Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03018223|
Recruitment Status : Active, not recruiting
First Posted : January 11, 2017
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma Acute Leukemia in Remission Chronic Myeloid Leukemia Primary Myelofibrosis Chronic Myelomonocytic Leukemia Myelodysplastic Syndromes Hodgkin Lymphoma Multiple Myeloma||Drug: Fludarabine Drug: Busulfan Drug: Cyclophosphamide Radiation: Total body irradiation (TBI) Procedure: Peripheral Blood Hematopoietic Cell Transplantation (HCT) Drug: Sirolimus (SIR) Drug: Mycophenolate mofetil (MMF) Drug: Granulocyte-colony stimulating factor (G-CSF)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haploidentical Peripheral Blood Stem Cell Transplantation|
|Actual Study Start Date :||January 10, 2017|
|Actual Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||January 2021|
Experimental: Conditioning/HCT/GVHD Prophylaxis
Pre-HCT Conditioning, HCT, GVHD Prophylaxis.
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.
Other Name: Fludara, Oforta
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).
Other Name: Busulfex, Myleran
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.
Other Name: Cytoxan
Radiation: Total body irradiation (TBI)
Reduced intensity conditioning: 200 centigray (cGy) on day -1.
Other Name: radiotherapy
Procedure: Peripheral Blood Hematopoietic Cell Transplantation (HCT)
On day 0, patients will receive a peripheral blood hematopoietic cell graft.
Other Name: 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.
Other Name: Rapamune
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.
Other Name: CellCept
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.
Other Name: Neupogen, Filgrastim
- Incidence of Grade II-IV Acute Graft vs. Host Disease (GVHD) [ Time Frame: 100 days post hematopoietic cell transplant (HCT) ]Cumulative incidence of grade II-IV acute GVHD by day 100 after HCT. Acute GVHD organ staging and assessment of overall grade will use standard consensus criteria. The cumulative incidence of acute and chronic GVHD will be estimated, considering malignancy relapse and non-relapse death as competing risk events.
- Incidence of Chronic GVHD [ Time Frame: 1 year post HCT ]Cumulative incidence and severity of chronic GVHD by 1 year. Chronic GVHD diagnosis and severity scoring will follow National Institutes of Health (NIH) Consensus guidelines.
- Overall Survival (OS) [ Time Frame: Up to 1 year post HCT ]Overall survival defined as time from transplant to death or last follow-up.
- Progression Free Survival (PFS) [ Time Frame: Up to 1 year post HCT ]Progression-free survival defined as the minimum time interval from transplant to relapse/recurrence, to death or to last follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018223
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Nelli Bejanyan, M.D.||H. Lee Moffitt Cancer Center and Research Institute|