Clinical trial · Interventional
Apolizumab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase II Study of Thrice Weekly Apolizumab in Patients With Chronic Lymphocytic Leukemia : CRC Master Protocol
NCT00089154CI-TRIAL-00011372completedPhase 2ClinicalTrials.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)
This phase II trial is studying how well apolizumab works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Monoclonal antibodies such as apolizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Noncontiguous Stage II Small Lymphocytic Lymphoma | — | UNRESOLVED | — |
| Recurrent Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | CURATED_BROADER | 0.78 |
| Stage III Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | CURATED_BROADER | 0.78 |
| Stage IV Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| apolizumab | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (apolizumab)
- description
- Patients receive apolizumab IV over 2-4 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: apolizumab
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (3)
- measure
- Response rate (CR+PR)
- timeFrame
- Up to 3 years
- measure
- Progression-free survival rate
- timeFrame
- Up to 3 years
- measure
- Frequency and severity of treatment-related adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed hematologic malignancy of 1 of the following histologies:
* Chronic lymphocytic leukemia (CLL)
* Small lymphocytic lymphoma (SLL)
* Noncontiguous stage II or stage III or IV disease
* Received \>= 1 form of prior immunotherapy or chemotherapy
* Completed therapy at least 4 weeks ago
* Requires therapy (unless early bone marrow transplantation is planned), as indicated by 1 of the following criteria:
* Progressively worsening disease (symptoms increasing in severity by 1 toxicity criterion over a period of \>= 2 weeks)
* Progressively worsening anemia or thrombocytopenia
* Progressively worsening lymphadenopathy
* Massive splenomegaly or hypersplenism
* Hyperlymphocytosis (WBC \> 200,000/mm\^3) OR lymphocyte doubling time \< 12 months
* Marrow failure due to marrow infiltration by leukemia or lymphoma
* Leukemia cells must express 1D10 antigen \> 2 times mean fluorescent intensity of the control by flow cytometry of blood or bone marrow cells
* Performance status - ECOG 0-2
* At least 2 years
* Platelet count \>= 50,000/mm\^3 (transfusion independent)
* Bilirubin =\< 3 mg/dL (unless due to tumor involvement)
* Creatinine =\< 2.0 mg/dL
* No decompensated congestive heart failure
* No unstable angina
* No myocardial infarction within the past 6 months not corrected by surgery or percutaneous transluminal coronary angioplasty
* No active infection requiring oral or IV antibiotics
* No other malignancy that limits life expectancy to \< 2 years or that requires active anticancer therapy within 4 weeks of study entry
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study treatment
* Recovered from prior immunotherapy
* More than 3 months since prior alemtuzumab or rituximab
* No prior apolizumab
* Recovered from prior chemotherapy
* More than 4 weeks since prior anticancer hormonal therapy
* More than 4 weeks since prior anticancer radiotherapy
* More than 4 weeks since prior anticancer surgery
* At least 4 weeks since other prior therapy for CLL or SLL and recoveredReferences
Publications (0)
Data not yet available
No reference posted for this study.