Clinical trial · Interventional
A Phase II Study to Evaluate Efficacy and Safety of P276-00 in Relapsed and/or Refractory Mantle Cell Lymphoma
Single-Arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of P276-00 in Patients With Relapsed and/or Refractory Mantle Cell Lymphoma
NCT00843050CI-TRIAL-00007571terminatedPhase 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): The study was terminated based on interim results and all subjects were off study at that time. No major safety or tolerability concerns
Summary
Brief summary (as posted)
The purpose of this study is to determine whether P276-00 is safe and effective in treatment of Mantle Cell Lymphoma that is recurred after or not responding to at least one previous line of treatment.
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 |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| P276-00 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- P276-00
- description
- P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
- interventionNames
- Drug: P276-00
Primary outcomes (1)
- measure
- Best Overall Objective Response Rate
- timeFrame
- End of every 2 cycles and end of the study treatment
- description
- The primary efficacy endpoint is the proportion of subjects achieving an objective response. The proportion of patients achieving an objective response is the best overall objective response rate.
Secondary outcomes (2)
- measure
- Duration of Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Histological diagnosis of MCL and presence of either nuclear Cyclin D1 positivity by immunohistochemistry or t(11;14) by fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), or conventional karyotyping * Documented progression or relapse after at least 1 line of prior chemotherapy * Presence of measurable disease * ECOG performance status 0, 1, or 2 * Life expectancy of at least 3 months * Ability to understand and the willingness to sign a written informed consent document (ICD) * Full recovery from all prior treatment toxicities of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≤ 1 Exclusion Criteria: * Prior radiation therapy, chemotherapy or biologic/targeted anticancer agents within 4 weeks of study drug administration * Prior treatment with monoclonal antibodies or any radio- or toxin- immunoconjugates within 3 months of study drug administration; however, a patient who has had rituximab treatment within 3 months and has had PD after such treatment is allowed in the study. * Prior allogeneic stem cell transplantation within 1 year of study drug administration * Current or prior CNS lymphoma * QTc \> 450 msec * Unstable angina, myocardial infarction, CHF or stroke within previous 6 months of study drug administration * Presence of active and serious comorbidity and uncontrolled illness other than MCL * History of other prior malignancies except for properly treated basal cell or squamous cell carcinoma of skin, in situ cervical cancer, in situ breast cancer or early stage prostate cancer * Hemoglobin \<8.0 gm/dL * Absolute neutrophil count \<1000/mm3 * Platelet count \<50,000/mm3 * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>3 × institutional upper limit of normal (ULN) (\> 5 × institutional ULN if liver is involved with lymphoma or if patient has Gilbert's Disease) * Total bilirubin, \>1.5 × institutional ULN (\> 3 × institutional ULN if liver is involved with lymphoma or if patient has Gilbert's Disease) * Serum creatinine \>1.5 × institutional ULN * Patients known to be suffering from infection with human immunodeficiency virus (HIV), tuberculosis, Hepatitis C or Hepatitis B * Pregnant or lactating women * Women of childbearing potential or men not willing to use at least 2 approved methods of contraception (one of which being a barrier method) after signing the ICD, during the entire study and for at least 4 weeks following withdrawal from the study
References
Publications (0)
Data not yet available
No reference posted for this study.