A Study of Escalating Doses of DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma
Status: | Completed |
---|---|
Conditions: | Blood Cancer, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | March 2011 |
End Date: | November 2014 |
An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics Of Escalating Doses of DCDS4501A in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and DCDS4501A in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma
This is a Phase I, multicenter, open-label, dose-escalation study of DCDS4501A administered
as a single agent by IV infusion to patients with relapsed or refractory hematologic
malignancies. In Phase Ib, patients will receive DCDS4501A in combination with rituximab.
as a single agent by IV infusion to patients with relapsed or refractory hematologic
malignancies. In Phase Ib, patients will receive DCDS4501A in combination with rituximab.
Inclusion Criteria:
- Life expectancy of at least 12 weeks
- History of one of the following histologically-documented hematologic malignancy for
which no effective standard therapy exists: indolent non Hodgkin's lymphoma (NHL),
Grade 3b FL, diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), or
chronic lymphocytic leukemia (CLL)
- All patients (NHL and B-CLL) must have at least one bi-dimensionally measurable
lesion
- For all men or women of childbearing potential (unless surgically sterile): use of
adequate methods of contraception such as oral contraceptives, intrauterine device,
or barrier method of contraception in conjunction with spermicidal jelly
Exclusion Criteria:
- Prior use of any monoclonal antibody or antibody-drug conjugate within 4 weeks before
Cycle 1, Day 1
- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other
investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1. Adverse
events from any previous treatments must be resolved or stabilized prior to Cycle 1,
Day 1, except for neuropathy
- Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1
- Prior allogeneic stem cell transplant
We found this trial at
7
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials