NCT02652468 is a NA clinical trial of Fludarabine Phosphate in Lymphoma, sponsored by University of Wisconsin, Madison.

Who is sponsoring NCT02652468?

NCT02652468 is sponsored by University of Wisconsin, Madison.

What drugs are being tested in NCT02652468?

Interventions in NCT02652468: Fludarabine Phosphate, Mesna, Cyclophosphamide, Total nodal irradiation, T Cell-Depleted Hematopoietic Stem Cell Transplantation, Allogeneic Hematopoietic Stem Cell Transplantation, Peripheral Blood Stem Cell Transplantation, Mycophenolate Mofetil, Tacrolimus, Rituximab.

Is NCT02652468 still recruiting?

NCT02652468 is currently completed. Last updated 5 January 2022.

Are results published for NCT02652468?

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

Last reviewed 2022-01-05 · How we verify

NCT02652468

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

TCR-α/β and CD19 Depleted Stem Cell Grafts From Haplo Donors for HSCT in Relapsed Lymphoma

Completed NA Results posted Last updated 5 January 2022

What this trial tests

NA trial testing Fludarabine Phosphate in Lymphoma in 11 participants. Completed in 17 September 2021.

Timeline

10 March 2016

Primary endpoint
1 September 2018

17 September 2021

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	10 March 2016
Primary completion	1 September 2018
Estimated completion	17 September 2021
Sites	1 location across United States

Drugs / interventions tested

Fludarabine Phosphate (FLUDARABINE PHOSPHATE) — full drug profile →
Mesna
Cyclophosphamide (cyclophosphamide) — full drug profile →
Total nodal irradiation
T Cell-Depleted Hematopoietic Stem Cell Transplantation — full drug profile →
Allogeneic Hematopoietic Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation
Mycophenolate Mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
Tacrolimus
Rituximab

Conditions studied

Lymphoma — all drugs for Lymphoma →

Sponsor

University of Wisconsin, Madison

Who can join

Adults 18 to 75, 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.

Number of Participants With Absolute Neutrophil Count >= 500/Mcl for 3 Consecutive Measurements on Different Days and Platelet Count > 20,000/mm^3 With no Platelet Transfusions in the Preceding 7 Days Primary · At day 28 after transplantation

To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for stem cell transplant in relapsed lymphoma.

Group	Value	95% CI
Peripheral Blood Stem Cell Transplant	11

Number of Participants With Grade III-IV Acute GVHD as Determined by International Bone Marrow Transplant Registry (IBMTR) Severity Index Criteria Secondary · Day +100

The number of participants with grade III - IV acute Graft versus host disease (GVHD) by Day +100 is reported.

Group	Value	95% CI
Peripheral Blood Stem Cell Transplant	3

Number of Participants With Severe Chronic GVHD Secondary · Day +180

The number of participants with severe chronic GVHD by Day +180 will be reported.

Group	Value	95% CI
Peripheral Blood Stem Cell Transplant	0

Number of Participants With Graft Failure Secondary · Up to 2 years after graft

Graft failure - defined as \< 5% donor chimerism in the CD3 and/or CD33 selected cell populations at any time during the study follow up period once initial engraftment has been achieved.

Group	Value	95% CI
Peripheral Blood Stem Cell Transplant	0

Number of Participants With Treatment-related Mortality Secondary · Up to 2 years after graft

Treatment-related mortality is defined as death from any cause other than disease progression.

Group	Value	95% CI
Peripheral Blood Stem Cell Transplant	4

Progression-free Survival Secondary · Median follow up of 1689 days

Progression-free survival will be analyzed as time before any progression by either Positron Emission Tomography/Computed Tomography (PET/CT) or bone marrow,

Group	Value	95% CI
Peripheral Blood Stem Cell Transplant	352	27 – 1875

Overall Survival (OS) Secondary · Median follow up of 1689 days

Group	Value	95% CI
Peripheral Blood Stem Cell Transplant	352	27 – 1875

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 5.5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Peripheral Blood Stem Cell Transplant

Serious: 10/11 (91%)

Deaths: 6/11

Serious adverse events (28 terms)

