A Phase 2 interventional study of gemcitabine and mitoxantrone in Relapsed or Refractory Mantle Cell Lymphoma (MCL), sponsored by US Oncology Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-03.
Sponsored by US Oncology Research · Phase 2, Interventional, and Treatment
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 16 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →US Oncology Research is the lead sponsor of 29 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: gemcitabine · Drug: mitoxantrone · Drug: rituximab
900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.
Also known as: Gemzar
Novantrone 10 mg/m2on Day 1. The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.
Also known as: Novantrone
Rituxan 375 mg/m2 on Day 1. The order of administration will be: Gemzar--\>Novantrone--\>Rituxan.
Also known as: Rituxan
Objective Response Rate (CR + PR)
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.
Time frame: 2 years
Duration of Response
The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time frame: From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 33 months.
Overall Survival (OS) Rate at 1 Year
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Time frame: 1 year.
Progression-free Survival Rate at 1 Year.
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Time frame: 1 year.
| Milestone | Gemzar + Novantrone + Rituxan |
|---|---|
| Started | 16 |
| Completed | 9 |
| Not completed | 7 |
| Withdrew: Adverse event | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Patient request | 1 |
| Withdrew: Investigator request | 1 |
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.
| percentage of participants | Gemzar + Novantrone + Rituxan |
|---|---|
| Objective Response Rate (CR + PR) | 46.7 (21.3 to 73.4) |
The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
| months | Gemzar + Novantrone + Rituxan |
|---|---|
| Duration of Response | 7.9 (4.8 to 31.3) |
OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
| Probability of Survival | Gemzar + Novantrone + Rituxan |
|---|---|
| Overall Survival (OS) Rate at 1 Year | 0.57 (0.28 to 0.78) |
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
| Probability of Progression-free Survival | Gemzar + Novantrone + Rituxan |
|---|---|
| Progression-free Survival Rate at 1 Year. | 0.54 (0.24 to 0.77) |
Collected over During the whole treatment period, up to 30 days following last dose.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gemzar + Novantrone + Rituxan | — | 4/15 (26.7%) | 15/15 (100%) |
| Event | Gemzar + Novantrone + Rituxan |
|---|---|
| FEVERGeneral disorders | 2/15 |
| CACHEXIAGeneral disorders | 1/15 |
| PAIN ABDOGastrointestinal disorders | 1/15 |
| Event | Gemzar + Novantrone + Rituxan |
|---|---|
| NEUTROPENIABlood and lymphatic system disorders | 15/15 |
| ASTHENIAGeneral disorders | 14/15 |
| ANEMIABlood and lymphatic system disorders | 13/15 |
| THROMBOCYTOPENIABlood and lymphatic system disorders | 12/15 |
| LEUKOPENIABlood and lymphatic system disorders | 9/15 |
| NAUSEAGastrointestinal disorders | 9/15 |
| ANOREXIAGastrointestinal disorders | 7/15 |
| CONSTIPGastrointestinal disorders | 6/15 |
| ALOPECIASkin and subcutaneous tissue disorders | 3/15 |
| DIZZINESSNervous system disorders | 3/15 |
ITT population
| Age, Continuous(years) | Gemzar + Novantrone + Rituxan |
|---|---|
| Mean | 68 ± 12.3 |
| Sex: Female, Male(Participants) | Gemzar + Novantrone + Rituxan |
|---|---|
| Female | 5 |
| Male | 11 |
| Race/Ethnicity, Customized(participants) | Gemzar + Novantrone + Rituxan |
|---|---|
| Caucasian | 16 |
| Region of Enrollment(participants) | Gemzar + Novantrone + Rituxan |
|---|---|
| United States | 16 |
No study locations are listed for this record.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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