Non-Hodgkin lymphoma, Chronic lymphocytic leukemia, Multiple myeloma
Conditions
Interventions
Stage I
14F mAb intravenously in 5 dose levels (25 mg, 50 mg, 100 mg, 200 mg o 400 mg) every 15 days (5 doses) in induction period and, then every 28 days (4 doses) in maintenance period.
Stage II
14F
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Refractory or relapsing B-cell cell lymphoproliferative syndrome, ganglioside NGlicolilGM3 (NGGM3) positive. 2. Age =18 years, any gender and race. 3. ECOG = 3. 4. Life expectancy of 6 months. 5. No candidates for transplant of hematopoietic progenitors or immunochemotherapy schemes not previously used. 6. Four or more weeks from the previous specific therapy (QT, RT, biological therapies) (applicable to patients’ refractory to the previous treatment). 7. Patients with laboratory parameters as detailed below: Hemoglobin = 80 g / L, Absolute neutrophil count = 1.5 x 109 / L, Platelet count = 75 x 109 / L, Liver function (bilirubin, ASAT or ALAT = 2.5 times the normal reference range of each institution), Renal function preserved (creatinine clearance =45 mL / min according to the Cockcroft and Gault formula). 8. Voluntary signature of the informed consent model. 9. Subjects of childbearing age and sexually active should agree to use a method of contraception during treatment (criteria valid only for patients of childbearing age).
Exclusion criteria
Exclusion criteria: 1. Pregnant, puerperal or breastfeeding 2. Cytopenia of uncontrolled immune cause 3. Active infection or known positivity for HIV, hepatitis B or C virus 4. Heart failure grade III / IV according to NYHA criteria (New York Heart Association) 5. Chronic decompensated diseases such as: arterial hypertension, diabetes mellitus, ischemic cardiopathy or other symptomatic cardiovascular diseases, epilepsy, obstructive pulmonary disease. 6. Acute allergic states or known hypersensitivity to any component of the formulation under study. 7. Obvious mental disability or other limitation that prevents the patient from signing their consent or hinders the evaluation of the study. 8. Being receiving another research product. 9. Another clinically active neoplasm that needs specific treatment (except basal cell carcinomas or cutaneous carcinomas in situ).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage I Serious Adverse Events (SAE) with causality relationship (Serious Adverse Events those that: 1. Produce death, 2. life-threatening, 3. hospitalization or prolongation of hospitalization indicated, 4. Produce disability / persistent or significant disability, 5. Produce birth defect or congenital anomaly. Will be consider causality relationship when the SAE has definitive/highly probable or probable causality relationship). Measuring time: during and after each administration, throughout the study period until week 52. Stage II Objective response (Complete response y partial response according to the international criteria for each chronic B-cell lymphoproliferative syndrome). Measurement time: weeks 13, 29, 41 and 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Control of the disease (It will to evaluate according to the International response criteria for each chronic B-cell lymphoproliferative syndrome (CLPS) in the categories "Control of the disease" (complete + partial response + stable disease) and "Non-responders" (death + progressive disease) . Measurement time: weeks 13, 29, 41 and 52. Relapse-Free Survival (The time from the date of achievement of a complete response until the date of relapse or death from any cause. Defined only for patients achieving complete response). Measuring time: 52 weeks Event-free survival (The time from treatment began until treatment failure, or relapse or death from any cause). Measurement time: 52 weeks Progression free survival (The time from the start of treatment until to the date of disease progression or death from any cause) Measurement time: 29 and 52 weeks Survival rates (Percentage of patients alive from the diagnosis and the start of treatment). Measuring time: week 29 and week 52 Time to progression (Time measured from the start of treatment to the date of disease progression). Measurement time: 52 weeks Time to treatment failure (Time from the start of treatment to the interruption of treatment for any reason, including disease progression, toxicity or death). Measurement time: 52 weeks Immunogenicity HAHA response (Yes, No. It will be "Yes" when the value of the density of the patient serum is greater than 2 standard deviations of the value of the sera of healthy donor). Measurement time: At baseline, prior to each administration of product, week 29 and week 52. Pharmacokinetics Bioavailability of mAb 14F7hT (numerical value). Measurement time: 1st and 5th administration Volume of distribution of the MAb 14F7hT (numerical value). Measurement time: 1st and 5th administration Constant of elimination of the AcM 14F7hT (numerical value). Measurement time: 1st and 5th administration Maximum concentration of mAb 14F7hT (numerical value). Measurement time: 1st and 5th administ | — |
Countries
Cuba
Contacts
Public ContactIvis Mendoza Hernandez
National Coordinating Center for Clinical Trials (CENCEC)
Outcome results
None listed