Clinical trial · Interventional
Weekly Subcutaneous Alemtuzumab and Rituximab for Relapsed CLL
NCT00330252CI-TRIAL-00022161completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the combination of alemtuzumab and rituximab is safe and effective in treating patients with relapsed Chronic Lymphocytic Leukemia (CLL) and to determine whether alemtuzumab can be given as a single weekly subcutaneous dose, together with rituximab.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Drug | Alemtuzumab | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alemtuzumab & Rituximab
- description
- Alemtuzumab Dosage will vary during Phase I of trial: Given intravenously on days 1, 3, and 5 for weeks one and two, on days 1 and 4 for weeks three and four and on day 1 for weeks five through eight. Participants may receive either one eight-week course of treatment or two eight-week courses of treatment (16 weeks) Rituximab- Given intravenously on day 1 of every week for eight weeks (or 16 weeks)
- interventionNames
- Drug: Rituximab
- Drug: Alemtuzumab
Primary outcomes (2)
- measure
- Maximum tolerated dose of alemtuzumab given once weekly
- timeFrame
- 2 years
- measure
- Response rate of combined rituximab and subcutaneous alemtuzumab (complete or partial response)
- timeFrame
- 2 years
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must be diagnosed with B-CLL / SLL (B-chronic lymphocytic leukemia / small lymphocytic lymphoma) based on the standard histologic and immunophenotypic criteria described in the WHO classification of lymphoid malignancies, including immunophenotypic confirmation that the tumor cells co-express B cell antigens CD19 / 20 and CD5. Mantle cell lymphoma should be excluded based on positive staining of the tumor cells for CD23, or the absence of staining of the tumor cells for cyclin D1 or the absence of t(11;14). * The above diagnosis must be confirmed at Brigham \& Women's Hospital or Dana-Farber Cancer Institute. * Subjects must have relapsed after at least one prior fludarabine-containing regimen and require treatment based on NCI-WG criteria (Appendix A). * Subjects must have measurable disease (lymphocytosis \> 5,000 / ml, or palpable lymphadenopathy or CT measurable lymphadenopathy \> 1.5 cm, or bone marrow involvement \>30%). * Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment. * Age \>= 18 * WHO Performance status \<= 2 * Subject has provided written informed consent. * Expected survival \> 3 months Exclusion Criteria: * History of HIV * Active infection uncontrolled by appropriate antibacterial, antiviral or antifungal therapy * Known CNS involvement with CLL * Pregnant (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment) or currently lactating women * Prior anti-neoplastic therapy within the last three weeks * Patients will NOT be excluded because they have received prior rituximab or alemtuzumab
References
Publications (1)
- DERIVEDBrown JR, Messmer B, Werner L, Davids MS, Mikler E, Supko JG, Fisher DC, LaCasce AS, Armand P, Jacobsen E, Dalton V, Tesar B, Fernandes SM, McDonough S, Ritz J, Rassenti L, Kipps TJ, Neuberg D, Freedman AS. A phase I study of escalated dose subcutaneous alemtuzumab given weekly with rituximab in relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma. Haematologica. 2013 Jun;98(6):964-70. doi: 10.3324/haematol.2013.086207. Epub 2013 May 3. PMID 23645694