A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
A Parallel Randomised Phase II Trial of CHOP Chemotherapy With or Without Bortezomib in Relapsed Mantle Cell Lymphoma
OBJECTIVES:
Primary
- To evaluate the rates of overall response (complete response [CR], CR unconfirmed
[CRu], and partial response).
Secondary
- To evaluate the rates of CR and CRu.
- To determine the median time to progression.
- To determine the median overall survival.
- To evaluate the toxicity and tolerability.
- To compare the responses to these treatment regimens with those from first line
therapy.
- To compare the quality of life.
OUTLINE: This is a randomized, open-label, parallel group, multicenter study. Patients are
randomized to 1 of 2 treatment arms.
- Arm I (CHOP): Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV, and
vincristine IV on day 1 and oral prednisolone on days 1-5.
- Arm II (CHOP with bortezomib): Patients receive bortezomib IV over 3-5 seconds on days
1 and 8; doxorubicin hydrochloride IV, cyclophosphamide IV, and vincristine IV on day
1; and oral prednisolone on days 1-5.
In both arms, treatment repeats every 21 days for up to 8 courses in the absence of disease
progression or unacceptable toxicity.
Patients complete quality of life questionnaires at baseline, prior to each treatment
course, and then at 30 days after completion of treatment.
After completion of study treatment, patients are followed at 30 days and then every 12
weeks thereafter.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of mantle cell lymphoma (MCL)
- Expression of cyclin D1 or evidence of t(11;14) translocation by cytogenetics,
FISH, or polymerase chain reaction
- Refractory to or relapsed or progressed after first line antineoplastic therapy
- Measurable disease
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Karnofsky performance status (PS) 50-100% OR ECOG PS 0-2
- ANC ≥ 1,000/mm³ (not related to lymphoma)
- Platelet count ≥ 30,000/mm³
- AST and ALT ≤ 3 times upper limit of normal (ULN)
- Total bilirubin ≤ 2 times ULN
- Creatinine clearance ≥ 20 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Exclusion criteria:
- Known serological positivity for HBV, HCV, or HIV
- History of allergic reaction attributable to compounds containing boron or mannitol
- Diagnosed or treated for a malignancy other than MCL within the past 5 years except
for completely resected basal cell or squamous cell carcinoma of the skin or any in
situ malignancy
- Active systemic infection requiring treatment
- Serious medical or psychiatric illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- Toxic effects of prior therapy or surgery must be resolved to ≤ grade 2
- Prior splenectomy or localized radiotherapy allowed
- Any prior chemotherapy regimen allowed
- Chemotherapy may have been given in combination with rituximab
- Concurrent enrollment in a nontreatment study allowed, provided it does not interfere
with participation in this study
Exclusion criteria:
- Prior bortezomib
- Antineoplastic therapy within the past 3 weeks
- Nitrosoureas within the past 6 weeks
- Rituximab, alemtuzumab (Campath®), or other unconjugated therapeutic antibody within
the past 4 weeks
- Radiotherapy within the past 3 weeks
- Major surgery within the past 2 weeks
- Concurrent investigational agents
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease progression
Safety Issue:
No
Principal Investigator
Simon Rule, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Derriford Hospital
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
CDR0000559820
NCT ID:
NCT00513955
Start Date:
June 2006
Completion Date:
June 2014
Related Keywords:
- Lymphoma
- recurrent mantle cell lymphoma
- Lymphoma
- Lymphoma, Mantle-Cell
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