Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome

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• Leukemia 5,441
• Leukemia, Myeloid 2,443
• Leukemia, Myeloid, Acute 2,971
• Neoplasm Metastasis 3,517
• Preleukemia 1,317
• Leukemia, Myelomonocytic, Chronic 329

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 18 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Lead sponsor

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.

Study arms

• Experimental
  Dose Level 1: 12 Gy iodine-131 monoclonal antibody BC8

  RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.

  Radiation: iodine I 131 monoclonal antibody BC8 · Drug: fludarabine phosphate · Radiation: total-body irradiation · Procedure: allogeneic hematopoietic stem cell transplantation · Procedure: peripheral blood stem cell transplantation · Drug: cyclosporine · Drug: mycophenolate mofetil · Other: laboratory biomarker analysis

• Experimental
  Dose Level 7: 22 Gy iodine-131 monoclonal antibody BC8

  RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.

  Radiation: iodine I 131 monoclonal antibody BC8 · Drug: fludarabine phosphate · Radiation: total-body irradiation · Procedure: allogeneic hematopoietic stem cell transplantation · Procedure: peripheral blood stem cell transplantation · Drug: cyclosporine · Drug: mycophenolate mofetil · Other: laboratory biomarker analysis

• Experimental
  Dose Level 8: 24 Gy iodine-131 monoclonal antibody BC8

  RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.

  Radiation: iodine I 131 monoclonal antibody BC8 · Drug: fludarabine phosphate · Radiation: total-body irradiation · Procedure: allogeneic hematopoietic stem cell transplantation · Procedure: peripheral blood stem cell transplantation · Drug: cyclosporine · Drug: mycophenolate mofetil · Other: laboratory biomarker analysis

• Experimental
  Dose Level 9: 26 Gy iodine-131 monoclonal antibody BC8

  RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.

  Radiation: iodine I 131 monoclonal antibody BC8 · Drug: fludarabine phosphate · Radiation: total-body irradiation · Procedure: allogeneic hematopoietic stem cell transplantation · Procedure: peripheral blood stem cell transplantation · Drug: cyclosporine · Drug: mycophenolate mofetil · Other: laboratory biomarker analysis

• Experimental
  Dose Level 10: 28 Gy iodine-131 monoclonal antibody BC8

  RADIOIMMUNOTHERAPY: Patients receive therapeutic iodine I 131 monoclonal antibody BC8 IV on day -12. CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo TBI on day 0. TRANSPLANTATION: After completion of TBI, patients undergo allogeneic PBSC transplant on day 0. IMMUNOSUPPRESSION: Patients with a matched related donor receive cyclosporine IV or PO BID on days -3 to 56 followed by a taper to day 180 in the absence of graft-versus-host disease. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO 2 BID on days 0 to 27. Patients with a matched unrelated donor receive cyclosporine IV or PO BID on days -3 to 100 followed by a taper to day 180. Beginning 4-6 hours after PBSC transplant, these patients also receive mycophenolate mofetil PO TID on days 0 to 40 followed by a taper to day 96.

  Radiation: iodine I 131 monoclonal antibody BC8 · Drug: fludarabine phosphate · Radiation: total-body irradiation · Procedure: allogeneic hematopoietic stem cell transplantation · Procedure: peripheral blood stem cell transplantation · Drug: cyclosporine · Drug: mycophenolate mofetil · Other: laboratory biomarker analysis

Interventions

• Radiationiodine I 131 monoclonal antibody BC8

  Given IV

  Also known as: I 131 MOAB BC8, I 131 Monoclonal Antibody BC8, iodine I 131 MOAB BC8

• Drugfludarabine phosphate

  Given IV

  Also known as: 2-F-ara-AMP, Beneflur, Fludara

• Radiationtotal-body irradiation

  Undergo TBI

  Also known as: TBI

• Procedureallogeneic hematopoietic stem cell transplantation

  Undergo PBSC transplantation

• Procedureperipheral blood stem cell transplantation

  Undergo PBSC transplantation

  Also known as: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell

• Drugcyclosporine

  Given IV or PO

  Also known as: ciclosporin, cyclosporin, cyclosporin A, CYSP, Sandimmune

• Drugmycophenolate mofetil

  Given PO

  Also known as: Cellcept, MMF

• Otherlaboratory biomarker analysis

  Correlative studies

Primary outcomes

1. Number of Participants With Dose-limiting Toxicities (DLT) 100 Days After Transplant

   The criteria of Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT) are as follows: Grade 1 Development of transient chemical abnormalities which are not of major clinical consequence and which reverse without requiring major medical interventions. In general, the intent of this toxicity scale is to observe transient target organ toxicity which is reversible. Grade 2 Development of chemical or laboratory abnormalities that are persistent and which may represent target organ damage that may not be readily reversed. It is anticipated that at this dose of the drug, the toxicity obtained would be manageable by clinical methods but may interfere with other therapies. Grade 3 Development of major clinical, chemical or laboratory abnormalities which represent maximum toxicities without being fatal. This grade of toxicity is designed to be the dose-limiting toxicity.

   Time frame: Up to 100 days post-transplant

Secondary outcomes

1. Number of Participants With Transplant Related Mortality Within 100 Days After Transplant

   Number of participants that received and completed study treatment who died within 100 days after transplant

   Time frame: Up to 100 days post-transplant

2. Participant Disease Response Within 4 Weeks After Transplant

   The number of participants that are in complete remission (CR) or relapsed within 4 weeks after transplant. Complete Remission is defined as complete resolution of all signs of leukemia for at least four weeks with all of the following: * Normal bone marrow with blasts \<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis. * Normalization of blood counts (no blasts, platelets \>100,000/mm3, granulocytes \>1,500/mm3). * No extramedullary disease. Relapse is measured as follows: * After CR: \>5% blasts in the bone marrow and/or peripheral blood. * Confirmation of relapse by bone marrow analysis with more than 10% blasts. * Extramedullary disease confirmed cytologically or histologically.

   Time frame: 4 weeks after transplant

3. Severity of Acute GVHD in Patients Who Completed the Study Treatment

   The severity of acute GVHD is measured based on Graft-vs-Host Disease: Severity of GVHD Grade I +1 to +2 skin rash No gut or liver involvement Grade II +3 skin rash or * 1 gastrointestinal involvement and/or +1 liver involvement Grade III +2 to +4 gastrointestinal involvement and/or * 2 to +4 liver involvement with or without a rash Grade IV Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

   Time frame: 100 days after transplant

4. Number of Participants With 100% Donor Chimerism at Day 28 and Day 84

   Post-transplant bone marrow samples were collected on day 28 and day 84 after transplant for DNA Chimerism Analysis

   Time frame: Day 28 and Day 80 after transplant

5. Two-year Disease-free Survival of Study Participants Who Completed the Study Regimen

   Survival and complete resolution of all signs of leukemia for 2 years after transplant with all of the following: 1. Normal bone marrow with blasts \<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis and more than 25% granulocytopoiesis. 2. Normalization of blood counts (no blasts, platelets \>100,000/mm3, granulocytes \>1,500/mm3). 3. No extramedullary disease.

   Time frame: 2 years post transplant

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Sep 17, 2014

Documents are hosted by the registry — open the source record to download them.