NCT00571493 is a Phase 1, PHASE2 clinical trial of Bortezomib in Non-hodgkin's Lymphoma, sponsored by University of Nebraska.

Who is sponsoring NCT00571493?

NCT00571493 is sponsored by University of Nebraska.

What drugs are being tested in NCT00571493?

Interventions in NCT00571493: Bortezomib, BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan).

What condition does NCT00571493 study?

NCT00571493 studies Non-hodgkin's Lymphoma, Mantle Cell Lymphoma.

Is NCT00571493 still recruiting?

NCT00571493 is currently completed. Last updated 28 September 2023.

Are results published for NCT00571493?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-09-28 · How we verify

NCT00571493

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

VELCADE®-BEAM and Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin's Lymphoma, or Mantle Cell Lymphoma

Completed Phase 1, PHASE2 Results posted Last updated 28 September 2023

What this trial tests

Phase 1, PHASE2 trial testing Bortezomib in Non-hodgkin's Lymphoma in 42 participants. Completed in 1 November 2014.

Timeline

14 April 2006

Primary endpoint
1 November 2014

1 November 2014

Quick facts

Lead sponsor	University of Nebraska
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	14 April 2006
Primary completion	1 November 2014
Estimated completion	1 November 2014
Sites	1 location across United States

Drugs / interventions tested

Bortezomib (bortezomib) — full drug profile →
BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) — full drug profile →

Conditions studied

Non-hodgkin's Lymphoma — all drugs for Non-hodgkin's Lymphoma →
Mantle Cell Lymphoma — all drugs for Mantle Cell Lymphoma →

Sponsor

University of Nebraska

Who can join

19 and older, any sex, with Non-hodgkin's Lymphoma or Mantle Cell 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.

Maximum Tolerated Dose (MTD) of Bortezomib Primary · 14 months

The maximum tolerated dose (MTD) is defined to be the dose cohort below which 3 of 6 patients experience dose limiting toxicity (DLT), or the highest dose cohort of 1.5 mg/m², if 2 DLT were not observed at any dose cohort.

Group	Value	95% CI
Phase I	1.5
Phase II	1.0

Preliminary Estimate of Overall Response Rate (ORR) Secondary · 100 day post autologous hematopoietic stem cell transplantation (ASCT), one year post ASCT

To obtain a preliminary estimate of overall response rate (ORR). The overall response rate is calculated as the number of patients who achieved complete response (CR) and partial response (PR) divided by the total number of evaluable patients.

Overall Response Rate (100 days after transplant)

Group	Value	95% CI
Phase II: Overall Response Rate	38

Overall Response Rate (1 year after transplant)

Group	Value	95% CI
Phase II: Overall Response Rate	33

Progression-free Survival (PFS), and Overall Survival (OS) Secondary · one year post autologous hematopoietic stem cell transplantation (ASCT) , 5 years post ASCT

To obtain a preliminary estimate of PFS and OS. Overall survival (OS) is defined as time from the first chemotherapy administered on the transplant trial until death from any cause. Progression free survival (PFS)is defined as time from therapy until relapse, progression, or death from any cause.

Progression Free Survival 1 year after transplant

Group	Value	95% CI
Phase II: Progression Free Survival and Overall Survival	83	68 – 92

Overall Survival 1 year after transplant

Group	Value	95% CI
Phase II: Progression Free Survival and Overall Survival	91	79 – 96

Progression Free Survival 5 years after transplant

Group	Value	95% CI
Phase II: Progression Free Survival and Overall Survival	32	15 – 51

Overall Survival 5 years after transplant

Group	Value	95% CI
Phase II: Progression Free Survival and Overall Survival	67	50 – 79

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase I: Intervention

Serious: 0/13 (0%)

Deaths: —

Phase II: Survival

Serious: 1/29 (3%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Phase I: Intervention	Phase II: Survival
adynamic ileus	Gastrointestinal disorders	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Phase I: Intervention	Phase II: Survival
Neutropenic Fever	Blood and lymphatic system disorders	—	—
Anorexia	Metabolism and nutrition disorders	—	—
Vasovagal syncope/orthostatic hypotension	Nervous system disorders	—	—
Peripheral Neuropathy	Nervous system disorders	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—
Ileus	Gastrointestinal disorders	—	—

Most-reported serious reactions: adynamic ileus.

Data from ClinicalTrials.gov NCT00571493 adverse events section.

Sponsor's own description

This is a Phase I/II trial designed to study the toxicity and Maximum Tolerated Dose (MTD) of bortezomib in combination with BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) and autologous hematopoietic stem cell transplantation (ASCT) and to obtain a preliminary estimate of the response rate to this combination.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Bortezomib

Trials testing the same drug.

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Other recruiting trials for Non-hodgkin's Lymphoma

Currently open trials in the same condition.

NCT04662294 — CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases · EARLY_PHASE1 · recruiting

Other University of Nebraska trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00571493 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Nebraska
Last refreshed: 28 September 2023

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/NCT00571493.

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