A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Primary Purpose
Non-Hodgkin's Lymphoma
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
PRO131921
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring NHL, Indolent, Follicular
Eligibility Criteria
- Signed informed consent
- Ability and willingness to comply with the requirements of the study protocol
- Age ≥ 18 years
- Documented history of histologically confirmed CD20-positive follicular NHL (Phases I and II); for Phase I, other CD20-positive indolent lymphomas (marginal zone lymphoma and small lymphocytic lymphoma) are also included. Patients with a history of a CD20-positive NHL of mixed (indolent/aggressive) histology may also be included in Phase I if the most recent relapse biopsy shows only indolent NHL
- Indolent lymphoma (Phase I) or follicular lymphoma (Phase II) that either has relapsed after a documented history of response (CR, CRu, or PR) of ≥6 months to a rituximab-containing regimen or was refractory to a previous rituximab-containing regimen
- Bi-dimensionally measurable disease, with at least one lesion >1.5 cm in its largest dimension
- Absolute B-cell count ≥LLN at screening (Phase I only)
- ECOG performance status of 0, 1, or 2
- For patients of reproductive potential (males and females), use of a reliable means of contraception during the study and for 1 year following the last dose of study treatment
- For females of childbearing potential, a negative serum pregnancy test within 14 days prior to enrollment
Exclusion Criteria:
- Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab or radioimmunotherapy)
- Prior use of any non-CD20-targeted monoclonal antibody therapy within 6 months of enrollment
- Current or recent lymphoma treatment
- History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
- Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
- Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination
- Untreated or persistent/recurrent malignancy (other than lymphoma)
- Known active bacterial, viral, fungal, mycobacterial, or other infection
- A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening
- History of recurrent significant infection or bacterial infections
- Positive hepatitis B or C serology
- Positive human immunodeficiency virus (HIV) serology
- Pregnancy or lactation
- Central nervous system lymphoma
- Recent major surgery within 4 weeks of screening, other than diagnostic surgery
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Dose-limiting toxicities and adverse events
Secondary Outcome Measures
Pharmacokinetic parameters; CD19-positive B-cell counts
Overall response; and progression-free survival (Ph. 2 only)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00452127
Brief Title
A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Official Title
An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Have Been Treated With a Prior Rituximab-Containing Regimen
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
Brief Summary
This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with relapsed or refractory CD20-positive indolent NHL. The trial will enroll in two phases: a Phase I dose-escalation portion for patients with indolent NHL and a Phase II portion with enrollment of additional patients with follicular NHL into two expanded treatment cohorts in order to expand the safety database and collect preliminary anti-lymphoma activity data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
NHL, Indolent, Follicular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PRO131921
Intervention Description
Escalating doses by IV infusion
Primary Outcome Measure Information:
Title
Dose-limiting toxicities and adverse events
Time Frame
Length of study
Secondary Outcome Measure Information:
Title
Pharmacokinetic parameters; CD19-positive B-cell counts
Time Frame
Length of study
Title
Overall response; and progression-free survival (Ph. 2 only)
Time Frame
Length of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Signed informed consent
Ability and willingness to comply with the requirements of the study protocol
Age ≥ 18 years
Documented history of histologically confirmed CD20-positive follicular NHL (Phases I and II); for Phase I, other CD20-positive indolent lymphomas (marginal zone lymphoma and small lymphocytic lymphoma) are also included. Patients with a history of a CD20-positive NHL of mixed (indolent/aggressive) histology may also be included in Phase I if the most recent relapse biopsy shows only indolent NHL
Indolent lymphoma (Phase I) or follicular lymphoma (Phase II) that either has relapsed after a documented history of response (CR, CRu, or PR) of ≥6 months to a rituximab-containing regimen or was refractory to a previous rituximab-containing regimen
Bi-dimensionally measurable disease, with at least one lesion >1.5 cm in its largest dimension
Absolute B-cell count ≥LLN at screening (Phase I only)
ECOG performance status of 0, 1, or 2
For patients of reproductive potential (males and females), use of a reliable means of contraception during the study and for 1 year following the last dose of study treatment
For females of childbearing potential, a negative serum pregnancy test within 14 days prior to enrollment
Exclusion Criteria:
Prior use of anti-CD20 monoclonal antibody therapy (other than rituximab or radioimmunotherapy)
Prior use of any non-CD20-targeted monoclonal antibody therapy within 6 months of enrollment
Current or recent lymphoma treatment
History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
Evidence of myelodysplasia or myelodysplastic changes on bone marrow examination
Untreated or persistent/recurrent malignancy (other than lymphoma)
Known active bacterial, viral, fungal, mycobacterial, or other infection
A major episode of infection requiring hospitalization or treatment with IV antimicrobials within 4 weeks of screening or oral antimicrobials within 2 weeks of screening
History of recurrent significant infection or bacterial infections
Positive hepatitis B or C serology
Positive human immunodeficiency virus (HIV) serology
Pregnancy or lactation
Central nervous system lymphoma
Recent major surgery within 4 weeks of screening, other than diagnostic surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bill Ho, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
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