Non-Hodgkin's Lymphoma Clinical Trial
Official title:
A Multi-Center, Randomized, Phase III Study of Rituximab Versus Iodine I 131 Tositumomab Therapy for Patients With Relapsed Follicular Non-Hodgkin's Lymphoma
A total of 506 patients, 253 per arm, will be enrolled at 30 to 40 sites in the United
States and Europe.
Patients will be randomly assigned to one of two treatment arms. In Arm A, patients will
receive 375 mg/m2 of rituximab (US, Canada – Rituxan®; EU - Mabthera®), given as an IV
infusion once weekly for 4 weeks. In Arm B, patients will receive Iodine I 131 Tositumomab
therapy. For Arm B, patients undergo a two-phase treatment. In the first phase, termed the
“dosimetric dose,” patients will receive an infusion of unlabeled Tositumomab (450 mg)
immediately followed by an infusion of Tositumomab (35 mg) that has been labeled with 5 mCi
(0.18 GBq) of iodine 131. Whole body gamma camera scans will be obtained three times (Day 0,
Day 2, 3, or 4, and Day 6 or 7) following the dosimetric dose. Using the dosimetric data
from these three imaging timepoints, the patient’s weight, and platelet count, a
patient-specific administered activity of iodine I 131 Tositumomab (expressed in mCi or GBq)
will be calculated to deliver the desired total body dose of radiation (65 or 75 cGy). In
the second phase, termed the “therapeutic dose,” patients in Arm B will receive an infusion
of unlabeled Tositumomab (450 mg) immediately followed by an infusion of the
patient-specific administered activity of Iodine 131–conjugated Tositumomab (35 mg).
Patients on study will be followed for response and safety at Week 7, Week 13, and every 3
months for the first and second years, every 6 months for the third year, and then annually
for the fourth and fifth years. Patients will be followed for safety only annually for years
6-10.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Completed |
NCT01878890 -
Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.
|
Phase 1 | |
| Completed |
NCT04152148 -
A Phase I Clinical Trial of BAT4306F on Safety, Tolerability and Pharmacokinetics for Patients
|
Phase 1 | |
| Recruiting |
NCT05096234 -
18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma
|
Phase 2 | |
| Recruiting |
NCT05191225 -
Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study
|
Phase 4 | |
| Recruiting |
NCT05623982 -
Phase Ib/II Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03664635 -
MB-CART20.1 Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02356159 -
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
|
Phase 1/Phase 2 | |
| Terminated |
NCT01699581 -
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
|
Phase 2 | |
| Completed |
NCT01763398 -
Analysis of the Risk Factors for the Neutropenic Fever in the High Risk NHL Patients for Developing Febrile Neutropenia Who Received 3-weekly CHOP-like Chemotherapy With Primary G-CSF Prophylaxis; Prospective Multicenter Observation Study
|
N/A | |
| Completed |
NCT01205503 -
Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release
|
Phase 2 | |
| Completed |
NCT00975975 -
Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
|
Phase 2 | |
| Completed |
NCT00969462 -
Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma
|
Phase 4 | |
| Completed |
NCT00659425 -
CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Withdrawn |
NCT00577161 -
Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
|
Phase 3 | |
| Completed |
NCT00608907 -
An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib)
|
Phase 1 | |
| Terminated |
NCT00475332 -
Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar
|
Phase 2 | |
| Completed |
NCT00533728 -
Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00581646 -
Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance
|
N/A | |
| Completed |
NCT00430352 -
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
|
Phase 4 |