Clinical trial · Interventional
Alemtuzumab and Pentostatin In T-cell Neoplasms
A Phase II Study of Alemtuzumab and Pentostatin In T-Cell Neoplasms
NCT00453193CI-TRIAL-00007747terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual.
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if giving pentostatin with alemtuzumab can help to control T-cell malignancy. The safety of this combination therapy will also be studied.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Drug | Alemtuzumab | ALIAS |
| Pentostatin | Drug | Pentostatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alemtuzumab + Pentostatin
- description
- Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m\^2 IV weekly for 4 weeks then every 2 weeks
- interventionNames
- Drug: Pentostatin
- Drug: Alemtuzumab
Primary outcomes (1)
- measure
- Number of Participants With Objective Response
- timeFrame
- After a maximum of 6 months of therapy maintained for one month.
- description
- Objective Responses are Complete or Partial Responses: Complete Response defined as disappearance of all evidence of disease detectable by morphology of peripheral blood and bone marrow and computer tomography scanning at the end of therapy, if indicated; and Partial Response as 50% or more reduction in detectable disease, but short of complete response, maintained for 1 month or at least 50% reduction of sum of the products of the diameter of all lesions for 1 month.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years and older 2. Diagnosis of T lymphoid malignancy established by peripheral blood, bone marrow or tissue (skin, lymph node or other) examination and using the standard criteria. 3. Patients with untreated T-cell-prolymphocytic leukemia (T-PLL), peripheral T-cell lymphoma, hepatosplenic T-cell lymphoma and NK/T cell lymphoma are eligible. 4. Patients with relapsed/refractory T-PLL, T-lineage acute lymphoblastic leukemia (T-ALL), Adult T-cell leukemia/lymphoma (ATLL), peripheral T-cell lymphoma, hepatosplenic T-cell lymphoma and NK/T cell lymphoma and other T-lymphoid malignancies are eligible. Patients who have had prior therapy with either alemtuzumab or pentostatin as single agents are eligible. 5. Willing to use adequate contraception for the entire duration of the study. 6. Performance status 0-2. 7. Creatinine less than or equal to 2.0 mg/dL and calculated creatinine clearance greater than 40 8. Bilirubin less than or equal to 3.0 mg/dL, transaminases (aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT)) less than 4 x upper limit of normal unless related to the disease. 9. Left ventricular ejection fraction greater than 30%. Exclusion Criteria: 1. Unable or unwilling to sign the consent form. 2. Pregnant or lactating 3. Known to be HIV+ 4. Active and uncontrolled infection as judged by treating physician
References
Publications (0)
Data not yet available
No reference posted for this study.