Reaction	System	Peripheral Blood Stem Cell…
Infections and infestations - Other, specify	Infections and infestations	—
Pericardial effusion	Cardiac disorders	—
Acute kidney injury	Renal and urinary disorders	—
Heart Failure	Cardiac disorders	—
Lung Infection	Infections and infestations	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—
Cardiac Arrest	Cardiac disorders	—
Sepsis	Infections and infestations	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—
Right ventricular dysfunction	Cardiac disorders	—
Platelet count decreased	Investigations	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Atrial Fibrillation	Cardiac disorders	—
Atrial Flutter	Cardiac disorders	—
Diarrhea	Gastrointestinal disorders	—
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Thromboembolitic Event	Respiratory, thoracic and mediastinal disorders	—
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	—
Hematoma	Vascular disorders	—
Hypotension	Vascular disorders	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—
Anorexia	Metabolism and nutrition disorders	—
Blood Bilirubin Increased	Investigations	—
Nausea	Gastrointestinal disorders	—

Other adverse events (167 terms — click to expand)

Reaction	System	Peripheral Blood Stem Cell…
Anemia	Blood and lymphatic system disorders	—
Diarrhea	Gastrointestinal disorders	—
Fever	General disorders	—
Hypoalbuminemia	Metabolism and nutrition disorders	—
Lymphocyte count decreased	Investigations	—
Nausea	Gastrointestinal disorders	—
Neutrophil count decreased	Investigations	—
Platelet count decreased	Investigations	—
White blood cell decreased	Investigations	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—
Fatigue	General disorders	—
Headache	Nervous system disorders	—
Hypokalemia	Metabolism and nutrition disorders	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—
Aspartate aminotransferase increased	Investigations	—
Creatinine increased	Investigations	—
Edema limbs	General disorders	—
Vomiting	Gastrointestinal disorders	—
Chills	General disorders	—
Hyponatremia	Metabolism and nutrition disorders	—
Pain	General disorders	—
Alanine aminotransferase increased	Investigations	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Dizziness	Nervous system disorders	—
Hypomagnesemia	Metabolism and nutrition disorders	—
Hypotension	Vascular disorders	—
Sore throat	Respiratory, thoracic and mediastinal disorders	—
Abdominal pain	Gastrointestinal disorders	—
Constipation	Gastrointestinal disorders	—
Dry mouth	Gastrointestinal disorders	—
Hypermagnesemia	Metabolism and nutrition disorders	—
Hypocalcemia	Metabolism and nutrition disorders	—
Infections and infestations - Other, specify	Infections and infestations	—
Insomnia	Psychiatric disorders	—
Alkaline phosphatase increased	Investigations	—
Anxiety	Psychiatric disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—
Immune system disorders - Other, specify	Immune system disorders	—
Malaise	General disorders	—

Most-reported serious reactions: Infections and infestations - Other, specify, Pericardial effusion, Acute kidney injury, Heart Failure, Lung Infection, Hypoxia, Cardiac Arrest, Sepsis.

Data from ClinicalTrials.gov NCT02652468 adverse events section.

Sponsor's own description

To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell and CD19 cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for peripheral blood stem cell transplant in relapsed lymphoma. Assess incidence of acute Graft Versus Host Disease (GVHD), chronic GVHD, graft failure rate, treatment related mortality rate, progression free survival and overall survival of patients. The stem cell product will be processed using an investigational Miltenyi cell selection device/system that removes the alpha/beta T-cells and CD19+ cells, immune system cells that are more likely to cause GVHD.

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 Fludarabine Phosphate

Trials testing the same drug.

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Other recruiting trials for Lymphoma

Currently open trials in the same condition.

NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT06856226 — Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing · recruiting
NCT07226934 — An AI-Generated, Personalized Question Prompt List Intervention for Patients With Hematologic Cancers · NA · recruiting
NCT07138547 — GSL Synthetase Inhibitor Eliglustat Combined With CD30 Target Immunotherapy for the Treatment of of CD30+ Lymphoma · Phase 1, PHASE2 · recruiting

Other University of Wisconsin, Madison trials

Trials by the same sponsor.

NCT07440004 — Testing a Digital Mindfulness Program to Support People Experiencing Suicidal Thoughts · Phase 1 · recruiting
NCT07278466 — The COMParing App Support Strategies Study · NA · recruiting
NCT07475104 — Redesigning Surgical Care for Patients in Wisconsin · NA · enrolling by invitation
NCT07470723 — The ORIGIN-FH Study · NA · recruiting
NCT06975657 — Well-being Skills for Reentry · NA · recruiting

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 NCT02652468 (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 Wisconsin, Madison
Last refreshed: 5 January 2022

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/NCT02652468.

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