Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Acute Lymphoblastic Leukemia, or Acute Myeloid Leukemia
Phase I Study of Thrice Weekly Hu1D10*in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Acute Leukemia
NCT00017472CI-TRIAL-00010550completedPhase 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)
Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have chronic lymphocytic leukemia, lymphocytic lymphoma, acute lymphoblastic leukemia, or acute myeloid leukemia.
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue | Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue | ALIAS | 0.90 |
| Nodal Marginal Zone B-cell Lymphoma | Nodal Marginal Zone Lymphoma | ALIAS | 0.90 |
| Noncontiguous Stage II Marginal Zone Lymphoma | — | UNRESOLVED | — |
| Noncontiguous Stage II Small Lymphocytic Lymphoma | — | UNRESOLVED | — |
| Recurrent Adult Acute Lymphoblastic Leukemia | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Marginal Zone Lymphoma | Marginal Zone Lymphoma | CURATED_BROADER | 0.78 |
| Recurrent Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma |
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
- Arm I
- description
- Patients receive apolizumab IV over at least 2 hours on days 1, 2, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with a complete or partial response who relapse after 2 months may receive an additional course of therapy provided they still express the 1D10 antigen.
- interventionNames
- Biological: apolizumab
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (1)
- measure
- MTD defined as the dose level below which two or more of six patients experience a DLT assessed using NCI CTC version 2.0
- timeFrame
- Up to 30 days
Secondary outcomes (4)
- measure
- Evaluation of the degree of apoptosis induced by ex vivo incubation of human CLL cells with Hu1D10
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* One of the following diagnoses:
* Histologically confirmed chronic lymphocytic leukemia (CLL) or non-contiguous stage II or stage III-IV small lymphocytic lymphoma (SLL)
* Previously treated with at least 1 form of chemotherapy or immunotherapy
* Histologically confirmed acute lymphoblastic leukemia (enrolled after the maximum tolerated dose (MTD) is determined)
* Must have failed 1 prior therapy
* Ineligible for allogeneic stem cell transplantation
* Histologically confirmed acute myeloid leukemia (enrolled after the MTD is determined)
* Primary refractory or relapsed (within the past year) disease
* Ineligible for potential curative therapy
* Express Hu1D10 antigen
* Greater than 2 times the mean fluorescence intensity of the control by flow cytometry (blood or bone marrow cells) OR
* Positive by immunohistochemical staining (lymph node)
* Presenting with one of the following indications for treatment unless early bone marrow transplantation is planned (CLL or SLL patients only):
* Disease-related progressive symptoms
* Progressively worsening anemia or thrombocytopenia
* Progressively worsening lymphadenopathy
* Massive splenomegaly or hypersplenism
* Hyperlymphocytosis (WBC greater than 200,000/mm3) or lymphocyte doubling time less than 12 months
* Marrow failure secondary to marrow infiltration by leukemia or lymphoma
* Performance status - ECOG 0-2
* At least 2 years
* See Disease Characteristics
* Platelet count at least 50,000/mm\^3 (without transfusion)
* Bilirubin no greater than 3 mg/dL (unless elevated secondary to tumor)
* Creatinine no greater than 2.0 mg/dL
* No prior decompensated congestive heart failure, unstable angina, or myocardial infarction within the past 6 months not corrected by percutaneous transluminal coronary angioplasty or surgery
* No active infection requiring oral or IV antibiotics
* No other malignancy that would limit life expectancy
* HIV negative
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study
* See Disease Characteristics
* At least 1 month since prior rituximab or alemtuzumab (unless CD20 or CD52 antigen is expressed on tumor cells)
* No prior monoclonal antibody Hu1D10
* See Disease CharacteristicsReferences
Publications (0)
Data not yet available
No reference posted for this study.