NCT00038571

Brief Summary

Purpose of Phase II study for B-cell lymphoma using PS341: Evaluate efficacy and toxicity of bortezomib in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2002

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

May 31, 2002

Last Update Submit

October 30, 2018

Conditions

Lymphoma, B-Cell

Keywords

CancerRelapsedRefractoryB cell lymphomaProteasome InhibitorPS-341

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Response to PS-341

    Patient response evaluated according to criteria of Cheson et al. Endoscopy obtained every two cycles to evaluate response using Complete Response (CR), Partial Response (PR), Progressive Disease, or Stable Disease.

    Every two 21-day cycles

Study Arms (2)

Arm A (mantle-cell lymphoma)

EXPERIMENTAL
Drug: PS341 (Bortezomib)

Arm B (other B-cell lymphomas)

EXPERIMENTAL
Drug: PS341 (Bortezomib)

Interventions

PS341 (Bortezomib)DRUG

1.5 mg/m2 intravenous (IV) bolus push over 3 to 5 seconds on days 1, 4, 8, and 11, followed by a 10-day rest for a 21-day cycle.

Also known as: Velcade, LPD-341, MLN341, PS-341
Arm A (mantle-cell lymphoma)Arm B (other B-cell lymphomas)

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Relapsed or Refractory B cell lymphoma.
  • Zubrod status \</= 3.
  • Measurable disease.
  • No anti-cancer treatment within past 3 weeks.
  • ANC \>= 1500/uL, Plt \>/= 50,000, Bilirubin \<2 mg/dL, SGPT \<2.5xULN, creatinine \<2. Patients with ANC\>/1000, PLT\>/30000 will be eligible if due to massive splenomegaly and/or BM involvement.
  • HIV negative.
  • No active CNS lymphoma.
  • No serious intercurrent illness, active infections or cancer except basal cell carcinoma of the skin or in situ cervical carcinoma.
  • Not eligible for treatment of a higher priority. Patients may be entered before BMT.
  • No pregnancy \& age bearing females must be practicing adequate contraception.
  • Age \> 16.

You may not qualify if:

  • Patients with platelets \<30x10(9)/L within 14 days before enrollment.
  • Patients with ANC\<1.0 x10(9)/L within 14 days before enrollment.
  • Patients with peripheral neuropathy \>/= grade 3 within 14 days before enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Goy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F, Fayad L, Dang NH, Samaniego F, Wang M, Broglio K, Samuels B, Gilles F, Sarris AH, Hart S, Trehu E, Schenkein D, Cabanillas F, Rodriguez AM. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005 Feb 1;23(4):667-75. doi: 10.1200/JCO.2005.03.108. Epub 2004 Dec 21.

    PMID: 15613697RESULT

Related Links

MeSH Terms

Conditions

Lymphoma, B-CellNeoplasmsRecurrence

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Luis Fayad, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2002

First Posted

June 3, 2002

Study Start

May 1, 2002

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

October 31, 2018

Record last verified: 2018-10

Locations

US(1)