Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT)

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

April 24, 2019

Study Completion Date

April 24, 2019

Conditions
LeukemiaLymphoma
Interventions
DRUG

Rituximab

250 mg/m2 by vein preceding 111In Ibritumomab and (90Y) ibritumomab tiuxetan administration, respectively on Days -22 and -14.

DRUG

111In Ibritumomab

(5.0 mCi +/- 10% of 111In) by vein immediately following the infusion of rituximab on Day -22.

PROCEDURE

Planar Scintigraphy Imaging

Day -22, -21 to -16: Planar scintigraphy whole-body imaging started on Day -22 post 111In Ibritumomab infusion prior to voiding, and repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Whole-body planar scintigraphy imaging will be repeated between 22-26 hours, then between 70-74 hours, and later between 142-146 hours post 111In Ibritumomab injection.

DRUG

90Y IbritumomabTiuxetan

Calculated to deliver not below 10 Gy to normal organs (liver, lungs, kidneys) by vein post rituximab on Day -14.

DRUG

Fludarabine

30 mg/m2 intravenously on Days -5, -4, and -3.

DRUG

Bendamustine

130 mg/m2 intravenously on D-5, -4 and -3.

DRUG

Thymoglobulin

1 mg/kg (based on actual body weight) on Days -2 and -1 will be administrated to patients receiving a cord blood (CB) and a matched unrelated donor (MUD).

DRUG

Tacrolimus

"Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus is changed to oral dosing when tolerated and can be tapered off after day +90 if no Graft versus Host Disease (GVHD) is present.~For patients receiving cord blood (CB) graft, the Graft versus Host Disease (GvHD) prophylaxis will be with Tacrolimus. Tacrolimus will start on D-2 administrated at starting dose 0.03 mg/kg or 0.015 mg/kg (ideal body weight) by vein starting on D -2 and will be tapered around Day +180 if no GvHD is present."

DRUG

Methotrexate

5 mg/m2 by vein on Day +1, +3 and +6. Patients receiving an unrelated graft will also be given methotrexate on Day +11 after the transplant.

DRUG

Mycophenolate

15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or by mouth administered from Days -3 to +45 and then tapered to end by day 100 if there is no Graft versus Host Disease (GVHD).

DRUG

G-CSF

5 mcg/kg/day subcutaneously beginning Day +7 for patients receiving related and matched unrelated donor (MUD) grafts and on Day 0 for patients receiving a cord blood (CB). G-CSF will continue until the absolute neutrophil count (ANC) is \> 500 \* 10/L for 3 consecutive days.

PROCEDURE

Stem Cell Transplantation

Stem Cell Transplantation on Day 0

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

Spectrum Pharmaceuticals, Inc

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT01490723 - Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT) | Biotech Hunter | Biotech Hunter