Clinical trial to evaluate the treatment with a drug (lenalidomide) with the usually prescribed chemotherapy in patients diagnosed with diffuse large B-cell lymphoma (sort of blood cancer) which did not respond to previous treatments and who can not receive high-dose chemotherapy.

• Conditions: Refractory Diffuse large B-cell lymphoma.; MedDRA version: 17.0Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001620-29-ES
• Lead Sponsor: Grupo Español para el Tratamiento y Estudio de los Linfomas (GOTEL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-22
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

1. Patients over 18 years old.
2. Patients with diffuse large cell lymphoma (DLBCL) diagnosed by biopsy, including immunohistochemical positivity for CD20 study.
3. Patients with relapsed or refractory DLBCL (DLBCL r / r) after receiving at least a first line of treatment that included chemotherapy and anti-CD20 monoclonal antibodies. Biopsy recommended but not mandatory.
4. Patients who are not candidates for autologous hematopoietic cell transplantation according to the investigator´s criteria.
5. ECOG Performance Status ? 2.
6. Life expectancy over 3 months.
7. All patientsmust accept common contraception methods in clinical trials with lenalidomide.
8. Women of childbearing potential must have a negative pregnancy test result at screening.
9. Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 77
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who may be susceptible of autologous bone marrow transplant during the evolution of the disease according to investigator´s criteria.
2. Patients with inadequate renal, hepatic or haematological function, and / or showing any of the following laboratory parameters (It is not allowed the use of colony stimulating factors and other similar measures for the inclusion of patients):
- ANC < 1000 células/mm3
- Platelets < 75.000/ mm3
- GOT o GPT > 5 normal level
- Total bilirubin > 2 mg/dl o conjugated bilirubin > 0.8mg/dl, except if hemolytic anemia.
- Creatinine clearance < 30 ml/minute
3. ECOG Performance Status 3 ó 4.
4. Any other serious medical condition, laboratory abnormality, or psychiatric illness that hinders obtaining informed consent from the patient.
5. Systemic infection not solved> 2 months before starting experimental treatment despite adequate anti-infective treatment.
6. Pregnant or lactating women.
7. Rejection of contraceptive methods according to the protocol.
8. Patients who had received any experimental therapy within 28 days prior to inclusion in the clinical trial.
9. Involvement of central nervous system confirmed by cerebrospinal fluid cytology or imaging test.
10. Previous history of malignant disease unless the patient has been free of disease ? 3 years. The following neoplasia are excluded:
- Basal cell carcinoma of skin
- Squamous cell carcinoma of skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of breast
- Incidentally diagnosed prostate carcinoma (T1a or T1b)
11. Seropositivity for HIV, Hepatitis B or Hepatitis C
12. Uncontrolled intercurrent illness, such as:
- Active infection requiring parenteral antibiotics
- Uncontrolled diabetes mellitus
- Chronic heart failure (class III or IV NYHA)
- Unstable angina or angioplasty, stent or heart attack in the last 6 months
- Thromboembolic disease grade 3-4 in the past 6 months
- Prior neuropathy grade ? 2
13. Patients who have received any of the following treatments in the specified period prior day 1:
- Any chemotherapy in the previous 2 weeks
- Nitrosoureas in the previous 6 weeks
- Monoclonal antibodies in previous 8 weeks
- External radiotherapy in the previous 3 weeks
- Radioimmunoconjugates in the previous 12 weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified