Clinical trial NCT02267915: Phase II of Efficacy and Toxicity of Maintenance Sub. Rituximab After Induction in Relapsed MCL and Non-eligible HSCT
Official title: An Open Multicenter Phase II Study of Efficacy and Toxicity of Maintenance Subcut. Rituximab After Induction With Rituximab in Patients With Relapsed or Refractory Mantle-cell Lymphoma Non-eligible for HSCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Mantle-cell Lymphoma
Keywords: Relapsed or refractory patients with mantle-cell lymphoma
Progression after high-dose chemotherapy and autologous HPT
Lead sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Time to progression, (Measured from achievement of response -partial or complete- to to disease progression)
timeFrame: 2 YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Gijon
country: Spain
facility: Geltamo Investigational Site
state: Asturias
city: Santiago de Compostela
country: Spain
facility: Geltamo Investigational Site
state: LA Coruña
city: Alcorcon
country: Spain
facility: Geltamo Investigational Site
state: Madrid
city: Majadahonda
country: Spain
facility: Geltamo Investigational Site
state: Madrid
city: Barcelona
country: Spain
facility: Geltamo Investigational Site
city: Barcelona
country: Spain
facility: Geltamo Investigational Site
city: Barcelona
country: Spain
facility: Geltamo Investigational Site
city: Barcelona
country: Spain
facility: Geltamo Investigational Site
city: Barcelona
country: Spain
facility: Geltamo Investigational Site
city: Burgos
country: Spain
facility: Geltamo Investigational Site
city: Granada
country: Spain
facility: Geltamo Investigational Site
city: Madrid
country: Spain
facility: Geltamo Investigational Site
city: Salamanca
country: Spain
facility: Geltamo Investigational Site
city: Santander
country: Spain
facility: Geltamo Investigational Site
city: Sevilla
country: Spain
facility: Geltamo Investigational Site
Study officials:
affiliation: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
name: Andres Lopez, DOCTOR
role: STUDY_DIRECTOR
References: