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NCT00290498

Study of Rituximab-HCVAD Alternating With Rituximab-Methotrexate-Cytarabine Versus Standard Rituximab-CHOP Every 21 Days for Patients With Newly Diagnosed High Risk Aggressive B-Cell Non-Hodgkin's Lymphomas in Patients 60 Years Old or Younger

Completed Phase 2 Results posted Last updated 2 June 2020
What this trial tests

Phase 2 trial testing Rituximab in Lymphoma in 67 participants. Completed in 11 August 2017.

Timeline
1 August 2005
Primary endpoint
11 August 2017
11 August 2017

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment67
Start date1 August 2005
Primary completion11 August 2017
Estimated completion11 August 2017
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 16 to 60, any sex, with Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Response Rate R-HCVAD vs. R-CHOP Primary · 3 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Complete Remission
GroupValue95% CI
R-HCVAD40
R-CHOP7
Inevaluable
GroupValue95% CI
R-HCVAD2
R-CHOP1
Progressive Disease
GroupValue95% CI
R-HCVAD1
R-CHOP1
Partial Remission
GroupValue95% CI
R-HCVAD4
R-CHOP0
Complete Remission Unconfirmed
GroupValue95% CI
R-HCVAD2
R-CHOP1
Progression Free Survival (Rate) Secondary · 3 years post-therapy

Progression free survival (PFS) for three years following therapy with Rituxan-HCVAD alternating with Rituximab with high -dose methotrexate/ara-C and standard R-CHOP in patients with newly diagnosed B-cell aggressive non-Hodgkin's lymphomas younger than 60 years old and with adjusted IPI 2 or higher adverse prognostic features.

GroupValue95% CI
R-HCVAD/MA35
R-CHOP7

Adverse events — posted to ClinicalTrials.gov

Time frame: From the initiation of the regimen until the end of chemotherapy, an average of 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RHCVAD
Serious: 49/49 (100%)
Deaths: 4/49
RCHOP
Serious: 7/10 (70%)
Deaths: 0/10

Serious adverse events (167 terms)

ReactionSystemRHCVADRCHOP
HEMOGLOBIN DECREASEInvestigations——
LEUKOPENIAInvestigations——
INFECTION(S)Infections and infestations——
NEUTROPENIAInvestigations——
PLATELETS DECREASEDInvestigations——
FATIGUEGeneral disorders——
NAUSEAGastrointestinal disorders——
FEBRILE NEUTROPENIABlood and lymphatic system disorders——
HYPOALBUMINEMIAInvestigations——
HYPERGLYCEMIAInvestigations——
VOMITINGGastrointestinal disorders——
DYSPNEARespiratory, thoracic and mediastinal disorders——
PAIN( HEAD/HEADACHE)Nervous system disorders——
ALOPECIASkin and subcutaneous tissue disorders——
MUCOSITISRespiratory, thoracic and mediastinal disorders——
NEUROPATHY:SENSORYNervous system disorders——
RIGORS/CHILLSGeneral disorders——
ALT,SGPT INCRInvestigations——
AST,SGOT INCRInvestigations——
COUGHRespiratory, thoracic and mediastinal disorders——
CONSTIPATIONGastrointestinal disorders——
MOOD ALTERATIONPsychiatric disorders——
HYPOCALCEMIAInvestigations——
HYPOKALEMIAInvestigations——
DIZZINESSNervous system disorders——
Other adverse events (6 terms — click to expand)

ReactionSystemRHCVADRCHOP
NeutrophilsBlood and lymphatic system disorders——
PlateletsBlood and lymphatic system disorders——
InfectionInfections and infestations——
Febrile NeutropeniaInfections and infestations——
Thrombosis/EmbolismVascular disorders——
Renal FailureRenal and urinary disorders——

Most-reported serious reactions: HEMOGLOBIN DECREASE, LEUKOPENIA, INFECTION(S), NEUTROPENIA, PLATELETS DECREASED, FATIGUE, NAUSEA, FEBRILE NEUTROPENIA.

Data from ClinicalTrials.gov NCT00290498 adverse events section.

Sponsor's own description

The overall goal of this clinical research study was to find out which of two different chemotherapy drug combinations, R-CHOP and R-HCVAD, is more effective in treating B-cell lymphoma. At this point, all participants will now be assigned to the R-HCVAD arm of the study. Researchers will study the safety and effectiveness of this drug combination.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Prospective phase II study of rituximab with alternating cycles of hyper-CVAD and high-dose methotrexate with cytarabine for young patients with high-risk diffuse large B-cell lymphoma.
    Oki Y, Westin JR, Vega F, Chuang H, et al · · 2013 · cited 22× · PMID 24117234 · DOI 10.1111/bjh.12585

Verify or expand the search:

Other trials of Rituximab

Trials testing the same drug.

Other recruiting trials for Lymphoma

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00290498.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing