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Randomized controlled trial of GemOx+/-R regimen in first-line treatment of elderly aggressive B cell lymphoma

Randomized controlled trial of GemOx+/-R regimen in first-line treatment of elderly aggressive B cell lymphoma

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002256
Enrollment
Unknown
Registered
2012-05-29
Start date
2012-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggressive B cell lymphoma

Interventions

experimental group:GemOx+Rituximab

Sponsors

JiangSu Province Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed aggressive B cell lymphoma; 2. New-diagosis and untreated; 3. Age older than 70 years or older than 60 years with ECOG PS>=2; 4. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Inadequate hepatic, nephritic and cardiac function:total bilirubin, ALT, AST,Cr more than two fold of upper normal level. cardiac function more than Grade II; 2. Presence of Grade III nervous toxicity with two weeks; 3. HBV virus load (HBV DNA) >1*10E5 copies/ml; 4. Concomitant malignancy other than aggressive B cell lymphoma and need to treat; 5. Concomitant with other hematologic diseases(such as leukemia,hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial; 6. Active and severe infectious diseases; 7. Major surgery within three weeks; 8. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment; 9. In any conditions which investigtor considered ineligible for this study; 10. Known sensitivity or allergy to investigational Product.

Design outcomes

Primary

MeasureTime frame
overall response rate;safety and toxicity;

Secondary

MeasureTime frame
PFS;OS;mortality rate;

Countries

China

Contacts

Public ContactWEI XU
xuwei10000@medmail.com.cn+86 025 68136034

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026