Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01490723 | Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT) | PHASE2 | COMPLETED | 20 | — | — | Jan 1, 2013 | Apr 24, 2019 | May 5, 2020 | 1 | United States |
Number of participants without treatment related mortality at day 100.
| Arm | Type | Description |
|---|---|---|
| Yttrium-90 Ibritumomab + Chemo | EXPERIMENTAL | Day -22 and -14, Rituximab 250 mg/m2 preceding 111In Ibritumomab and (90Y) ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14, (90Y) ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment. |
| Name | Type | Description |
|---|---|---|
| Rituximab | DRUG | 250 mg/m2 by vein preceding 111In Ibritumomab and (90Y) ibritumomab tiuxetan administration, respectively on Days -22 and -14. |
| 111In Ibritumomab | DRUG | (5.0 mCi +/- 10% of 111In) by vein immediately following the infusion of rituximab on Day -22. |
| Planar Scintigraphy Imaging | PROCEDURE | 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. |
| 90Y IbritumomabTiuxetan | DRUG | Calculated to deliver not below 10 Gy to normal organs (liver, lungs, kidneys) by vein post rituximab on Day -14. |
| Fludarabine | DRUG | 30 mg/m2 intravenously on Days -5, -4, and -3. |
| Bendamustine | DRUG | 130 mg/m2 intravenously on D-5, -4 and -3. |
| Thymoglobulin | DRUG | 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). |
| Tacrolimus | DRUG | 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. |
| Methotrexate | DRUG | 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. |
| Mycophenolate | DRUG | 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). |
| G-CSF | DRUG | 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. |
| Stem Cell Transplantation | PROCEDURE | Stem Cell Transplantation on Day 0 |
Inclusion Criteria: 1. 18 to 70 years of age. 2. Patients with the following CD20+ lymphoid malignancies who are eligible for allogeneic transplantation: a. Relapsed or refractory follicular lymphoma; b. Relapsed or refractory or high risk mantle cell lymphoma (hi ki67; blastic); c. Recurrent or re...