NCT03480360View on ClinicalTrials.gov

Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

March 28, 2018

Primary Completion Date

March 27, 2023

Study Completion Date

September 13, 2025

Conditions
Acute Myeloid LeukemiaChronic Lymphocytic LeukemiaChronic Myeloid LeukemiaMyelodysplasiaMyeloproliferative DisorderMyelofibrosisLymphomaLymphoma, Non-HodgkinPlasma Cell Disorder
Interventions
DRUG

Cyclophosphamide

14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)

DRUG

Fludarabine

30 mg/m2 daily for 5 days

RADIATION

Total Body Irradiation

200 centigray (cGy) for one day (day -1)

DRUG

Tacrolimus

1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.

DRUG

cellcept

dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.

DRUG

g-csf

5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \> 1000/mcL for 3 days.

PROCEDURE

Peripheral Blood Transplant

cell dose goal: \< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight

Trial Locations (1)

03756

Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center, Lebanon

All Listed Sponsors
lead

Dartmouth-Hitchcock Medical Center

OTHER