NCT00577629 is a Phase 2 clinical trial of cyclophosphamide in Lymphoma, B-Cell, sponsored by Duke University.

Who is sponsoring NCT00577629?

NCT00577629 is sponsored by Duke University.

What drugs are being tested in NCT00577629?

Interventions in NCT00577629: cyclophosphamide, etoposide, rituximab, cytarabine, doxorubicin, tositumomab.

What condition does NCT00577629 study?

NCT00577629 studies Lymphoma, B-Cell.

Is NCT00577629 still recruiting?

NCT00577629 is currently completed. Last updated 30 May 2017.

Are results published for NCT00577629?

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

Last reviewed 2017-05-30 · How we verify

NCT00577629

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

Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

Completed Phase 2 Results posted Last updated 30 May 2017

What this trial tests

Phase 2 trial testing cyclophosphamide in Lymphoma, B-Cell in 39 participants. Completed in 3 November 2016.

Timeline

18 June 2005

Primary endpoint
8 April 2012

3 November 2016

Quick facts

Lead sponsor	Duke University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	18 June 2005
Primary completion	8 April 2012
Estimated completion	3 November 2016
Sites	1 location across United States

Drugs / interventions tested

cyclophosphamide (cyclophosphamide) — full drug profile →
etoposide (etoposide) — full drug profile →
rituximab — full drug profile →
cytarabine — full drug profile →
doxorubicin
tositumomab — full drug profile →

Conditions studied

Lymphoma, B-Cell — all drugs for Lymphoma, B-Cell →

Sponsor

Duke University

Who can join

18 and older, any sex, with Lymphoma, B-Cell. 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.

1 Year Progression-free Survival Rate Primary · 1 year

Progression-free survival is measured from the first day of induction chemotherapy to the date of progression, relapse or death. Definitions of response criteria are as described by Cheson. Progressive Disease: \>50% increase from nadir in the sum of the products of the greatest diameters (SPD) of any previously identified abnormal node for PDs or nonresponders, appearance of any new lesion during or at the end of therapy.

Group	Value	95% CI
Experimental: Induction + Consolidation + Bexxar	0.74	0.635 – 0.91

Disease-free Survival Secondary · 10 years

Disease-free survival is measured from the date of CR or CRu to date of relapse or death

Group	Value	95% CI
Experimental: Induction + Consolidation + Bexxar	54.10	2 – 116

Overall Survival Secondary · 10 years

Overall Survival is measured from the first day of chemotherapy until death from any cause.

Group	Value	95% CI
Experimental: Induction + Consolidation + Bexxar	82

Overall Response Secondary · up to 1 year

Percent of subjects who achieved a complete response (CR) or partial response (PR) any time during the treatment period. CR = complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR = 1. \>/= 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. 2. No increase should be observed in the size of other nodes, liver, or spleen. 3. Splenic and hepatic nodules must regress by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. 4. Exce

Group	Value	95% CI
Experimental: Induction + Consolidation + Bexxar	92

Secondary Malignancies Secondary · 10 years

The number of patients who develop secondary malignancies including solid tumors, acute leukemia and myelodysplasia or other bone marrow failure syndromes.

Myelodysplastic Syndrome (MDS)

Group	Value	95% CI
Experimental: Induction + Consolidation + Bexxar	3

Acute Myeloid Leukemia (AML)

Group	Value	95% CI
Experimental: Induction + Consolidation + Bexxar	1

Pancreatic Cancer

Group	Value	95% CI
Experimental: Induction + Consolidation + Bexxar	1

Hodgkins Lymphoma

Group	Value	95% CI
Experimental: Induction + Consolidation + Bexxar	1

Melanoma

Group	Value	95% CI
Experimental: Induction + Consolidation + Bexxar	1

Renal Cell Carcinoma

Group	Value	95% CI
Experimental: Induction + Consolidation + Bexxar	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years from the start of treatment with the following exception: data on malignancies/bone marrow failures will be collected for 10 years.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental: Induction + Consolidation + Bexxar

Serious: 28/39 (72%)

Deaths: —

Serious adverse events (22 terms)

