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A Phase Ib/II, Open-Label, Multicenter Study of the Safety, Pharmacokinetics, and Efficacy of Dulanermin Administered Intravenously in Combination With Rituximab to Subjects With Follicular and Other Low-Grade, CD20+, B-Cell Non-Hodgkin's Lymphomas That Have Progressed Following Previous Rituximab Therapy


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Phase Ib/II, Open-Label, Multicenter Study of the Safety, Pharmacokinetics, and Efficacy of Dulanermin Administered Intravenously in Combination With Rituximab to Subjects With Follicular and Other Low-Grade, CD20+, B-Cell Non-Hodgkin's Lymphomas That Have Progressed Following Previous Rituximab Therapy


Inclusion Criteria:



- Signed Informed Consent Form

- Age ≥ 18 years

- History of histologically confirmed CD20+ follicular NHL Grade 1, 2, or 3a

- Progression of disease following the most recent treatment with rituximab-containing
therapy that resulted in stable disease or a partial or complete response lasting ≥ 6
months

- Measurable disease

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- For subjects of reproductive potential (males and females), use of a reliable means
of contraception (e.g., contraceptive pill, intrauterine device [IUD], physical
barrier throughout the trial and for 1 year following their final exposure to study
treatment).

- Life expectancy of > 3 months

Exclusion Criteria:

- Prior radiotherapy to a measurable, metastatic lesion(s) to be used to measure
response unless that lesion shows unequivocal progression at baseline

- Radiation therapy to a peripheral lesion within 14 days prior to Day 1; Radiation
therapy to a thoracic, abdominal, or pelvic field within 28 days prior to Day 1

- Chemotherapy, hormonal therapy, radiotherapy, or immunotherapy within 4 weeks prior
to Day 1

- Patients who have received radioimmunotherapy for relapsed or refractory, follicular
NHL are eligible for the study if they received this therapy at least 1 year prior to
Day 1, they have adequate bone marrow function, and they have no evidence of
myelodysplastic syndrome on bone marrow aspirate/biopsy

- Prior treatment with dulanermin or an agonist antibody to DR4 or DR5

- Concurrent systemic corticosteroid therapy

- Evidence of clinically detectable ascites on Day 1

- Other invasive malignancies within 5 years prior to Day 1

- History or evidence upon physical examination of central nervous system (CNS) disease
within 1 year prior to study entry

- Active infection requiring parenteral antibiotics on Day 1

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 1 or anticipation of need for major surgical procedure during the course
of the study and fine needle aspirations within 7 days prior to Day 1

- Pregnancy or lactation

- Serious nonhealing wound, ulcer, or bone fracture

- Current or recent participation in another experimental drug study

- Clinically significant cardiovascular disease

- Known positive test result for HIV, hepatitis B surface antigen (sAg), hepatitis B
IgG or IgM core antibody, or hepatitis C antibody

- Known sensitivity to murine or human antibodies

- History of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates use of an investigational drug or that might affect
interpretation of the results of the study or render the subject at high risk from
treatment complications

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase Ib: Number of Participants With a Dose-limiting Toxicity

Outcome Description:

A dose-limiting toxicity (DLT) was defined as a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 Grade ≥ 3 hematologic or major organ toxicity that was related to study drug (i.e., dulanermin). Although a patient may have experienced a DLT at any time during the study, only events that occurred within the DLT assessment window were considered for dose-escalation decisions and determination of the maximum tolerated dose (MTD).

Outcome Time Frame:

The DLT assessment window was defined as the duration required to complete two full cycles of treatment with dulanermin (2 * 21 days) and four doses of rituximab (usually through Day 28).

Safety Issue:

No

Principal Investigator

Chia Portera, PhD., M.D

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

APO3585g

NCT ID:

NCT00400764

Start Date:

June 2006

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • NHL
  • Follicular NHL
  • Rituxan
  • Apo2L/TRAIL
  • APO2L/TRAIL
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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