Phase I (II) study of the combination of lenalidomide and alemtuzumab in patients with chemotherapy refractory chronic lymphocytic leukemia (CLL)

• Conditions: Refractory or relapsed chronic lymphocytic leukemia (CLL); MedDRA version: 9.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemia

• Registration Number: EUCTR2007-007434-20-SE
• Lead Sponsor: Deptartment of Hematology, Karolinska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-28
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Understand and voluntarily sign an informed consent form.
2. Age >=18 years at the time of signing the informed consent form.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Diagnosed with CLL and failed chemotherapy for CLL defined as refractory or relapsed with new need of treatment within 12 months after chemotherapeutic regimens in use for CLL therapy.
5. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to first treatment dose in this study.
6. ECOG performance status of <= 2 at study entry (see Appendix 1).
7. Laboratory test results within these ranges:
- Absolute neutrophil count >=0.5 x 109/L
- Platelet count >=25 x 109/L
- Serum creatinine 177 µmol/L
- Total bilirubin 26 µmol/L
- ASAT (SGOT) and ALAT (SGPT) <= 2 x ULN or <= 5 x ULN unless attributable to CLL
8. Disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of the cervix or breast.
9. Able to take aspirin (75 or 160 mg) daily as prophylactic anticoagulation, unless patients intolerant to ASA may use low molecular weight heparin. If platelet count < 50 x 109/L, prophylactic anticoagulation should not be given.
10. Females of childbearing potential (FCBP)‡ must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner’s vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
4. Use of any other experimental therapy within 28 days of baseline.
5. Any prior use of lenalidomide or thalidomide.
6. Concurrent use of other anti-cancer agents or treatments.
7. Known positive for HIV or infectious hepatitis, type A, B or C.
8. Opportunistic infections within the last 4 months.
9. Previous alemtuzumab therapy within the last 4 months.
10. Renal impairment, defined as calculated creatinine clearance below 60mL/min as defined by the method of Cockroft-Gault.
11. Evidence of pre-existing TLS per the Cairo-Bishop definition of laboratory TLS(Subjects may be enrolled upon correction of electrolyte abnormalities).
12. History of renal failure requiring dialysis.
13. Uncontrolled hemolytic anemia or autoimmune thrombocytopenia.

Study & Design

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