Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

December 15, 2018

Study Completion Date

March 18, 2021

Conditions
Non-Hodgkin's LymphomaAcute Leukemia in RemissionChronic Myeloid LeukemiaPrimary MyelofibrosisChronic Myelomonocytic LeukemiaMyelodysplastic SyndromesHodgkin LymphomaMultiple Myeloma
Interventions
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.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

All Listed Sponsors
lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT03018223 - Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT | Biotech Hunter | Biotech Hunter