Chronic Lymphocytic Leukemia (CLL) Clinical Trial
Official title:
PHASE II CLINICAL PROTOCOL FOR THE TREATMENT OF PATIENTS WITH RELAPSED/REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH A COMBINATION OF BENDAMUSTINE AND OFATUMUMAB
Investigational Drugs:
Ofatumumab (Azerra) + bendamustine (Trenda)
Route of Administration:
Intravenous (IV)
Hypothesis:
This study is designed to assess the toxicity and overall response rate. Ofatumumab is a
fully human monoclonal antibody (A type of protein made in the laboratory that can bind to
substances in the body, including tumor cells) that shows promising activity in the
treatment of CLL as a single agent. It is thought that by combining it with Bendamustine, an
FDA approved treatment for CLL, the effect on CLL will be greater than if Ofatumumab is
given alone. Ofatumumab is FDA approved for the treatment of relapsed/refractory CLL.
Participation:
Approximately 37 relapsed/refractory CLL subjects will participate in this study over two
years.
Treatment Plan:
A maximum of 6 cycles of treatment will be allowed. During day 1 of cycle 1 ofatumumab IV
300mg will be administered. On day 1 of all cycles ofatumumab treatment will be followed by
bendamustine IV 90mg/m2. On day 2 of all cycles, bendamustine IV 90mg/m2 will be
administered. On day 3 of all cycles, neulasta SQ 6mg will be given. On day 8 of cycle 1
only patients will receive ofatumumab IV 1000mg. During cycles 2 through 6 ofatumumab 1000mg
will be given on day 1 only.
Follow-up:
Patients will be followed monthly for six months, then every three months for five years
then annually thereafter.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03588598 -
Safety, Tolerability, and Pharmacokinetics of SHC014748M in Patients With Indolent B-Cell Hematologic Malignancies
|
Phase 1 | |
| Recruiting |
NCT06043011 -
Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms
|
||
| Completed |
NCT02265731 -
Study Evaluating Venetoclax in Subjects With Hematological Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT02582879 -
informCLL™: A Disease Registry for Patients With Chronic Lymphocytic Leukemia
|
||
| Completed |
NCT02553304 -
Molecular Features Underlying Racial Differences in Survival of Taiwanese Chronic Lymphocytic Leukemia Patients
|
||
| Completed |
NCT01419691 -
Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)
|
Phase 2 | |
| Completed |
NCT01188681 -
Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04758975 -
Venetoclax, Rituximab and Ibrutinib in TN Patients With CLL Undetectable Minimal Residual Disease (uMRD) in Treatment-naïve Patients With Chronic Lymphocytic Leukemia (CLL)
|
Phase 2 | |
| Terminated |
NCT02914938 -
A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma
|
Phase 1 | |
| Active, not recruiting |
NCT01976520 -
Vaccine Therapy for Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
|
Phase 1 | |
| Terminated |
NCT01463852 -
A Study of the Effect of Vinca Alkaloids on c-Jun N-terminal Kinase (JNK) Phosphorylation in Patients With Chronic Lymphocytic Leukemia (CLL)
|
Phase 0 | |
| Terminated |
NCT01203930 -
A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL
|
Phase 2 | |
| Recruiting |
NCT02966756 -
A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
|
Phase 2 | |
| Active, not recruiting |
NCT05105841 -
Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax in Combination With Intravenous (IV) Obinutuzumab or Oral Ibrutinib in Adult Participants With Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
|
Phase 2 | |
| Recruiting |
NCT04072458 -
A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies
|
Phase 1 | |
| Withdrawn |
NCT01754870 -
Phase II Study of Bendamustine and Rituximab Induction Chemoimmunotherapy Followed by Maintenance Rituximab (Rituxan®) and Lenalidomide (Revlimid®) in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)
|
Phase 2 | |
| Recruiting |
NCT01758042 -
Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders
|
N/A | |
| Completed |
NCT01885897 -
IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04830137 -
A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies
|
Phase 1 | |
| Recruiting |
NCT03547115 -
A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML
|
Phase 1 |