Post-Transplant Bortezomib and High Dose Cyclophosphamide as Graft-Versus-Host Disease (GVHD) Prophylaxis

Browse trials for

• Hematologic Neoplasms 1,494

Keywords

• Blood and Marrow Transplant (BMT)
• MRD
• MUD
• GVHD

Hematologic Neoplasms

1,494 studies on the registry are indexed under Hematologic Neoplasms; 438 are open to participants now.

This study's enrollment of 28 is below the median of 45 across 1,090 interventional studies indexed under Hematologic Neoplasms.

Lead sponsor

Corewell Health West is the lead sponsor of 16 studies on the registry; 9 are open to participants now.

Study arms

• Active comparator
  Cohort 1-Bortezomib (Velcade®)

  Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.

  Drug: Cohort 1-Bortezomib (Velcade ®)

• Active comparator
  Cohort 2-Bortezomib (Velcade®)

  Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.

  Drug: Cohort 2-Bortezomib (Velcade ®)

• Active comparator
  Cohort 3-Bortezomib (Velcade®)

  Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.

  Drug: Cohort 3-Bortezomib (Velcade ®)

Interventions

• DrugCohort 1-Bortezomib (Velcade ®)

  Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1. Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0. Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.

  Also known as: Cyclophosphamide (Cytoxan ®), Bortezomib (Velcade ®)

• DrugCohort 2-Bortezomib (Velcade ®)

  Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1. Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0. Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.

  Also known as: Cyclophosphamide (Cytoxan ®), Bortezomib (Velcade ®)

• DrugCohort 3-Bortezomib (Velcade ®)

  Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1. Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0. Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.

  Also known as: Cyclophosphamide (Cytoxan ®), Bortezomib (Velcade ®)

Primary outcomes

1. Dose Limiting Toxicity

   Grade 3 non-hematologic Common Toxicity Criteria toxicity directly related to bortezomib (such as peripheral neuropathy) or Grade 2 or \> hepatic bilirubin Common Toxicity Criteria Graft failure

   Time frame: Assessed daily (while inpatient) through clinical and laboratory examination up to 90 days.

Secondary outcomes

1. Engraftment

   Neutrophil engraftment is defined as achieving an absolute neutrophil count (ANC) \> 0.5 109/L for 3 consecutive measurements on different days. The first of the 3 days will be considered the day of neutrophil engraftment. Platelet engraftment is defined as platelet count \> 20 109/L for 3 consecutive measurements over at least 3 days. The first of the 3 days will be considered the day of platelet engraftment. In this study, graft failure is defined as lack of achieving neutrophil engraftment by day 22 and donor chimerism \> 50% by day 45.

   Time frame: Assessed daily by laboratory evaluation until engraftment or up to 90 days.

Other outcomes

1. GVHD

   aGVHD onset at a certain grade will be used to calculate the cumulative incidence for that grade (e.g., onset of grade 70 post-transplant , time to grade III is 70 days). This end point will be evaluated through day 150 post-transplant. The diagnosis of aGVHD is based on clinical and pathological evaluation by the treating physician. The first day of cGVHD will be used to calculate the cumulative incidence of cGVHD. The diagnosis of cGVHD is based on clinical and pathological evaluation by the treating physician.

   Time frame: Assessed routinely by clinical and pathological evaluation. Acute GVHD will be assessed up to day 150 post-transplant. Chronic GVHD will be assess up to 2 years post-transplant.

Baseline characteristics

Individual participant data

Plan to share: No