 9/10 related donor transplants only)
target serum level is 5-10 ng/mL. Start with 0.03mg/kg PO bid Day -1 to Day 90, then taper thru Day 150 for HLA identical donor transplants and Day -1 to Day 180 then taper for MUD and 9/10 related donor transplants
2,000,000-8,000,000 CD34+ cells total via infusion Days 0 and 1
300 mg/day PO Days -8 thru -1
Treatment-related mortality
Time frame: 6 months post transplant
Per cent donor chimerism
Time frame: 30, 60, 90, 180 days post transplant
Disease-free survival
Time frame: 12 months up to 5 years post study entry
Graft-versus-host disease incidence
Time frame: 6 months post transplant
Response Rates
Time frame: 6 and 12 months
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology