NCT03018223

Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT

A Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haploidentical Peripheral Blood Stem Cell Transplantation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to find out if a combination of drugs (these are called: cyclophosphamide, sirolimus, and mycophenolate mofetil) will protect participants better against graft vs. host disease (GVHD) after receiving a hematopoietic cell transplant from a related partially matched (haploidentical) donor. As part of the treatment for their blood cancer, participants need a hematopoietic cell transplantation (HCT) to improve their chances of cure. In any HCT, after the stem cell infusion is given, a combination of drugs is needed to prevent GVHD and facilitate acceptance of the graft.

Conditions

• Non-Hodgkin's Lymphoma
• Acute Leukemia in Remission
• Chronic Myeloid Leukemia
• Primary Myelofibrosis
• Chronic Myelomonocytic Leukemia
• Myelodysplastic Syndromes
• Hodgkin Lymphoma
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Fludarabine	Myeloablative conditioning: 40 mg/m\^2 daily for 4 days. Dose will be adjusted for estimated creatinine clearance. Reduced intensity conditioning: 30 mg/m\^2 daily on days -6, -5, -4, -3 and -2. Dose will be adjusted for estimated creatinine clearance.
DRUG	Busulfan	Myeloablative conditioning: IV dosing targeted for a daily total area under curve (AUC) 5300 mmol\*min/L for 4 days. Busulfan AUC will be pharmacokinetically targeted. An AUC 3500 mmol\*min/l may be considered in patients over 60 years of age or with multiple comorbidities. Chemotherapy may start on day -6 or day -5 depending on the day of admission (-6 for Wednesday admission, -5 for Sunday admission).
DRUG	Cyclophosphamide	Reduced intensity conditioning: 14.5 mg/kg/day on days -6, -5. GVHD prophylaxis: 50 mg/kg ideal body weight (IBW) daily dose will be given on days +3 and +4 post-transplant as an IV infusion over 1-2 hours.
RADIATION	Total body irradiation (TBI)	Reduced intensity conditioning: 200 centigray (cGy) on day -1.
PROCEDURE	Peripheral Blood Hematopoietic Cell Transplantation (HCT)	On day 0, patients will receive a peripheral blood hematopoietic cell graft.
DRUG	Sirolimus (SIR)	GVHD prophylaxis: SIR will be administered as a 9 mg oral loading dose on day +5, followed by maintenance. SIR levels will be monitored and maintenance dosing adjusted as needed for a target trough level 8 to 14 ng/ml, per Moffitt BMT program standard practice. In the absence of acute GVHD, sirolimus taper will start on day +90 (+/- 10 days) and it is suggested to finish by day +180.
DRUG	Mycophenolate mofetil (MMF)	GVHD prophylaxis: MMF will start on day +5 at a dose of 15 mg/kg every 8 hours IV with the maximum daily dose not to exceed 3 gm. MMF will be changed to orally (PO) and discontinued on day +35 (without taper) in the absence of acute GVHD.
DRUG	Granulocyte-colony stimulating factor (G-CSF)	Growth factor support: G-CSF will be given beginning on day 5 at a dose of 5 mcg/kg/day (rounding to the nearest vial dose), until absolute granulocyte count (ANC) is \> 1,000/mm\^3 for three consecutive days. G-CSF may be given IV or subcutaneously.

Timeline

• Start date: 2017-01-31
• Primary completion: 2018-12-15
• Completion: 2021-03-18
• First posted: 2017-01-11
• Last updated: 2021-09-16
• Results posted: 2020-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study