Clinical trial · Interventional
Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell
A Phase II Study of Gemzar, Novantrone and Rituxan in Relapsed or Refractory Mantle Cell Lymphoma (MCL) (B9E-US-X436)
NCT00656084CI-TRIAL-00024716completedPhase 2Results postedClinicalTrials.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)
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
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 |
|---|---|---|---|
| Relapsed or Refractory Mantle Cell Lymphoma (MCL) | Mantle Cell Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| mitoxantrone | Drug | Mitoxantrone | ALIAS |
| rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and rituximab.
- interventionNames
- Drug: gemcitabine
- Drug: mitoxantrone
- Drug: rituximab
Primary outcomes (1)
- measure
- Objective Response Rate (CR + PR)
- timeFrame
- 2 years
- description
- Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage III or IV, histologically confirmed relapsed or refractory MCL as reviewed by the SI * Is CD20 positive (by immunohistochemistry or FACS) * Is Cyclin D positive (by immunohistochemistry or FACS) * Has received prior chemotherapy (required minimum of 1 prior therapies) * Has received prior treatment with Rituxan * Has an ECOG Performance Status (PS) 0-2 * Is greater than or equal to 18 years of age * Has appropriate laboratory values (please refer to protocol for specific laboratory values) * If a history of cardiac disease is indicated, patient has an LVEF greater than or equal to 50% (MUGA) * Has a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential) * If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 2 months thereafter * Has signed a Patient Informed Consent Form * Has signed a Patient Authorization Form Exclusion Criteria: * Has other lymphomas not classified as MCL * Has had prior treatment with Gemzar and/or Novantrone * A history of known hypersensitivity to Gemzar, Novantrone, Rituxan, or any component of these drugs * Has a history of hypersensitivity to murine-cell derived therapeutics * Has a LVEF indicative of a cardiac condition (LVEF \< 50%) * Is receiving concurrent immunotherapy * Has evidence of CNS involvement * Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection * Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs * Is a pregnant or nursing woman * Is unable to comply with requirements of study
References
Publications (0)
Data not yet available
No reference posted for this study.