Phase II of Efficacy and Toxicity of Maintenance Sub. Rituximab After Induction in Relapsed MCL and Non-eligible HSCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-02-29

Brief Summary

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1. Primary endpoint: Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy
2. Secondary endpoints:

1. Quality of response obtained after subcutaneous Rituximab maintenance.
2. Progression-Free Survival (PFS)
3. Overall Survival (OS)
4. Time to Next Therapy (TTNT)
5. Value of MRD in the disease outcome
6. Toxicity

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Detailed Description

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This is a phase II trial evaluating the role of maintenance with subcutaneous Rituximab in patients with stage II-IV relapsed or refractory mantle-cell lymphoma with complete or partial response after the administration of a salvage regimen with R-GemOx-D.

Before the study start and in order to standardize the results, the same R-GemOx-D salvage regimen will be used: Rituximab: 375 mg/m2 on day 1, Gemcitabine: 1000 mg/m2 on day 2 (over 30 minutes) and Oxaliplatin: 100 mg/m2 on day 2 (over 3 hours), Dexamethasone 20 mg on day 1-3. Cycles should be repeated every 14 days, up to 8 cycles.

Patients who present a complete or partial response, after the salvage therapy, will start the study receiving subcutaneous Rituximab maintenance at dose of: 1400 mg every 2 months for 2 years; the study treatment will start 6-8 weeks after finishing the salvage therapy.

Patients will be evaluated every 2 months during treatment study phase and every 4 months in the follow up phase. More details in Appendix 1 (Schedule of Assessments)

Conditions

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Mantle-cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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subcutaneous rituximab

MabThera 1400 mg solution for subcutaneous injection

Group Type EXPERIMENTAL

subcutaneous Rituximab

Intervention Type DRUG

MabThera 1400 mg solution for subcutaneous injection

Interventions

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subcutaneous Rituximab

MabThera 1400 mg solution for subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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MABTHERA

Eligibility Criteria

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Inclusion Criteria

* Basal diagnosis of mantle-cell lymphoma in relapse or refractory.
* Achievement of a CR or PR after salvage therapy with R-GemOxD (6 to 8 cycles) as previously described4-5.
* Age \> 18 years.
* One or maximum two prior chemotherapy or immunochemotherapy lines.
* Patients should not be considered candidates for high-dose chemotherapy and autologous stem-cell transplantation.
* No clinical evidence of CNS involvement
* Signed informed consent
* Serum creatinine less than 2 and/or bilirrubin less than 2.5 UNL.
* Pregnant or lactating woman. FCBP must agree to ongoing pregnancy testing during the course or study and commit to use effective contraception during the study

Exclusion Criteria

* Prior organ transplantation.
* HIV positive.
* HBV related disease
* Any serious active disease or co-morbid medical condition (according to the investigator's decision)
* Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 cervix carcinoma.
* Less than 50% of tumor response.
* Platelet counts less than 50 x 109/L.
* Neutrophil counts less than 1.0 x 109/L.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No