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

Mantle-cell Lymphoma Clinical Trial

— MAN2  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02267915
• Other study ID #: GELTAMO-MAN2
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: February 2020

Study information

• Verified date: May 2019
• Source: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: February 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle-cell Lymphoma

Intervention

Drug:
• subcutaneous Rituximab
MabThera 1400 mg solution for subcutaneous injection

Locations

Country	Name	City	State
Spain	Geltamo Investigational Site	Alcorcon	Madrid
Spain	Geltamo Investigational Site	Barcelona
Spain	Geltamo Investigational Site	Barcelona
Spain	Geltamo Investigational Site	Barcelona
Spain	Geltamo Investigational Site	Barcelona
Spain	Geltamo Investigational Site	Barcelona
Spain	Geltamo Investigational Site	Burgos
Spain	Geltamo Investigational Site	Gijon	Asturias
Spain	Geltamo Investigational Site	Granada
Spain	Geltamo Investigational Site	Madrid
Spain	Geltamo Investigational Site	Majadahonda	Madrid
Spain	Geltamo Investigational Site	Salamanca
Spain	Geltamo Investigational Site	Santander
Spain	Geltamo Investigational Site	Santiago de Compostela	LA Coruña
Spain	Geltamo Investigational Site	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression, (Measured from achievement of response -partial or complete- to to disease progression)	2 years after last patient randomized in maintenance	2 YEARS