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A Phase 1b/2 Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
B-cell Small Lymphocytic Lymphoma Recurrent

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Trial Information

A Phase 1b/2 Study of TRU-016 in Combination With Rituximab and Bendamustine in Subjects With Relapsed Indolent Lymphoma

Inclusion Criteria


Inclusion Criteria

1. Age 18 years or older

2. Histologically confirmed diagnosis of indolent non-Hodgkin's B-cell lymphoma (ie,
follicular lymphoma, small lymphocytic lymphoma, and marginal zone lymphoma) that has
relapsed (relapsed is defined as confirmed progressive disease [PD] after receiving
the most recent prior therapy, or failure to achieve at least a PR while receiving
the most recent prior therapy)

3. At least one prior line of therapy for indolent lymphoma

4. Bi-dimensionally measurable disease with at least one lesion measuring >=1.5 cm in a
single dimension

5. Eastern Cooperative Oncology Group (ECOG) performance status of <= 2

6. Creatinine clearance of >40 mL/min as calculated by the

Cockcroft-Gault method as follows:

(140 - age) * (weight in kg [* 0.85 if female] / 72 * serum creatinine level) 7. Adequate
hepatic function, indicated as follows:

- aspartate aminotransferase (AST) of <2.5 x upper limit of normal (ULN)

- alanine aminotransferase (ALT) of <2.5 x ULN

- total bilirubin of <= 1.5 x ULN 8. Absolute neutrophil count (ANC) >=1000/mm3
(1000/┬ÁL) 9. Platelet count >= 100,000/mm3 10. Female subjects of child-bearing
potential and male subjects must use an acceptable form of birth control for the
duration of their study participation and for 6 months after completing study drug
dosing; acceptable forms of birth control, unless dictated otherwise by local
regulatory authorities 11. For women of childbearing potential, a negative serum
pregnancy test result obtained during the screening period and a negative urine
pregnancy test result within 24 hours before first administration of study drug 12.
Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use protected health information

Exclusion Criteria

1. Diagnosis of grade 3b follicular lymphoma or transformed lymphoma of any grade

2. Previously received TRU-016

3. Prior treatment with rituximab if subject discontinued rituximab due to unresolved
toxicity

4. Refractory to bendamustine, defined as follows:

- progression within 6 months of last dose of bendamustine

- failed to achieve at least a PR while receiving bendamustine

- discontinued bendamustine due to toxicity

- received bendamustine within 6 months prior to first dose of study drug

5. Received chemotherapy, radiotherapy, or immunotherapy including investigational
agents within 28 days prior to the first dose of study drug

6. Received therapeutic corticosteroids at doses equivalent to >10 mg prednisone per day
for longer than 5 days within 14 days prior to the first dose of study drug, except
if needed as a pre-medication

7. Received filgrastim or equivalent within 14 days prior to screening (ie, collection
of samples for laboratory tests) or pegfilgrastim within 28 days prior to screening
(ie, collection of samples for laboratory tests)

8. Prior allogeneic bone marrow transplant

9. Prior autologous bone marrow transplant within 12 months prior to the first dose of
study drug

10. Received blood or platelet infusion within 7 days prior to screening (ie, collection
of samples for laboratory tests)

11. Previous or concurrent additional malignancy except non-invasive, non-melanomatous
skin cancer or in situ carcinoma of the cervix, or other solid tumors if the subject
has been disease-free for a minimum of 2 years prior to the first dose of study drug

12. Known central nervous system or leptomeningeal lymphoma

13. Any significant concurrent medical diseases or conditions, including but not limited
to the following:

- Clinically significant pulmonary dysfunction requiring oxygen therapy

- An active infection (viral, bacterial, or fungal) requiring systemic therapy;
subjects receiving prophylactic therapy are eligible

14. Known allergy to mannitol

15. History of positive serology for human immunodeficiency virus (HIV)

16. Positive serology for hepatitis B (surface antigen or core antibody) Note: If a
positive test result for hepatitis B core antibody is due to immunoglobulin
treatment, the subject may be enrolled if the hepatitis B viral deoxyribonucleic acid
(DNA) is negative.

17. Positive serology for hepatitis C

18. Pregnant or breastfeeding

19. Other severe, acute, or chronic medical or psychiatric condition, laboratory
abnormality, or difficulty complying with protocol requirements that may increase the
risk associated with study participation or study drug administration or may
interfere with safety

20. Any condition that, in the investigator's opinion, makes the subject unsuitable for
study participation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase 1b:incidence of dose limiting toxicities during cycle 1 of each dose cohort to determine Maximum Tolerated Dose of TRU-016

Outcome Description:

A dose limiting toxicity is Grade 4 hemaological toxicity that has not resolved to /=Grade 3 non-hematolgoical adverse event (with some exceptions), Grade 3 nausea for > 5 days, Grade 4 febrile neutropenia, infusion reaction, Grade 5 toxicities

Outcome Time Frame:

Cycle 1 (28 days)

Safety Issue:

Yes

Principal Investigator

Scott Stromatt, MD

Investigator Role:

Study Director

Investigator Affiliation:

Emergent Product Development Seattle LLC

Authority:

United States: Food and Drug Administration

Study ID:

16011

NCT ID:

NCT01317901

Start Date:

May 2011

Completion Date:

April 2016

Related Keywords:

  • B-cell Small Lymphocytic Lymphoma Recurrent
  • follicular lymphoma
  • small lymphocytic lymphoma
  • marginal zone lymphoma
  • non-Hodgkin's lymphoma
  • indolent lymphoma
  • NHL
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma

Name

Location

Site Reference ID/Investigator# 61543 Birmingham, Alabama  35294
Site Reference ID/Investigator# 61542 Augusta, Georgia  30912
Site Reference ID/Investigator# 61523 Omaha, Nebraska  68114
Site Reference ID/Investigator# 61522 Hackensack, New Jersey  07601
Site Reference ID/Investigator# 61544 Chapel Hill, North Carolina  27599-7305
Site Reference ID/Investigator# 61524 Seattle, Washington  98109-1023