Reaction	System	Experimental: Induction + …
Malignancy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils	Infections and infestations	—
Febrile neutropenia (fever of unknown origin without documented infection)	Blood and lymphatic system disorders	—
Infection - Other	Infections and infestations	—
Mucositis / Stomatitis (clinical exam)	Gastrointestinal disorders	—
Hemorrhage, pulmonary / upper respiratory - Nose	Respiratory, thoracic and mediastinal disorders	—
Infection with normal ANC or Grade 1 or 2 neutrophils	Infections and infestations	—
Colitis, infectious (e.g., Clostridium difficile)	Infections and infestations	—
Pain - Abdomen NOS	Gastrointestinal disorders	—
Supraventricular and nodal arrhythmia - Atrial fibrillation	Cardiac disorders	—
Speech impairment (e.g., dysphasia or aphasia)	Nervous system disorders	—
Thrombosis / thrombus / embolism	Vascular disorders	—
Ataxia (incoordination)	Nervous system disorders	—
Thrombosis / embolism (vascular access-related)	Surgical and medical procedures	—
Gastrointestinal - Other	Gastrointestinal disorders	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—
Hypotension	Vascular disorders	—
Dermatology / Skin - Other	Skin and subcutaneous tissue disorders	—
Leukocytes (total WBC)	Investigations	—
Cardiac Arrhythmia - Other	Cardiac disorders	—
Ascites (non-malignant)	Gastrointestinal disorders	—
Infection with unknown ANC - Lung (pneumonia)	Infections and infestations	—

Other adverse events (100 terms — click to expand)

Reaction	System	Experimental: Induction + …
Hemoglobin	Blood and lymphatic system disorders	—
Platelets	Investigations	—
Leukocytes (total WBC)	Investigations	—
Fatigue (asthenia, lethargy, malaise)	General disorders	—
Nausea	Gastrointestinal disorders	—
AST, SGOT (serum glutamic oxaloacetic transaminase)	Investigations	—
Mucositis / Stomatitis (clinical exam)	Gastrointestinal disorders	—
Diarrhea	Gastrointestinal disorders	—
ALT, SGPT (serum glutamic pyruvic transaminase)	Investigations	—
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils	Infections and infestations	—
Hair Loss / Alopecia (scalp or body)	Skin and subcutaneous tissue disorders	—
Vomiting	Gastrointestinal disorders	—
Neutrophils / granulocytes (ANC / AGC)	Investigations	—
Alkaline phosphatase	Investigations	—
Febrile neutropenia (fever of unknown origin without documented infection)	Blood and lymphatic system disorders	—
Rash / desquamation	Skin and subcutaneous tissue disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Anorexia	Metabolism and nutrition disorders	—
Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	—
Pain - Other	General disorders	—
Pulmonary / Upper Respiratory - Other	Respiratory, thoracic and mediastinal disorders	—
Insomnia	Psychiatric disorders	—
Constipation	Gastrointestinal disorders	—
Nail Changes	Skin and subcutaneous tissue disorders	—
Urinary frequency / urgency	Renal and urinary disorders	—
Edema: limb	General disorders	—
Albumin, serum-low (hypoalbuminemia)	Metabolism and nutrition disorders	—
Muscle weakness, generalized or specific area (not due to neuropathy)	Musculoskeletal and connective tissue disorders	—
Dizziness	Nervous system disorders	—
Calcium, serum-low (hypocalcemia)	Metabolism and nutrition disorders	—
Dry Skin	Skin and subcutaneous tissue disorders	—
Neuropathy: sensory	Nervous system disorders	—
Sweating (diaphoresis)	Skin and subcutaneous tissue disorders	—
Dermatology / Skin - Other	Skin and subcutaneous tissue disorders	—
Heartburn / dyspepsia	Gastrointestinal disorders	—
Rigors / chills	General disorders	—
Infection - Other	Infections and infestations	—
Hypotension	Vascular disorders	—
Creatinine	Investigations	—
Joint-function	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Malignancy, Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils, Febrile neutropenia (fever of unknown origin without documented infection), Infection - Other, Mucositis / Stomatitis (clinical exam), Hemorrhage, pulmonary / upper respiratory - Nose, Infection with normal ANC or Grade 1 or 2 neutrophils, Colitis, infectious (e.g., Clostridium difficile).

Data from ClinicalTrials.gov NCT00577629 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether using high-dose chemotherapy, monoclonal antibodies, and targeted radioimmunotherapy will slow the progression of disease in patients with high-risk Non-Hodgkin's Lymphoma (NHL).

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:

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Currently open trials in the same condition.

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Other Duke University 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 NCT00577629 (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 Duke University
Last refreshed: 30 May 2017

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/NCT00577629.

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