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An Open-Label Study to Evaluate Bendamustine Hydrochloride in the Treatment of Chinese Patients With Indolent Non-Hodgkin Lymphoma (NHL) Refractory to Rituximab Treatment


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin Lymphoma

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Trial Information

An Open-Label Study to Evaluate Bendamustine Hydrochloride in the Treatment of Chinese Patients With Indolent Non-Hodgkin Lymphoma (NHL) Refractory to Rituximab Treatment


This is a multicenter, nonrandomized, open-label, single-agent clinical study conducted in
China, and is designed to investigate the use of bendamustine in the treatment of Chinese
patients with relapsed, rituximab-refractory indolent NHL. The study consists of a screening
period of up to 4 weeks, a treatment period of approximately 24 weeks (up to eight 21-day
cycles), and a long-term follow-up period for up to 2 years after the last dose of study
drug. Patients are expected to participate in this study for approximately 2.5 years.


Inclusion Criteria:



Patients are included in the study if all of the following criteria are met:

1. The patient has documented relapse from indolent B-cell NHL. Patients with the
following subtypes of indolent NHL are eligible for this study:

- small lymphocytic lymphoma (peripheral B cell count <5000 cells/mm3)

- lymphoplasmacytic lymphoma

- splenic marginal zone B-cell lymphoma (┬▒villous lymphocytes)

- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
type

- nodal marginal zone lymphoma (┬▒monocytoid B-cells)

- follicle center lymphoma

- follicular (grade 1, 2, or 3a) lymphoma

2. The patient has disease documented to have progressed despite rituximab treatment.
The patient's disease is considered to be rituximab refractory if any of the
following criteria are met at any time during the patient's treatment history
(progression must be documented by computed tomography [CT] scan or magnetic
resonance imaging [MRI] or biopsy) or if a patient has palpable lymph nodes that were
well documented in size and, after rituximab treatment, palpable disease remains or
comes back [CT, MRI, or biopsy is preferred and performed whenever possible to
document progressive disease(PD)]:

- rituximab-only regimen: Patients who receive a full course of single-agent
rituximab (at least 2 doses of 375 mg/m2 [or a therapeutically-active dose]
weekly) and have no response (do not obtain a PR or better) to treatment or
progress after a full regimen of rituximab was given.

- rituximab maintenance therapy or extended schedule: Patients who have a history
of a full course of rituximab (at least 2 doses of 375 mg/m2 [or a
therapeutically-active dose] as a single agent [weekly] or in combination with
chemotherapy [day 1 of each of 4 cycles]) and are on a maintenance regimen, and
progress before the next scheduled rituximab dose or after completing a
maintenance rituximab regimen.

- rituximab-chemotherapy combination regimen: Patients who receive a full course
of rituximab (at least 2 doses of 375 mg/m2 or a therapeutically-active dose [on
day 1 of each of 2 cycles]) in combination with chemotherapy and have no
response (do not obtain a PR or better) to treatment or progress after the last
dose of rituximab in a regimen.

- full rituximab exposure treatment: Patients who have a history of a full course
of rituximab treatment (at least 2 doses of 375 mg/m2 [or a
therapeutically-active dose] as a single agent or in combination with
chemotherapy) and, in a subsequent rituximab/chemotherapy combination regimen,
have no response (do not obtain a PR or better) to treatment or progress after
the last dose of rituximab in a given regimen, even if the subsequent regimen
included less than 2 doses of rituximab. Patients could receive additional
systemic treatment after the qualifying rituximab regimen.

3. The patient has received treatment with at least 1, but no more than 3, previous
chemotherapy regimens. A regimen is defined as a new treatment combination or agent.
Retreatment with the identical regimen or agent does not count as a new regimen;
however, change from cyclophosphamide, vincristine, and prednisolone (CVP) to
cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) is counted as a
new regimen. Rituximab, radioimmunotherapy, or other biologic treatments not
combined with chemotherapy are not counted as a regimen.

4. The patient has a bidimensionally measurable disease with at least 1 lesion measuring
2.0 cm or more in a single dimension. Patients who have previous involved-field
irradiation can be included, provided the irradiated area is not the only source of
measurable disease.

