Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis

PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

November 4, 2015

Primary Completion Date

March 18, 2022

Study Completion Date

March 18, 2022

Conditions
Hodgkin's LymphomaLymphoid LeukemiaLymphomaLeukemiaMyelomaAcute Lymphocytic LeukemiaNon Hodgkin LymphomaChronic Lymphocytic LeukemiaMultiple MyelomaChronic Myelogenous LeukemiaMyelodysplastic SyndromesRecurrent Acute Myeloid Leukemia, AdultRecurrent Hodgkin LymphomaRecurrent Non-Hodgkin LymphomaRecurrent Plasma Cell MyelomaRecurrent Chronic Lymphocytic LeukemiaRecurrent Chronic Myelogenous LeukemiaAcute Myelogenous Leukemia
Interventions
DRUG

mycophenolate mofetil

Given PO, by mouth, orally or IV, intravenous medication administration.

BIOLOGICAL

Sargramostim

"GM-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-15 cohort will receive sargramostim (GM-CSF) 250 mcg/m2/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.~Patients receiving GM-CSF will also receive inhaled corticosteroids, fluticasone (Flovent) 2 puffs twice daily, starting on post-transplant day 4 and stopping after cessation of GM-CSF, to diminish the risk of pneumonitis.~Note: At investigator discretion, patients in the MMF-15 cohort who have preexisting pulmonary risk factors, will be permitted to receive G-CSF."

BIOLOGICAL

Filgrastim

G-CSF beginning post-transplant day 4 and continuing until hematopoietic reconstitution. Patients in the MMF-30 cohort will receive filgrastim (G-CSF) 5 mcg/kg/day beginning on post-transplant day 4 and continuing until neutrophil engraftment.

Trial Locations (1)

23298

Virginia Commonwealth University/Massey Cancer Center, Richmond

All Listed Sponsors
collaborator

Massey Cancer Center

OTHER

lead

Virginia Commonwealth University

OTHER

NCT02593123 - Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis | Biotech Hunter | Biotech Hunter