5. The patient is at least 18 years old at the time of informed consent.

6. The patient has a WHO performance status of 0, 1, or 2.

7. The patient has absolute neutrophil count (ANC) 1000 cells/mm3 or more and platelet
count 85000 cells/mm3 or more.

8. The patient has a creatinine clearance of more than 30 mL/min as determined by the
Cockcroft-Gault calculation.

9. The patient has adequate hepatic function (no more than 2.5 times the ULN for
aspartate aminotransferase (AST) and alanine aminotransferase (ALT), and no more than
1.5 times the upper limit of the normal range (ULN) for total bilirubin). Patients
with nonclinically significant elevations of bilirubin due to Gilbert's disease are
eligible.

10. The patient has had a bone marrow biopsy within 6 weeks before the 1st dose of
bendamustine.

11. Women of childbearing potential (not surgically sterile or 1 year postmenopausal)
must use a medically accepted method of contraception and must agree to continue use
of this method starting 2 weeks before the start of study drug treatment, during
study drug treatment, and for 4 weeks after the end of study drug treatment.
Acceptable methods of contraception include abstinence, barrier method with
spermicide, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal,
implanted, and injected) in conjunction with a barrier method.

12. Women of childbearing potential must have a negative serum or urine pregnancy test.

13. Men not surgically sterile or who are capable of producing offspring must practice
abstinence or use a barrier method of birth control, and must agree to continue use
of this method starting 2 weeks before the start of study drug treatment, during
study drug treatment, and for 4 weeks after the end of study drug treatment.

14. The patient has an estimated life expectancy of at least 3 months.

15. The patient (or patient's legal representative) provides written informed consent.

Exclusion Criteria:

Patients are excluded from participating in this study if 1 or more of the following
criteria are met:

1. The patient has received previous radiotherapy, radioimmunotherapy, chemotherapy, or
immunotherapy within 4 weeks before day 1 of cycle 1 or has failed to recover (to
Common Terminology Criteria for Adverse Events [CTCAE] toxicity grade 1 or 2) from
clinically significant nonhematologic adverse events due to any agents administered
previously.

2. The patient has received treatment with an investigational agent within 4 weeks of
day 1 of cycle 1.

3. The patient has received hematopoietic growth factors within 4 weeks of day 1 of
cycle 1. However, patients receiving chronic erythropoietin treatment are eligible
for inclusion in this study.

4. The patient has a history of previous high-dose chemotherapy with allogeneic stem
cell support (history of autologous stem cell support is permissible).

5. The patient is receiving or has received treatment with therapeutic doses of systemic
steroids within 4 weeks of day 1 of cycle 1. (Low doses of chronic steroids
[prednisone or equivalent] up to 20 mg/day for non-neoplastic disorders or for
indications other than lymphoma or lymphoma-related complications are permitted.)

6. The patient has transformed disease.

7. The patient has any history of central nervous system (CNS) or leptomeningeal
lymphoma.

8. The patient has, or has had within the past 5 years, an active malignancy other than
the target cancer. The exceptions are prostate cancer (Gleason grade <6 with
prostate specific antigen (PSA) levels within the normal range), in situ cervical or
breast carcinoma, and nonmelanoma skin cancer that have received definitive
treatment.

9. The patient is a pregnant or lactating woman. (Any women becoming pregnant during
the study will be withdrawn from the study immediately.)

10. The patient has a serious infection, medical condition, or psychiatric condition
that, in the opinion of the investigator, might interfere with the achievement of the
study objectives.

11. The patient is known to be positive for human immunodeficiency virus (HIV), have
active hepatitis B, or active hepatitis C (anti-hepatitis C virus [HCV] positive).
Hepatitis B surface antigen must be tested. The determination of active disease is
left up to the Investigator.

12. The patient has a known hypersensitivity to mannitol.

13. The patient has used bendamustine previously.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (ORR)

Outcome Description:

The ORR is defined as the proportion of patients who achieve a best response of complete response (CR) or partial response (PR) during the study based on the modified International Workshop Response Criteria.

Outcome Time Frame:

up to 2.5 Years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

C18083/3076

NCT ID:

NCT01596621

Start Date:

June 2012

Completion Date:

October 2016

Related Keywords:

  • Non-Hodgkin Lymphoma
  • Bendamustine hydrochloride
  • CEP-18083
  • Treanda┬«
  • Non-Hodgkin Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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